Data Gaps Exist for Transgender Patients Living with HIV, Despite Need

The current unequal representation and inadequate amounts of data on transgender people in terms of HIV poorly represents this subpopulation group in the LGBTQ+ community in the US. Diana Tordoff writes about this issue in an article published in STAT, where she writes that the scarce amount of data concerning trans people affects how policy is shaped in the country.

Per a study published by the National Institute of Health, several barriers hindering participation from trans people were things like logistical concerns, mistrust, lack of awareness, and psychosocial/emotional concerns related to being “outed”. This separate study provides probable insight on why there may be less amounts of data on transgender people in terms of HIV.

The Centers for Disease Control (CDC) recently published data about HIV prevalence among trans people based on public health surveillance data, however gender identity data is not collected consistently across local jurisdictions. As a result, mathematical models can’t be built effectively to help policymakers if there are poor amounts of data regarding trans people and their experience with HIV.

Tordoff writes that there are likely hundreds of mathematical models focused on HIV. Only seven of these models include trans people at all. There are two key problems that Tordoff and her co-authors note in models that do include trans people. The first problem is that there are models only including trans women and not trans men or nonbinary people. Tordoff notes that there seems to be regurgitated information across such models and this first problem may be a reason why.

In a separate study published by the National Institute of Health, researchers state that by acknowledging less visible identities, transgender individuals may be better represented by research studies. The study also refers to recent research highlighting the experience that transgender people have had in completing questionnaires for research studies. Questionnaires will often only include the choices “male” or “female”, and even if there are options like “transgender male” or “transgender female”, researchers are at risk of ignoring nonbinary identities.

The second problem is that such models assume trans women exclusively partnering with cisgender men, however there are other choices that trans women make when choosing who to partner with.

There’s evidence that access to gender-affirming care (e.g., hormones) can increase adherence to other types of disease prevention among trans people (PrEP and getting STI-tested). In general, researchers and advocates have long called for the inclusion of SOGIE data (sexual orientation, gender identity expression) to get a better understanding of these sidelined populations.

Tordoff notes a separate study where Minalga looked at 41 milestone HIV trials between 1991-2023 and this study found that out of more than 170,000 total participants, less than 1% were identified as part of the trans community and 94% of those were trans women.

Minalga notes that when data from such studies gets analyzed and published, that data does not make it back to trans people.

The analysis notes that lack of data on trans people is harmful to trans people and policies, but it is also harmful to other areas of health that aren’t publicly tied to LGBTQ+ populations. An example of this is clinicians not having enough data on how interventions or treatment may work for trans patients. A lack of this data often leads clinicians to extrapolate data from cisgender people despite some physicians not being comfortable with that.

The Centers for Medicare and Medicaid Services (CMS) introduced optional questions on SOGIE data for state Medicaid programs to collect from applicants. CMS recommended collecting information on sex assigned at birth, gender identity and sexual orientation.

Although this data would not be nationally representative, self-reported SOGIE data has never been collected on such a large scale according to Nathaniel Tran at the University of Illinois at Chicago School of Public Health in JAMA. This is good because only a few states collect this type of data.

Legislation continues to restrict gender-affirming care across the country, preventing the collection of additional meaningful data on queer populations.

Queer people living in states that restrict access to gender-affirming care don’t trust the state to protect their personal data. On the other hand, most clinicians simply don’t know much about LGBTQ+ populations in the first place. Trans people are often frustrated by the way they are considered in the research they participate in. Despite the need, data gaps will continue to hamper policy changes designed to improve access to care and services for this already underserved population.

HCV Prevalence Burden Higher Among HIV-Positive MSM

In a study published in the Oxford Academic, researchers established the New York Acute C Surveillance Network to study potential risk behaviors leading to primary Hepatitis C Virus (HCV) infection and reinfection among men who have sex with men (MSM) with HIV. The study was performed over the span of two decades from 2000-2018 to determine both incidence factors and risk factors for HCV reinfection among MSM with HIV in New York City. 

The World Health Organization published a systematic review outlining that there is an elevated HCV prevalence among HIV-positive MSM and that this burden is higher among this community compared to the general population. The study found that primary HCV infection rates among MSM with HIV were lower than among individuals who inject drugs but that reinfection rates are higher for MSM and higher compared to individuals who inject drugs. Researchers define HCV clearance as an undetectable HCV viral load at or greater than 12 weeks after the end of treatment.

The study asked participants about behavioral risk factors for primary HCV infection. First, the study asked about receipt of semen ejaculated into the rectum with condomless receptive anal intercourse (CRAI). Second, the study asked about methamphetamine use during sex and if the route of use was by injection.

Besides risk factors for primary infection, the study also assessed MSM with HIV for reinfection beginning on January 1, 2000. Researchers defined HCV reinfection as the detection of new HCV viremia after clearance of a previous infection. The date of onset of reinfection was recorded in two ways–either by detection of new HCV viremia or of alanine aminotransferase (ALT) elevation. A study published by the National Library of Medicine (NLM) defines ALT as a surrogate marker and predictor of liver disease and liver-related mortality.

Data collected and considered as risk factors for reinfection were:

• Date of birth 

• Race

• Ethnicity 

• Health insurance type (public or private)

• HCV genotype

• Interferon (IFN) λ3

• Haplotype 

• Calendar year of clearance of primary HCV

• Mode of clearance of primary HCV 

• Timing of HCV clearance 

• CD4 cell count 

• HIV VL suppression: defines as <50 copies/mL 

The study determined the incidence rates of first reinfection, second reinfection and overall reinfection. 

Researchers observed 304 MSM with HIV with clearance of a primary HCV infection for reinfection. At the time of clearance, the median age of participants was recorded to be 45 years of age. About 18% were black and 21% were hispanic. Public health coverage funded for 160 participants and private health coverage funded for 140 participants. 

About 10% of participants were spontaneously cleared for HCV and 90% were cleared by treatment either with an IFN-based regimen or a direct-acting antiviral (DAA) regimen. The study recorded that 37% of participants were cleared with an IFN-based regimen and 61% were cleared with a DAA regimen.

Researchers found that for recurrent events with reinfection as an outcome, receiving semen in the rectum was associated with HCV reinfection but that sexualized methamphetamine use was not associated with reinfection. Reinfection therefore was associated with sexual behaviors but not with drug use behaviors. 

The study further discussed that MSM that participated in sexualized methamphetamine use belonged to sexual networks that had a high HCV prevalence enough to result in onward HCV transmission. On the other hand, those not participating in sexualized methamphetamine use were part of sexual networks in which HCV prevalence was low enough to result in fewer transmissions of HCV. Researchers noted that semen transmits most HCV infections among MSM with HIV and that those who participate in sexualized methamphetamine use are more likely to receive HCV-containing semen in their rectums.

The study notes additional issues that likely result in an increased transmission of HCV among MSM with HIV. 

First, delays in insurance companies prescribing DAA treatments are likely a factor in the increased transmission of HCV. Second, MSM have not accepted condom use as a means to prevent HCV infection. Third, DAA treatments can’t help individuals who do not attend care. Individuals who have untreated HCV are less likely to engage in HIV care, further perpetuating these high-prevalence sexual networks. 

With the findings that researchers gathered, they note that there is a need for novel interventions to prevent sexual transmission of HCV among MSM.

Breakthroughs in HIV Research from CROI 2024

This month, the global health community convened at the Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, spotlighting groundbreaking advancements in HIV research and treatment. This year's conference highlighted significant progress in long-acting HIV therapies and innovative strategies for pediatric HIV care, pointing towards a future where HIV management is more effective and less burdensome.

Key discussions focused on the success of long-acting treatments like Cabenuva (cabotegravir and rilpivirine), which have demonstrated remarkable efficacy in clinical trials, offering new hope for those challenged by daily medication regimens. These developments promise to enhance adherence and improve the quality of life for millions living with HIV.

Advancements in HIV prevention were also notable, with the introduction of once-weekly oral treatments and the confirmation of safety for HIV prevention methods during pregnancy. These innovations expand the tools available to combat HIV transmission and emphasize the need for accessible and inclusive prevention strategies.

Additionally, the conference highlighted the importance of addressing co-occurring conditions such as liver disease and cardiovascular risks in people living with HIV. The exploration of pediatric HIV treatment also showed promising paths towards ART-free remission in children, potentially leading to a cure for young patients.

The role of community-engaged research was underscored, ensuring that the developments reflect the needs and voices of those most affected by HIV. The insights from CROI 2024 mark a path forward in the HIV fight, characterized by innovation, collaboration, and a commitment to enhancing the lives of those impacted by the virus.

Advancements in Long-Acting HIV Treatments

The landscape of HIV treatment and prevention is undergoing a significant transformation, heralded by the advent of long-acting therapies. These innovations promise a new era of convenience and efficacy, potentially changing the lives of millions of people living with HIV (PLWH) worldwide.

At the forefront of this shift are long-acting injectable treatments, such as Cabenuva (cabotegravir and rilpivirine), which have demonstrated remarkable success in clinical trials. A new study reveals that "These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking." This statement underscores the potential of long-acting injectables to revolutionize HIV treatment by alleviating the daily burden of pill-taking, with more than 90% of participants receiving their injections on time.

The development of ultra-long-acting formulations, such as the cabotegravir injection for HIV prevention, represents another leap forward. With a predicted half-life significantly longer than existing formulations, these treatments offer the promise of even greater adherence and convenience, potentially reducing the frequency of dosing to just 3 times a year.

Moreover, the integration of broadly neutralizing antibodies (bnAbs) with long-acting antiretrovirals is opening new avenues for more durable treatment options. As Liz Highleyman summarizes, "Broadly neutralizing antibodies appear to work well with lenacapavir or cabotegravir in long-acting regimens for HIV treatment, but studies are still in early stages." This collaboration between bnAbs and long-acting antiretrovirals has shown promising results, with studies reporting up to 95% of participants maintaining viral suppression.

Apart from injectable treatment options, the introduction of a once-weekly oral HIV treatment presents another long-acting option for patients who prefer treatment without needles. The convenience of a once-weekly regimen cannot be overstated, with one researcher emphasizing the importance of such developments: "Developing once-weekly treatment options could help meet the needs of each person, aiming toward maximizing long-term outcomes for people with HIV." This approach has demonstrated remarkable efficacy, with over 90% of participants maintaining viral suppression, showcasing the potential of once-weekly treatments to significantly enhance adherence and, consequently, the effectiveness of HIV treatment.

Breakthroughs in HIV Prevention

In addition to advancements in treatment regimens, significant progress has been made in ensuring the safety of HIV prevention methods during pregnancy. The use of the vaginal ring and oral PrEP has been thoroughly evaluated, with findings affirming their safety for pregnant women—a critical consideration given the increased vulnerability to HIV infection during pregnancy. Remarkably, "95% of deliveries were at term and 4% were preterm, with no study participants acquiring HIV," highlighting the effectiveness and safety of these prevention tools in protecting both mothers and their unborn children from HIV.

Furthermore, the Together Take Me Home project has made significant strides in expanding access to HIV prevention through the distribution of HIV self-test kits. In just nine months, the project saw over 181,558 orders placed, with 337,812 tests distributed, many to people who had never tested for HIV or had not tested in over a year. Sixty percent of all orders contained enough information to describe participants, with 61% from men reporting male partners in the past 12 months, 10.7% from gender-diverse persons, and 10% from Black women. This initiative underscores the importance of meeting people where they are, providing accessible and confidential testing options. As Dr. Neblett Fanfair noted, "This shows how impactful this is to meet people where they are with what they need to be met with. We’re really excited that it’s not just about HIV self-tests, but it also opens the door to STI testing and PrEP as well," highlighting the project's role in broadening the reach of HIV prevention efforts.

Addressing Co-Occurring Conditions

The intersection of HIV with other health conditions underscores the complexity of care required for people living with HIV. Recent research has brought to light significant advancements in addressing co-occurring conditions, such as liver disease and cardiovascular risks.

A groundbreaking study on the use of semaglutide has shown promising results in reducing the severity of metabolic dysfunction-associated steatotic liver disease (MASLD) in people living with HIV. MASLD, characterized by excessive fat accumulation in the liver, poses a significant risk of progressing to more severe liver diseases. The introduction of semaglutide, a medication initially used for diabetes and weight management, into the treatment regimen for PLWH has marked a notable advancement, with participants experiencing "an average 31% reduction in liver fat." This significant decrease highlights semaglutide's potential as a therapeutic agent in managing liver health in people living with HIV.

Furthermore, the issue of cardiovascular health in PLWH has been brought to the forefront by recent findings indicating that current tools may significantly underestimate the risk of cardiovascular events in this population. Notably, "Cardiovascular event rates were higher overall, with cisgender women experiencing about two and a half times more events than predicted." This discrepancy underscores the need for more accurate assessment tools and tailored prevention strategies to mitigate the elevated risk of cardiovascular diseases among people living with HIV.

Additionally, research into prostate cancer screening among men with HIV has revealed a concerning "screening gap." According to a study, men with HIV were significantly less likely to receive PSA screening prior to diagnosis, leading to a higher incidence of advanced prostate cancer at the time of diagnosis. This gap in screening and early detection highlights the need for increased awareness and proactive screening measures for men living with HIV, to ensure timely diagnosis and treatment of prostate cancer.

Innovations in Pediatric HIV Treatment

Pediatric HIV treatment is witnessing remarkable innovations, particularly in the areas of early treatment and the exploration of long-acting therapies. These advancements are not only enhancing the quality of life for children living with HIV but also paving the way toward potential remission and a future where daily medication may not be necessary.

In a new study highlighted in POZ and further discussed on HIV.gov has brought to light the significant potential of initiating ART within the first days of life. This approach has led to ART-free remission in some cases, with "four of the six children achieving ART-free remission." Such findings are groundbreaking, as they suggest that early intervention can drastically alter the course of HIV in children, offering a glimpse into the possibility of a cure or long-term remission. The impact of these results cannot be overstated, as they represent a monumental step forward in the quest to end HIV as a lifelong condition.

Further extending the scope of pediatric HIV treatment, recent research has also explored the benefits of long-acting HIV treatments for adolescents. Long-acting, injectable antiretroviral therapy has been found safe and effective in adolescents with HIV viral suppression. This study marks the first instance where adolescents with HIV have an alternative to daily pills for treatment, showcasing very encouraging outcomes. All participants in the study remained virally suppressed, and none experienced serious adverse events related to the drug regimen. This advancement is particularly significant as it addresses one of the major challenges in adolescent HIV care—adherence to daily medication. By providing a less frequent dosing schedule, long-acting treatments can significantly ease the treatment burden on young patients and their families.

Community-Engaged Research and Future Directions

These groundbreaking advancements in HIV research and treatment are increasingly being achieved thanks to community-engaged research. This approach not only enriches the research process but ensures that the outcomes are more aligned with the needs and realities of those most affected by HIV. Dr. LaRon Nelson's insights underscore the critical role of community involvement: "If we don’t have community voices or engaged communities, we aren’t going to be asking the right questions." This perspective highlights the indispensable value of incorporating diverse community experiences and insights into the research process, ensuring that the studies conducted are both relevant and impactful.

A prime example of the success of community-engaged research is the implementation and study of Doxy-PEP (doxycycline post-exposure prophylaxis) for the prevention of sexually transmitted infections (STIs) alongside HIV. Research and real-world application in San Francisco have demonstrated remarkable outcomes, with bacterial STIs decreasing by nearly 60% in less than a year at the San Francisco AIDS Foundation’s (SFAF) clinic. This significant reduction showcases the potential of community-engaged approaches in addressing public health challenges effectively. The collaboration between researchers, healthcare providers, and community members facilitated the rollout of Doxy-PEP, leading to substantial public health benefits.

Furthermore, the ongoing exploration of HIV vaccine research represents another frontier where community engagement is vital. As discussed in HIV.gov’s updates from CROI 2024, the development and testing of HIV vaccines are critical to the future of HIV prevention. Engaging communities in this research not only helps in designing more effective studies but also in building trust and ensuring broader acceptance and uptake of future vaccines.

Conclusion

CROI 2024 showcased significant progress in HIV research, highlighting innovations in long-acting treatments, prevention strategies, and care for co-occurring conditions and pediatric HIV. These advancements signal a shift towards more effective, less burdensome HIV management, tailored to meet diverse needs. They not only aim to improve the lives of millions living with HIV but also to significantly reduce new infections.

These developments are the culmination of years of research, collaboration, and community engagement, emphasizing the crucial role of community-involved research in addressing the real needs and voices of those affected by HIV.

To fully leverage these breakthroughs, continued research investment and stronger community partnerships are vital. We're at the cusp of a new era in HIV care, characterized by innovative treatments and comprehensive prevention efforts, all geared towards improving the lives of those living with or at risk for HIV. While these innovations are welcomed, necessary, and exciting, we must also recognize the policy landscape that affects access to care. In order to End the Epidemic, we must ensure consistent, open, equal access to individualized care and medications.

Upholding Our Ethical, Moral, and Bipartisan Commitment to HIV/AIDS

"Where your treasure is, there your heart will be also."

These words from Jesus found in Matthew 6:21 resonate profoundly as we examine the current legislative actions on HIV/AIDS funding in the U.S. Congress. It is hard to imagine forty years into the epidemic that we’d be witnessing a systemic attack on numerous HIV-related programs, especially ones with proven track records of success. The House L-HHS Appropriations Bill (H.R. 5894), proposing a staggering $767 million in cuts to domestic HIV programs, starkly contradicts the values of compassion and faith professed by certain lawmakers. These cuts, detailed by the AIDS Budget and Appropriations Coalition (ABAC), threaten to dismantle decades of public health progress, disproportionately impacting marginalized communities, minorities, and the LGBTQIA+ community. The appropriations bill is only the tip of the iceberg.

The irony of these legislative actions is both profound and deeply troubling. Lawmakers, often vocal about their 'pro-life' stance, are endorsing policies that will cause significant harm to millions of Americans dependent on HIV services. This bill represents more than just fiscal adjustments; it's a direct attack on the services and supports afforded to people living with HIV (PLWH), reflecting a worldview that stigmatizes and punishes rather than supports and heals. This approach starkly betrays the bipartisan legacy of the HIV/AIDS fight, which brought together the ideological opposites of the late Senators Orrin Hatch (R-UT) and Edward Kennedy (D-MA).

The bill's proposed eliminations include funding for the bipartisan Trump-era Ending the HIV Epidemic Initiative, the Ryan White HIV/AIDS Program, and the Community Health Centers Program. Alarmingly, it suggests completely eliminating Part F of the Ryan White HIV/AIDS Program (RWHAP), which supports critical components like Dental Programs and AIDS Education and Training Centers. Additionally, the bill proposes a 53% cut in the Minority HIV/AIDS Fund and the total elimination of Minority AIDS Initiative funding within the Substance Abuse and Mental Health Services Administration.

But the attack isn’t exclusive to domestic programs combating HIV/AIDS.

The stalemate over the reauthorization of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), as highlighted in a recent POLITICO article, further exemplifies the moral failure of the Freedom Caucus – which is driving most of the vitroil behind these proposed cuts. Disputes over abortion and a blatantly bigoted reluctance to aid Africa have jeopardized the most successful global health initiatives of our time.

“I’m disappointed,” Rep. Michael McCaul (R-Texas) told POLITICO. “Honestly, I was looking forward to marking up a five-year reauthorization, and now I’m in this abortion debate.” Additionally, he said, “a lot of the Freedom Caucus guys would not want to give aid to Africa.”

Jen Laws (he/him/his), President & CEO of the Community Access National Network (CANN), poignantly captures this duplicity in a tweet: “HIV is a bipartisan issue and always has been. May those who wish to insert their culture war politics onto this historical space enjoy their moral rot for as long as the spotlight lasts because the sense of power certainly won't.”

We stand at a critical crossroads, not merely facing a policy challenge but a profound moral crisis. The battle against HIV/AIDS reflects our societal values of empathy, compassion, and collective responsibility. The proposed cuts and the deadlock over PEPFAR reauthorization challenge the very foundations of equity and justice, calling for a decisive response to maintain the fragile progress made in HIV/AIDS care and prevention. These cuts are not distant policy changes; they are immediate threats to lives and well-being, demanding our urgent attention and action.

Critical Juncture

RWHAP and PEPFAR stand at a critical juncture, pivotal to the global and domestic response to HIV/AIDS. The Ryan White Program, a testament to America's commitment to combating HIV/AIDS, is under threat from the proposed House L-HHS Appropriations Bill (H.R. 5894), which includes significant funding cuts. Concurrently, PEPFAR, a global beacon in the fight against HIV/AIDS and the largest commitment by any nation to address a single disease, faces legislative hurdles that could impede its future effectiveness.

The Ryan White Program has been a cornerstone in achieving a 90% viral suppression rate among its clients, as reported by the Health Resources and Services Administration (HRSA). PEPFAR, on the other hand, has been instrumental in saving 25 million lives and supporting over 5 million infants born HIV-free, providing antiretroviral treatment to over 20 million people across 55 countries. This program has played a crucial role in significantly reducing new HIV infections worldwide.

The potential funding cuts under H.R. 5894 pose a severe risk to the Ryan White Program's continued success in the United States, especially in light of the 12% decline in new HIV infections from 2017 to 2021. The reauthorization stalemate of PEPFAR underscores the moral failure of certain lawmakers, who, despite their 'pro-life' claims, are obstructing a program that has been a lifeline for millions globally.

Comprehensive Strategy is Key

The achievements made over the last four decades in the fight against HIV/AIDS underline the necessity of a comprehensive strategy. The increase in PrEP prescriptions in the United States and the high rate of viral suppression achieved through treatment as prevention exemplify the effectiveness of a holistic approach, encompassing treatment, prevention, care, and support services. It is crucial that policymakers and the public recognize the importance of these programs and advocate for their continued support, ensuring the progress in combating HIV/AIDS is not only maintained but also advanced. Time is of the essence to embrace and implement a comprehensive HIV/AIDS strategy that goes beyond mere treatment to encompass prevention, care, and support.

Challenging Extremism and Fostering Advocacy

The battle against H.R. 5894 transcends mere policy disagreements. It represents a stand against a form of political extremism that poses a grave threat to marginalized populations, including people living with HIV/AIDS. These proposed cuts, in stark contrast to the proclaimed pro-life stance of the very lawmakers pushing them, unveil a troubling hypocrisy reminiscent of the words of Jesus in Matthew 23:27-28: "Woe to you, teachers of the law and Pharisees, you hypocrites! You are like whitewashed tombs, which look beautiful on the outside but on the inside are full of the bones of the dead and everything unclean."

Just as Jesus admonished the outwardly righteous but inwardly corrupt, these policies, under the guise of fiscal prudence, risk causing significant harm to the most vulnerable, particularly PLWH, minorities, and the LGBTQIA+ community. The stark contrast between the proclaimed values and the actual legislative actions of these lawmakers echoes the biblical warning against such duplicity. The time to stand against this political extremism is now. We cannot afford to be bystanders as these policies threaten to unravel decades of progress.

A Resounding Call to Action:

This critical juncture calls for a united, nonpartisan response from all who value public health, health equity, and human dignity. Health and human dignity are not political weapons to be wielded in service of talking points when lives hang in the balance. We urge individuals and organizations across the political spectrum to join the Southern AIDS Coalition in their efforts to push back against these cuts by signing their letter. Your voice and actions are crucial in shaping the future of HIV/AIDS policy and ensuring our continued progress towards Ending The Epidemic.

There are easy to use tools to contact your congressional representation in Congress. Not sure of your congressional district or who your member of the U.S. House of Representatives is? This service will assist you by matching your ZIP code to your congressional district, with links to your member's website and contact page. Or complete this online form to find your two U.S. Senators.

Now is the time to reaffirm our bipartisan commitment to fighting HIV/AIDS. This battle is not just about preserving past achievements; it is about resolutely advancing our collective efforts against HIV/AIDS. Your involvement is not just beneficial; it is essential. By standing together, regardless of political affiliation, we can overcome these challenges and continue our journey towards a world free from HIV/AIDS. Act now, for this fight is about life, justice, and human dignity. Your voice and action are indispensable in this crucial hour.

Beyond the Test: Ensuring Linkage to Care After HIV Self-Testing

HIV self-test kits have emerged as a pivotal tool in the fight against HIV/AIDS, offering a private and convenient method to determine one's status. The World Health Organization endorsed these kits in 2016, marking a significant step in global HIV/AIDS prevention. The COVID-19 pandemic further highlighted their importance as traditional testing declined, with the Centers for Disease Control & Prevention (CDC) emphasizing their role in ensuring continued access to HIV testing.

In the U.S., 14% of the estimated 1.1 million people living with HIV are unaware of their status. Men who have sex with men (MSM) have a particularly high prevalence of undiagnosed men with sero-positive status. Yet, a study in JAMA Network found that only 25.7% of MSM in urban areas had used an HIV self-test. This limited adoption and data indicating that many don't pursue necessary treatment or prevention post-testing, highlights the challenges ahead.

HIV Self-Testing: Nuances and Linkage to Care

HIV self-test kits, endorsed for their easy access to HIV testing, come with detailed instructions for self-administration and result interpretation. However, users are strongly advised to verify their results at a healthcare facility, particularly if they end up with a reactive (“positive”) result.

While the potential of HIV self-testing is evident in its ability to increase the number of people aware of their HIV status, the real challenge lies in ensuring that those who test positive are seamlessly linked to appropriate medical care and support. A study in The Lancet highlighted a significant gap in connecting these individuals to post-testing HIV care. This gap is alarming, considering the importance of early intervention in HIV management, which not only benefits a person’s health but also reduces the risk of transmission.

A systematic review by The Conversation further emphasized this challenge:

• There's an 8% increase in users finding an HIV clinic post-testing.

• A significant number of users did not initiate HIV treatment or PrEP after self-testing.

• Women sex workers were 47% more likely to seek medical care post-testing, yet testing rates among clients of sex workers remained unchanged.

• MSM users might engage more in condomless anal sex post self-testing.

One major obstacle in this linkage to care is the lack of localized resources accompanying the test kits. For example, kits from OraSure, a leading manufacturer, provide general post-test advice but often lack specific resources or directions for localized care, leaving people, especially those testing positive, uncertain about their next steps.

To address these challenges, it's crucial to not only link people to care but also ensure they access the necessary treatment and preventive measures. Strategies that have proven effective in bridging care gaps for chronic conditions, like hepatitis B, can be adopted. Leveraging community-based participatory approaches, partnering with community organizations, and implementing robust referral systems can ensure that people receive the essential care and support post-testing.

Benefits, Hurdles, and Real-World Implications of Self-Testing

HIV self-testing offers a private and convenient alternative to traditional methods, addressing barriers such as transportation, stigma, confidentiality concerns, and outdated HIV criminalization laws. A Vital Signs report from 2016 revealed that 38% of new HIV transmissions were from people who were unaware of their status, emphasizing the need for increased testing. The CDC's eSTAMP study found that self-tests doubled the likelihood of MSM identifying new HIV transmissions.

However, challenges persist. Many users, despite recognizing their status, don't or can’t take subsequent necessary steps, such as pursuing HIV treatment or initiating PrEP, as highlighted in The Conversation. Additionally, functional considerations like storage conditions play a role in the effectiveness of self-tests. For instance, the OraQuick test should be stored between 36°F and 80°F, a factor that becomes increasingly relevant in the face of climate change, hot summers, and extended transit times. Similarly, self-testing kits produce physical evidence of screening that needs to be discarded by the person using the test. If that person is in a safe, welcoming situation, storing the test or disposing of the materials from the test might result in risks of experiencing stigma, discrimination, or even harm.

Accuracy in self-testing is paramount. The OraQuick In-Home HIV Test claims over 99% accuracy for negative results and 91.7% for positive ones, though the testing window period can influence accuracy. Users appreciate the autonomy self-testing offers, but it should be part of a broader strategy, complemented by counseling and care linkage and stigma reduction, as emphasized by The Lancet study.

Financial Incentives and Real-Life Implications:

In many studies evaluating the effectiveness and adoption of HIV self-tests, participants were often provided financial incentives to report their test results. This approach ensured a higher rate of result reporting and offered insights into user behavior post-testing. However, in real-life scenarios, such financial incentives are absent. This discrepancy raises concerns about the actual rate of result reporting and subsequent linkage to care when people purchase and use these kits outside of a study environment. Without the motivation of financial incentives, there's a potential risk that some people might not seek further care or counseling after a reactive test, especially if they lack access to localized resources or support systems.

Economic Factors, Barriers, and the Way Forward

Self-testing presents a promising avenue to increase HIV status awareness, but economic and psychological barriers hinder its adoption. The CDC found that 61% of Americans had never been tested for HIV, and less than 30% of those most at risk had been tested in the preceding year.

The CDC's eSTAMP study highlighted the effectiveness of mailing free self-tests, with recipients being more likely to discover their HIV status. Such initiatives are cost-effective, with potential savings of nearly $1.6 million in lifetime HIV treatment costs, as estimated from the eSTAMP trial.

Despite these advantages, challenges like misconceptions about HIV risk, unawareness of self-tests, and cost considerations persist. Additionally, the emotional toll of a reactive result, especially when received alone, is a significant concern. The CDC's efforts to make HIV self-testing more accessible are commendable and addressing these barriers is essential for the initiative's success.

Conclusion

HIV self-testing is a crucial and beneficial tool in our ongoing fight against the HIV/AIDS epidemic. Yet, as with any innovative solution, it's not without its challenges. The true measure of our commitment to Ending the HIV Epidemic lies not just in the tools we develop but in the systems we put in place to ensure their effective use. As we embrace the promise of self-testing, we must also confront the gaps in linkage to care, address the barriers to widespread adoption, and ensure that every person and community, regardless of background, has the support they need post-testing.

We must ask ourselves: Are we doing enough? Are we truly leveraging the potential of these tools to make a lasting impact? The answers to these questions will shape the trajectory of our fight against HIV/AIDS.

Healthcare advancements are made every day, and it's our collective responsibility to ensure these innovations reach and benefit all, especially the most vulnerable among us. As we move forward, let's commit to not only advocating for the tools but also for the comprehensive systems of support that make them truly transformative. Because in the end, it's not just about testing; it's about reducing stigma, saving lives, building healthier communities, and creating a future free from the shadow of HIV/AIDS and that’s worth investing in.

Unveiling Disparities: OIG Report on HIV Care in Medicaid

A recent report by the U.S. Department of Health & Human Services’ (HHS) Office of Inspector General (OIG) unveiled a startling revelation: one in four Medicaid enrollees with HIV may not have received critical services in 2021. At a time when healthcare systems worldwide were grappling with the COVID-19 pandemic, these findings highlight the compounded struggles faced by People Living with HIV (PLWH) in accessing essential care.

Beyond safeguarding the health of PLWH, viral suppression plays a pivotal role in curbing HIV transmission, a critical metric in the public health effort to end HIV. In alignment with HHS guidelines, achieving consistent viral suppression necessitates three foundational elements: routine medical consultations, ongoing viral load assessments, and unwavering commitment to ART regimens.

Unveiling the Care Gaps

The OIG's analysis reveals pressing challenges within our system:

• Out of the 265,493 Medicaid enrollees diagnosed with HIV, a startling 27% were missing evidence of receiving at least one of the pivotal services last year.

• 10% were missing evidence of medical visits, and 11% were missing evidence of an ART prescription, raising concerns around disease progression and higher incidence of AIDS diagnosis, increased risk of transmitting the virus, and developing antiviral resistance.

• The most pronounced gap? Viral load tests. A staggering 23% of enrollees lacked evidence of even a single viral load test in 2021. This absence not only impedes clinicians from making informed decisions but also hampers our collective ability to monitor and respond to the evolving nature of the HIV epidemic.

• Perhaps most concerning is the fact that more than 11,000 of these enrollees didn't have evidence of availing any of the three critical services. This is not just a statistic; it's a reflection of real individuals, facing amplified health risks due to system inadequacies.

Jen Laws, CANN's President and CEO, poignantly remarked, "Medicaid represents the greatest public program coverage of PLWH. It also represents the greatest public program coverage of people at risk of acquiring HIV. Medicaid compliance and efficacy is critical to Ending the HIV Epidemic and this report has identified gaps where states have failed to meet their obligations to Medicaid beneficiaries and where CMS has failed to ensure compliance. We must do better if we are going to reach our public health goals."

The report underscores stark disparities in care access between Medicaid-only and dual-eligible enrollees (those with both Medicaid and Medicare). Specifically, Medicaid-only enrollees were three times more likely to lack evidence of any of the three critical services compared to dual-eligible enrollees, with 6% of Medicaid-only enrollees missing out, as opposed to just 2% of the dual-eligible group. Such disparities might stem from various factors, including Medicare's higher fee-for-service rates and the observed long-standing adherence patterns among older adults who have had HIV for prolonged periods.

State-wide Disparities: A Complex Landscape

The disparities in HIV care access across states offer both a grim reality check and a clarion call for systemic reform. Drawing from the OIG report, certain states, notably Arizona, Arkansas, the District of Columbia, and Utah, have alarmingly high proportions of Medicaid-only enrollees without evidence of at least one of the three critical services. For instance, Utah stands out with a staggering 87% of such enrollees missing out on essential care. These aren't just numbers; they represent real individuals grappling with a system that's failing them.

Conversely, some states demonstrate better compliance and efficacy in delivering HIV care, which suggests potential models or strategies that could be emulated across the board. However, the stark variability across states points to the undeniable influence of state-specific policies, the quality of local HIV care infrastructures, and broader challenges associated with healthcare access.

State agencies clearly have much work ahead. These disparities not only indicate potential inefficiencies or gaps in policy implementation but also suggest a pressing need for introspection and reform at the state level. Coupled with challenges in the broader Medicaid system, there's a compelling case for a comprehensive overhaul.

The onus is on both state agencies and the Centers for Medicare & Medicaid Services (CMS) to rise to the occasion. The disparities, as evidenced in the report, necessitate a deep dive to understand the underlying causes. Is it a matter of policy misalignment, funding constraints, administrative challenges, or a combination thereof?

For instance, the significant variation in care access among dual-eligible enrollees, ranging from 9% to 53% across states, speaks volumes about the discrepancies in policy implementation and oversight. It's vital to pinpoint these issues, develop tailored interventions, and ensure that every Medicaid enrollee, irrespective of their state, receives the essential services they need.

The Pandemic's Shadow

The COVID-19 pandemic exerted immense pressure on healthcare systems, with profound implications for HIV care. The OIG report highlights the challenges faced by Medicaid enrollees with HIV during the COVID-19 pandemic. A significant finding from the report is the notable deficiency in viral load tests among these enrollees. This underscores the need for healthcare systems to effectively manage and prioritize essential services, even amidst broader healthcare crises. The report serves as a reminder of the importance of consistent and uninterrupted care for conditions like HIV, even when healthcare systems face external pressures.

Steering Towards a Brighter Future

Addressing the glaring disparities laid out in the OIG report goes beyond mere policy recalibration; it challenges our collective resolve to uphold equitable healthcare. In the shadow of the pandemic's aftermath, it's imperative that essential services for PLWH are not just nominally available but are genuinely accessible.

The OIG report's findings don't merely spotlight discrepancies; they highlight systemic lapses. States have fallen short in fulfilling their obligations to Medicaid beneficiaries, and the CMS has not adequately ensured compliance.

To translate this call to action into meaningful change, it's essential to:

1. Strengthen state-level accountability frameworks to ensure Medicaid obligations are met comprehensively, particularly among states utilizing Managed Care Organizations – ensuring those contracted for-profit insurance companies are meeting their contractual obligations to states. The tools for accountability already exist within these contracts, they merely must be used.

2. Bolster CMS oversight mechanisms, driving proactive interventions that hold states to account and rectify compliance lapses.

3. Engage in continuous dialogue with stakeholders, including healthcare providers and beneficiaries, to identify and remedy bottlenecks in care access.

The findings from the OIG report serve as a stark reminder of the work ahead. As Jen Laws aptly states, "We must do better." HIV advocates should consider assessing our engagement with their state Medicaid programs and look for opportunities to act, akin to our engagement Ryan White programs. With concerted efforts, policy reforms, and collective commitment, we can bridge the gaps and ensure comprehensive care for all PLWH.

House Appropriations Mark-Up Alarms HIV Advocates

On July 14th, the U.S House of Representatives Committee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) issued its fiscal year (FY) 2024 appropriations mark-up (Editor’s Note: the mark-up hearing can be viewed here). The bill passed out of committee on a party line vote, with Republicans voting in favor and Democrats voting against. The party split reflects what Democrats have framed as bad faith undermining of agreements on spending levels made in May’s debt limit ceiling deal and include policy provisions geared toward stoking a “culture” war. While the leading issue is incredibly steep cuts to public health programs, including entirely eliminating funding for the previous administration’s Ending the HIV Epidemic initiative (which the Biden Administration wished to continue), the policy riders at issue would also undermine best practices for achieving our public health goals by limiting the types of care, education, and support services communities accessing HIV services might be able to access.

Brass tax, Committee proposed:

• Ending the HIV Epidemic eliminated (-$524M)

• Ryan White HIV/AIDS Program reduced (-$74M, eliminates dental coverage and AIDS Education Training Centers [AETCs], as included in Part F)

• Minority AIDS Initiative reduced (-$32M)

• Substance Abuse Mental Services Administration – MAI eliminated (-$117M)

• Flat funding for the Centers for Disease Control and Prevention’s HIV and HCV prevention programs

• Flat funding for other parts of the Ryan White HIV/AIDS Program, particularly for AIDS Drug Assistance Programs (ADAPs)

Non-HIV related cuts seek to further defund public education and the National Institutes of Health and eliminate Title X and Teen Pregnancy Prevention Programs, the federal work-study program, among other things.

HIV advocates across the country decried the bill, including but not limited to The AIDS Institute, HIV + Hepatitis Institute, AIDS United, the National Association of State and Territorial AIDS Directors (NASTAD), and the National Minority AIDS Council. Southern AIDS Coalition (SAC) has organized a letter for individual advocates and organizations to sign-on. The letter is addressed to Senators Tammy Baldwin and Shelly Moore Capito. Astute observers already recognize this appropriation will not survive the Senate as drafted by the House.

Earlier this year, HIV media outlet The Body called these efforts out for what they are and by title “HIV is Being Swept Up in the Anti-Woke Agenda”. Mandisa Moore-ONeal, Executive Director of the Center for HIV Law and Policy (CHLP), drew a direct link between behavior seen earlier this year in Tennessee as a forebearer of federal moves, “Can’t help but think back to all those…who dismissed us when we said to notice these state funding cuts and to start moving against them but told us again and again ‘It’s just the South’.” The Centers for Disease Control & Prevention’s landing page for regional analysis on HIV identifies that 51% of new HIV diagnoses are among Southerners.

Politically, Southern states are often dismissed by politicians (and advocates) not from here because some of the country’s most conservative strategies are developed in the South. However, the racial diversity of the South is also the reason progressive advocates need to focus on the region. That same diversity is precisely why the nation’s civil rights battles started here and why the forefront of combatting the domestic HIV epidemic, be it advocacy, services, or policy, must be focused here.

The Community Access National Network has already joined our colleagues in signing-on and condemning these cuts which, if enacted would not only bring a halt toward our progress in combatting HIV and other public health concerns, but would signal a dramatic step back and make our goals impossible to achieve. The House’s appropriation amounts and the policy riders included are not only mean-spirited, political jockeying of resources the most vulnerable communities in the country rely upon, they are staggeringly dangerous.

Mid-Year Public Health Policy Update

Ya’ll…the last 4 months have been wild.

Let’s start with the “win”, shall we?

Last week, the Supreme Court of the United States (SOCTUS) issued its ruling in Talevski, authored by Justice Jackson and siding 7-2 in favor of patients’ private right of action to initiate lawsuits when their rights issued by law or regulation relative to a federally funded program are violated by an entity paid under that program. Now, the Taleski family still has to go back to district court to fight the Health and Hospital Corporation of Marion County (HHC) – SCOTUS just denied the effort by HHC to claim patients didn’t have a right to seek remedy when the payor was the government. As we described in January, this idea that patients couldn’t initiate lawsuits when federally funded programs weren’t administered fairly or didn’t comport with the statutory language or regulatory definitions is pretty bonkers. Indeed, for most actions regarding any kind of federally funded programming, the government typically comes in after the fact and those injured have to initiate the court processes themselves. Some advocates, particularly disability and Medicaid advocates, called the potential of the court to rule restrictively in Talevski “the Dobbs of Medicaid”, and urged the parties to consider settling ahead of a ruling. However, the potential crisis was averted because, as Justice Jackson put it, “Hewing to [the relevant statute]’s text and history (not to mention our precedent and constitutional role), we reject HHC’s request, and reaffirm that ‘laws’ in [the statute’s text] means what it says.”

Fancy that, laws meaning what they say.

Speaking of laws and problematic folks tryna skirt them, the 5th Circuit Court of Appeals heard oral arguments as to the stay – not the whole merits of the case – of Judge Reed O’Connor’s effort to strip the Affordable Care Act’s (ACA) preventative coverage mandate by way of extraordinary bigotry – targeting HIV prevention medication because “ewww, the gays”. As our friend, Chris Geidner, over at Law Dork covered those arguments and boy howdy! I wouldn’t wanna be Jonathan Mitchell – well for a lot of reasons but this one is pretty good, too. Mitchell’s name should look familiar as he’s arguing for book bans, helped author Texas’ head-hunting abortion law known as SB8, and is, in general, a deeply rotten human being. During thee oral arguments Mitchell fell more than a little flat, in no small part because the Department of Justice’s attorney, Alisa Klein, was gracious in asking “what’s the harm in putting in a stay?” In essence, she argued the physicians that Mitchell represented – who have themselves claimed to have never personally administered to an abortion or anyone needing HIV-related services but might, maybe, one day have to help a patient who experienced adverse events as a result of these extremely safe medications on the off chance they respond poorly to them – don’t actually have a tangible harm in putting off implementing O’Connor’s “universal remedies”, while some 2 million health plans as an industry and millions of patients across the country certainly will experience an impact if the ruling were to go into effect while being appealed. Mitchell kinda fell flat footed and basically asked the court to speculate what would happen if the stay wasn’t implemented. Hint: Courts aren’t actually supposed to pull conclusions out of thin air, “facts” must be presented inside of defined rules. So Mitchell then hedges cuz everybody suddenly seems real skeptical in how this might relate to standing and he asks of he can maybe meet with the DOJ to come up with some settlement agreement between the parties on the stay.

Now for the not so good news and there’s two bits to this one we’re gonna need to watch for quite some time; 1. Medicaid unwinding and 2. public health funding claw backs in the debt ceiling deal.

Last week, CANN hosted it’s third and final Community Roundtable in a series on COVID-19 impacts on public health and all the bad news is related to that intersection.

Because the House and the Senate voted to end the COVID-19 public health emergency a month early, Medicaid’s continuous coverage unwinding began pretty chaotically. To literally no one’s surprise, millions of folks are already losing their Medicaid coverage and not necessarily because they don’t qualify. The administrative or procedural disenrollments happen not because of a person or family no longer being qualified for Medicaid, but because a program administrator has not received necessary document responses. But the thing about that is, not a whole lot of folks who gained coverage for the first time during COVId-19 actually know a whole lot about the process, according to a Kaiser Family Foundation survey. And not every state is making it easy. Indeed, Arkansas and Florida are in a massive rush to get folks off Medicaid rolls – so fast that advocates are begging those states’ governors to slow down the process in order to reduce the risks of losing people to care who might otherwise qualify. Those states’ governors aren’t likely to respond to these pleas, despite guidance from the Centers for Medicare and Medicaid (CMS) to “not rush” the process. Those disproportionately at risk for being thrown off Medicaid are also those who are most at risk for acquiring HIV or already living with HIV and being covered by Medicaid. Again, about 40% of people living with HIV are covered by Medicaid, it stands to reason our patient population is at risk of potentially falling out of care if these processes are rushed.

Back in April, CANN reviewed annual sexually transmitted infection (STI) surveillance data released by the Centers for Disease Control and Prevention (CDC). In doing so, we pointed out the potential hazards of the Biden Administration failing to uphold its promise to reinvest in public health programming, specifically million dedicated to replenishing the workforce via disease intervention specialists (DIS). Those dollars were promised under the American Rescue Plan (ARP) but, as with all federal programs, take time to disburse. In the case of workforce development in state health departments, that means identifying an appropriate vendor to contract with to provide training, then contracting them to develop a curriculum, then giving guidance as to qualifying certification, then disbursing dollars to contract provider entities, then actually hiring people (in which there’s serious churn), training them, and so on. It takes time. But states weren’t quick to use those dollars and many of them remained unspent as the debt ceiling approached. A late-minute deal was struck between the White House and House Republicans in which certain public health funding allocated under the ARP are being clawed back. How this impacts our nation’s ability to provide meaningful public health services and address rising crises like STIs, we’ll find out in the worst possible way. For what it’s worth, our friends over at the National Coalition of STD Directors has called on the Administration to protect the public health workforce in light of the country’s first STI National Strategic Plan and how cutting those dollars risks any tangible ability to respond.

Advocates have tons more to pay attention to as the Biden Administration begins responding to this state legislative session’s “Hate Slate”, targeting LGBTQ people and our care. And because Congress is working to address things like reforming pharmacy benefit managers and 340B.

In all, advocates should work to focus on their strengths, strengthening relationships with service providers and legislators – sharing the human costs of these moves – and taking care themselves. With so much going on all of the time, we have to celebrate our wins while fighting for a fairer system serving patients. In order to do that, we have to also take care of ourselves.

Jen’s Half Cents: Digging Deep on Leadership Equity in HIV

Much focus is given to the “noise” leadership from advocacy organizations have to offer. Public statements are signed by folks with titles like Chief Communications Officer or Executive Director. Media interviews focus on selecting personalities based on their organizational role. This isn’t necessarily a bad thing. It’s a chance to set public narratives and share personal backgrounds in a storytelling fashion…it’s how we humanize what often feels like a faceless discussion. That humanization is critically necessary for effective advocacy. Patients, people living with HIV, are not blots of ink on paper or some series of numbers assigned in a budget. We’re more than the “black and white” of a grant application. We are certainly more than our titles or our jobs. We are whole persons with a plethora of experiences and aspirations and families and communities that depend on us in all variety of ways.

There’s a quality of those ongoing discussions of public health that’s enriched and made more effective, more tangible when those speaking to the issues also live those issues. The discussion itself, at least with regard to HIV, centers on issues of equity across the lives of those most affected – economic equity, health, education, and so on. The quality of that discussion is so sufficiently elevated that we built community principles which are meant to guide our engagement; Meaningful Involvement of People with AIDS (MIPA), the Denver Principles, and so on. Hell, the statutory requirements of the Ryan White CARE Act includes these ideas in requiring recipient jurisdictions to have planning and advisory councils.

So must our organizational leadership reflect these ethical directives in exactly who sits in those seats and their experiences in getting there.

As we begin to see some, though not enough, generational shift in HIV leadership, how we get there is going to matter as to our sustainability.

For those not “in the know”, an unsurprising fact of this generational shift is the “new” leaders talk to one another about how we’re navigating those changes. For me, it was the absence of a mentor in Bill Arnold’s death. For others, it might look like fighting an institution’s inclination to rely upon previous leadership to undermine decisions of the current or incoming leadership, for others still, it might look like founders prioritizing legacy contacts over that of newer blood. We need places to vent but also to share strategic alignment, which might look different than things have in the past.

We are, after all, each other’s peers in every professional respect.

In discussing with a colleague their experiences with how these shifts feel very reminiscent of the very problems we’re being tasked to address by our mere presence, they shared the following, “The intersections of founder’s syndrome and white supremacy are profound and real and exhausting. For all the emphasis we put on new Black queer leadership, let’s also hold the old leaders accountable for not letting go.”

My colleague… my friend asked of anonymity if I were to include this quote anywhere. I’m endlessly grateful I have earned their trust and will work to continue to earn their trust.

And we really do need to do more than sit with this idea if we’re to not beat down the fabulous innovation and talent that awaits us. The time for “sitting” and reflecting on how our leadership might be more reflective of the epidemic, how we might address “subtle” (it’s not subtle, ya’ll) slights and “cultural competency trainings” aren’t going to do it.

HIV diagnoses have not meaningfully declined in the last decade in the United States, except for white, gay, bisexual, and same-gender loving men. Our overall leadership, the slow pace of generational change, and the barriers to meaningful leadership change are all part of the reasons for that.

We will not make meaningful progress by doing the same things, with the same people, over and over and over again. We will not break chains of racism or misogyny or stigma or ableism or any other bigotry by requiring a new generation to perform in the environment in which those…less than palatable ideas flourished to begin with.

HIV not only needs to consider the necessity to expedite leadership changes but how we get there.

How do we ensure we’re not burning out bright stars before they even start? How are we actively planning for success in succession? How is old leadership, including board members, releasing its idea of how thing “should” be, going beyond “allowing” new leadership to guide, and moving forward with enthusiastic support for a different vision of how to get to the same goal?

“How” matters as much as “who” or “when”.

We need to dig deep to ensure the equity we seek in the world around us is also reflected in the leadership guiding us and the experiences of those coming into leadership.

Analysis: Biden’s Budget Request Emphasizes HIV, HCV Goals

On March 9th, President Joe Biden released his proposed budget. As with all Presidents, in all years, and in all sorts of political climates, it outlines what can generously be called a “wish list”. Rarely, even under unified control of the government, does a President’s budget request get a full match. Most often, the budget Congress passes and the budget a President proposes are dramatically different. In 2022 (and in decades past), Biden attributed a quote to his father: “Don’t tell me what you value. Show me your budget – and I’ll show you what you value.” To that end, Biden’s budget proposal has a few notable areas of interest with regard to HIV, hepatitis C, public health in general, and with regard to priorities that might affect various stakeholders along the chain from manufacturing medications to patients.

In a call to advocates, just prior to the full court press release of the President’s budget, White House staff touted a proposed expansion of the Inflation Reduction Act’s (IRA) drug price negotiation provisions to include more medications up for government control of list prices as part of a “savings” counterbalance to expenditures in the proposed budget. It’s important to note no specific medications have yet been proposed under the IRA, any proposed “savings” the government expects to see have not been tested, and, yet again, these potential “savings” are not required to be passed down to patients or even back to the government as a public sponsor of affected plans. Similarly, on the call, officials said the proposed budget would stop “subsidizing” pharmaceutical manufacturers and, immediately thereafter, stated a priority in the budget would be to incentivize innovation as part of the administration’s “Cancer Moonshot”.

There are several HIV-related provisions in the budget request as well. First up, the proposal seeks to expand funding for the Ending the HIV Epidemic initiative started under the previous administration by about $313 million. These dollars would be bolstered by a $90 million increase for HIV prevention activities at the Centers for Disease Control and Prevention (CDC) and a $15 million increase for associated CDC programming around pre-exposure prophylaxis (PrEP) for the prevention of HIV. Notably, these same funds are a portion of dollars Tennessee will be rejecting later this year. Right along with these increases, Biden’s budget seeks to increase Ryan White HIV/AIDS Program funding by $125 million in order to better ensure those already living with HIV have better access to care and treatment.

One of the crowning jewels of the request includes funding for a national PrEP program to the tune of $9.7 billion over 10 years. That particular request may get passed and have some funding, but it is not likely to be funded at this level…or anywhere near sufficiently to meet the need. As it stands, relatively few people who would benefit from PrEP are taking the medication and that number, based on preliminary data for 2022, might be falling again. Largely, PrEP is being used by white men who have sex with men, who are already highly activated, while fewer Black Women and Black men who have sex with men are accessing the medication. A national program may help on this front, but only if it’s handled correctly and carefully. To that end, the CDC has been making a concerted effort to urge primary care providers to adjust their comfort level with prescribing PrEP and having conversations with patients about their sexual activities.

The proposal, however, did not include an increase in funding for Housing Opportunities for People with AIDS (HOPWA), a particular priority of advocates.

Biden’s proposal also includes an increase in funding for the Indian Health Service to better address HIV and Hepatitis C by about $5 million.

In line with these efforts, the Administration unveiled the financial cost of a national Hepatitis Elimination Program (HEP): $11 billion (over 10 years). Now, effort has been in the works for a while, benefitting from a boost of interest from advisor Francis Collins. Biden’s team is already working hard blunt the shock of the request, arguing that making the investment now would, in that same timeframe, actually only amount to about $5.2 billion, thanks to savings realized by a reduction of costs associated with treating long-term impacts of Hepatitis C, including certain cancers. The program would aim to save 100,000 lives by 2050, if goals are achieved.

Of these ideas, HEP likely has the best chance of getting closer to its goal (though, not nearly as close as the Administration or advocates might like), in part, because the idea is largely modeled after cost savings realized in Louisiana and Washington after implementing a “subscription” model of drug purchasing for public programs. While these programs have indeed saved monies for those states, and would do so for the country at large, and increased the number of people accessing curative direct acting agents, they have also stagnated in reaching their goals. That lack of progress after making a giant leap can be attributed to several factors, of which both Ending the HIV Epidemic and a national Hepatitis Elimination Program will face.

Let’s break those factors down real quick by highlighting the Hepatitis C program, which focuses on medication cost and access among at-risk communities near exclusively.

A report from the CDC released last year found just 1 in 3 insured patients who need access to curative treatment for Hepatitis C received it. These are patients whose coverage is already guaranteed. Barriers included payer administrative burdens, including prior authorization requirements, and, likely most importantly, providers just not…providing; not screening, not referring patients for diagnostic testing, not prescribing curative medications for patients (hoping the virus will clear on its own), and not following up to ensure sustained virologic response. And that’s for well connected and engaged patients. Hepatitis C thrives among populations which are routinely hardly reached – people who use drugs, poorer populations, imprisoned people, persons experiencing homelessness, a whole host of folks who need a whole awful lot of help. While the Administration’s proposals would look at encouraging using local pharmacies as points of access and investing in innovative screening tools, like rapid tests, none of those things speak to identifying and treating people most affected by Hepatitis C and HIV. And none of those things would incentivize private providers to increase their frequency of screening for and treating Hepatitis C and HIV.

These lofty goals are admirable. And frankly, they’re achievable. We would also need these tools already mentioned, certainly. But without baseline investments in making HIV and Hepatitis C screening a standard of care, a mandatory inclusion in annual wellness checks, requiring prisons and jails to screen, report to state health departments, and provide curative care on both intake and release, without ensuring clinics are sufficiently funded to have staff to do street outreach, we’re gonna keep missing the mark. Reaching communities that are hardly reached means spending more money per patient in order to reach each patient, not less.

So yes, this is a great start. Yes, these investments need to be made. Yes, this is a great starting point. No, it’s not enough.

Advocates would be well-served to fine tune messaging that thanks allies in power for supporting these tools while also emphasizing that we haven’t yet used all of the tools still in our toolbox. We need to continually re-invest in the foundation of this work while also growing and innovating. Medication is but one tool and without the support for patients to even get to a provider who is willing to screen and treat them, all the medication in the world won’t help.

We need to invest in our own “Yes, and…show me your values…” as we meet with each other, our partners, law makers, policy makers, and the Administration.

Tension in Tennessee: HIV Crisis Looms

Earlier this month, Tennessee announced it would begin refusing federal funding for HIV prevention activities including surveillance activities, which monitor the progress of reducing new HIV transmissions and diagnoses as well as help identify populations and geographies disproportionately affected by HIV. The funding mechanisms targeted by the state for being rejected are known as PS 18-1802 (surveillance and prevention funding) and PS 20-2010 (supporting state health departments in Ending the HIV Epidemic). The U.S. Centers for Disease Control and Prevention (CDC) announcements for recipients of these dollars show Tennessee receives about $6.2 million from PS 18-1802 and just under $2.1 million from PS 20-2010. A letter issued to subrecipients on January 17, 2023 from Dr. Pamela Talley, Medical Director of Tennessee’s HIV, STI, and Viral Hepatitis Programs, the move is supposed to “decrease its [Tennessee’s] reliance on federal funding and assume increased independence,” with an end date for those federal funds to be May 31, 2023. The same letter promises, “Other state initiatives will support all HIV prevention and surveillance staff and activities in funded metro health departments. Our goal is for new service contracts to be in place on” June 1, 2023.

It's not yet entirely clear how Tennessee will make up for the $8.3 million dollars the two funding streams offer but Governor Lee has emphasized a desire to not have “strings attached” that come with federal dollars. It’s also not clear that Tennessee can effectively have those replacement dollars and contracts in place in the less-than-six-months deadline described in the aforementioned letter.

PS 20-2010 specifically funds efforts aimed at addressing needs in Shelby County, where Memphis is situated, as a priority jurisdiction for Ending the HIV Epidemic (EHE), an initiative started under President Trump and continued by President Biden (displaying the long, historical record of bipartisan support regarding HIV). According to AIDSVu, as of 2020, 6,283 people are living with HIV/AIDS (PLWHA) in Shelby County, with 81.7% of those PLWHA whose race is identified are Black. The county’s rate of PLWHA is more than twice that of the state overall (819 vs 314 per 100,000) and the rate of new HIV diagnoses is nearly three times the rate of the rest of the state and the country at large (31 vs 11 per 100,000). The CDC’s dashboard to track EHE progress, known as America’s HIV Epidemic Analysis Dashboard (AHEAD), shows provisional data which indicates a decrease in new diagnoses (this does not mean fewer transmissions), a light increase in linkage to care rates (which could be explained by the decrease in new diagnoses), and a decrease in pre-exposure prophylaxis (PrEP) coverage in years 2020-2022. According to the U.S. Census Bureau, Shelby County’s racial demographics are 54.6% Black and 40.4% white, including Hispanic white persons. Furthermore, the CDC’s 2020 analysis of counties vulnerable to HIV outbreaks included an astounding forty-two counties in Tennessee were among the two hundred twenty top counties at risk, with Hancock County, a rural area which boarders closely to Kentucky, Virginia, and North Carolina, ranks as thirteenth most likely to experience an HIV outbreak. Separately, but certainly related, local news reported a “spike” in new HIV diagnoses in Chattanooga in November 2022.

While the state says it can best manage these dollars, there’s good reason to doubt that and to doubt that this move is not ideologically driven.

For example, the state, through reports to news outlets, has said it will emphasize prevention programming on non-profits to best serve human trafficking victims, first responders, and to prevent perinatal HIV transmission from mothers to children. However, According to Tennessee’s own epidemiological report there were zero perinatal HIV transmissions in 2019. The CDC tracks certain occupational transmissions of HIV and describes the risk associated with certain situations of exposure, which few first responders even experience. To that end, even the CDC admits “occupational HIV transmission is extremely rare” on a page that tracks occupational transmissions among health care personnel, where first responders of ilk are most likely to be at risk. According to the CDC’s page dedicated to occupational transmission, only 58 cases of confirmed occupational transmission have ever been reported in the US, with an additional 150 possible transmissions reported to the agency. Yet and still, since 1999, only one confirmed occupational transmission has occurred among health care personnel. As for human trafficking victims, there’s a bit more opacity there. Likely, those victims are already well-served by those entities already contracted by the current funding mechanisms tied to federal dollars. Limiting or shifting those resources away from well-established service providers risks harming the communities served, reducing access to care, and might run up a pre-existing injunction.

Planned Parenthood just so happens to be one of the contracted service providers for the state and has already run up against the state attempting to strip funding from the entity. In 2012, Judge William Haynes issued an injunction against the state of Tennessee from attempting to stop HIV prevention dollars going to the provider. At the core of the issue, the state through then-Governor Haslam, who committed to defunding Planned Parenthood and public statements to that effect were submitted as evidence of animus against the entity’s First Amendment protected speech and advocacy, sought to refuse grant renewal with Planned Parenthood. Planned Parenthood had responded to a request for proposals (RFP) for these dollars and had previously scored well in the grant application to independent grant reviewers at United Way, the state’s assigned administrative agent for distributing the federal awards. Planned Parenthood also had a successful track record of meeting the grant deliverables associated with the funding, which was mostly centered around condom distribution. Judge Haynes found the state did not have just cause for refusing to continue contracting with Planned Parenthood, given their score, past success with the same funding, and because Planned Parenthood’s “clientele and communities will lose important public health services on matters of grave public health concern.” The injunction still exists today, though it was issued in federal courts, not state courts, because the dollars used are federal dollars.

That said, it’s entirely clear, given the state’s suggestion these dollars will also flow through non-profit providers, if the injunction would not still apply. However, the state has since removed Planned Parenthood from its website listing contracted condom distributors.

Other changes to the state’s website include removing all mention of priority populations identified by the federal government, according to an internet archive, including the MSM (men who have sex with men) taskforce and the transgender taskforce.

The state’s transgender taskforce specifically came to Governor Lee’s attention because of right-wing attacks on Vanderbilt University medical Center’s gender affirming care clinic in later 2022. Vanderbilt receives some state dollars to provide a wide variety of care, not just HIV-related services or gender affirming care for transgender and non-binary people. Conversations with local advocates found a broad understanding the Governor’s commitment to “investigate” Vanderbilt and the entity’s use of state dollars, which would have readily disclosed the CDC’s designated priority populations to include transgender people and which entities are funded by the CDC’s grants.

Tennessee service providers funded by these federal dollars have voiced their concerns repeatedly through media interviews, some specifically pointing towards how this disruption will also be detrimental to the state’s response to the opioid epidemic.

It is currently unclear how much Tennessee’s new health commissioner, former state-Senator from Kentucky Dr. Ralph Alvarado, had a hand to play in these developments. While Alvarado officially began his duties just a couple of weeks ago, he was appointed by Governor Lee in November. Alvarado’s voting record and public statements show animus toward transgender people and abortion access, with him voting to bar transgender girls from playing on sports teams and to increase various abortions restrictions in Kentucky’s 2022 legislative session. When Alvarado was introduced to the Tennessee Senate’s Health and Welfare Committee on Wednesday, January 25, 2023, rather than the typical meet and greet type hearing, Senator Jeff Yarbro, who has a personal connection to HIV, asked Alvarado about the changes and was met with a regurgitation of the state’s letter to health departments. Alvarado is expected to return to the Committee in March, even as time ticks down.

Senator Yarbro and Representative John Clemmons have introduced state legislation which would require Tennessee to pursue and accept federal dollars “to implement programs for the prevention, testing, and treatment of” HIV. These bills largely mirror state statutes which require states pursue all federal dollars made available to state unemployment insurance funds. They make sense on the surface, if federal dollars are available for programming important to the residents of a state, the state should be pursuing those dollars first. The bills, in an already packed legislative session and a hyper-partisan atmosphere, are not likely to pass.

Additionally, Tennessee Representative Steve Cohen (TN9-D) publicized a formal request to Health and Human Services Secretary, Xavier Becerra, about redirecting funding through county health departments to circumvent the state’s moves. The request also copied the CDC’s Director, Dr. Rochelle Walensky.

As of yet, news reports seeking to touch base with the CDC on the status of these changes have found the CDC has not yet been notified of Tennessee’s withdrawal from these funding mechanisms. Without formal notification, those dollars will renew automatically at the end of the grant year.

Part of the struggle in nailing down exactly the extent of the impact refusing these federal dollars will create is the complicated structure behind providing services and funding those employees who provide those services. For many entities funded by multiple streams of federal dollars, employees, measured in grant language as “full-time equivalent” (FTE), may have related duties in which each duty under their job description is funded by separate grants. For example, in a federally qualified health center (FQHC) providing counseling, testing, education, linkage to care, and HIV treatment services, a single employee might be funded by one grant to provide counseling and testing while also being funded by another grant to link patients to care when a test comes back reactive or doing what’s known as partner notification (an activity performed with the participation of a newly diagnosed patient but designed to maintain the patient’s anonymity, if they so desire). Similarly, state disease surveillance infrastructure might employ one or two data analysts to compile data on a number of conditions, each of those conditions funded by separate grants, even though the employee doing the work is the same. So, if said analyst is examining reports on HIV diagnoses one day, another day they might be examining particular sexually transmitted infections – both activities funded by different federal grants. Surveillance activities also include things like monitoring PrEP uptake, a distinctly prevention activity.

Directly speaking to the duties which might be dually funded by multiple grants, the treatment, linkage-to-care, and re-engagement in care activities a FQHC employee might be engaging in will impact people living with HIV, not just those seeking prevention services. This does nothing to speak of health care providers or their support staff who also see their salaries dually funded. So while Tennessee’s refusal of federal prevention dollars does not directly hit funding streams tied to the Ryan White CARE Act grantees, subrecipients, and contracted service providers, PLWHA may well still an impact in the quality of treatment services provided to them due to staffing changes, including those support services which are dually funded for prevention and treatment.

Adding one last layer of complication onto matters, it is also not known how much of Tennessee’s prevention programming generates 340B revenues and savings, which would typically be directed back into prevention programming. Those dollars, if any (there are certainly significant sums involved as each grant requires the recipient, subrecipient, and contractors to propose revenue generating activities and 340B is considered a significant source of those revenue dollars), will be gone from the state’s health ecosystem. With Tennessee also pointing at redirecting dollars from other state initiatives, there’s good reason to believe some, if not all, of those suggested dollars might be from state programs generating 340B revenues. All of that means other programming benefitting from 340B rebates would then see a reduction of programmatic dollars for those programs – whichever they might be. And there’s reason to believe that might be what’s happening, if we look at what New York is proposing in terms of the state usurping 340B revenues to prop up its budget at the expense of grantee service providers who have come to rely upon those monies to meet the needs of patients. Certainly, redirecting 340B revenues to fill budgetary shortfalls from any state away from service providers who are expected to produce accounting as part of their federal grantee status does not serve the intent of the 340B program, “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive care.” In order to stretch federal resources, those federal resources must be there to begin with.

With questions remaining on exactly how Tennessee, which up until now, has not directly funded those programs which have been federally funded, advocates and service providers remain nervous about how this whole thing shakes out. Even if there were private interests ready to “save the day” by providing stop-gap funding, those same private interests cannot fund state surveillance activities. There will be a gap, regardless of efforts to fill the gaps that manifest as a result of these types of reckless moves. And those gaps, created on ideological lines and conspiracy theories, might well be something other states pick up on – a fear many advocates, local and national, have looking forward. What is clear, regardless of why one finds themselves as stakeholders in this space, active efforts to fortify both prevention and treatment funding and services are direly needed.

Without prevention properly funded, fewer people will be testing or linked to PrEP. Without testing and PrEP, fewer people will be linked to care upon diagnosis. Without diagnosis, fewer people will receive the treatment and support services necessary to achieve viral suppression. Without treatment and support services, more diagnoses will occur.

Our ecosystem is fragile and very carefully built. Removing one key component risks destroying all of our progress and returning us to a very localized version of the AIDS crisis.

Navigating Monkeypox: Challenges Patients Face

The Community Access National Network (CANN) has launched an ambitious patient awareness campaign focused on the ongoing Monkeypox (MPV) outbreak. Its ‘MPV Response Project for People Living with HIV’ seeks to gather data and issue reports covering MPV in the United States. The reports will focus on epidemiological trends, vaccine access and equity, state-level access to vaccine and antiviral supplies, HIV and MPV co-infection risk and reporting, and the latest news related to the outbreak. The project is broad in scope, and it will tackle the MPV outbreak in a way that is both data-focused and patient-centric.

One of the first things CANN discovered while seeking this data is that, as is the case with many relatively new outbreaks, what data are available are both disjointed and confusing for any patients and affected communities to try to navigate. While the U.S. Centers for Disease Control & Prevention (CDC) has done an admirable job in creating a data reporting center that is relatively timely in terms of updates and data availability, their data are only as good as the data they receive from states.

This has been a problem across numerous disease states for decades: state epidemiology departments and state and local departments of health across the United States are almost universally chronically underfunded, understaffed, poorly regulated, and frequently disorganized and disconnected from even state-level, much less federal-level, networks and reporting standards.

The issues include:

1.) A lack of federal reporting standards and duplicative reporting across funding opportunities makes gathering, interpreting, and reporting data about disease states, such as MPV, an arduous and frustrating task.

An example, out of 55 reporting jurisdictions in the United States, MPV vaccine administration data presented by the CDC only accounts for 48 of them. The jurisdictions that are not included—Arizona, the District of Columbia, Indiana, Mississippi, Montana, Nebraska, and Puerto Rico—represent some of the poorest, most underserved patient populations in the U.S. Another example is that, of the 527,818 first-dose vaccine administrations reported in the U.S., an astounding 44,192 (8.4%) had no accompanying racial demographic information included.

This issue extends beyond vaccine reporting. Because MPV diagnoses and testing information reporting requirements are not standardized, each state can (and does) provide vastly different reporting based upon local standards. An example of this is that the state of Alabama breaks reporting of race categories into “White,” “Black,” and “Other.” This is despite the fact that 18.7% of Alabama’s population is Hispanic and 6% is Asian. Apparently, other races need not apply? Other states, such as Alaska, report their data directly to the CDC and provide no epidemiological information specific to the state on their state websites.

It can be incredibly frustrating, particularly as community service organizations and healthcare providers seek and use data as a tool for advocacy and patient engagement. It is certainly not a lofty expectation that each state’s governmental agencies be required to comport with some sort of standard. It is not a Herculean task for states to report data in a similar manner and format, but for this to become the standard, those at the federal law and policy needs to define and implement reporting requirements across disease states. As it stands, except in limited circumstances, states are not required to report these data, rather the CDC and other federal entities are left to negotiate data collection and sharing agreements as part of federal funding opportunities.

2.) States are still ill-prepared to deal with disease outbreaks.

One would think that, after nearly three years of dealing with a global pandemic outbreak, state departments of health might have figured out ways to deal with getting out information quickly, effectively, and in an organized manner. One would be wrong.

A big hurdle that CANN encountered while seeking state-level data was that state websites are, by and large, disorganized, confusing messes, even for the most experienced patient. For the average patient, trying to find information about MPV in most states requires several steps through difficult-to-find links to try to get where they need to go. Additionally, these pages are not uniformly located on state websites as opposed to state health department websites, when those websites are different, rather than integrated into the same website.

It is not too much to ask for state websites to have a featured link on the homepage of their websites for disease outbreaks that are of national and state-level importance? Indeed, many states and state health departments are quite familiar with using banner bulletins as seen during the initial crisis phase of the COVID-19 pandemic, as an example.

More galling is the fact that, despite nearly two years of administering mass vaccination drives, several states still don’t have this down to a science. An essential tool, only realized broadly on the federal level and through private partnerships, is a centralized vaccine scheduling system. Again, not to belabor the point, we did this with COVID-19 vaccines. We should be able to provide similar supports and patient access tools across all disease states and especially in infectious disease outbreaks in which a vaccine product is available.

Instead, what we have is a sort of secret club lottery that leaves patients with the onus of calling multiple healthcare providers and health departments just to check to see if the vaccine is available, and to try to schedule an appointment.

3.) Event-based testing and vaccination drives are effective, but underutilized and overly depended upon tools for addressing MPV.

There are two men for whom CANN has the absolute highest respect: Dr. Demetre Daskalakis and Dr. David Holland. Both of these men have taken amazing steps to go out into communities that are at high risk of transmission of diseases like HIV and MPV and deliver care where people are. From drag brunches to bathhouses to leather bars and circuit parties, they have consistently led the charge in a very public way. We have been doing this with HIV testing for decades but delivering point-of-care services at these locations has always been something of a taboo that needs to be overcome for reasons including addressing these outbreaks and overcoming social stigma which harms members of marginalized sexual and gender identity communities beyond these health disparities.

That said, it is a drop in the bucket. An important drop, but a drop, still. These events still run into issues of being accessible to people who work non-traditional hours, in service industries, do not have reliable transportation, or face any host of barriers, including social stigma which may make associating receiving care at these events unsafe or feel less welcoming for people outside of the immediately targeted community. Gay, bisexual, transgender, and other men who have sex with men, the population most affected by the current MPV outbreak, are not uniformly attracted to attending drag brunches or circuit parties but may lead full and active sex lives outside of those spaces. Considering the disparities already manifesting in the current MPV data, those people making up more and more of the share of new MPV diagnoses may well be best approached outside of these types of events. This is not to suggest we should cease having vaccination and testing events in sex positive spaces. This is to say our approach should be an “and” approach.

Beyond just COVID and MPV vaccines, we need to start delivering additional vaccine services in these locations, including influenza, Hepatitis A/B, Shingles, and the like.

4.) This nation needs round-the-clock medical services.

It’s time to leave behind the 8:00 – 4:00 and 9:00 – 5:00 physician and clinic hours of operation. We have known for decades that limited office hours force patients to choose between earning enough money to survive and receiving medical care. While some federally qualified health centers and STI clinics have offered services outside of traditional healthcare hours, many have not, insisting either their communities don’t need these extended hours or stating plainly, the funding does not exist to maintain the necessary staff to operate outside of traditional business hours. Even fewer private providers and health department clinics offer non-traditional hours.

It has never made sense that physicians' offices are only open during working hours…when people are expected to be working. Maybe it has to do with the idea that, at one point in American history, at least one parent was a stay-at-home parent who had the time and wherewithal to take kids and partners to the doctor’s office. Now that virtually every family member is required to work to make ends meet, we need a different solution.

The arguments against it consistently have to do with money—it’s expensive, and you can’t turn a profit. Healthcare provision should never be about making a profit at the expense of helping people. If that means that you find physicians, physician assistants, nurses, and administrative staff to work later shifts, that’s what it means. More likely, however, it means we need to address public and private payer efforts to constantly reduce provider reimbursement, given full credentialling to nurse practitioners in all states, and more readily hire non-clinical support staff from the communities immediately served by these entities.

Beyond the fact that this move would make basic healthcare services, such as testing and vaccination, more easily accessible to people who work during the day, it might also open up additional opportunities for more people to schedule appointments that don’t require sitting in a waiting room for a half-hour beyond their appointment time.

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Editor’s Note: These issues may sound minor—like the sour grapes of an exhausted and annoyed patient advocate—but the truth is that patients get frustrated with the lack of user-friendliness of every aspect of our public health infrastructure.

Patients need to be able to find what they’re looking for without having to jump through seven different hoops to find out where to schedule a vaccine appointment. Patients should be able to find what they’re looking for without having to jump through seven different hoops and spend hours trying to find out where to schedule a vaccine appointment.

We should expect to be able to see if various locations actually have vaccine stock on hand without having to call an office and annoy an administrative employee to find out if they have it in stock and if any appointments are available.

It’s 2022, basic technology has existed since the mid-2000s and these better practices in public health and healthcare engagement have been known since the late 1980’s. It’s time to get it together.

Special Interests Favor S.4395, but Patients Oppose It...Here's Why

This blog post is a collaborative piece, co-written by Brandon M. Macsata, CEO of ADAP Advocacy Association, and Jen Laws, CEO of Community Access National Network.

The very first words of the Ryan White HIV/AIDS Treatment Extension Act of 2009 read, “An Act to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS.” These words reflect the true legislative intent of the Act, which is to provide life-saving care and treatment for people with HIV/AIDS (PLWHA). For over thirty years, these words have represented a contract between our government and PLWHA, reflecting a commitment to patients. The Ryan White HIV/AIDS Program (RWHAP), as the payor of last resort, has literally served as the only lifeline for hundreds of thousands of patients in some of the most marginalized communities. That is why the ADAP Advocacy Association and the Community Access National Network (CANN) have led a national advocacy campaign to thwart any effort to undermine the legislative intent.

A proposed bill, S.4395 (otherwise known as the "Ryan White PrEP Availability Act"), would, for the first time in the 32-year history of this life-saving contract, open the Act to divert programmatic funding from PLWHA to people who are not living with HIV. The legislation is not only ill-conceived, it is potentially very dangerous. The special interests behind this legislation, as well as their inside-the-beltway lobbying tactics, do not reflect the general sense of the much broader HIV patient advocacy community. 

In fact, nearly 100 national, state, and local organizations joined the ADAP Advocacy Association and Community Access National Network in submitting a sign-on letter to Congress expressing the HIV patient advocacy community's collective concerns over the legislation. The sign-on letter was sent to Chair and Ranking Member of the Senate Committee on Health, Education, Labor & Pensions (HELP), Chair and Ranking Member of the House Committee on Energy & Commerce (E&C), and the Co-Chairs of the Congressional HIV/AIDS Caucus. Several of these offices applauded our efforts upon acknowledging receipt of the letter.

David Pable, who has been deeply embedded in South Carolina's patient advocacy community, expressed strong sentiments against the legislation. Pable said, "For almost 20 years, Ryan White has been a lifeline for me, and it was truly the safety net that saved my life. Ryan White-funded medical care, case management, and mental healthcare services have transform my life and the lives of countless others to survive and thrive." Pable's views are shared by nearly all PLWHA who learn about the potential danger lurking behind S.4395.

Over the years, Pable had the opportunity to be involved in many planning meetings for prevention services, including the need for an adequate PrEP program with dedicated funding. According to Pable, never in any of those meetings was it discussed as a good idea to funnel funding from the Ryan White Program to pay for PrEP. "Treatment, care and prevention make up three sides of the triangle," he said. "Together they each hold up the other, but take one piece away to support the other and eventually it will all fall apart." 

S.4395 would authorize the Health Resources & Services Administration (HRSA) to divert already limited resources away from providing care and treatment for PLWHA. The legislation reads, in part, "Any eligible area, State, or public or private nonprofit entity that receives a grant under part A, B, C, or D may use program income received from such a grant to provide to individuals who are at risk of acquiring HIV... drugs and biological products for pre-exposure prophylaxis (PrEP)... medical, laboratory, and counseling services related to such drugs and biological products...and referrals and linkages to appropriate services for the prevention of HIV."

The legislation is extremely ill-advised for numerous reasons. Amending the Ryan White Program (Pub.L. 101-381) would:

• Open-up the law, (which is currently unauthorized) and thus subject it to potentially harmful changes in a hyper-partisan political environment.

• Change the purpose of the law, in that the purpose of the Ryan White Program is serving people living with HIV/AIDS.

• Create yet another access barrier for the approximately 400,000 PLWHA who are not in care.

• Further isolate PLWHA who are already disproportionally impacted by homelessness, hunger, substance use disorder, and undiagnosed and/or untreated mental health conditions.

• Impede Ending the HIV Epidemic's efforts to both increase enrollment and expand services for low-income PLWHA, especially since discretionary funding is already limited.

Unfortunately, special interests continue to push false narratives in their efforts to shove the harmful legislation through the Congress. Probably one of the most egregious claims, “The bill’s intent and text doesn’t take money from people living with HIV.” This is false! 

Indeed, legislative language reads, “To allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV.” While subsection “B” of the legislation entitles the program as “voluntary” and to not allow federal grant dollars for the use of funding PrEP or PrEP services, it would allow federal grant dollars to be used for referrals – explicitly providing funding for people not living with HIV.

Photo Source: oncnursingnews.com

More concerning, special interests supporting the legislation conflate programmatic revenue as not grant dollars, as a somehow meaningful distinction. There is no difference in this distinction because each funded RWHAP recipient and subrecipient is required under current law to use their programmatic revenue to support providing services included in the grant – for people living with HIV. The design of these programs are significantly dependent on revenues generated from the 340B Drug Discount Program (340B) in order to meet the goals outlined in each of the grants. 

And that gets to the heart of the issue here. 340B's intent was “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program, amid much criticism, allows federal grants funding public health programs count on 340B revenues in order to show they can operate a sustainable program.

Let's be clear: S.4395 would divert RWHAP programmatic revenues – including 340B dollars – away from providing services and supports to PLWHA who are living at or below 400% of the federal poverty level (the income threshold for qualifying as eligible for receiving RWHAP funded services). It is important to remember that more than 50% of the patients receiving care from the State AIDS Drug Assistance Program are living at or below 100% of the federal poverty level. More than 250,000 patients, or approximately one quarter of all the estimated people living with HIV in the United States are earning less than $13,000 per year. 

Kathie Hiers, President & CEO of AIDS Alabama argued, "The HIV community needs to get its act together around funding for PrEP.  We have been told by the Director of the Office of National AIDS Policy that our messaging is not cohesive. At AIDS Alabama, we understand that stable PrEP programs are absolutely necessary if we ever hope to end HIV as an epidemic. However, raiding the Ryan White Program to fund prevention is not the answer, particularly as the needs of an aging HIV-positive population continue to grow."

As it stands, gaps in care still remain for too many marginalized communities. It isn't uncommon for patients to fall out of care because they have to prioritize work, or child care, or buying food, or finding affordable housing, or finding transportation. Funding to meet the needs for these patients is already stretched way too thin and the current inflationary pressures have only made things harder for far too many PLWHA. There are tens of thousands of people living with HIV who have no roof over their heads when they try to find a safe spot to sleep tonight.

Photo Source: debralmorrison.com

Robbing Peter to pay Paul is not the solution to funding HIV prevention efforts in the United States. A better option to meet the needs of people who would benefit from PrEP, and that is additional HIV prevention funding. This approach would allow patient choice in medicines and support for ancillary services, provider education and outreach. Additionally, HIV prevention funding could be directed to communities that are most in need of prevention medicines and services, thereby providing more equitable access. This approach would also use and could strengthen the existing HIV prevention infrastructure.

One local health department official (who asked to remain anonymous) in Florida said the people behind the legislation did not understand the nuances between funding for HIV prevention and HIV treatment. We couldn't agree more!

The HIV+Hepatitis Policy Institute's Carl Schmid summarized, "It's not an issue of not wanting clinics that receive Ryan White Program funding to be engaged in PrEP, we think they are the perfect places for PrEP to be delivered. It is an issue of taking funding generated from caring and treating for people living with HIV away from the intended purpose of the Ryan White Program – to provide for people living with HIV. With so many people with HIV living longer, who are not in care or have fallen out of care, you would think that these Ryan White grantees would devote that money to people who are living with HIV, as it was intended."

With more than a decade of science to back the position that effectively treating PLWHA, ensuring viral suppression both empowers positive health outcomes for PLWHA and prevents new transmissions. One of the most startling and, frankly, concerning shifts in the public policy conversation regarding Ending the [domestic] HIV Epidemic is a move away from focusing on the needs of PLWHA in favor of PrEP. The policy issues at hand, including the necessary funding, should not be proposed as an “either/or” situation, but an “and” situation. The same things that make a person vulnerable to contracting HIV are the same things that are killing people already living with HIV. 

While the U.S. Centers for Disease Control and Prevention (CDC) 2020 Surveillance data found 70% of white PLWHA were virally suppressed, only 60% of their Black/African American peers were virally suppressed. Additionally, while the U.S. Department of Housing and Urban Development (HUD) reported a general homelessness rate across the country as about 0.2% of the population, the CDC’s 2019 data found that PLWHA among communities of color were experiencing homelessness at a rate of 11%. It cannot be understated how the power RWHAP dollars hold to address these disparities specifically affecting patients. Failing to do so not only betrays the contract at the center of the legislative intent, it perpetuates injustices levied against our peers, our family, and our community. Raiding precious dollars from this program is nothing short of consenting to the unjust neglect of our communities.

Said Murray Penner, U.S. Executive Director for Prevention Access Campaign: "The Ryan White Program is crucial for people living with HIV, providing treatment and supportive services to keep people healthy and undetectable so they will not sexually transmit HIV. With over 400,000 people living with HIV in the U.S. who are not virally suppressed, there is significant unmet need for additional services. S.4395 would move money out of the Ryan White Program, potentially leaving people without the crucial treatment and services that keep them healthy and prevent new transmissions. Ensuring that the Ryan White Program is fully funded is critical for us to improve the quality of life for people living with HIV and thus improve our country's viral suppression rate and help us end the HIV epidemic."

A cornerstone of the HIV patient advocacy community's success over the last 40 years has been its desire to come together for a common purpose, which has centered around the notion of do no harm! S.4395 and the special interests and inside-the-beltway lobbyists pushing it have failed to meet that test. Raiding Ryan White programmatic funding for PrEP would negatively impact patients. Trying to authorize or amend an already underfunded program, when there is still so much unmet need in its originally intended population, undermines the goals of the program. If we try to be everything to everyone, we will end up failing on all fronts. The powers that be in Congress have assured us that this legislation "ain't going anywhere" this year!

European Commission Approves Once Every 6 Month Supplemental HIV-Treatment

Last week, the European Commission (EC) approved use of Gilead Sciences’ investigational medication, lenacapavir (branded as Sunlenca), for use in treatment for people whose HIV is highly treatment resistant. Lenacapvir has been closely watched by advocates because of great anticipation regarding injectable and otherwise long-acting agents (LAAs) and because of its exceptionally long half-life in the body, providing efficacy for about 6 months from just one subcutaneous injection, providing a potential for the longest acting agent to hit the market thus far.

Lenacapavir also stands out as a first-in-class product because it works in a way that no other antiretroviral medication works. Offering a novel mechanism of action, binding the shell (capsid) surrounding viral genetic material that highjacks our own cells in HIV reproduction, capsid inhibitors will work against HIV in multiple areas of the virus’ life cycle. And because this is a tool we’ve never used before, it’s ideal for meeting the treatment needs of people living with highly resistance HIV – the virus doesn’t recognize the medication and has not yet found a way around it. Because HIV is highly adaptable, that lack of resistance may be short-lived once broad reach of the product is made available but excitement remains for a novel product, especially for people who have developed such resistance that options of effective care have diminished to near zero.

Gilead Sciences is awaiting a decision from the United States’ Food and Drug Administration (FDA) on its recently resubmitted “New Drug Application” (NDA), after the agency declined to accept the NDA due to issues with the glass vials used for the injectable form of the medication. The vial issue has since been fixed and research resumed for use of lenacapavir as a supplement to “background” treatment, first-line treatment, and as pre-exposure prophylaxis (PrEP). At the end of July, the FDA provided Gilead with a December 27, 2022 prescription drug user fee date. This is one of the final steps in an initial new drug approval. (Briefly, the Prescription Drug User Fee Act funds a massive portion of the FDA and those medications which pose potential benefit to public health may receive an expedited fee date; HIV advocates historically championed the act as a massive “win” in the early 90’s when introducing this funding scheme sped up their processes to make oncology and HIV medications more readily accessible.)

Patients who may hear about “once every 6-month treatment) should be kindly reminded lenacapavir will serve only as a supplement to other therapies – administering the medication is required to be done by a provider and patients will still need to remain adherent to their existing treatment regimen. HIV medications for treatment need between 2 and 3 different combinations of medications and PrEP only needs 1. As such, there may be a disparity in lenacapavir as PrEP and Sunlenca as treatment in terms of uptake because, while lenacapavir won’t require maintenance of other medications, Sunlenca as treatment will require patients to continue to take the oral medications that are “optimized” with Sunlenca acting almost like a “soft reset” for patients.

Operationalizing will remain an issue, especially for state ADAP Program’s that have not fully implemented access to cabotegravir, in terms of injectable medication management and for arguments that frame investing in successful patient care as something that requires a “cost consideration”. Patient advocates should be well-prepared to defend a desire to see this product come to their patients as those patients so desire it.

ADAP Advocacy Association Resumes Fireside Chat Retreats

The Community Access National Network (CANN) celebrated the return of ADAP Advocacy Association’s (aaa+) “Fireside Chat” retreats after a two and a half years pause, due to the COVID-19 pandemic. CANN has regularly participated in the Fireside Chats since their inception and enjoys a robust partnership with our sister organization aaa+. The event, held in Wilmington, NC, featured 23 stakeholders, including patients, advocates, and manufacturer representatives and discussed the issues of “utilization management”, the status of Ending the HIV Epidemic (EHE) plans and activities in the South, and the overall impact of the COVID-19 pandemic on public health.

Recognizing current COVID-19 transmission and community level trends, aaa+ developed a robust self-administered testing protocol, wherein participants tested prior to travel, upon arrival, and after returning to their home areas. aaa+ provided rapid self-test kits to each of the attendees. The idea here is important to note, in part, because a chain of transmission was indeed interrupted when one planned attendee reported a reactive test result from their test upon arrival, despite having had a nonreactive test result from their pre-travel test the day before. As a result, the person affected did not actually attend any sessions and appropriately self-isolated. Other attendees expressed gratitude for the reduction of risk, respect of their health and the health of attendee household members, and wished the person affected a speedy recovery. Truly, gathering safely can be done and done well, as demonstrated by aaa+’s efforts here.

Prevention Access Campaign’s United States Executive Director, Murray Penner, presented the issue of payer “utilization management” affecting people living with HIV and AIDS (PLWHA), with respect to broad issues of health care and specific to AIDS Drug Assistance Programs (ADAPs). Opening commentary reminded the audience that utilization management practices affecting health other than HIV also affects access to care for PLWHA and, in some cases, where care or coverage is denied may also result in a patient disengaging from their HIV-specific care. Conversation also discussed utilization management affecting access to pre-exposure prophylaxis for the prevention of HIV (PrEP), in the context of generic antiretroviral (ARV) products, barriers to accessing new products, as a benefit of reducing unnecessary medical tests and preventing contraindicated care. Patients and advocates readily shared how utilization management being a barrier to care is not an “outlier” situation in which patients being denied medically necessary care only occurs in “rare” occasions, rather this is a frequent occurrence with these payer practices routinely and regularly require additional administrative burdens to be met and sometimes requiring circumstances contraindicated by the Food and Drug Administration’s (FDA) approved indications for products or services. Advocates pushed back against the idea “you just want the latest drug like you want the latest iPhone” by emphasizing how the fight against HIV will not be won by having disparities in access maintained along lines of who can afford the most “elite” health care plans. Discussing how advocates can leverage state planning bodies and the role public payers could play in directing managed care organizations to reduce barriers to care as presented under utilization management practices, attendees envisioned robust yet protective access to care aimed at addressing issues of health equity and the critical role of payers in Ending the HIV Epidemic. Attendees also suggested evaluating utilization management practices under a lens of the Affordable Care Act’s rules against “discriminatory plan design”.

A lovely networking lunch followed the first discussion and attendees got the chance to bond with others they had yet to meet or reconnect with those they haven’t seen in a while. Honestly, the amount of respect and joy had during the lunch filled the room, with discussion of other areas of interest and even raucous laughter could be heard from the hallway. The energy generated from the first discussion was readily palpable.

The second discussion, lead by Community Education Group’s Director of Regional and National Policy, Lee Storrow, lead the second discussion on the status of Ending the HIV Epidemic in the South. In providing context for the update, advocates discussed their hopes and expectations when EHE had been announced under the Trump administration. While much energy had been generated, and that in and of itself is exceptionally valuable in the context of the 40-year fight against HIV, the “significant resources” advocates expected have not materialized and the addition of yet another plan has further complicated already layered reporting burdens for service providers funded under Ryan White and other HIV related initiatives and governmental funding streams. One attendee remarked “we’ve been doing the same thing for 30 years and the last 10 haven’t progressed, it’s time to do something different.” As a response, discussion moved to develop planning and programming to include the lens of “economic empowerment” of PLWHA by way of employment opportunities generated from these programs being targeted to recruiting staff from affected patient populations and served zip codes. Another attendee discussed how such an opportunity elevated her own professional experience and helped ensure her program better reflected the demographics of affected communities – ensuring better engagement and more effective outreach in her area. Attendees discussed the idea behind EHE as a “moon shot” but really seems to be hindered by the lack of cohesive systems communication across public health programs, in particular with data sharing between Medicaid and Ryan White funded programs in various states. This highlighted opportunities and barriers, manifesting in strategic planning on what cohesive data sharing might look like in an ideal.  The session ended with conversation regarding “gatekeeping” among certain advocate circles when it comes to accessing institutional and governmental power and a certain lack of transparency as to exact “who” decision makers are due to bureaucratic processes, with the final note being “where is the red tape and who has scissors?”

The first day of planned discussion was capped with a dinner in which attendees continued to share with one another personal and professional details and ideas, making plans to socialize, discussing advocacy development opportunities, upcoming concerns regarding court ruling, legislation, and regulation, and programmatic planning within each other’s specific entities. The theme being “how can we help each other succeed?”

The second day of discussion held the final topic, COVID-19 impacts on public health, facilitated by CANN’s chief executive officer, Jen Laws (me). I opened the conversation by sharing the goal of the conversation being to “define” the impacts of COVID-19 on public health infrastructure and programs. Attendees were asked to share one “good” thing to come out of our collective response to the cOVID-19 pandemic and one “bad” thing (or “something we would like to go away”). Many attendees celebrated the innovation of flexibilities offered by various temporary governmental regulation and the “forced modernization” of health care in many situations – namely, telehealth. These flexibilities, including the continuous coverage requirement for Medicaid programs under the public health emergency declaration, are threatened to end as the public health emergency winds down and advocates attend the Fireside Chat expressed a certain foreboding of returning to “normal”. Specific highlights were given to the downside of relying on telehealth, especially for rural communities lacking the necessary infrastructure to make health care accessible – particularly in hospital deserts. Attendees reflected on the data “blindness” of the current moment, noting the Centers for Disease Control and Prevention’s (CDC) 2020 HIV surveillance report lack of completeness compared to previous years. “Bill Arnold reminded me frequently that the AIDS crisis is still just around the corner. We can’t blink,” I shared with the group to many nods as concerns for patients who dropped out of care weighed on the moment. Moving the discussion forward, attendees identified methods of advocate development and influencing state and federal power by more readily engaging manufacturers in their efforts to prioritize patient voices and experiences. The necessity to recognize the state of advocacy as needing re-development and investment was apparent and the note the event ended on, as attendees reflected the impacts of the COVID-19 pandemic on the public health and advocacy workforce.

While much discussion was had throughout the Fireside Chat, much more was committed to following the event. As with many in-person events, as opposed to virtual events, the quality of the experience was not absent on anyone there. It felt good to be in the physical presence of one another. We sought and gained inspiration and enthusiasm and we do so with clear cognizance of COVID-19 as a risk. If advocates and our partners can continue to similar efforts that both keep us safe and connected, the future (not without its challenges) is bright, equity-focused, empathic, and patient-driven.

Addressing the Intersection of HIV and Methamphetamine Use

A recent convening, hosted by the O’Neill Institute, found government representatives, service providers, and community advocates discussing methamphetamine use among gay/bisexual men, transgender women, and transgender men under the lens of exploring stigma, sexual health, and HIV. The intersectionality between HIV and Methamphetamine, commonly known as “meth”, is significantly associated with greater risk for HIV transmission and numerous co-morbidities for people living with HIV.

Attendees received updates on existing data and policy relevant to methamphetamine use. Often overshadowed by the opioid epidemic, wherein the “gaps” in epidemiological data explicitly on meth use were glaringly obvious and largely dependent on supplemental data gathered during HIV outreach activities or related to broader assessments of substance use. Similarly obvious were the reasons why these data would be challenging to gather: law enforcement. According to the Substance Abuse and Mental Health Data Archive (SAMHDA), in 2019, more than 400,000 people who use methamphetamine were arrested and booked into jail for at least one time during the previous twelve (12) months. While the convening focused on gay, bisexual, and other men who have sex with men (MSM), transgender women, and transgender men, federal data found similar rates of methamphetamine use among heterosexual men and MSM. Additionally, there was no statistical difference in methamphetamine use between heterosexual women and lesbian-identified women. There was however an increase in self-reported methamphetamine use among bisexual women. Data provided did not distinguish between cisgender and transgender people, an issue explained as participants in data gathering were not asked necessarily asked questions regarding their sexual or gender identity, rather this information was largely assumed unless a participant disclosed otherwise.

Following the data sharing, patient advocates and service providers discussed their perspectives on what to consider in assessing policy and federally funded programs. Presenters highlighted their own lived-experiences as influencing their ideas on where policies and programs have succeeded and failed – largely coming to an unspoken consensus that we must do at least something differently than we are today. One presenter stated existing funding structures tend to reward large entities which is perceived to be at the expense of small service entities, which may or may not be trusted by people who use substances. Another focused on the contrary policy priorities being voiced by the Biden Administration between supporting harm reduction and supporting law enforcement – giving an explicit voice from community advocates that law enforcement often poses a threat of harm to drug users. Presenters also pointed out the need to distinguish between recreational use, misuse, and addiction, as the stigma associated with substance use often conflates these experiences with one another, when the reality is very, very different. For my part, I shared the idea that existing funding designs associated with HIV, where substance use harm reduction is largely aligned both on issues advocacy and service provision, may perpetuate social stigma by prioritizing the experiences and work of health care providers over that of patients – especially with regard to metrics of “success”. A reworking of funding and program designs and incentives that look at addressing health disparities from a human rights lens is necessary. Envisioning Ryan White programs as workforce development and community investment programs in addition to being public health programs, recognizing the potential detriment of a consolidating provider market and the need to incentivize provider diversification, and shifting funding and goals to better reflect efforts to meet the needs of communities as those communities define them.

Lastly, presenters shared honest assessments of “on the ground” perspectives and what programs are working. With meaningful geographic and demographic diversity represented on the final panel, confirming sentiments of the previous one, presenters discussed novel (and often underfunded) approaches to ensuring affected communities are receiving high quality sexual health education, linkage to care, and low-barrier interventions for those people are seeking them. Panelists discussed the need for policy makers and funding to reinforce those novel programs which do work and to consider novel metrics to better capture these successes. From reinvestments in the Ballroom scene as a safe and empowering space of expression to the successful effort from affected Latino communities in Texas to engage with their state health department, educating health care administrators and providers on the necessity of harm reduction, these programs which originate from the priorities of communities, rather than from the dictates of statehouses are already doing more and going farther than traditional programming.

So…why don’t we have more of this?

To learn more about the initiatives of the O’Neill Institute at Georgetown University, click here.

Community Roundtable Defines the Shape of Public Health Advocacy Amid COVID-19

Last week, Community Access National Network (CANN) hosted its annual Community Roundtable event, like last year, focused on the impacts of COVID-19 on public health programs and patient advocacy around HIV, viral hepatitis, and substance use disorder. CANN’s President & CEO (your’s truly) was joined by Kaiser Family Foundation’s (KFF) Director of LGBTQ Policy, Lindsey Dawson, and Georgetown University’s Katie Keith. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmaceutical companies, and federally or state funded service providers. The virtual event was sponsored by ADAP Advocacy Association, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and ViiV Healthcare.

I welcomed attendees, noting my own professional admiration for both Lindsey and Katie, as experts leading in education on policy issues and data analysis around issues affecting communities highly impacted by HIV, viral hepatitis, and substance use disorder. Prior to co-presenters introducing themselves, audience members were reminded both KFF and Georgetown University are both non-partisan, education entities. The impetus and aims of this year’s event in including these astounding co-presenters was to help define the ecosystem of public health affecting programs particularly serving patient communities CANN serves.

Lindsey’s presentation offered a “potpourri” of relevant data regarding AIDS Drug Assistance Programs and Ryan White Funding stagnating, tele-PrEP, the federal Ending the HIV Epidemic (EHE) initiative, Medicaid programs, and LGBTQ people’s health outcomes (especially mental health) throughout the pandemic thus far. Reviewing previously published KFF data and briefs, Lindsey reminded attendees that federal appropriations for HIV programs have largely stagnated for more than a decade and, when adjusted for inflation, have fallen. Despite the federal EHE initiative, seeking to jump start the country’s stagnating HIV progress, does not meet the funding requests of advocates. Large doubt remains as to exactly how much can be done with how little has yet to be given. For good reason, the audience was asked to consider if the existing roadmap is the “right” roadmap and what EHE might need to look like in the coming years in order to meet the goals of the initiative. Lindsey reminded attendees that 36% of PLWH live in Medicaid non-expansion states, including Georgia (which just last week shut down a proposal to expand the state’s Medicaid program to PLWH under a waiver). Moving onto a particular point with regard to access to care, tele-PrEP program successes (and weaknesses) could be attributed to flexibilities which have been the direct result of early policy answers to COVID-19. These flexibilities are among policies patient and provider communities stand to lose when the public health emergency comes to an end, unless legislators take action. Wrapping up her presentation, Lindsey drew attention to the health outcomes affecting a highly impacted patient population, LGBTQ people. Data from KFF showed LGBTQ people were more likely have received a COVID-19 vaccination series, more likely to consider COVID-19 vaccination a duty to community and others in an effort to help keep healthy, and more likely to have experienced negative mental health outcomes as a result of the pandemic.

I followed Lindsey’s presentation discussing the landscape of patient advocacy in the age of COVID. Recognizing COVID-19, despite any sentiment of the public at large, is not “over”. Considerations regarding in-person attendance to events, meetings, and travel are still in flex. Also recognizing the political landscape has significantly soured relative to “public health” in general, even if not to HIV, viral hepatitis, and substance use programs specifically, and that dramatically impacts both court rulings and legislators’ willingness to consider the crucial role “legacy” public health programs play in maintaining the health of the nation. Cautioning against potential neglect, rather than support (so much for the “heroes” of the early epidemic), I reminded audiences of the power of in-person events and the need to weigh precautions and monitoring of COVID transmission metrics when planning in-person events, regardless of how big or small they may be. Further on, the presentation focused on the structure of effective advocacy via storytelling, personalizing experiences, providing supporting data to make those personal experiences tangible among a constituency, defining an “ask” by knowing the mechanisms of action (re: actionable policy), and readily recognizing the powers, humanity, and limits of an advocate’s audience.

The final presentations, provided by, Katie Keith, reviewed historical and anticipated policy changes, including those relative to the Affordable Care Act (ACA) – specifically, the family glitch and section 1557 – and those as a result of early COVID-19 legislation, much of which is quickly coming to the end of their legislatively defined program periods, either by specified date or by way of ending the federally declared public health emergency. Katie reviewed how the Biden administration approached some of these issues upon transition to power, having already met 8 of the policy requests of advocates, have yet to meet 4 of those requests, and at least 1 request was “in progress” with potential for administrative resolution any day now (section 1557 final rule re-write, specifically defining the edges of the ACA’s non-discrimination protections. Katie also briefly discussed how the Dobbs (abortion) ruling may impact domestic public health programs, urged attendees to watch Kelley v. Becerra, and urged advocates to closely watch the 2022 midterm elections as legislators have an unbridled ability to impact public health programs.

Panelists wrapped up by reminding attendees they and their organizations remain a readily available resource. The slide deck can be downloaded here.

Jen’s Half Cents: Supporting Patients by Supporting Families and Survivors of Intimate Partner Abuse

I’m a family man. I always have been. I tend to write in the evenings or at night and I like to do so sitting in bed. As I write this, my partner has dozed off next to me and her children are sleeping down the hall after a busy day of school and family time. I’m thinking about one colleague who had a health scare over the last couple of days (he’ll be ok) and the depth of emotion between worry and love is something that I can near physically feel. My sense of family is strong and the relationships I consider familial extend to a very select group of colleagues in the space of patient advocacy. I’ve often cited that sense of family as part of what keeps me happy in this work. That love is one I am fortunate to have and it’s something I like to remind folks of from time to time, in part, because this work is hard and paying witness to struggles comes with its own emotional toll and reminding colleagues we are driven to this work from a sense of justice and love is often…refreshing, reinvigorating.

A few years ago, at one of ADAP Advocacy Association’s first Fireside Chats, one of my most favorite industry partners, and one of the most brilliant people I’ve had the pleasure of knowing, raised the issue of intersections between the dual epidemics of HIV and substance use. Particularly, she focused on needing to raise awareness of long-term risks for those experiencing non-fatal overdoses, those intersections with infectious disease, and how public health programming would be better served with a more holistic approach to patient care, rather than the often-segmented or siloed environment we still have today. While more syringe services programs are adopting HIV and Hepatitis C testing and linkage to care activities and more HIV programs are offering more competent care for substance users, especially around medication assisted treatment, outside of these activities, there’s little being done to ease the high burden on patients to coordinate their own care across multiple providers or entities. National strategies and funding certainly prioritize referrals, but referrals aren’t the same as successful linkage, successful linkage isn’t the same as retention in care, and at the point of patient experience and meeting public health goals, those distinctions are important. I am of the somewhat unpopular opinion among some recipients and subrecipients that program metrics and grant awards should reflect these differences but that’s for another discussion.

My friend would move the discussion forward by talking about how powerful and moving testimony and advocacy from affected mothers and families, targeting these voices for education on the intersection of infectious disease and substance use, building coalitions would serve to advance the interests of both of these patient communities and especially so for patients living at the intersection of these conditions. As I was meeting with her in December of this year, I had to tell her, “I think about this conversation a lot.” And I do. Years later, this conversation pops up in my mind as I think about patient stories and priorities, different data about isolation as a predictor of substance use or how social supports are clear indicators in successful retention in care and viral suppression. We dedicate a massive chunk of behavioral health resources to ensuring patients have social supports precisely because having those supports is such a strong indicator of successful care. I often find myself thinking about the role families play in being a primary source of social support for many people, how ever we define family for ourselves. I think about this role of family when I assess intimate partner abuse data or read about how mothers experience legal abuse as a form of coercive control in custody situations. I think about it anytime we approach the issue of caregiver supports. I certainly thought about it last year when I wrote about how family courts and child welfare agencies are missed opportunities for linkage to care. I thought about the role of family and that conversation when a former co-worker was being stalked by the father of child at work and the employer failed to support or protect her. I thought about that conversation when recently asked to provide input on an academic institution’s midwifery committee and when a couple we’re friends with announced they’re going to start working to have another baby. I think about that conversation at every headline involving COVID and kids and how the financial supports extended in 2020 and 2021 reduced child poverty. I thought about that conversation while listening to a constituent impact panel on HIV criminalization in the state of Louisiana, how much patients rely on their families to advocate, navigate, support, and love them through what ever health challenges they may be facing. I think about that conversation when considering my own end of life planning and what I want for my family.

I found myself thinking again about that conversation and the need to better support families through public policy as one of many vehicles necessary for addressing the needs of people living with HIV, eliminating Hepatitis C, and tackling the substance use epidemic. I thought about that conversation last week as a bipartisan group of Senators introduced the Violence Against Women Reauthorization Act of 2022, after 3 years of failing to advance a reauthorization. As I read through the bill, I was happy to see funding for marginalized populations, including at-risk populations in Alaska and LGBTQI+ communities. I was happy to see Senators invest funding in directing a federal study on how parents alleging intimate partner violence are likely to lose primary custody over their children, already knowing how abusers leverage family court processes as a means of post-separation abuse is well-documented. I was happy to find a similar study on the association between intimate partner violence and substance use, specifically, how intimate partner violence increases the risk of substance use. I was disappointed to see a failure to more directly require family courts to be educated as to these issues because regardless of those study outcomes, families are weakened when abusers are able to leverage divorce proceedings as a means of further abusing their victims.

I think about all of these things when I think about what our advocate partners and funders are willing to take up as an issue worthy of their labor and dollars. While “mission creep” and maximizing our limited resources are certainly issues patient advocates and our funders must balance, we also have a moral and ethical calling to consider how those whose interests we seek to represent must also be represented holistically in the actions we take. More directly, those providers, patient advocates, and our funders should work to support public policies aimed at strengthening families and ending intimate partner violence on national and state levels. Today, we can do so by vocally supporting the long-overdue reauthorization of VAWA.

How One FQHC is Advancing Health Communication

Earlier this month, new outlets got a hold of a local (to me) treasure: NoiseFilter. Local health heroes, Dr. MarkAlain Dery and Dr. Eric Griggs, have been hosting Noise Filter since the beginning of the COVID-19 pandemic as an innovative way to educate the public about pressing health issues. The show started as a podcast, moved to live streams on Facebook, and has recently found a niche in animated shorts designed to engage and entertain patients. One of the latest episodes, titled Test, Treat, Cure, focuses on explaining Hepatitis C and curative treatments.

Before we go further, you can check out other Noise Filter animated videos here and you really should. They’re fun! At a recent virtual event aimed at educating stakeholders on the issue of HIV criminalization, after reviewing the science behind Undetectable Equals Untransmittable (U=U) and other access to care issues, Dr. MarkAlain played this episode for the audience. The audience happened to include Centers for Disease Control and Prevention Division of HIV Prevention Director, Dr. Demetre Daskalakis, who may or may not have chair danced with the end of the video. They really are that exciting!

This isn’t Dr. MarkAlain’s first foray into utilizing broadcasting platforms to reach patients as audience members. In 2014, the good doctor helped found local radio station WHIV (102.3FM). Staffed by volunteer hosts and DJs and focused on issues of social justice, human rights, and community health, WHIV titles itself as “…not a radio station with a mission…a mission with a radio station.” The station’s programming digs into issues of policy, politics, faith, entertainment, and more.

Both Doc Griggs and Dr. MarkAlain and both programs are tied to one of Louisiana’s largest Federally Qualified Health Center networks, Access Health Louisiana. AHL is actively involved in the state’s health planning activities and has been one of the mobile testing providers even before the COVID-19 pandemic and was one of the state’s first at-home testing providers (for HIV screenings), positioning the entity well in terms of already having infrastructure in place to mobilize and having Doc Griggs’ astounding communications talent for breaking down complex health issues, setting patients at ease, and empowering communities to activation makes the entity accessible and flexible in meeting the needs of served communities.

In many ways, both Noise Filter and WHIV seek to speak to patients as whole people, with whole lives, living in whole communities.

We need more of that. We need more of this.

2022: New Beginnings, New Changes

The Community Access National Network (CANN) ushers in a new beginning with the 2022 New Year, evidenced not only by the changing of the guard with our new President & CEO, but also with some important programmatic changes with our organization. We felt it important to share these changes with you.

Our weekly blog, previously branded as the HEAL Blog (Hepatitis Education, Advocacy & Leadership), is being repurposed to serve our broader mission “to define, promote, and improve access to healthcare services and supports for people living with HIV/AIDS and/or viral hepatitis through advocacy, education, and networking.” As such it is now the CANN Blog, and its areas of interest will focus on HIV/AIDS, viral hepatitis, substance use disorder, harm reduction, patient assistance programs (PAPs), Medicare, Medicaid, and the ongoing Covid-19 pandemic and its impact on public health. In keeping with the desire to monitor broader public health-related issues and appropriately engage stakeholders, our CANN Blog will be disseminated to a larger audience. Therefore, some of you may notice one more email in your inbox each Monday morning since we’re employing our general listserv to share the blog posts. It is our hope that you’ll deem the added email of value and thus maintain yourself on our listserv.

Additionally, our acclaimed HIV/HCV Co-Infection Watch will also be shared with our general listserv. But don’t worry, it only means one additional email each quarter! The HIV/HCV Co-Infection Watch offers a patient-centric informational portal serving three primary groups - patients, healthcare providers, and AIDS Service Organizations. The quarterly Watches are published in January, April, July, and October.

In 2022, our Groups will also be more active. Since 1996, our National ADAP Working Group (NAWG) has served as the cornerstone of CANN’s advocacy work on public policy. Whereas NAWG will continue to engage our HIV/AIDS stakeholders with monthly news updates, we will also convene periodic stakeholder meetings to discuss important issues facing the HIV community. Likewise, our Hepatitis Education, Advocacy & Leadership (HEAL) Group has served as an interactive national platform for the last decade on relevant issues facing people living with viral hepatitis. Periodic stakeholder meetings to discuss important issues facing the Hepatitis community will now complement the HEAL monthly newsletter. If you would like to join either the NAWG or HEAL listserv, then please do so using this link.

CANN will also launch its 340B Action Center this year. It is designed to provide patients with content-drive educational resources about the 340B Drug Discount Program and why the program matters to you. The importance of the 340B Program cannot be under-stated, and CANN remains committed to taking a balanced “money follows the patient” approach on the issues facing the program and advocating for needed reforms.

Finally, like most advocacy organizations, CANN is constantly evaluating whether it is safe (or not) to host in-person stakeholder meetings. Covid-19 has changed the advocacy landscape. Over the last two years our two signature meetings (Community Roundtable and Annual National Monitoring Report on HIV/HCV Co-Infection) have been hosted virtually, rather than in-person. CANN is taking a “wait and see” approach on how best to proceed in 2022 with these events. We will keep you apprised of our decision.

As we close the door on 2021 and open it for 2022, CANN looks forward to working with all of its community partners, industry partners, and you!