A Patient Advocate’s Perspective: The Call of this Moment
Earlier this year, I asked myself and the global public health field a serious question; Are we dedicated to the service of humanity, or are we serving our egos? That question rightfully ruffled feathers that needed to be ruffled. The reality is we live in a time that because of the loudest parties doing the very least, the “truth” is a question instead of fact.
We seem to be on a precipice when we should be finding ourselves at a critical decision point. As we approach the end of the year, an election that will undoubtedly shape our work, global conflict, the realization of climate change and the 2025 Standard Development Goals, I find myself asking a different question, “Are we ready and willing to do what is needed to meet this moment?” Additionally, are we prepared to get out of our own way or get out of the way of others if we are the obstacles?
We find ourselves in a world of increased polarization, the “us versus them” chasm that has only widened over the years, creating an environment that makes bipartisanship seem impossible. We also find ourselves at a stalemate in the HIV space; it is no longer the “sexy” disease with the global leadership and investment it has had. Our political leadership lacks follow through on its historical, robust commitments, non-profits are strained and advocates are burnt out. We have yet to acknowledge the lasting impact COVID-19 has had on all of us and the permanent damage it has done to trust in governments, science, and the goodwill of our neighbors, both domestically and globally. We have long shouted that communities who have led our movement since the early days should be involved in every element of the process. I believe that it is long past due to these same communities who are most impacted (not only by HIV and chronic illnesses but are in the center of the target of divisive political issues) should be holding the reins, they know what their communities need and want.
Self-reflection should be an essential part of our work, collectively and individually. We need to have space and time to reflect on our personal impact, influence, and commitment. In the field of public health, who does and how we decide who has power can have lasting and profound impact on the well-being of millions. Who is sitting at the top of the food chain at places like the CDC matters. Qualifications and experience over the partisan nonsense that we daily find ourselves in should be priority number one. When we allow the divisive climate to infiltrate our own ranks it has consequences. CANN’s CEO, Jen Laws, frequently reflects on the damage caused by Democrats’ role in forcing out Dr. Brenda Fitzgerald at the Centers for Disease Control & Prevention (CDC). “Fitzgerald had an objectively good background for leading the CDC, especially with her history of improving Georgia’s childhood vaccine uptake. Ending up in an environment where a known HIV vaccine scam artist was leading the CDC was absolutely catastrophic to our COVID response, public trust in public health, and renewed vaccine hesitancy.” Jen has never been one to mince words. Indeed, that short-sightedness led by partisan motivation has resulted in renewed vaccine hesitancy, HIV denialism, and weaponizing health conditions in order to oppose the civil rights of immigrants.
While ethical oversight is critical, our focus should remain on appointing leaders who are scientifically rigorous, experienced, and free from extreme ideological positions that could harm public health efforts. Effective public health leadership requires the ability to build coalitions, foster trust, and base decisions on the best available evidence—regardless of political affiliation. The COVID-19 pandemic laid bare the need for clear, consistent messaging and policies that prioritize public health over politics.
As we tackle ongoing public health challenges from infectious diseases to the opioid epidemic, rising rates of chronic illness and emerging health threats, it is imperative that future CDC leaders be chosen based on their qualifications and experience, not as a result of political maneuvering. Bipartisan collaboration ensure that the CDC and other agencies remain focused on their primary mission: protecting the health and well-being of all Americans.
This moment calls for us to return to objective truth instead of fear mongering and conspiracy, the acceptance that two things can be true at the same time, but it also calls on us to have hope that there is a future where public health is something we can agree on both sides of the aisle about. I don’t think that starts with our politicians, that starts with each of us willing to cross the street to meet our neighbors, to find what we have in common instead of the things that have separated us for far too long. We need to return to a culture where our politicians are far more concerned about their constituents instead of sound bites, where we lead with the intention of collaboration and finding bipartisan ways to renew political investment ensuring equitable access to health for everyone.
We are indeed at an inflection point, as highlighted by our friends at the O’Neill Institute. We must renew our commitment to ending HIV and the partisanship that drives disparities in access to care, degradation of our civil and human rights, and blinds us to the humanity of our neighbors.
Public Input Needed: Offer Input on HIV, STI, Vaccine, and Hepatitis Policies
The Office of Infectious Disease and HIV/AIDS Policy (OIDP) at the Department of Health and Human Services (HHS), alongside the White House Office of National AIDS Policy (ONAP), has released a Request for Information (RFI) to inform the 2026–2030 national strategic plans for HIV/AIDS, sexually transmitted infections (STIs), vaccines, and viral hepatitis. This RFI represents a key opportunity for public health stakeholders to shape policies that will directly impact prevention, treatment, and care for millions of people across the country.
Why Strategic Planning Matters
National strategic plans guide public health efforts at federal, state, and local levels. They establish priorities, direct resource allocation, and shape policies that determine the availability and quality of health services. The upcoming 2026–2030 plans aim to build on past progress while addressing new and evolving challenges.
For instance, the National HIV/AIDS Strategy for 2022–2025 set ambitious goals to reduce new HIV infections by 75% by 2025 and by 90% by 2030. Similarly, the Viral Hepatitis National Strategic Plan aims to eliminate viral hepatitis as a public health threat by 2030. These strategies are powerful tools that help us move toward improved health outcomes by setting clear goals and priorities.
What the Strategic Plans Address
Each of the four national strategies addresses unique public health challenges:
National HIV/AIDS Strategy – Sets forth a roadmap to end the HIV epidemic in the United States, with goals including:
Prevent New HIV Infections: Increasing awareness, testing, and access to prevention tools like PrEP and PEP, while reducing HIV-related stigma.
Improve Health Outcomes for People with HIV: Promoting early linkage to care, long-term retention, and viral suppression through integrated and culturally competent health services.
Reduce Disparities and Inequities: Addressing structural factors such as stigma and discrimination and focusing efforts on disproportionately affected populations.
Achieve Integrated, Coordinated Efforts: Promoting collaboration across sectors to integrate HIV prevention with services for STIs, viral hepatitis, and mental health, among others.
Sexually Transmitted Infections National Strategic Plan – Aims to respond to rising STI rates by:
Preventing New STIs: Increasing awareness, expanding prevention activities, and improving vaccination rates for HPV.
Improving Health Outcomes: Expanding screening and treatment in impacted communities.
Accelerating STI Research and Innovation: Supporting the development of vaccines, diagnostic tools, and treatment options.
Reducing STI Disparities and Inequities: Addressing stigma, expanding culturally competent services, and addressing social determinants of health.
Achieving Integrated, Coordinated Efforts: Promoting collaboration across STI, HIV, and viral hepatitis prevention efforts.
Vaccines National Strategic Plan – Focuses on eliminating vaccine-preventable diseases by:
Fostering Innovation in Vaccine Development: Supporting research and development of new vaccines and technologies.
Maintaining Vaccine Safety: Enhancing safety monitoring and public awareness of vaccine-related risks.
Increasing Vaccine Knowledge and Confidence: Addressing vaccine misinformation and improving public understanding of vaccine benefits.
Improving Access and Uptake: Reducing barriers to vaccine access and improving coverage, especially in underserved populations.
Supporting Global Immunization Efforts: Strengthening international collaboration on vaccine initiatives.
Viral Hepatitis National Strategic Plan – Targets the elimination of viral hepatitis as a public health threat, with goals such as:
Preventing New Infections: Increasing vaccination for hepatitis A and B and addressing transmission among people who use drugs.
Improving Health Outcomes: Ensuring timely testing, treatment, and retention in care for people with viral hepatitis.
Reducing Disparities and Inequities: Addressing stigma, enhancing culturally competent care, and focusing resources on high-risk populations.
Improving Surveillance and Data Usage: Enhancing data collection and sharing to better understand and address viral hepatitis trends.
Achieving Integrated, Coordinated Efforts: Promoting partnerships that address viral hepatitis, HIV, STIs, and substance use disorders together.
The Importance of Public Input
Public participation in the RFI process ensures that these plans reflect the real needs of communities. When stakeholders provide insights based on their experiences, it helps to ensure that strategic plans are grounded in the realities of public health challenges. The voices of people living with HIV (PLWH) and their advocates have led to a greater emphasis on reducing stigma and expanding access to essential services like mental health and substance use support. This type of feedback is needed in order to ensure that health strategies address barriers to care, particularly among marginalized populations, and incorporate promising approaches to delivering services and engaging communities.
By providing input, you can help shape strategies for integrating services across HIV, STIs, viral hepatitis, and vaccine-preventable diseases, making it easier for patients to navigate the healthcare system. Your insights could also highlight ways to leverage new technologies and data systems to improve health outcomes, ultimately influencing policies that determine the availability and quality of health services across the country.
How to Participate
To make your feedback impactful, it's important to examine the existing strategic plans (linked above) and identify areas that could benefit from improvement or expansion. Consider submitting detailed, data-driven feedback based on your experiences or expertise, connecting your observations with broader public health trends or research. Highlighting emerging issues that are currently underrepresented in the plans can also make a significant difference. Additionally, sharing effective practices from your work or community that could be scaled nationally will help ensure that these strategies are practical and inclusive.
The deadline for submitting comments is December 6, 2024, at 11:59 pm ET. You can participate by submitting your feedback through the online form. Your contribution can help create a public health system that is responsive to the needs of all communities.
Why Your Input Matters
By contributing to this RFI, you help ensure that public health strategies are grounded in evidence and lived experience, and are responsive to the communities most affected by HIV, STIs, viral hepatitis, and vaccine-preventable diseases. Your feedback can shape policies that address the most pressing needs of people impacted by these conditions, advance evidence-based approaches, reduce health disparities, and promote equity. Moreover, your input can help improve coordination across healthcare systems and levels of government, ultimately leading to better health outcomes for millions of people.
Your voice matters in shaping the future of public health. Participate in advocacy campaigns by joining public health advocacy groups working to ensure equitable health policies. Share this information with colleagues, networks, and community members who might also want to contribute their insights. Engaging in webinars or public discussions related to the strategic plans can also help you stay informed and connected, providing more opportunities to make an impact.
Final Thoughts
The 2026–2030 national strategic plans will shape public health policy in the U.S. for years to come. Your participation in the RFI process gives you a voice in crafting strategies that are effective, equitable, and responsive to community needs. By sharing your knowledge and experiences, you can help create a future where public health efforts truly serve all communities.
Together, we can make a difference—let's ensure that these plans reflect the needs of everyone, especially those most impacted.
The Great Disenrollment: Examining Medicaid's Post-Pandemic Shift
The Medicaid unwinding process that began in April 2023 has significantly impacted healthcare access and coverage retention across the United States. The unwinding, triggered by the end of pandemic-era continuous enrollment provisions, led to substantial shifts in Medicaid enrollment and revealed both strengths and weaknesses in our healthcare system. The process disproportionately affected communities of color and highlighted the need for targeted policy interventions to maintain healthcare access for vulnerable groups, including people living with HIV (PLWH).
The Scope of Medicaid Unwinding
During the COVID-19 pandemic, the Families First Coronavirus Response Act implemented the continuous enrollment provision in March 2020. This policy prohibited states from disenrolling Medicaid beneficiaries in exchange for enhanced federal funding, ensuring that people maintained health coverage during a time of unprecedented health and economic uncertainty. As a result, Medicaid enrollment surged from 71 million people in February 2020 to 94 million by April 2023, according to a Kaiser Family Foundation (KFF) analysis.
The end of the continuous enrollment provision on March 31, 2023, initiated a complex process of eligibility redeterminations for all Medicaid enrollees—a task of immense scale and complexity. By the end of the unwinding period, over 25 million people had been disenrolled from Medicaid, while over 56 million had their coverage renewed, as reported by KFF. The overall disenrollment rate stood at 31%, with significant variation across states. For instance, Montana reported a 57% disenrollment rate, while North Carolina's rate remained below 20%.
Systemic Challenges in the Unwinding Process
One of the most concerning aspects of the unwinding process was the high rate of procedural disenrollments. Of those who lost coverage, 69% were disenrolled for procedural reasons, such as not returning renewal paperwork, rather than being determined ineligible. This suggested that many people who lost coverage may have still been eligible for Medicaid but faced significant challenges navigating the renewal process successfully.
The Government Accountability Office (GAO) highlighted that administrative barriers contributed significantly to these procedural disenrollments. These barriers included:
Outdated Technology Systems: At least 11 states reported that their systems were old or difficult to use, making it challenging to produce real-time analytics essential for processing renewals effectively. This technological lag complicated efforts to implement necessary changes swiftly and efficiently.
Staffing Shortages: High turnover rates among eligibility workers led to vacancy rates reaching up to 20% in some states. Reports of low morale and burnout further affected the workforce's ability to handle the increased workload during the unwinding process.
Communication Barriers: States struggled to effectively engage people in the renewal process, particularly those facing language barriers. Non-English speakers often encountered longer wait times and struggled to reach assistance through call centers. These issues were compounded by a lack of robust state communication and engagement strategies.
Complex Paperwork: The renewal process often involved complicated forms and documentation requirements, which proved challenging for many enrollees to navigate, especially those with limited literacy or language skills.
Dr. Benjamin Sommers, a health policy expert at Harvard T.H. Chan School of Public Health, noted during the process, "The high rate of procedural disenrollments is particularly troubling. It indicates that we're not just seeing people leave Medicaid because they no longer qualify, but because they're struggling with the administrative hurdles of the renewal process."
These challenges led to frustration among enrollees and advocacy groups, highlighting the need for more streamlined and accessible renewal processes. The experience underscored the importance of investing in modernized eligibility systems, adequate staffing, and comprehensive communication strategies to ensure that eligible patients can maintain their coverage during future eligibility redeterminations.
National Enrollment Trends and State-Level Variations
Despite significant disenrollments during the unwinding process, Medicaid enrollment remained higher than pre-pandemic levels. As of May 2024, 81 million people were enrolled in Medicaid, an increase of about 10 million compared to pre-pandemic enrollment. However, this growth was not uniform across all populations. While adult enrollment remained over 20% above February 2020 levels, child enrollment was only about 5% higher.
Several factors influenced these disparities:
The pandemic's economic impact led to more adults becoming eligible for Medicaid due to job losses and income reductions.
States that expanded Medicaid under the Affordable Care Act saw more substantial increases in adult enrollment.
Children's enrollment remained relatively stable due to higher pre-pandemic enrollment rates and broader eligibility criteria through programs like the Children's Health Insurance Program (CHIP).
The impact of the unwinding process varied significantly across states, reflecting differences in policies, system capacities, and approaches. States that expanded Medicaid under the Affordable Care Act generally showed higher retention rates. Additionally, states that adopted strategies to streamline the renewal process, such as increasing ex parte (automated) renewals, saw better outcomes.
For example, Arizona, North Carolina, and Rhode Island achieved ex parte renewal rates exceeding 90%, while states like Pennsylvania and Texas had rates of 11% or less. These differences underscored the importance of state-level policies and systems in determining unwinding outcomes.
The Centers for Medicare & Medicaid Services (CMS) reported that states with higher ex parte renewal rates tended to have modernized eligibility systems that could effectively leverage data from other programs to confirm eligibility. This reduced the administrative burden on patients and helped maintain continuous coverage.
These variations highlighted the critical role of state-level decision-making and infrastructure in shaping Medicaid enrollment outcomes during and after the unwinding process. They also pointed to potential best practices for maintaining coverage and streamlining enrollment processes in the future.
Racial and Ethnic Disparities in Medicaid Disenrollment
A particularly concerning aspect of the unwinding process is its disproportionate impact on communities of color. According to the Southern Poverty Law Center (SPLC), more than half of the people who lost coverage were people of color. This disparity is exacerbated by existing barriers to healthcare access. The SPLC notes that communities of color face more barriers to healthcare access, such as limited internet, transportation, and inflexible job schedules.
The impact is particularly severe in states that have not expanded Medicaid. The SPLC report highlights that "residents from Alabama, Florida, Georgia, and Mississippi make up over 40% of the adults in the coverage gap nationwide. People of color make up about 60% of the coverage gap nationwide."
The Human Impact of Coverage Loss
The impact of coverage loss extends beyond statistics. Personal stories highlight the real-world consequences of the unwinding process. Justin Gibbs, a 53-year-old from Ohio, had to go without blood pressure medication for a week after losing his Medicaid coverage in December, according to CNN. Such disruptions in care can have serious health implications, particularly for people managing chronic conditions.
A KFF survey reveals the broader health impacts of coverage loss. Among those who became uninsured after losing Medicaid:
75% reported worrying about their physical health
60% worried about their mental health
56% said they skipped or delayed getting needed health care services or prescription medications
Impact on HIV Care and Policy Implications
The Medicaid unwinding process also highlighted significant challenges in maintaining healthcare access for people living with HIV (PLWH). While specific data on Medicaid disenrollment among PLWH during the unwinding were limited, general trends among vulnerable populations indicated potential risks. A KFF report found that many of those who lost Medicaid coverage experienced increased out-of-pocket costs, interruptions in medication adherence, and deteriorating health outcomes. These challenges were particularly critical for PLWH, for whom continuous access to antiretroviral therapy (ART) is essential.
Key considerations for PLWH during the unwinding process included:
Continuity of ART: Ensuring uninterrupted access to antiretroviral medications is mandatory for maintaining viral suppression and overall health.
Role of Ryan White HIV/AIDS Program: This program played a critical role in filling coverage gaps, but it's not a substitute for comprehensive health insurance.
Targeted Outreach: Community-based organizations and AIDS Service Organizations (ASOs) were essential in providing specialized support and enrollment assistance to PLWH.
Data Collection: Improving data collection on Medicaid disenrollment rates among PLWH can inform targeted interventions and policy adjustments.
The unwinding process underscored the need for policies that safeguard continuous healthcare access for PLWH. Implementing strategies that address these specific needs can help prevent coverage disruptions and improve overall health outcomes for people living with HIV.
Economic Implications of the Unwinding Process
The Medicaid unwinding process had significant economic implications for patients, healthcare providers, and states. For people who lost Medicaid coverage, the consequences often included financial instability and increased medical debt. A study by the Urban Institute found that adults who experienced a gap in Medicaid coverage were more likely to report problems paying medical bills and to have medical debt.
Healthcare providers, particularly safety-net hospitals and community health centers, faced increased rates of uncompensated care as a result of the unwinding process. This strained their financial resources and potentially affected their ability to provide care to their communities. The Commonwealth Fund noted that increased uninsured rates could lead to higher healthcare costs in the long term due to delayed care and increased emergency room visits.
For states, the unwinding process presented complex economic challenges. As the enhanced federal matching rate provided during the pandemic phased out, many states grappled with increased administrative costs associated with the unwinding process. A report from the Brookings Institution highlighted that states faced a complex set of trade-offs as they navigated the unwinding process, balancing the need to control Medicaid spending with the imperative to maintain access to care for vulnerable populations.
The full economic impact of the unwinding process continues to unfold, with ongoing implications for state budgets, healthcare provider finances, and patient economic well-being. These insights will be important in shaping future Medicaid policies and developing strategies to mitigate economic challenges associated with coverage transitions.
Policy Recommendations and Best Practices
To address these challenges, several key strategies have been identified:
Streamlining Renewal Processes: Increasing ex parte (automated) renewal rates can reduce the burden on people and minimize procedural disenrollments. For instance, Louisiana achieved a 49% ex parte renewal rate by leveraging data from other public benefit programs and improving data matching processes.
Targeted Outreach: Conducting outreach to vulnerable populations, including communities of color and people with chronic conditions, can help reduce disenrollments. The Ohio Department of Medicaid partnered with community-based organizations for door-to-door outreach in areas with high procedural disenrollments.
Implementing Continuous Eligibility: Policies that provide 12-month continuous eligibility can stabilize coverage and reduce churn. Oregon implemented a two-year continuous eligibility policy for children under six.
Enhanced Federal Oversight: Strengthening monitoring and enforcement of federal requirements ensures state compliance. CMS should leverage new authorities to require corrective action plans from states with high procedural disenrollments.
Improving Data Collection: Robust data collection and timely reporting enable quick identification of problems. States should report disaggregated data on disenrollments by race, ethnicity, and other demographics to address disparities.
Leveraging Technology: Modernizing eligibility systems improves accuracy and efficiency. Implementing text messaging, email communication, and mobile-friendly online portals helps people update information and complete renewals more easily.
Expanding Presumptive Eligibility: Allowing qualified entities to make preliminary eligibility determinations provides temporary coverage while full applications are processed, ensuring continuous access to care.
Addressing Systemic Inequities and Long-Term Solutions
The unwinding process exposed systemic inequities within the healthcare system, particularly affecting communities of color and rural areas. Long-term solutions include:
Investing in Underserved Communities: Enhancing access to healthcare services in marginalized areas.
Improving Health Literacy: Providing education to help people understand their health coverage options and navigate the system.
Strengthening Social Safety Nets: Expanding programs that address social determinants of health, such as housing, nutrition, and transportation.
Without significant policy interventions, coverage losses could lead to worse health outcomes and increased disparities, as emphasized by the Urban Institute.
Conclusion
The Medicaid unwinding process revealed both challenges and opportunities in our healthcare system. It highlighted the need for more efficient, equitable, and resilient approaches to health coverage. Key lessons include the importance of streamlined processes, targeted outreach, and robust oversight.
Moving forward, policymakers, healthcare providers, and advocates must work together to implement solutions that ensure continuous, accessible care for all, especially vulnerable populations. This effort is not just about health policy—it's a matter of equity and human rights.
As we continue to navigate the evolving healthcare landscape, our goal should be to build a system that provides stable, continuous coverage and leaves no one behind. This commitment is essential for improving health outcomes, reducing disparities, and strengthening our nation's overall health infrastructure.
Global & National Perspectives on HIV & HCV Co-Infection
On April 26, UNAIDS issued a report briefly detailing the state of HIV and Hepatitis deaths, globally, taking particular note of the issue of coinfection among people who inject drugs. Here in the United States, multiple jurisdictions have declared new HIV and ongoing Hepatitis C outbreaks, all combined with a surge in overdose deaths.
Domestically, federal public health initiatives have long sought to understand and address intersections of these issues, offer guidance, and shifted – albeit slowly – to understand HIV, HCV, and SUD exist as syndemics. And I want to talk about this language.
Syndemic, in general, means two or more linked health problems, interacting synergistically, and contributing to the disease burden of a given population; operating in a fashion that feed one another. To prevent or treat a syndemic, entities must not only treat each health problem but also the social ills that bridge these health problems.
This distinction is important – if we are to meet any of our public health goals on any of these, we need expertise, advocates, and structural support that both address the singular nature of each and the intersections, un-siloed from one another. Unique expertise in designing solutions is as valuable and necessary as expertise with the vision to see the whole system.
As we move through the COVID-19 pandemic, well-publicized discussion on the conflicts between national strategies and local actions mirrors fights patient and policy advocates have been fighting for four decades and continue to fight today. Even as we’ve made progress in ensuring direct acting agents (DAAs) are included in AIDS Drug Assistance Program (ADAP) formularies, at least one state has set an unchallenged precedent of denying this basic care to incarcerated people based on budgets and the Democratic mayor of the city with the “most concerning” HIV outbreak in the nation has back tracked on commitments to work with local public health experts.
This quarter’s HIV-HCV Coinfection Watch Report highlights some progress in syndemic-oriented policy changes and some more…unfortunate changes. While the American Rescue Plan, passed earlier this year, provides for more funding to address state budgets harmed by COVID-19 related revenue decreases, a few states have instituted – and currently maintain – restricted services. For example, while Georgia’s ADAP maintains DAAs on the formulary, payment for same is halted due to funding and Texas’s ADAP has removed all HCV medications, except one DAA from the formulary. Positive notes from earlier this year include Kentucky’s Medicaid program moving to a universal preferred drug list (PDL).
Of the space that has the greatest amount of room to progress and needing nuanced advocacy changes is harm reduction policies. Well-established federal policy and laws only reach so far if state and local laws act in direct opposition to those model positions or even merely lack the funding to establish comprehensive programs. One such space is the near universal adoption of “Good Samaritan Laws”, wherein, generally speaking, if a person, regardless of capacity, does their level best to help another, they cannot be held liable. However, several states have amended their “Good Samaritan Laws” or criminal codes to remove that liability protection from people who distribute illicit substances – disincentivizing reporting of overdose incidents and calling for medical help as they happen. Along the same lines, doctor shopping laws are aimed at preventing patients from seeking multiple prescriptions or seeking multiple providers if one is unsatisfied with their care. However, many states rely upon “lock-out” programs administered by insurance providers or managed care plans to implement under the guise of preventing “drug seeking behavior”. As Alison Gaye stated in a recent presentation to Louisiana’s Commission on HIV, AIDS, and Hepatitis C Education, Prevention, and Treatment, “drug seeking behavior often looks like care seeking behavior, subject to the personal biases of the examining provider”.
Harm reduction policies are in dire need to evolve and delve into the difficult nuanced spaces currently unaddressed if we’re to meaningfully work to end the syndemics of HIV and HCV. Far, far too often the solution found by policy makers in addressing public health needs has been to incarcerate those among us who need help. Driven by stigma, whether the issue is HIV criminalization or lack of access to standard HCV care or refusing adequate insurance coverage for recovery programs, shoving people into prisons has not served this country well on any front.
As we step into the next phase of our advocacy, evaluating existing programs, practices, and priorities cannot include a carceral mindset if we are to effectively reduce the harm caused by these syndemics and our past policies.
Covid-19: How Far We’ve Come & How Far We Have to Go
Unraveling a tangle of yarn can be maddening. Pull here, threads get tighter. Pull there, you’ve created another knot. Now, imagine having to weave with the same tangle – “undo” a well-organized mess and make it something functional, beautiful even. The fragile public health system in United States during the Covid-19 pandemic is much like that tangled yarn.
This dual task is very much an oversimplified explanation of where the American health care landscape exists in this moment. Like most collective traumas, this stage isn’t the “undoing” stage, it’s the stop the damage stage. In writing the first blog of the year, tracking site Worldometers reported 20 million confirmed COVID-19 cases in the United states and about 345,000 COVID-19 deaths. As of the time of this writing, the same site is reporting more than 30 million confirmed COVID-19 cases in the US and about 550,000 COVID-19 deaths. Daily case counts continue to remain high at around 50 thousand confirmed cases a day and around 1,100 deaths per day on average. While the introduction of 3 vaccine products has brought hope and another tool to our COVID toolkit, and daily new cases and deaths are far below their height, the pandemic still rages on.
Which is…concerning for the entirety of the health care spectrum and especially so for those spaces that have been historically underserved or needing additional protection or funding. From the Centers for Disease Control report at the Conference on Retroviruses and Opportunistic Infections (CROI) the United States performed at least 700,000 fewer HIV screenings and 5,000 fewer new diagnoses in the first 6 months of the pandemic (compared to the same time in 2019) to the extraordinary implications of COVID among vulnerable populations to Senators Grassley and Klobuchar introducing legislation to allow drug importation (despite very clear warnings about why this is not a great idea) to the Biden Administration issuing a formal disapproval of Medicaid work requirements, to say information is coming at “break neck speed” may well be as much of an understatement as a tangled ball of yarn.
With an emerging “surveillance gap” for both HIV and HCV, a startling HIV outbreak in West Virginia, overdoses increasing as a result of COVID, some of greatest tools gained in combating this pandemic, even those advocated for by the CDC, have already started to go away as states begin to “open up”. Indeed, Congress has already begun taking up old questions regarding telehealth restrictions and payment systems designs, this time with an eye for permanency.
While President Joseph R. Biden’s American Rescue Plan, recently passed by Congress and signed into law, offers a great deal of funding to address the needs of certain entities and programs to tackle COVID and even offers the most meaningful adjustments to the Affordable Care Act by expanding subsidies, the existing needs of the health care ecosystem have largely been neglected for the last year. Well…far longer…but I digress. Like any trauma, our need to strengthen patient protections and access, incentivize quality of care over quantity of services, and meaningfully reduce health disparities have been the ends of thread tightening around the knot of COVID. This pandemic did not create these disparities and the needs outlined above – but not having a plan for a pandemic, not addressing structural inequities and these burning policy needs with the urgency they so deserve absolutely made us more vulnerable to the most devastating impacts of any pandemic.
This isn’t “the end”, certainly. For advocates, this has always been our “normal”. We need those who have hung on our every word and insight through this emergency to stay at the table – we’re not done yet. Everything you were outraged by (and may still be enraged by thanks to vaccine access scarcity) remains and will continue to loom just over our shoulders, waiting to be exploited by an opportunistic disaster.
Indeed, the ghost of Scott County may well continue to haunt us for some time to come. This is, after all, a very big ball of very tangled yarn.
The Future is Now: Welcome to the Age of Injectables
For years, HIV advocates have anticipated injectable antiretroviral therapies (ART) – often with a level of excitement. I recall listening to robust discussions between advocates and officials in statewide meetings, reviewing candidate treatments, discussing labor and staffing needs for providers, potential regulatory changes needed to ensure programs could cover the actual syringes associated with injectable ART, given state-based restrictions. The excitement extended from a sense of no longer needing daily tablets (pills) in order to maintain adherence and thus an undetectable viral load, extend quality of life for those experiencing barriers to care like homelessness, and otherwise welcome a new age of treatment – if only by new method of delivery.
In late 2019, we seemed on the edge of such an accomplishment. ART focused pharmaceutical manufacturers Glaxo Smith Kline subsidiary, ViiV, and Johnson & Johnson subsidiary, Janssen, had paired up in an effort to provide the world with its first long-acting ART via injection. However, the Food and Drug Administration (FDA) refused to grant the companies an approval for the dual shot regimen of cabotegravir and rilpivirine (together, “Cabenuva”) due to concerns related to “Chemistry Manufacturing and Controls”. Thirteen months later, on January 21, 2021, Janssen and ViiV announced FDA approval of Cabenuva.
ViiV Healthcare understands the transformative nature of Cabenuva and the many “firsts” associated with a provider-administered injectable therapy for HIV. We will be educating HCPs on how to identify appropriate patients who may prefer or benefit from an option other than daily, oral therapy. Two key considerations are that patients agree to the required monthly dosing schedule and understand the importance of adherence to scheduled dosing visits. We also will be helping educate people living with HIV about Cabenuva and these commitments. - ViiV
According to the product monograph, Cabenuva is a dual intramuscular injection protocol (requiring one shot of cabotegravir and one shot of rilpivirine) monthly, administered by a health care provider. Prior to starting the monthly injections, providers should test tolerability via “oral lead-in” via once daily tablets of both cabotegravir and rilpivirine with a meal. If consumers expect to miss a monthly injection by more than 7 days, once daily oral tablets of cabotegravir and rilpivirine may be used to replace the injections for up to two injection cycles (or 2 months). Contraindictions include any known or suspected resistance to either or both drugs and any intolerability of components of either or both drugs. The injections cannot, at this time, be self-administered.
Despite all of the antici…pation and data showing a higher level of satisfaction than with current regimens among trial participants, some advocates are still cautious and concerns remain regarding logistical accessibility. Regarding financial accessibility, ViiV has already launched its patient assistance program for Cabenuva through ViiVConnect. Florida advocates and members of Florida HIV/AIDS Advocacy Network, Ken Barger, Joey Wynn, and David Brakebill, discussed in…spirited detail varying perspectives on rural access.
Wynn advocated for diversifying public funds, if rural health departments couldn’t meet the demand of a once monthly injection protocol, “If a rural health department can’t do a monthly injection [for ART], when they do injections for all sorts of other disease states, they need to give their money to providers who can.” Barger and Brakebill pointed out that for many rural counties, the health department may be the only provider in the area that’s accessible, with a highlight on concern regarding capacity. Wynn suggested the need for investment in better planning and preparation – not just for injectables, but for situations of natural disasters which have been known to disrupt access to medications and care in the state regularly.
When asked about these concerns, ViiV acknowledged the challenges and provided the following commitment to invest in ensuring more equitable access to care: ViiV Healthcare is also dedicated to improving how HIV treatment and care are delivered in the “real-world” environment through our Implementation Science program. One example of this focus is a study evaluating how improvements in transportation and use of digital tools can help get people living with HIV to their healthcare providers on a regular basis, which if successful we’ll look to implement on a broader scale
This week’s HEAL blog wouldn’t have been possible without the coverage of and reporting on treatment developments in this and other therapeutic areas by Liz Highleyman.
Quotes attributed to ViiV Healthcare are direct and were provided by Robin Gaitens, Product Communications Director.