DOGE-related Funding Cuts Threaten the Fight to End the HIV Epidemic

By: Ranier Simons, ADAP Blog Guest Contributor

Actions driven by the so-called Department of Government Efficiency (DOGE) continue destabilizing the U.S. public health and scientific research infrastructure. Funding cuts, including eliminating grants and dismissing thousands of employees at the National Institutes of Health (NIH) and Center for Disease Control & Prevention (CDC), are being announced increasingly quickly. The onslaught of DOGE actions is aggressively wielding a hatchet from multiple angles without guidance to those affected, leaving confusion and a paucity of guidance in its wake. Diverse stakeholders are concerned about the potentially grave impending impacts of these cuts on the fight to end the HIV epidemic and public health overall.

Photo Source: NBC News

One notable loss was incurred by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Recently, NIH announced the halt of two of its principal funding grants, pulling $18 million annually from its operations (Oza, 2025). The ATN was established over 20 years ago when evidence-based research identified the very specific needs of adolescents and young adults living with HIV as compared to children born with HIV or adults living with HIV. The ATN’s work includes several multidisciplinary clinical trials aimed at improving HIV prevention, as well as treatment improvements across the entire HIV care continuum for youth, which are all being eliminated. One of the many successes of ATN is the development of a PrEP protocol for adolescents, which was approved in 2018. The termination of funding effectively terminates current trials, such as examining doxycycline prophylaxis in women and an investigational study for a multipurpose injectable to prevent HIV and pregnancy (Oza, 2025).

NIH grant cuts are also targeting health equity research. Health equity research seeks to identify and address avoidable adverse health outcomes experienced by specific populations due to social determinants of health, including socioeconomic status and race (Braveman et al., 2017). The current administration does not appear to recognize health disparities as a credible public health threat and views the work as baseless DEI conjecture. 

One such canceled grant involved research on maternal health. Jaime Slaughter-Acey, an associate professor at the University of North Carolina at Chapel Hill, was studying the poor maternal health and birth outcomes of black women (Hellman, 2025). The health crisis of poor maternal and infant mortality among black women is backed by sound scientific data and is a recognized consensus in the medical community. The risk of maternal mortality is the most significant disparity among all conventional population perinatal health measures, regardless of geographic location (Krishnamoorthi et al., 2023). 

Photo Source: Inquisitr

Multiple health disparity grants specifically focused on LGBTQ issues have also been canceled. For example, several researchers at George Washington University lost grants for studies exploring HIV outcomes in minority populations (Lee, 2025). NIH grant funding was canceled for Jonathon Rendina, an associate research professor of public health, who was studying the inequities of HIV experienced by women and transgender people of color. The research was already underway and will lose $1.4 million that had not yet been spent. Derek Dangerfield II, an associate professor of prevention and community health, lost two grants. His grants funded studies investigating healthcare outcomes and systemic stigma in the healthcare system for Black men living with HIV. Together, both grants took almost $1.5 million away (Lee, 2025).

Explicitly, NIH has targeted and canceled funding for transgender health studies. It has issued internal guidance stating it no longer supports any research on transgender health issues or gender identity (Kozlov, 2025). Sari Reisner, associate professor of epidemiology at the University of Michigan, lost his grant entitled “Strategies to Prevent HIV Acquisition Among Transgender MSM in the US” (Spring, 2025). At least five of seven recently canceled grants at the University of Michigan involved gender identity research. Studies show that HIV disproportionately impacts transgender individuals. Transgender women are 49 times more likely to have HIV compared to the general population, and transgender men have higher rates of HIV acquisition as well (Baral et al., 2012).

Transgender health, in general, has been under consistent attack. Shanna Kattari, an associate professor of social work and women’s studies at the University of Michigan, explains, “The current political climate and anti-trans attacks have already harmed healthcare access for transgender and gender-diverse (TGD) people, from directly clinics shutting down puberty blocks or HRT for young people … to more indirectly, (where) many TGD people (are) choosing to avoid needed care, whether preventative care or gender-affirming care, due to fear of being denied, mistreated or being put on a ‘list’ for accessing such care” (Spring, 2025).

Photo Source: THEM

The majority of those receiving notification of their grant funding by NIH received letters with verbiage expressing that NIH no longer holds their research as a priority. The letters state, “Research programs based primarily on artificial and non-scientific categories, including amorphous equity objectives, are antithetical to the scientific inquiry, do nothing to expand our knowledge of living systems, provide low returns on investment, and ultimately do not enhance health, lengthen life, or reduce illness…”(Spring, 2025). They further legitimize their choice to defund, adding, “…so-called diversity, equity, and inclusion (“DEI”) studies are often used to support unlawful discrimination on the basis of race and other protected characteristics, which harms the health of Americans. Therefore, it is the policy of NIH not to prioritize such research programs”(Spring, 2025).

There is a human toll to the Trump Administration's slash and burn. Michigan resident Jeremy Toney summarized, "Being directly affected by these recent funding cuts to public health, specifically HIV prevention and research, has left me feeling very uncertain about the future. My team and I experienced a massive direct cut to our NIH R01 research grant that was set to change how we look at HIV Prevention in Primary Care from a health system perspective. We were on the heels of implementation as we put time and effort into building a project from scratch. The devastation of our grant being terminated without warning and true reason is quite egregious and speaks to how this current administration views science and the work that so many credible individuals have put into saving lives. We're all feeling unsafe and uncertain about the future of our jobs, the loss of impactful research, and the distrust of the government, but we must fight back against it."

Population health is not an amorphous equity objective. HIV prevention and treatment studies do indeed enhance health, lengthen life, and reduce illness. The average estimated lifetime HIV-related medical expenditure per individual in the U.S. is around $420K (Bingham, 2021). Saving over $420K per person by preventing HIV infection is a significant return on investment. Medical knowledge gained from the study of population subsets can be expanded to application to the general population. That is the epitome of expanding our knowledge of living systems. As we continue to monitor ongoing DOGE-related funding cuts and “reductions in force,” it is imperative to find ways to mitigate the present dangers as well as offensively protect the future.

[1] Baral, S. D., Poteat, T., Strömdahl, S., Wirtz, A. L., Guadamuz, T. E., & Beyrer, C. (2012). Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. The Lancet Infectious Diseases, 13(3), 214–222. https://doi.org/10.1016/s1473-3099(12)70315-8. Retrieved from https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(12)70315-8/fulltext

[2] Bingham, A., Shrestha, R. K., Khurana, N., Jacobson, E. U., & Farnham, P. G. (2021). Estimated Lifetime HIV-Related Medical Costs in the United States. Sexually transmitted diseases, 48(4), 299–304. https://doi.org/10.1097/OLQ.0000000000001366. Retrieved from https://pubmed.ncbi.nlm.nih.gov/33492100/#:~:text=Results:%20We%20estimated%20an%20average%20lifetime%20HIV%2Drelated,and%20$326%2C411%20in%20our%20least%20favorable%20scenario.

[3] Braveman, P., Arkin, E., Orleans, T., Proctor, D., Plough, A. (2017, May 1). What is health equity? Retrieved from https://www.rwjf.org/en/insights/our-research/2017/05/what-is-health-equity-.html#:~:text=In%20a%20report%20designed%20to,in%20discussions%20around%20the%20concept.

[4] Hellman, J. (2025, March 24). Trump cancels NIH grants on equity research. Retrieved from https://www.msn.com/en-us/health/other/trump-cancels-nih-grants-on-equity-research/ar-AA1BzOLx?ocid=socialshare

[5] Kozlov, M. (2025, March 26). Exclusive: NIH to cut grants for COVID research, documents reveal. Retrieved from https://www.nature.com/articles/d41586-025-00954-y

[6] Krishnamoorthi, M., Balbierz, A., Laraque-Arena, D., & Howell, E. A. (2023). Addressing the National Crisis Facing Black and Latina Women, Birthing People, and Infants: The Maternal and Child Health Equity Summit. Obstetrics and Gynecology, 141(3), 467–472. https://doi.org/10.1097/AOG.0000000000005067. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC9974748/

[7] Lee, J. (2025, March 31). GW researchers lose five NIH grants amid federal funding cuts. Retrieved from https://gwhatchet.com/2025/03/31/gw-researchers-lose-five-nih-grants-amid-federal-funding-cuts/

[8] Oza, A. (2025, March 25). NIH cuts halt 24-year program to prevent HIV/AIDS in adolescents and young adults. Retrieved from https://www.statnews.com/2025/03/25/nih-cuts-include-hiv-aids-prevention-program-for-adolescents/

[9] Spring, E. (2025, March 26). NIH pulls funding from UMich transgender health research. Retrieved from https://www.michigandaily.com/news/research/nih-pulls-funding-from-umich-transgender-health-research/

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Proposed CDC HIV Prevention Funding Cuts Loom Large; Advocates Fear for Treatment Dollars

By: Ranier Simons, ADAP Blog Guest Contributor

The current administration’s interest in a multitude of funding cuts and reorganization of federal programs and entities has been at the forefront of daily news for weeks. Recently, a Wall Street Journal report highlighted information sourced indicating the Trump administration is considering cuts to the CDC’s domestic HIV program (Wyte, Mosbergan, & Rockoff, 2025). Specifically, there are talks of significant cuts in HIV prevention funding, including a reduction of CDC personnel and possible restructuring or elimination of the CDC’s HIV Prevention division. Public health professionals, clinicians, patient groups, and many other stakeholders are alarmed by the detrimental ramifications of the cuts being discussed.

Photo Source: WSJ

There are an estimated 1.2 million people in the U.S. living with HIV, of whom 13% are unaware of their status (Wyte et al., 2025). Those who are unaware they are living with HIV are in dire need of testing to learn of their status and get into treatment. Testing is the cornerstone of HIV prevention. Mitchell Warren, executive director of HIV prevention organization AVAC, when speaking to the Wall Street Journal, stated, “One of the greatest lessons in public health is you can’t end epidemics with treatment alone. Without prevention, we are going to be fighting the virus with one hand behind our back.”

An opposition letter written by Representative Maxine Waters addressed to Robert F Kennedy, Jr., Secretary of the U.S. Health and Human Services delineates a reported elimination of $700 million in CDC HIV prevention funding because of the 2025 Congressional Continuing Resolution (Waters, 2025). HIV prevention funding was only 3% of the federal government’s fiscal expenditure on HIV in FY2022, even though the CDC represents %91% of federal HIV prevention funds. The FY2024 appropriation for HIV prevention at the CDC was approximately $1 billion, and the CDC spent $1.3 billion on HIV, viral hepatitis, STIs, and tuberculosis in FY2023 (Dawson,2025; Wyte et al., 2025). Thus, a $700 million cut is devastating.

The pushback was bipartisan, as evidenced by Representative Mike Lawler's taking to X to express his concern over the reports. "Our country has been at the forefront of the global fight against HIV and AIDS, and now is not the time to cut programming," he tweeted.

Photo Source: X

Additionally, ADAP Advocacy directed a letter to select Members of the North Carolina Congressional Delegation on the same day the Community Access National Network (CANN) appealed to Members of the Louisiana Congressional Delegation. According to the ADAP Advocacy letter, "North Carolina's effort to address HIV is nearly exclusively funded by the federal government. For example, approximately $42.7M was appropriated for the State AIDS Drug Assistance Program (ADAP), as well as prevention programs funded by President Trump's own Ending the HIV Epidemic initiative (EHE, announced in 2019), including a focus on Mecklenburg County." CANN's letter likewise noted the impact on Louisiana, "Louisiana's effort to address HIV is nearly exclusively funded by the federal government. These dollars, as addressed specifically by prevention programs, including President Trump's own Ending the HIV Epidemic initiative (EHE, announced in 2019), include $5.94M for programs, $1.12M for surveillance activities, and an additional $3M associated with EHE activities. In total, this type of "cut" would amount to the state of Louisiana losing more than $10.06M shift in cost to the state for HIV prevention and surveillance activities for the state of Louisiana alone, even as the state faces a fiscal cliff, making it unlikely that state appropriator, despite their best efforts, to be able to fill the gap caused by program elimination."

The majority of CDC HIV prevention funding is not spent on internal administration. The CDC is a primary funding funnel, with funds distributed to state and local health departments, including community health organizations. The Frannie Peabody Center, Maine's largest provider of HIV and AIDS services, has publicly spoken out against the cuts, as there are an estimated 1,800 Maine residents living with HIV. Executive Director Katie Rutherford stated, “Eliminating this division of the CDC would decimate decades of progress that we have made in fighting an end of HIV and AIDS in the U.S.” (WGME, 2025). 

Photo Source: Courage Forward Strategies

HIV disproportionately affects marginalized communities. Thus, cuts in HIV prevention funding would have disproportionately adverse health outcomes for groups such as Black and Latino gay men. In 2022, among the subpopulation of men who have sex with men, 38% of those who were diagnosed with HIV were Black, and 32% were Latino (Reed, 2025). Texas Health Action, a non-profit that operates several branches of culturally affirming Kind Clinic, states, “HIV prevention is a proven, cost-effective public health strategy. Reducing funding doesn’t save money—it leads to more infections and higher long-term healthcare costs. Nearly 5,000 Texans were diagnosed with HIV in 2022 alone. Cutting these essential programs now would be catastrophic for communities that rely on them.” (Texas Health Action, 2025).

Drastic cuts to HIV prevention funding would also harm the youth. In 2022, 1 in 5 new HIV diagnoses were in the 13 to 24-year-old cohort, and 56% of all new cases were among those 34 and younger (Reed, 2025). Raynard Washington, a county health director in Mecklenburg, North Carolina, when speaking to AXIOS news, stated, “There is nothing more heartbreaking than having to tell a 14-year-old that they have an illness that they won't be able to cure, and they'll have to take medication in various forms for the rest of their life” (Reed, 2025). Sexually active 13-24-year-olds have the highest probability of living with undiagnosed HIV and have lower rates of viral suppression (Hsu & Rakhmanina, 2024). It is imperative to strengthen HIV prevention and education efforts for the youth, not defund them.

In addition to the funding cuts, the administration is considering dismantling the CDC HIV Prevention Department and placing HIV prevention funding under HHS, such as with HRSA. This is also faulty reasoning. The CDC and HRSA are functionally separate entities. HRSA is tasked with HIV healthcare service delivery through the Ryan White HIV/AIDS Program. By statute, except for PrEP delivery at community centers, it is prohibited from providing most HIV prevention services for which the CDC is experienced and structured (Dawson, 2025). Moreover, the Substance Abuse and Mental Health Services Administration (SAMHSA) is considering cuts to its HIV programs (Waters, 2025). SAMHSA funding is crucial because it directs intervention to those who benefit from HIV prevention and substance addiction treatment. Reducing CDC HIV prevention funding, in addition to markedly reducing SAMHSA HIV-related funding, further leaves vulnerable populations subject to increases in HIV transmission and poor health outcomes from poor linkages to care.

Photo Source: HIVMA

During President Trump’s 2019 State of the Union address, he announced a heightened focus on eliminating HIV in the U.S. within ten years (Dawson, 2025). The administration’s Ending the HIV Epidemic in the U.S. Initiative (EHE) aimed to reduce new HIV infections by 90% by 2030. The current discussion of massive cuts to CDC HIV prevention funds starkly contrasts the 2019 EHE goals. Slashing HIV prevention funding means the destruction of programs for outreach, HIV surveillance, PrEP access, and seamless linkages to care.

In a joint statement put out by ADAP Advocacy and Community Access National Network (CANN), Jen Laws, CANN President & CEO, gave a fitting summation of the damage cutting HIV prevention programs will cause. He said, “Prevention programs further support treatment programs with testing, screening activities, and linkage to care upon reactive tests. The economic impact of these programs can be measured in more jobs, more clinics, healthier families, and more productive employees. Conversely, cutting these programs and their associated funding will be measured in terms beyond economic loss. It would be measured in the human toll, the harm to our communities, untreated illness, late diagnoses, families torn apart, and lives lost." (Macsata & Laws, 2025).

[1] Dawson, L. (2025, March 19). Cutting HIV Prevention Funding at CDC: What Would it Mean? Retrieved from https://www.kff.org/quick-take/cutting-hiv-prevention-funding-at-cdc-what-would-it-mean/

[2] Hsu, K., Rakhmannina, N. (2024, May 17). HIV in Children and Teens. Retrieved fromhttps://www.healthychildren.org/English/health-issues/conditions/sexually-transmitted/Pages/HIV-Human-Immunodeficiency-Virus.aspx

[3] Macsata, B., Laws, J. (2025, March 19). Joint Statement On Reported HIV Prevention Funding Cuts. Retrieved from  https://www.adapadvocacy.org/pdf-docs/202_ADAP_Press_Proposed_Cuts_HIV_Prevention_03-19-25-CANN-Joint-Statement.pdf

[4] Reed, T. (2025, March 20). Young people could be most at risk with HIV prevention cuts. Retrieved from https://www.axios.com/2025/03/20/cdc-hiv-prevention-cuts-trump-young-people

[5] Texas Health Action. (2025, March 18). Texas Health Action responds to proposed cuts in HIV prevention funding. Retrieved from  https://dallasvoice.com/texas-health-action-responds-to-proposed-cuts-in-hiv-prevention-funding/

[6] Waters, M. (2025, March 18). Letter to Robert F. Kennedy, Jr. regarding CDC HIV Prevention funding cuts. 

[7] WGME. (2025, March 19). Maine provider for HIV, AIDS services criticizes Trump administration cuts. Retrieved from https://www.msn.com/en-us/health/other/maine-provider-for-hiv-aids-services-criticizes-trump-administration-cuts/ar-AA1BgFhD?ocid=socialshare

[8] Wyte, L., Mosbergan, D., Rockoff, J. (2025, March 18). Trump Administration Weighing Major Cuts to Funding for Domestic HIV Prevention. Retrieved from https://www.wsj.com/health/healthcare/trump-administration-weighing-major-cuts-to-funding-for-domestic-hiv-prevention-8dcad39b

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Putting Politics Ahead of Public Health is Spelling Trouble for Tennessee

By: Ranier Simons, ADAP Blog Guest Contributor

In 2023, Tennessee Governor Bill Lee, rejected nine million dollars in federal HIV funding from the Centers for Disease Control & Prevention (CDC). This meant that the pass-through grant contracts associated with the Integrated HIV Programs for Health Departments to Support Ending the Epidemic in the United States CDC-RFA-PS20-2010 grant and the Tennessee Integrated HIV Surveillance and Prevention Programs for Health Departments CDC-RFA-PS18-1802 grant ended in May of 2023.[1] The decision meant a significant cut in funding for HIV prevention, education, and treatment for public health centers and many community-based organizations. The adverse effects of the decision are materializing, and experts continue to sound the alarm about how devastating the outcomes will impact the state.

Photo Source: The Tennessee Conservative

The governor stated he refused the funds to decrease dependence on federal funds and be more independent as a state. He also expressed that the move was to make it easier for organizations and public health departments to access funding without having to deal with bureaucratic red tape.[2] However, analysis shows that the decision was politically motivated. Lee is on public record expressing disapproval of two organizations that were HIV grant recipients, Planned Parenthood and a task force on transgender health issues.[3] Refusing CDC funding means that the state is no longer required to distribute funding based on science, evidence-based data, and research. The goal of the state was to replace the CDC funds with state funding.

In response to Tennessee’s refusal of funding, the CDC decided to try and circumvent the legislature. It decided to directly provide four million dollars in funding to United Way of Greater Nashville.[4] This would allow United Way to distribute funds to nonprofit organizations, such as Planned Parenthood, to continue their HIV prevention efforts. However, four million dollars is only half of the nine million dollars refused.

When the state government replaced the lost CDC funding with state funding, it was mainly local health departments that were guaranteed funding to make up for the cuts.[4] This meant the state health departments could make decisions concerning funding distribution that did not require alignment with CDC requirements. This was eventually followed by an announcement to reallocate funding away from the most at-risk priority communities, such as men who have sex with men, to new groups. The new groups are first responders, pregnant women, and survivors of sex trafficking. Studies are showing that this will result in unnecessary deaths and poor health outcomes because this group is not where the need resides.

Photo Source: Clinical Infectious Diseases

A study published in July of this year in the journal Clinical Infectious Diseases spells out the negative ramifications of Tennessee’s state resource allocation. Men who have sex with men, transgender women, and heterosexual Black women are the evidenced-based identified priority demographic most affected by HIV in Tennessee.[5] The study projected conservative estimates the Tennessee decision would mean 166 preventable HIV transmissions, 190 additional deaths, and 843 life-years lost over 10 years. The study’s more pessimistic or worst-case scenario projections were 1359 preventable HIV transmissions, 712 additional deaths, and 2,778 life-years lost over 10 years.[5] 

Comparatively, this means the reallocation in funding would be prohibitively damaging to the original priority group with negligible benefit for the new priority pivot. “Under Reallocation, MSM would comprise most of the HIV transmissions (77%), followed by TGW (8.6%) and HSBW (6.8%). First responders would contribute 0.5%, pregnant people 0.2%, and SST 6.9% to the total HIV transmissions over 10 years.”[5] The newly suggested priority populations only comprise %1 of all Tennesseans living with HIV compared to the CDC-defined priority populations, which comprise %99 percent.[6]

Funding losses have already begun to negatively affect agencies serving vulnerable populations. Before the change, CDC grant money provided stability for HIV programming for five years at a time. The new state-provided funds happen on a one-year cycle. The one-year budget rides on the auspices of the state legislature, which votes on it each year.[7] Reduced funding means loss of staff for many organizations. According to Amna Osman, CEO of Nashville CARES, “There’s no sustainable grant funding to support these positions…Employees really want some stability.”[7]

Moreover, the new funding plan routes money mainly to metro state health departments and groups associated with them. This translates into a drastic cut to resources for those in rural areas in addition to groups who, under the new reallocation priorities, would not be able to garner funding from the state. 

Photo Source: The New York Times

The motivation behind the original CDC funding was to concentrate efforts on HIV prevention, education, and treatment for those most in need in Tennessee. Prevention requires testing, surveillance, access to PrEP, and more. Before the funding reallocation, a third of those most in need of PrEP did not know where they could access it. Now, issues of access have worsened. Osman states she has heard from community members who say, “Well, I’m hearing there’s no dollars for prevention education for HIV. Then, that means ‘I think there’s no money for me to get a service,”[7] Memphis, Tennessee is second in the nation regarding the rate of new HIV cases. Over 7,500 people in Shelby County alone are living with HIV or AIDS.[8] That number is second only to Miami, Florida.[8]

HIV prevention and testing is not just about HIV. Testing involves STI testing. STI testing benefits the entire community as a public health safeguard as well as a tool in the fight to prevent HIV transmission. People living with HIV do not live in a vacuum, nor do those living with STIs. Effectively focusing funding and infrastructure on the populations that science and health professionals have identified as significantly at risk is the only way to reverse the tide in all of Tennessee’s communities. Only time will tell if voting and continued public and professional outcry, in combination with pressure from the medical community, will result in the legislature changing its course.

[1] Talley, P. (2023, January 17). Dear Colleagues Letter. Retrieved from https://wpln.org/wp-content/uploads/sites/7/2023/01/Notification-HIV-Funding-Changes.pdf

[2] Stillman, J. (2023, April 22). Tennessee Rejected HIV Funds From Feds, But The State Was Just Outsmarted. Retrieved from https://www.hivplusmag.com/politics/tennessee-rejected-hiv-funds-from-feds-but-the-state-was-just-outsmarted

[3] Cha, A., Nirallil, F. (2023, Januery 26). HIV at center of latest culture war after Tennessee rejects federal funds. Retrieved from https://www.washingtonpost.com/health/2023/01/26/tennessee-federal-hiv-funding/

[4] Watts, M. (2023, April 17). Federal HIV funding rerouted to nonprofits, bypasses Tennessee health department entirely. Retrieved from https://www.tennessean.com/story/news/local/2023/04/17/hiv-federal-funds-will-reroute-to-tennessee-nonprofits-state-cut-out/70116510007/

[5] Borre, E. D., Ahonkhai, A. A., Chi, K. K., Osman, A., Thayer, K., Person, A. K., Weddle, A., Flanagan, C. F., Pettit, A. C., Closs, D., Cotton, M., Agwu, A. L., Cespedes, M. S., Ciaranello, A. L., Gonsalves, G., Hyle, E. P., Paltiel, A. D., Freedberg, K. A., & Neilan, A. M. (2024). Projecting the potential clinical and economic impact of human immunodeficiency virus prevention resource reallocation in Tennessee. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae243

[6] Ridings, M. (2024, July 11). Study Finds That Tennessee’s Shift in HIV Prevention Funding Will Lead to Poorer Health Outcomes for its Residents. Retrieved from https://www.massgeneral.org/news/press-release/tennessee-shift-in-hiv-policy-will-lead-to-poorer-outcomes

[7] Sweeney, C. (2024, October 22). Tennessee replaced its federal HIV funding with state money. Public health experts say the change is causing damage. Retrieved from https://www.wkms.org/health/2024-10-22/tennessee-replaced-its-federal-hiv-funding-with-state-money-public-health-experts-say-the-change-is-causing-damage

[8] Paul, A. (2024, August 13). Memphis ranks second in the nation in highest number of new HIV cases. Retrieved from https://wreg.com/news/memphis-ranks-second-in-the-nation-in-highest-number-of-new-hiv-cases/l

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

HRSA Offers Guidance on Doxy-PEP to Stem the Tide of Rising STIs Among PLWHAs

By: Ranier Simons, ADAP Blog Guest Contributor

According to the Centers for Disease Control & Prevention (CDC), there were 2.5 million reported cases of gonorrhea, chlamydia, and syphilis in the United States in 2022.[1] The rates of sexually transmitted diseases (STIs) have been increasing globally, which is of particular concern for people living with HIV/AIDS (PLWHA). One strategy that is proving highly successful in combatting the spread of STIs is Doxy-PEP (post exposure prophylaxis).

Photo Source: The Washington Post

The presence of HIV in the body can, in some cases, make it harder to treat STIs.[2] Additionally, an STI can increase the HIV viral load in PLWHA who are not on treatment regimens.[3] For those with good antiretroviral adherence, an STI is not likely to change someone from undetectable to detectable. However, the numerous harms STIs inflict on the body make it essential to reduce STIs' impact on PLWHA. The Health Resources & Services Administration (HRSA) recently issued a letter to Ryan White HIV/AIDS Program (RWHAP) colleagues emphasizing their role in lowering the risk of STIs for PLWHA, as well as awareness of new clinical guidelines on the use of doxy PEP in preventing bacterial STIs.[4]

Doxy-PEP is the administration of 200 mg of doxycycline within 24-72 hours of condomless anal, vaginal, or oral sex and should not exceed a maximum of 200mg in any 24hr period.[5] Studies have shown that Doxy-PEP reduces syphilis and chlamydia infections by more than 70% and gonococcal infections by approximately 50%.[5]

Men who have sex with men (MSM) and transgender women (TGW) have been identified as groups disproportionately affected by STIs. Thus, CDC guidelines recommend that medical professionals target MSM and TGW who have had a bacterial STI in the past twelve months to offer education and counseling on the benefits of Doxy-PEP. After counseling and education, if desired, providers should provide prescriptions for Doxy-PEP to be self-administered.[5]

Photo Source: The PrEP Clinic

HRSA’s letter specifically encourages RWHAP recipients to adopt the CDC guidelines and integrate Doxy-PEP into their protocols and clinical programs. The letter also urges state AIDS Drug Assistance Programs (ADAPs) to add Doxy-PEP to their drug formularies to facilitate equitable access and coverage for their eligible populations. In case they are unaware, HRSA reminds RWHAP colleagues that purchasing Doxy-PEP is an allowable cost. “RWHAP Parts A, C, and D recipients may contribute RWHAP funds to ADAPs to purchase medications and/or health care coverage and medication cost sharing for ADAP-eligible clients.”[4]

Proper administration of Doxy-PEP requires STI testing every three to six months, as well as evaluation of the appropriateness of continued utilization of doxy PEP.[5] Increasing the number of those utilizing the antibiotic intervention will also increase the instances of contact with care professionals. Increased contact means more opportunities for strengthening linkages to care and exploration of other points of need. One of the main goals of RWHAP is to improve the health outcomes of PLWHA. Adoption of Doxy-PEP practices and protocols would be another tool to add to comprehensive whole-person care along with established practices such as harm-reduction and risk-reduction counseling, facilitating access to PrEP, and regular STI testing.

Photo Source: The PrEP Clinic

Notably, HRSA’s letter highlighted the RWHAP Part F's AIDS Education and Training Center (AETC) Program and the RWHAP Part F Special Projects of National Significance Addressing STIs: “Ask. Test. Treat. Repeat.” Initiative.[6,7] Both programs provide training and information on the proper implementation of Doxy-PEP and ways to adopt and normalize routine testing of STIs. This letter from HRSAs HIV/AIDS Bureau is more than just an F.Y.I. It is a tangible outreach of support for RWHAP colleagues. 

Ryan White-funded organizations work tirelessly to stretch federal dollars to improve the health and well-being of the vulnerable populations of PLWHA they serve. Clear guidance on Doxy-PEP and the proliferation of educational resources directly acknowledges that the federal government is an active partner with and sees and embraces the efforts of RWHAP recipients.

[1] CDC. (2024, January 30). CDC’s 2022 STI Surveillance Report underscores that STIs must be a public health priority. Retrieved from https://www.cdc.gov/std/statistics/2022/default.htm

[2] U.S. Department of Health & Human Services. (2024, June 27). Sexually Transmitted Infections. Retrieved from https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/sexually-transmitted-diseases#:~:text=Many%20STIs%20do%20not%20have,if%20you're%20sexually%20active.

[3] Stanford, A. (2023, September). Undetectable viral load and HIV transmission. Retrieved from https://www.aidsmap.com/about-hiv/undetectable-viral-load-and-hiv-transmission

[4] HRSA. (2024, July 31). Letter to Ryan White HIV/AIDS Program Colleagues. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/hab-doxy-pep-clinical-guideline-bacterial-sti-prevention.pdf

[5] CDC. (2024, June 6). CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024. Retrieved from https://www.cdc.gov/mmwr/volumes/73/rr/rr7302a1.htm

[6] AIDS Education and Training Center Program. https://aidsetc.org/topic/sexually-transmitted-infections

[7] TargeyHIV.org. (2024). Addressing STIs: Ask. Test. Treat. Repeat. https://targethiv.org/intervention/addressing-stis-ask-test-treat-repeat?utm_source=bpURL

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Ending the HIV Epidemic Data Shows Hits, and Misses

By: Ranier Simons, ADAP Blog Guest Contributor

Numbers may be boring, but when it comes to matters of life and death, numbers are essential, and quality data is indispensable. The Centers for Disease Control and Prevention (CDC) last week released its most recent HIV Incidence and Prevalence report.[1,2] The report is based on data from 2018-2022, with the data gathering completed in December 2023. The U.S. is not currently on track to reach Ending the HIV Epidemic (EHE) 2025 and 2030 prevention goals.[3] While progress is being made, there remains much work that needs to be done.

Photo Source: HIV.gov

Overall, estimated new HIV infection rates declined 12% in 2022 in comparison to 2018 among people 13 years of age or older.[2] The overall rate of decline encompasses higher levels of decline of specific groups. Bear in mind that the 12% decrease is attributed to a decline among men. No statistically significant change was observed among females. It is important to note the data is based on the sex assigned at birth (SAAS).[2] Although there was an overall decrease in the rate of new HIV infections, it is important to note that in 2022, 81% of all new infections were among males.[2]

A notable decrease, giving optimism for future trends occurred among young people. The largest reduction in HIV infections in 2022 compared to 2028 was among men ages 13-24, at 30%. The decrease was predominately among gay and bisexual men. The CDC suggests the data shows efforts to reach that demographic are working regarding testing, treatment, and PrEP uptake.

Concerning race and ethnicity, the new report indicated an 18% decrease in the HIV infection rate among people identifying as Black/African American.[2] In 2022, 37% of all new infections were among Black/African American persons, and the highest rate of infection was observed among the same group. The 18% decrease is undoubtedly a positive progression. However, people identifying as Black/African American are only 12% of the general population. Thus, the high infection rate informs the existence of factors causing disparities that need to be examined and corrected. The highest rates of new infection in 2022 in the US (per 100,000 people) were Black/African Americans at 34.1, those identifying as multiracial at 21.6, and Hispanic/Latino persons at 20.7.[2]

Photo Source: CDC

Regionally, data indicates a welcome improved trend in the South. Even though 49% of new infections in 2022 were in the South, the region experienced a 16% decrease in new infection rate.[2] Regional rates were 14.5 South, 11.0 West, 8.9 Northeast, and 7.4 Midwest.[2] The South historically has a heavy burden of HIV in comparison to the rest of the country. Much of that has been driven by socioeconomic factors. The region has the highest poverty rate and lowest household median income.[2,5] The South is also characterized as having the highest knowledge gap of HIV status in the US. In 2022, the report indicates that 14 out of 100 people 13 years of age and older in the South were unaware of their HIV status.[2] Lack of knowledge of status could mean untimely receipt of medical care and treatment.

The category of transmission was another positive area showing a decrease. There was a 10% decrease in new infections attributed to male-to-male sexual contact (MMSC) and a 27% decrease when grouping together MMSC and injection drug use (IDU).[2] There were no changes detected regarding heterosexual contact and IDU, nor infections among females. In 2022, 67% of all new HIV infections were a result of MMSC. Among male new infections, 83% were attributed to MMSC. Thus, the 10% decrease is a step in the new direction.

These trends are just a few of the positive highlights revealed in the latest CDC HIV surveillance report. While positive, statistics show that the US is not on track with EHE goals and lags improvements made in other developed countries. Hopefully, this new data will continue to drive optimism as well as drive continued scientific, financial, legislative, and social bolstering of the multifaceted fight to eradicate HIV.

[1] CDC. (2024, May 21). Estimated HIV Incidence and Prevalence. Retrieved from https://www.cdc.gov/hiv-data/nhss/estimated-hiv-incidence-and-prevalence.html?CDC_AAref_Val=https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-28-no-3/index.html

[2] CDC. (2024, May 21). HIV Surveillance Supplemental Report: Estimated HIV Incidence and Prevalence in the United States, 2018–2022. Retrieved from https://stacks.cdc.gov/view/cdc/156513.

[3] CDC. (2024, March 30). Ending the HIV Epidemic in the US Goals. Retrieved from  https://www.cdc.gov/ehe/php/about/goals.html

[4] Carson-Holt, E. (2024, May 2024). HIV transmissions down by 12%. One age group in particular is bringing those numbers down. Retrieved from https://www.lgbtqnation.com/2024/05/hiv-transmissions-down-by-12-this-age-group-in-particular-is-bringing-those-numbers-down/

[5] AIDSVU. (2024). Deeper Look: HIV in the South. Retrieved from https://aidsvu.org/resources/deeper-look-south/#:~:text=The%20heavy%20burden%20of%20HIV,factors%20like%20poverty%20and%20unemployment.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

U=U Principles Now Includes Breast Feeding

By: Ranier Simons, ADAP Blog Guest Contributor

The phrase ‘undetectable equals untransmittable’, commonly referred to as U=U, originated from the efforts of the Prevention Access Campaign in 2016.[1] This phrase explains the current scientific consensus that a person living with HIV (PLWHA) who has undetectable levels of the virus in their blood does not pose an infection risk and will not sexually pass the virus on to their partners.[2] Medical research is proving that U=U extends past sexual activities. A recent May 2024 clinical report released by the American Academy of Pediatrics (AAP) indicates evidence shows it is acceptable for HIV-positive mothers to breastfeed.[3] This is a reversal of previous guidance banning the activity.

Photo Source: CNN.com

Recommendations against breastfeeding by PLWHA date as far back as 1985, following the start of the HIV pandemic. This was well before the advent of modern antiretrovirals (ART). Before ART, about 30 percent of maternal-to-infant HIV transmission occurred during breastfeeding. In the early 1990s, there were about 2000 breastmilk-related transmissions annually in the US. Presently, the risk of maternal-to-infant HIV transmission from a parent who is on ART and is virally suppressed is less than one percent.[3]

The recently updated guidelines from the AAP follow 2023 updated recommendations by an advisory panel to the U.S. Department of Health and Human Services (HHS). That panel recommendation stated, “People with HIV should receive evidence-based, patient-centered counseling to support shared decision-making about infant feeding…individuals with HIV who are on ART with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision”.[4] In order to allow PLWHA to breastfeed safely, the AAP updated guidance lists specific requirements. ART must be initiated early in or before the pregnancy, sustained viral suppression must be maintained along with consistent access to ART, and infant prophylactic medication must be administered.[3] The guidelines also recommend regular monitoring of the parent’s viral load. Additionally, research indicates that if PLWHA are going to breastfeed, they must exclusively breastfeed for the first six months of the infant’s life without switching back and forth to formula.[3] Switching could increase transmission risk due to interruptions in the infants’ gut environment.

About 5,000 PLWHA give birth annually.[5] The new guidelines end the history of denying PLWHA the bond created between parent and child with breastfeeding. 

Photo Source: The Well Project

Bruce Richman, the Executive Director of the Prevention Access Campaign, explains, “This is incredible news for the rights, choice, and autonomy of people living with HIV and the joy and intimacy of parenthood! Too many people living with HIV faced criminalization and having their infants removed by child protective services if they chose to breastfeed or chestfeed despite this being a safe method when undetectable." 

Richman further stated the updates to guidance for pediatricians complement the recent HHS and Centers for Disease Control & Prevention [CDC] guidelines updates and further support people living with HIV in making healthy reproductive choices for themselves and their infants.” 

Breastfeeding has health-related benefits for both parent and infant in addition to the familial bond. Breastmilk provides optimal infant nutrition and protection from morbidity and mortality from infectious diseases, allergic conditions, obesity, diabetes, autoimmunity, and sudden infant death syndrome.[3] Breastfeeding protects the parent from breast and ovarian cancer, hypertension, and type 2 diabetes.[3]

Pediatricians and physicians receive their clinical guidance from groups such as the CDC, HHS, and AAP. It is crucial that these new guidelines be widespread and utilized to change the current paradigm of many medical professionals. Unfortunately, many clinicians still hold outdated attitudes regarding HIV as well as they are not up to date on evidence-based science. The new AAP guidelines will enable clinicians to support PLWHA in their decision to breastfeed and empower them to be partners in their care instead of just being told what they can and cannot do with their bodies and infants. The AAP plans to have webinars for clinicians concerning the new guidelines in hopes of effecting widespread adoption of the latest evidence-based recommendations.

Photo Source: American Academy of Pediatrics

Not only is U=U positively affecting breastfeeding, but it is enabling freedoms for PLWHA concerning conception. In the United Kingdom, laws are changing that will now allow heterosexual and same-sex couples with non-transmissible HIV to become parents.[6,7] Amendments to the Human Fertilization and Embryology Act will allow PLWHA with undetectable viral status to donate eggs or sperm to their partners. 

Current IVF law only allows male PLWHA to donate sperm to their female partners exclusively. This means that before the law changed, they could not donate to family or friends. Additionally, the law amendment will allow female same-sex couples undergoing shared motherhood IVF treatment to conceive. In the shared IVF treatment, one partner of the sero-discordant couple provides the egg, and the other carries the embryo.[6] The stipulations for PLWHA wishing to donate under the new law are: they have to have a sustained undetectable viral load, have to prove they have been on ART for at least six months prior to donation, and the person receiving the gamete consents and is aware of the donor’s HIV status.[6]

Not only have medical advancements changed an HIV diagnosis from a death sentence to a matter of chronic disease management, but they are continually taking the shackles off PLWHA's ability to live their lives. HIV stigma still exists. However, the more the understanding of U=U spreads, the easier the lives of PLWHA will become. Moreover, as medical advancements continue, U=U and future achievements will allow PLWHA to live as wholly integrated members of society defined by their humanity and not their disease.

[1] Third Amended Class Action Complaint. (2023, October 24) ). Retrieved from https://consumerwatchdog.org/wp-content/uploads/2023/11/2023-10-24-241_Third-Amended-Complaint.pdf

[2] John Doe One et al. v. CVS Pharmacy Ruling. (2024, April 18). Retrieved from https://www.courthousenews.com/cvs-medication-program-discriminates-against-hiv-aids-patients-judge-says/john-doe-one-et-al-v-cvs-pharmacy-et-al-mtd-ruling/

[3] Doe One et al. v. CVS Health Corporation et al. (2018, March 21). Retrieved from https://dockets.justia.com/docket/ohio/ohsdce/2:2018cv00238/211764

[4] Faul, A. (2018, March 29). CVS Health unintentionally revealed HIV status of 6,000 customers: Lawsuit. Retrieved fromhttps://abcnews.go.com/Health/cvs-health-unintentionally-revealed-hiv-status-6000-customers/story?id=54095674

[5] Schladen, M. (2018, June 29). State, CVS sued over HIV mailing. Retrieved from https://www.dispatch.com/story/news/politics/elections/2018/06/29/state-cvs-sued-over-hiv/11624806007/

[6] AIMED Alliance. (2020, May 15). CVS Health to Settle Lawsuit for Revealing HIV Status of Over 4,500 Patients. Retrieved fromhttps://aimedalliance.org/cvs-health-to-settle-lawsuit-for-revealing-hiv-status-of-over-4500-patients/

[7] Accetta, L. (2021). Expanding therapies, indications and implications for payors: Pipeline trends that will drive change in 2022. Retrieved from https://business.caremark.com/insights/2021/expanding-therapies-indications-and-implications-payors.html   

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Understanding Atlanta’s Persistently High Rate of HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Since the 1950s, Atlanta is commonly known as “Hot Lanta” popularized by the Allman Brothers Band’s song because of its hot and humid climate.[1] But the weather isn't the only thing "hot" in Atlanta as the metro area surrounding the city has become a burning epicenter of new diagnosis for HIV.

Photo Source: ANIZ

Proper data collection and analysis take time. This is especially true regarding public health surveillance and research. It is better to have robust sourcing of quality data collection than analysis of rushed volumes of collected data.[2] The Centers for Disease Control & Prevention (CDC) recently released a national HIV data analysis of infection rates from 2021. Overall, the national rate of new HIV infections has been decreasing over the past few years. However, this is not entirely true for the South.[3] Reporting indicates problematic infection trends in several southern metropolitan areas, one such area being metro Atlanta. 

Data shows that in 2021, metro Atlanta had the third highest new HIV infection diagnosis rate of metropolitan areas, only bested by Miami, Florida, and Memphis, Tennessee.[3] This data gives added context to preliminary data observed presently in 2024. According to Dwayne Ford, director of HIV prevention services with AIDS Atlanta, there are more reported positive individuals living with HIV in the first quarter of 2024 than in the first quarter of 2023.[4]

Various treatment and prevention tools exist, so healthcare professionals and community groups are trying to identify where more work needs to be done to reverse Atlanta and Georgia’s new infection rates. While metro Atlanta is the third highest ranking in new infections for metropolitan areas, Georgia is fourth overall as a state. One challenging area of concern is funding. Georgia is one of the few states that have not expanded Medicaid. If Georgia fully expanded Medicaid as allowed under the Affordable Care Act, over half a million Georgia residents would become eligible for health insurance.[5] 

Photo Source: Atlanta Journal Constitution

This would enable over half of the Georgian residents who are uninsured and enrolled in the Ryan White program to be moved to Medicaid. They would still be able to get all the care they received under Ryan White in addition to other services not available through Ryan White. That, in turn, would free up approximately $53.7 million of Ryan White funding to help non-Medicaid eligible people living with HIV not presently accessing services.[4] Treatment is prevention since increasing the number of people on ART means increasing viral suppression, lowering the number of those able to transmit HIV. Moreover, expanding Medicaid would mean increasing access to PrEP since Ryan White Funding cannot be used for PrEP medications nor its associated medical visits and laboratory testing.[6] African American and Hispanic males comprised the majority of reported new HIV infections yet have much lower utilization of PrEP in comparison to white residents.[3]

Access is a significant issue for low-income residents and the African American and Hispanic populations, which are disproportionately represented in new infection numbers. However, stigma is also still an issue.[3] In African American and Hispanic communities, HIV stigma remains a barrier to care, testing, and support. Efforts to encourage and expand testing lose impact when those who discover their positive status do not seek treatment. It is vital to bolster efforts to get newly diagnosed individuals into treatment as soon as possible and to help them remain in treatment. Support is needed since fear and privacy concerns hinder vulnerable populations from wanting their medications discovered by friends and family. Additionally, fear of the stigma of being seen at public clinics or other healthcare facilities hinders proper follow-up care and testing.

Support and prevention are the two areas many concerned parties are focusing on. Expanding prevention efforts such as PrEP access, education, and culturally competent messaging are imperative. Improving upon existing measures to help those negatively affected by social determinants of health, such as lack of transportation and insurance, is also necessary. 

Photo Source: endhivatl.org

The Fulton County Department for HIV Elimination recently launched a new website, ENDHIVATL.ORG,  in response to the metropolitan Atlanta area epidemic. Citizens can use the site to find service providers based on the services they provide and their proximity to where they live. The site also provides up-to-date information concerning how and where to access PrEP and other medical and non-medical services. To help address stigma, the site has a prominently displayed section entitled ‘Positive & Proud.’ It contains personal stories of local community members living with HIV regarding their lives in general and their experiences with utilizing the Department for HIV Elimination services. There is even a section of the site dedicated to assisting healthcare providers.

Atlanta’s high rate of HIV infection has persisted for years. While rates have declined slightly, they are still disproportionately higher than the rest of the country. Hopefully, continued efforts to highlight the status quo, maintain awareness, and provide further support and prevention will soon result in improved lives and outcomes.

[1] Kane, Deborah (2024, April 10). What is the nickname of Atlanta Georgia? NCESC. Retrieved from https://www.ncesc.com/geographic-faq/what-is-the-nickname-of-atlanta-georgia/

[2] Chiolero, A., Tancredi, S., & Ioannidis, J. P. A. (2023). Slow data public health. European journal of epidemiology, 38(12), 1219–1225. https://doi.org/10.1007/s10654-023-01049-6

[3] Gaines, J. (2024, April 1). New HIV case rate in metro Atlanta third highest in nation. Retrieved from https://www.ajc.com/news/atlanta-news/new-hiv-case-rate-in-metro-atlanta-third-highest-in-nation/6TDMS6CUTZG7RPVPRLE6O3JZCY/

[4] 11Alive. (2024, April 4).HIV cases on the rise in metro Atlanta - What local clinic says about it. [Video]. YouTube. https://www.youtube.com/watch?v=h2jh2TgxfcQ&list=WL&index=1

[5] Equality Foundation of Georgia. (2022). Implications of Medicaid expansion on Georgia's HIV Budget. Retrieved from https://georgiaequality.org/wp-content/uploads/2022/01/REPORT-Medicaid-Expansion-and-Ryan-White.pdf?emci=61ee3ed9-f179-ec11-94f6-c896650d4442&emdi=ea000000-0000-0000-0000-000000000001&ceid=

[6] Department of Health and Human Services. (2021, November 16). HRSA Letter to Ryan White Program Colleagues. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/hiv-care/prep-dcl-november-2021-508.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Evidence Suggests Long-Acting Injectables Game Changer for Adherence

By: Ranier Simons, ADAP Blog Guest Contributor

Adherence to medication is one of the most important tenets of antiretroviral therapy (ART) for people living with HIV (PLWH). Adherence is taking the appropriate medications in the proper dosages on the correct schedule. Reaching an undetectable viral load requires strict adherence, with which many PLWH have difficulty for various reasons. The recent innovation of long-acting injectables (LAI) is an attempt to strengthen adherence for PLWH who have difficulty with pill regimens. In January 2021, the U.S. Food & Drug Administration (FDA) approved Cabenuva, the first injectable drug combination for HIV.[2,5] GSK recently released results from clinical trial data indicating Cabenuva works better than daily pills for patients with adherence challenges.[1,4,5,6]

Photo Source: Pharmalive

Cabenuva is a two-injection regimen of cabotegravir and rilpivirine administered either once a month or once every two months.[7] This month, GSK released data from the LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study comparing the efficacy of Cabenuva in contrast with daily pill regimens regarding adherence.[1] The screened participants were verified as having challenges with ART adherence. They were initially given a three-drug oral ART regimen, receiving comprehensive and incentivized adherence support.[1] Once they were virally suppressed, they were randomly selected to receive Cabenuva injections every four weeks or continue with daily pill therapy.[1] The strong evidence of superior efficacy of Cabenuva over daily pill therapy led the Data Safety Monitoring Board (DSMB) for Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) to recommend removal of the randomization and offer all participants the option to take Cabenuva.[1]

This new development is an optimistic win in the fight against HIV. Joey Wynn, activist and chair of the ADAP Long-Acting Injectables Patient Advisory Committee, states, “Although definitely not for everyone, this is the next phase of evolution in HIV therapy. Injections allow us to get on with our lives and not be weighed down with the daily burden of taking pills.” 

There are many reasons daily pill therapy adherence is a challenge for some. Psychologically, taking daily pills is a reminder of disease that is too much for some to handle. There are people with developmental challenges who can't keep up a daily regimen. Stigma and privacy are adherence challenges for PLWH in living situations that are not safe or supportive, where the discovery of medication bottles is not ideal or dangerous.[2,3]

Photo Source: NIAID

As Riley Johnson, project manager for ADAP Advocacy's Long-Acting Injectables Project, points out, “LAIs can mean consistent medication instead of having meds lost or stolen and having to navigate bureaucratic hoops to pursue replacement.”

While very promising, Cabenuva does have hurdles to its implementation. Presently, there are three main criteria to be eligible for Cabenuva. It is only approved for PLWH who are virally suppressed, have documented absence of resistance to either cabotegravir or rilpivirine, and have no prior antiretroviral treatment failures.[2] Viral suppression requires adherence to oral medication, which is the challenge LAIs were created to remedy. In 2019, the Centers for Disease Control & Prevention (CDC) estimated that only 56.8% of PLWH were virally suppressed or undetectable.[2] This means that less than half of PLWH in the U.S. would qualify for Cabenuva. 

Just as with pill regimens, cost is also a hurdle for widespread adoption. The wholesale acquisition cost of the initial/loading dose is $5,940, and monthly/maintenance injections are $3,960.[5] Insurance companies must approve Cabenuva before patients can begin therapy. This is an access issue for those who do not have medical insurance. It is also an access issue for those with insurance because some insurance companies do not have an official classification of Cabenuva as a pharmaceutical or healthcare benefit. Thus, even though ViiV Healthcare has a payment assistance program for those who have commercial insurance, the lack of clarity of benefit status means ambiguity in which costs will be billed to patients and which to insurance companies.[2]

Studies have shown that multiple social determinants of health affect many patients' ability to maintain adherence regarding pill regimens. The same challenges apply to Cabenuva. Cabenuva must be administered in a healthcare setting by a health professional. Even though the visits would only be monthly or bi-monthly, that still poses a challenge for PLWH who lack reliable and affordable transportation. While pill forms of the medications are available for emergency doses if a patient misses an injection, on-time injections of Cabenuva are imperative to ensure resistance to either of the components does not occur.[2] Shipping doses of emergency medication is not viable for people with unstable housing or living situations where receiving medication is not optimal.

Photo Source: HIV.gov

Widespread adoption of Cabenuva also requires providers to adopt changes. Currently, with HIV healthcare, patients on established therapy only see their infectious disease doctors once or twice a year, and the responsibility of pill treatment adherence is on the patient. With Cabenuva injections, the facility's operational flow is disrupted since the injections require more frequent visits. Additionally, responsibility is added to the medical practices by ensuring patients do not miss their injection appointments and following up with them when they do. Moreover, practitioners must be trained in the z-track injection technique required for the intramuscular injection and have proper refrigeration equipment to store the Cabenuva between 2°C and 8°C.[8]

The recent data from the Cabenuva trial is a promising step in the right direction, though not without its challenges. Joey Wynn adds, “Understandably, there are issues of access for those on private insurance, clinic flow issues, and limited distribution shortages, meaning advocates need to demand improved pipeline delivery from the manufacturer so people can get what they need/want/require with less difficulties.” Riley Johnson adds, “no degree of adherence is possible if the medication is not available or accessible.” To ensure the success of the LAI landscape, policy and holistic community support will be required to keep up with the advances of science.

[1] GSK. (2024, February 21). Press release: LATITUDE phase III interim trial data indicates ViiV Healthcare’s long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) has superior efficacy compared to daily therapy in individuals living with HIV who have adherence challenges. Retrieved from https://www.gsk.com/en-gb/media/press-releases/latitude-phase-iii-interim-trial-data-indicates-cabenuva-has-superior-efficacy-compared-to-daily-therapy/

[2] Pinto, R. M., Hall, E., & Tomlin, R. (2023). Injectable Long-Acting Cabotegravir-Rilpivirine Therapy for People Living With HIV/AIDS: Addressing Implementation Barriers From the Start. The Journal of the Association of Nurses in AIDS Care: JANAC, 34(2), 216–220. https://doi.org/10.1097/JNC.0000000000000386

[3] Simoni, J. M., Tapia, K., Lee, S. J., Graham, S. M., Beima-Sofie, K., Mohamed, Z. H., Christodoulou, J., Ho, R., & Collier, A. C. (2020). A Conjoint Analysis of the Acceptability of Targeted Long-Acting Injectable Antiretroviral Therapy Among Persons Living with HIV in the U.S. AIDS and Behavior, 24(4), 1226–1236. https://doi.org/10.1007/s10461-019-02701-7

[4] Hart, R. (2024, February 21). First long-acting injectable HIV treatment works better than daily pills for some patients, GSK says. Retrieved from https://www.msn.com/en-us/health/other/first-long-acting-injectable-hiv-treatment-works-better-than-daily-pills-for-some-patients-gsk-says/ar-BB1iDCzR?ocid=socialshare

[5] Bernstein, L. (2021, January 22). FDA approves breakthrough injectable HIV medication. Retrieved from FDA approves breakthrough injectable HIV medication

[6] Liu, A. (2024, February 21).GSK’s long-acting HIV med Cabenuva beats daily therapy in patients who've faced adherence hurdles. Retrieved from https://www.fiercepharma.com/pharma/cabenuva-trial-modified-gsks-long-acting-hiv-med-beat-daily-therapy-patients-adherence

[7] VIIV Healthcare. (2024, January). Cabenuva. Retrieved from https://www.cabenuva.com/  

[8] De Vito, A., Botta, A., Berruti, M., Castelli, V., Lai, V., Cassol, C., Lanari, A., Stella, G., Shallvari, A., Bezenchek, A., & Di Biagio, A. (2022). Could Long-Acting Cabotegravir-Rilpivirine Be the Future for All People Living with HIV? Response Based on Genotype Resistance Test from a Multicenter Italian Cohort. Journal of personalized medicine, 12(2), 188. https://doi.org/10.3390/jpm12020188

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.