Choice, Access and Equity at AIDS 2024

Choice, access, and equity were central themes during the sessions and discussions at #AIDS2024 on Wednesday and Thursday. Highlights included new data on long-acting cabotegravir, a plenary calling out the need to move with speed, scale and equity in the rollout of new PrEP options, updated guidelines to improve access to post-exposure prophylaxis (PEP), a renewed commitment to the African Women’s Choice Manifesto, new data highlighting the omission of key populations from sustainability planning, and much more.

Click below to access AVAC’s daily reports from #AIDS2024 and read on for Wednesday and Thursday highlights.

Key Steps for Choice

The African Women’s Prevention Accountability Board (AWPCAB) continued to raise their voices and call on the international community to prioritize expanded access to existing products such as the dapivirine vaginal ring and injectable cabotegravir and developing new methods to ensure a range of prevention options for women and girls. Winnie Byanyima of UNAIDS pointed to her commitment to the Choice Manifesto, a declaration put forward by AWPCAB calling for sustained political and financial support for more choice in HIV prevention.  

At a Thursday satellite, HIV Prevention in the Time of Choice, Michelle Rudolph from WHO said they are “supporting PrEP options, also PrEP choice, prevention choice, and that includes the [dapivirine] ring, and we’ll continue to include the ring in all of our guidance moving forward.” Next steps for making choice a reality included curricula for training healthcare workers; more PrEP options for pregnant and lactating people; reducing costs through local manufacturing and technology transfers; and of course, community engagement.  

2 for the Price of 1: DPP as the next MPT 

In a workshop on the Dual Prevention Pill (DPP), Two for the price of one: Simplifying access to HIV prevention and contraception with multipurpose prevention technologies (MPTs), attendees brainstormed how to address real-world dilemmas that may come with rolling out the DPP, such as how to train HIV and family planning providers to deliver it; how will governments and donors balance the delivery of all proven methods for HIV prevention, including CAB for PrEP and the ring. Proposed solutions touched on the role of stakeholder engagement, models for demand creation and more. To learn more about the DPP and the full pipeline of MPTs, see AVAC’s Advocates’ Guide to MPTs. 

Pushing for Equity in Access: All PrEP & PEP

As the international community hailed the results of the PURPOSE 1 trial of injectable lenacapavir for PrEP in Wednesday’s Co-Chairs’ Choice session and called on its maker and international partners to plan for equitable access in its rollout (pending additional data and regulatory reviews), WHO published updated guidelines aimed at expanding access to post-exposure prophylaxis (PEP), a critical and under-used intervention in reducing new infections. These guidelines come on the heels of UNAIDS’ newest report showing an estimated 1.3 million new HIV infections in 2023, with increases seen in countries where  investment in prevention was lower. 

“We cannot say that we are doing well until we are doing well,” Jhpiego’s Elizabeth Irungu shared in Thursday’s plenary, HIV Prevention Strategies, speaking to the current state of PrEP choice, access and uptake globally. Irungu decried the historical delays in the rollout of oral PrEP and called on all stakeholders to break the 12-year cycle of squandering opportunities in prevention. 

The Inclusion of KPs in Country Planning for Sustainability: A report on pseudo engagement

The voices of key populations (KPs), such as gay men, other men who have sex with men, sex workers and people who inject drugs, are too often left out of sustainability planning, a process pushed by PEPFAR and UNAIDS. This was a finding from an analysis in six countries conducted by the Key Population Trans-National Collaboration (KP-TNC). From the session Integrating social enterprise for sustainability of key population programmes, AVAC’s Richard Muko, talked about some the causes behind this finding. These include cultural and religious beliefs that stigmatize KPs; reactionary policy moves that exclude KP voices; punitive laws targeting KPs; insufficient guidelines on how KP communities will be included in the sustainability framework; lack of political will and lack of understanding of KP needs in relation to HIV programming. “Some minimal communication can amount to pseudo involvement of KPs. But we see a signal that KP needs may be missing from the final sustainability roadmaps under development now.” The abstract on the study, Country HIV response sustainability roadmaps: where are key populations in the conversations?, calls for PEPFAR, Global Fund and UNAIDS to step up with frameworks for KP engagement in the development of sustainability roadmaps. 

Making the Case for an HIV Vaccine

Leaders in HIV prevention voiced unwavering support for vaccine development notwithstanding the scientific challenges, even as the world watches ARV-based interventions making enormous strides. In his plenary talk, Devin Sok of the Global Health Investment Corporation equated the HIV epidemic with a fire that can get out of control at any time. “We really need to reduce the embers to the point that we won’t have a fire… a vaccine will be essential for supporting epidemic control and eventually eliminating HIV as a public health threat.”  

Later in the day, the satellite session Ending the Epidemic: The role of a vaccine in the era of long-acting PrEP. Participants said the science in broadly neutralizing antibodies is accelerating with implications for vaccine research; investments in vaccine science have yielded unimaginable and enormous benefits (including COVID vaccines); and ultimately the choice of a vaccine remains essential to a sustainable and durable end to pandemic. As NIAID leader Jeanne Marrazzo said, “to understand any process that we can eventually apply to cure or to eliminate HIV, it’s got to involve an HIV vaccine.” And, ultimately, she said, there are populations of people who may never be as comfortable with ARV’s as a vaccine and vice versa.

AVAC’s AIDS 2024 Resources for Advocates

Stay tuned for more ways to unpack the new data, reports and discussion from AIDS 2024 including an upcoming webinar focused on what’s next in lenacapavir for PrEP advocacy. 

LEN in the Spotlight at AIDS 2024

Zero Infections!

Midpoint at #AIDS2024 in Munich, one of the most significant advances in HIV prevention in the history of the response, the efficacy of lenacapavir as PrEP, was presented at the Co-Chair’s Choice session. The findings, zero infections and 100% efficacy among the trial participants in the PURPOSE 1 trial, brought a standing ovation.

Presented by Linda-Gail Bekker of the Desmond Tutu Health Foundation, and published in the New England Journal of Medicine, PURPOSE I enrolled 5,300+ cisgender adolescent girls and young women (ages 16-26) in South Africa and Uganda. PURPOSE 1 also evaluated daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP, which was shown to be safe. Overall adherence in the F/TAF arm of the trial was low and the intervention did not show overall efficacy. But, among those trial participants with medium to high adherence (2-4 doses per week), data showed a significantly lower chance of HIV infection compared to participants with low adherence.

The introduction of oral PrEP has changed the lives of more than 6 million people globally who have accessed it. Despite the promise of PrEP, many young women have found the uptake of daily adherence and persistence to daily PrEP a social, emotional and physical challenge. We need new and diverse PrEP options,” said Bekker.

For more on PURPOSE 1 and the rest of the PURPOSE program evaluating lenacapavir across diverse populations, see AVAC’s primer for advocates, The Lens on LEN.

So now the work must accelerate.  

New UNAIDS data released at the meeting calculated that 44% of all new HIV acquisitions were among women and girls in 2023 globally, and young women in Africa accounted for 62% of new HIV acquisitions, making the case that there are millions of women in urgent need of HIV prevention and who must be given the opportunity to benefit from every proven method of HIV prevention. 

Data for key populations is just as stark. The latest data from UNAIDS points to marginalization, discrimination and criminalization as drivers pushing the median prevalence of HIV in 2023 to be much higher than the global average among sex workers, gay men and other men who sex with men, and transgender people (3%, 7.7% and 9.2% higher respectively than the global adult prevalence of .8%).  

All these populations represent individuals with unique and evolving needs. No single prevention product will ever be a miracle drug. People need real choices in programs tailored to reach them. Implementers, policymakers, donors, advocates and communities must collaborate for the speedy, reliable delivery of every option. Check out AVAC’s statement calling for early planning to accelerate LEN’s regulatory review and for ambitious introduction plans, and the joint civil society call to action with specific priorities about what needs to happen next. 

In a satellite session with advocates Wednesday, Winnie Byanyima of UNAIDS recommitted to the Choice Manifesto, a powerful declaration calling for continued political and financial support for more choice in HIV prevention. As Angeli Achrekar also of UNAIDS said at a subsequent session, “Both data and services need to be precisely tailored to the people who need prevention most, and we have to make solutions more affordable. We need a new HIV prevention revolution.”  

We couldn’t agree more. 

AIDS 2024 Preconference Highlights

AIDS2024, this year’s annual conference of the International AIDS Society opened with a spotlight on troubling trends. A series of preconferences took on critical topics including supporting key populations in a time of increasing discrimination; new and novel research and implementation of STI prevention and treatment, witnessing a soaring rise in incidence; and the importance of implementing new PrEP options to create more choice for people who need HIV prevention most.  

Key Populations at the Center of the Response

Breaking Barriers: Insights and Realities from Key Populations in HIV Prevention, organized by Global Black Gay Men Connect (GBGMC) and AVAC, featured the voices of speakers representing migrants, people who inject drugs, sex workers and LGBTQI+ people and the release of a new report, Making Rights a Reality: A GBGMC Roadmap. GBGMC executive director and former AVAC staffer, Micheal Ighodaro said the report challenges the “misinformation and complacency that assume the world can achieve HIV sustainability, biomedical HIV prevention progress and global health security without key populations’ leadership and insight.”

AVAC’s Cindra Feuer offered context on impending reductions in global spending on the HIV response, occurring not because resources are limited but because of waning interest. Inform your advocacy with AVAC and GBGMC’s 2023 Global HIV Prevention Roadmap for Key Populations.  

AVAC’s Kenyon Farrow presented on why researchers, implementers and community advocates can and should all play a role in shaping the PrEP pipeline, and how innovation in the pipeline should be implemented.  

Why STIs Matter

The preconference, Mobilize for Action on Sexually Transmitted Infections addressed the urgent need to confront the global spike in STI rates, particularly syphilis, gonorrhea, chlamydia, and trichomoniasis. Epidemiological data shows alarming growth in STI rates, and speakers discussed the morbidity and mortality that they’re causing, and an underfunded infrastructure for researching new diagnostics, antibiotics, vaccines and other treatments.  

Perhaps no more sobering of a statement was made than by Dr. Jeanne Marrazzo, director of NIAID, when discussing the number of global deaths from something as treatable as syphilis. “I think some of the more staggering statistics here, in addition to the sheer number of new infections, is the fact that we had in 2022 over 200,000 syphilis-associated deaths, which to me is practically medieval.”  

In addition to research for new treatments and increases in STI program funding, Alison Footman, AVAC’s senior program manager of STIs said it’s equally important to strengthen the capacity and role of community advocates in fighting STIs. 

“AVAC partners with many organizations across East and Southern Africa who are raising the profile of STI advocacy. From their guidance, we know there’s a need for community advisory boards [to be] involved in STI research. It can and will improve essential research.” 

Alison Footman, AVAC

A rigorous debate explored the question of implementing DoxyPEP, given there’s no efficacy data for cisgender women in light of fears of creating drug resistant strains of STIs from wider use of doxycycline. Strong arguments were made on both sides, but this controversy is one of the reasons AVAC recently published an Advocate’s Guide to Doxycycline to Prevent STIs. 

Cure and the Next Berlin Patient

With researchers announcing what appears to be the seventh person potentially cured of HIV following a stem cell transplant, a preconference on cure research, Towards a Truly Global HIV Cure, captured a feeling of momentum driving cure research today. Donors discussed new investments in African-based infrastructure and initiatives. Scientists explained where cure research is headed in both adult and pediatric populations. But none of these topics were more important than comments from a South African participant in the FRESH cohort trial that includes an analytic treatment interruption, one of the first in Africa, emphasizing that a strong commitment to communication was the foundation to building the trust necessary for these trials. ”Sharing strategies for communication and advocacy across the field of HIV cure research will be essential for it to advance.” 

PrEP Choice

With interim results of the PURPOSE 1 HIV prevention study of injectable lenacapavir (LEN) for PrEP among cisgender women and adolescent girls recently announced, the expanding landscape of PrEP options was the focus of Welcome to the Era of PrEP Choice. Organized by the Gates Foundation, Unitaid, USAID, and the World Health Organization, the message from this session echoed throughout the various presentations: Everyone has a role to play in expanding access to real choices for all who need and want them. Putting in place the right programs, policies and investment to deliver choices at scale and bend the curve of the epidemic utterly depends on a commitment to integrated, equitable, people-centered, and community-led approaches. See the latest quarterly update from The Coalition to Accelerate Access to Long-Acting PrEP, AVAC’s recent webinar on monitoring for PrEP choice to improve and simplify data, and the new Lens on LEN, an advocates guide explain the findings from Purpose 1 and next steps for advocacy.

Stay tuned for more highlights from AIDS 2024 and visit our curated conference webpage for new resources and ways to navigate #AIDS2024 including our roadmap.

A Champion for the Dual Prevention Pill

The Advocacy Chronicles with Ruth Akulu

We’ve got PrEP. We’ve got contraceptives. But what impact would there be on reducing HIV diagnoses if PrEP and contraception were rolled into one? The development of products and programs that integrate HIV prevention with other critical health-care needs is on the cusp of a new chapter. With advances in the development of the Dual Prevention Pill (DPP), a focus now on the role of multipurpose prevention technologies (MPTs) and how to integrate HIV services with sexual & reproductive health (SRH) is a must. The right conversations and the right commitments will speed investment and innovation in delivering a new paradigm in prevention: one that offers an integrated, person-centered experience for people who need prevention and want solutions that work for them.  

So, what are MPTs, and what is the DPP? 

An MPT refers to a single product (think condoms) designed to simultaneously address more than one health need (think prevention of both pregnancy and sexually transmitted infections). Condoms are the only MPT on the market today. But the DPP may soon change that. Now in late-stage development, the DPP combines an oral PrEP formulation with an oral contraceptive, preventing both transmission of HIV and pregnancy in one pill. 

Our next episode of the Advocacy Chronicles features the work of an unstoppable advocate who mobilized government action to prepare for the introduction of the DPP while also establishing a groundbreaking new initiative for ongoing engagement between regulatory authorities and young women representing their communities.

The field has arrived at a moment when advances in research and development for integrated products can and must be supported and sustained. And these integrated products must be matched with integrated programs, designed by and for the people who need them most. We hope these resources support and inspire your work. 

Advocates’ Primer on Lenacapavir for PrEP

Late last month, we learned of the exciting interim result of the PURPOSE 1 HIV prevention study of injectable lenacapavir (LEN) for HIV prevention among cisgender women and adolescent girls after an independent monitoring board found it to be safe and highly effective against HIV. AVAC issued a statement calling for early planning to accelerate its regulatory review and for ambitious introduction plans, and the PURPOSE 1 Global Community Accountability Group (GCAG) and the African Women’s Prevention Community Accountability Board also issued a statement celebrating the crucial role of African women and communities in this study. 

Today, AVAC, the GCAG and the Accountability Board are joined by the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, and the Coalition to Accelerate and Support Prevention Research (CASPR) in issuing a further call to action, with specific priorities about what needs to happen next. 

In addition, AVAC is releasing the Lens on LEN: The basics on injectable lenacapavir as PrEP. This Advocates’ Primer provides background on the product and trials; a summary of the early findings of PURPOSE 1; key remaining questions; and critical next steps.    

Read on for more about these resources.

Primer

Download The Lens on LEN: The basics on injectable lenacapavir as PrEP

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Twice-Yearly Injectable Lenacapavir for PrEP

In this call to action, the PURPOSE 1 Global Community Accountability Board (GCAG), the Civil Society Caucus of the long-acting PrEP Coalition, the African Women Community Prevention Accountability Board, and the Coalition to Accelerate and Support Prevention Research (CASPR) call on all stakeholders to urgently come together to learn the lessons of past PrEP product introduction and apply them to compress the timeline for making this important new option to become widely available to those who need and want to use it. 

New Drug Provides Total Protection from HIV in Trial of African Women

This  New York Times  article provides terrific perspectives from AVAC partners Linda-Gail Bekker, Yvette Raphael and Lillian Mworeko. “For a young woman who can’t get to an appointment at a clinic in a town, a young woman who can’t keep pills without facing stigma or violence — an injection just twice a year is the option that could keep her free of HIV,” said Lillian Mworeko, who leads a group called the International Community of Women Living With HIV Eastern Africa. 

We hope this new primer and our joint call to action are helpful in our collective advocacy to translate these exciting clinical trial results into actual public health impact with speed, scale and equity.

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Injectable Lenacapavir for PrEP

A Joint Statement

Today a global cadre of HIV prevention advocates is calling for an accelerated timeline for access to the HIV prevention drug lenacapavir. Gilead, the developer of the drug, announced topline results from a large study among cisgender African women on 20 June, followed shortly thereafter with a statement about access. 

There is much to do before this twice-yearly HIV prevention option can be included in comprehensive prevention programs, and this coalition of civil society groups is calling for all stakeholders to urgently come together to apply lessons of past PrEP introduction to accelerate the timeline for this important new option to become widely available to those who need and want to use it.

“This is an incredibly important day for African women. Twice-yearly injectable lenacapavir will be an important addition to HIV prevention choices and has the potential to expand access to more women who need and want effective prevention options.”

Ntokozo Zakwe, Community Media Trust in South Africa and a member of the PURPOSE 1 Global Community Advisory Group (GCAG)

“African women need and want new HIV prevention options. We need everyone who has a role to play in bringing lenacapavir to our communities to prioritize the most progressive timeline the world has seen for rollout of a new prevention option, while collaborating with civil society and advocates to ensure introduction plans will result in uptake and impact.”

Chilufya Kasanda Hampongo of Treatment Advocacy and Literacy Campaign in Zambia and a co-leader of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP

Leaders of the PURPOSE 1 Global Community Accountability Board (GCAG), the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, the African Women Prevention Community Accountability Board, and the Coalition to Accelerate and Support Prevention Research (CASPR) have partnered with AVAC to identify the following actions for Gilead, regulators, normative agencies, funders and national policymakers:

  • All stakeholders must prioritize and uplift community voices and community choices for including lenacapavir in the range of HIV prevention options that offer the widest choice to the most people.
  • Gilead should prioritize and quickly share analysis of the data from PURPOSE 1 and begin submission to multiple regulatory agencies on an accelerated and parallel schedule, with the potential to add data from PURPOSE 2 (among other studies) on a rolling basis to the regulatory portfolio. At the same time, national regulatory agencies need to be ready to review the data once submitted and act swiftly in making regulatory decisions.
  • WHO must begin preparations now for including lenacapavir, once approved, in HIV prevention guidelines as swiftly as possible, in time for regulatory approval.
  • Gilead should transparently share clear plans for pricing of lenacapavir and access for communities most in need, and commit to providing enough drug to support early launch and rollout.
  • Following Gilead’s announcement last week that they are developing a direct voluntary licensing program for lenacapavir, it is imperative that Gilead grants non-exclusive licenses to multiple generic manufacturers in multiple geographies before the end of the year; that license agreements are made publicly available; and that the licenses include access to finished product based on public health imperatives, and not on World Bank country classifications or geographical location. 
  • PEPFAR and the Global Fund should work urgently with other donors and Ministries of Health to negotiate price and volume guarantees with Gilead to ensure there is a sustainable supply for the initial introduction period until generics are registered and readily available.
  • Funders, Ministries of Health, implementers and civil society partners need to collaboratively ​​design a comprehensive introduction strategy that breaks the sequential nature of traditional approaches to scale and speed up introduction. Part of accelerating speed is moving toward a parallel approach where research, implementation science, and scale-up programs are designed, funded and implemented in parallel. All stakeholders, working through the Coalition to Accelerate Access to Long-Acting PrEP, should commit to developing a robust introduction strategy ahead of regulatory approvals and WHO guidelines to ensure time is not lost.
  • Ministries of Health and policymakers must work together and with donors to ensure lenacapavir is integrated swiftly into national guidelines and prevention programs and made available to all populations for which the drug is approved and recommended.
  • Ministries of Health, policy makers and donors must work to ensure strategic demand creation and health-systems strengthening to support robust HIV prevention programs that provide a full range of HIV prevention options that allow people to choose what works best for them.
  • All stakeholders must commit to speeding long-term access to lenacapavir to trial participants and to the women in the communities that hosted the study in parallel with increasing access to a full range of HIV prevention options to those who need and want them.

Advocates know that there are many more actions that will be needed to ensure lenacapavir and other HIV prevention options are widely available. Transparency, speed, scale and cooperation are essential as we work to end HIV as a public health threat.

“We have never seen such a good outcome from an HIV prevention trial, and to see such a result first among African women is groundbreaking. Gilead listened to advocates and followed Good Participatory Practice Guidelines to include two of the populations most in need of  HIV prevention – adolescent girls and pregnant women – in the study. National prevention programs must also prioritize these populations in PrEP programs that will provide lenacapavir.”

Lillian Mworeko, ICW East Africa and a leader of the African Women Prevention Community Accountability Board

“Results like this are what we’ve been waiting for throughout decades of HIV prevention research. We know what is needed now to move this drug swiftly to communities. Civil society stands ready as watchdogs of the process and as essential partners in a successful rollout.”

Stacey Hannah, director of the Coalition to Accelerate and Support Prevention Research (CASPR) and AVAC’s director of research engagement

Results from the ongoing PURPOSE 2 study among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth are expected in late 2024 or early 2025. This second pivotal study will provide data, not just for gay men, but for trans and gender non-binary people, populations that have often been ignored by HIV prevention studies. Data for PURPOSE 2, along with PURPOSE 3, 4 and 5 studies, will provide the most comprehensive range of data across populations that has been seen to date. A schematic of the suite of studies is here.

“We eagerly await the PURPOSE 2 data and hope to see similar results for the populations represented in that study who also need new choices for HIV prevention. Lenacapavir has the possibility of transforming the HIV prevention landscape and changing the lives of millions of people around the world. There must be no delays in making it available globally. Now more than ever, we need speed, scale and equity to ensure we get impact.”

Mitchell Warren, AVAC’s executive director.

About

  • PURPOSE 1 Global Community Accountability Board (GCAG): The PURPOSE 1 and 2 efficacy trials each include Global Community Accountability Groups (GCAGs). Members of the GCAGs include leaders in HIV advocacy and experience with engagement in research and  development. Individual trial sites also have their own community-specific community advisory board, creating multiple layers of advocacy feedback.
  • Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP: Established in 2022 to ensure civil society expertise influences the rollout of long-acting PrEP options, this Caucus includes representation from many civil society groups working on longer-acting PrEP introduction. These include, but are not exclusive to, the following: African Women Community Prevention Accountability Board; AfroCAB; APCOM; AVAC; Coalition to Accelerate and Support Prevention Research (CASPR); Frontline AIDS; Global Black Gay Men Connect (GBGMC); the Global Key Population Advisory Group; and ITPC.
  • African Women Prevention Community Accountability Board: The Accountability Board led the development of the Choice Manifesto and works ensure that the manifesto is translated into reality for all women, and is composed of 12 women from 7 countries representing East and Southern African nations.
  • Coalition to Accelerate and Support Prevention Research (CASPR): CASPR is an Africa-led coalition of 13 partners, funded by USAID and supported by AVAC, working together to change how HIV prevention is pursued and delivered. CASPR activities are focused primarily in key African countries with the highest burden of new HIV infections, and where biomedical HIV prevention research is ongoing or planned.
  • AVAC: AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity.

A Ray of Hope for Uganda LGBTQ Community Amidst Anti-Homosexual Law

Written by Namiganda Jael, a journalist in Kampala, Uganda. She is a health reporter, writer and anchor at Metro 90.8 FM. She is also media coordinator at Health Journalist Network Uganda and a member of Tobacco Harm Reduction Uganda and the Uganda Parliamentary Press Association.

When she felt a bruise on her private parts, Ramzay, a transgender woman and a sex worker who prefers to be identified by only one name for fear of persecution, rushed to the nearest health center for treatment. 

While there, Ramzay asked the doctor for an ointment cream. The doctor loudly wondered if she was gay because the ointment cream was for gay people.

“I felt embarrassed and stigmatized by the rudeness of the doctor and her coworkers,” she said, adding that the doctor’s response was a negative attitude she’d repeatedly experienced in other public hospitals whenever she visited to seek health services, including Human Immunodeficiency Virus (HIV) prevention.

When Ramzay tested HIV negative at the beginning of 2023, she decided to visit a local group, Justice and Economic Empowerment for Women and Girls Organization (JWEEG), for HIV preventive products, such as condoms, lubricants, Pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP).   

However, when the anti-homosexuality bill was signed into law by President Yoweri Museveni in May 2023, she became worried that access to HIV preventive treatment would be hampered. She was right.

PrEP and PEP are treatments for people at risk of HIV exposure. PEP is more commonly used and is given to people who have been raped and to medical professionals exposed to HIV while working. It’s only given to people who have tested HIV-negative.

JEEWG was founded in 2015 by Waseni Harriet, also known by her trade name Cindy. Her focus was to bring HIV preventive methods such as condoms to Kasensero village, where she saw her fellow sex workers washing and sharing condoms.

Harriet Wesani, founder JWEEG

It started with 25 members, but today, the organization has over 1,000 members who seek a wide range of services, including sexual and reproductive health, Waseni said.

To achieve her goal, Waseni looked for health service providers she could partner with to help bring HIV prevention and treatment measures to her community, including men who have sex with men and transsexual women.

But together with her partners, she did not give up. “So, we try to follow up on cases, especially those in the LGBT community affected by the law. At MARPI, we get all kinds of HIV medication; we collect ARVs for those who cannot pick it up from the facility because of fear or stigma,” she says, adding that for those who have relocated because of the law, HIV medication is taken to them or rendered to them in the nearest pick-up centers in the new areas. 

In May 2023, Uganda passed a draconian and unconstitutional anti-homosexuality law.   Sub-section two of Section Two of the Act states that a person who commits the offense of homosexuality is liable on conviction to life imprisonment.

In November 2023, human rights activists went to the constitutional court seeking nullification of the impugned law, arguing that it violated the human rights of homosexual people. 

The decision came on April 3, 2024. Despite the court agreeing with the petitioners that some sections of the law infringed human rights as they were “…inconsistent with the right to health, privacy and freedom of religion”, in a ruling read by Deputy Chief Justice Richard Buteere, it upheld the law to the chagrin of many observers.

Article 27 of the Constitution states that no person shall be subjected to unlawful search of the body, home or other property or to unlawful entry of his or her premises. Article 24 on freedom from inhuman treatment states that a person shall not be subjected to any form of torture, cruel, inhuman, or degrading treatment or punishment or held in slavery.

With the constitutional court upholding the anti-homosexuality law despite such provisions, the petitioners filed an appeal at the Supreme Court in April, says Nicholas Opio, a human rights lawyer and one of the petitioners.

Opio says he was disappointed in the court’s ruling. “Striking section of the right to privacy and right to health was an attempt to appease donors to the health sector,” he says, adding the ruling didn’t help with safeguarding the rights of the LGBT community, whose existence is criminalized.

Genesis, a gay man who prefers to be identified by his first name only for fear of stigma and harm, says, “…nullifying some sections of the law seems to slightly calm the pressure on the health of the LGBT+ community, but the law in its entirety is ridiculous”.

“When the court nullified sections that obliged a medical practitioner or any other person to report suspected acts of homosexuality to police, I felt some slight relief because I am at least not worried about being reported by a doctor to authorities after learning that I am gay. “At least the patient-doctor confidentiality has been reinstated,” says Genesis.

Sharaim Ismael has been a sex worker since 2020 at the age of 18. As a transgender woman, she was assigned a male identity at birth but identified as a female. She has been moving from one place to another as a security precaution for her safety since the passage of the anti-homosexual law, she intimates.

“Because of my sexual identity and work, I left home because most people were threatening me, especially after the passing of the bill (Anti-homosexuality bill), so I ran away to northern Buganda,” she says.

Sharaim gets lubricants and HIV testing kits at JEEWG, which she uses to test her partners as she neither takes PrEP nor uses condoms as an HIV preventive measure.

PrEP is HIV medication administered to prevent people from contracting HIV from unprotected sex by 99%. With the Injectable drug, the risk is reduced by 74%, according to the United States Centers for Disease Control and Prevention (CDC).

According to the World Health Organization, HIV prevalence among transgender women is estimated to be 28.4 in eastern and southern Africa. As of 2023, Uganda’s national HIV prevalence stood at 5.8%, according to the 2020-2021 Uganda Population HIV Impact Assessment.

Uganda Population HIV Impact Assessment

In 2017, the Uganda Ministry of Health introduced PrEP and PEP into the country to fight against HIV infections. However, it has been mostly out of reach to gay people “because of the stigma in some health facilities where they don’t feel safe to seek health services,” Sharaim laments.

Ramzay and Sharaim are among the key populations (most at risk) in Uganda, a community of people at a higher risk of getting HIV.

Key populations in Uganda include sex workers, prisoners, men who have sex with men, truck drivers, fishermen, and bodaboda riders.

According to the Uganda Population-Based HIV Impact Assessment 2020-2021, the HIV rate in the key population is said to be at about 11%. This is almost twice the national adult prevalence rate of 5.8%.

Another organization helping LGBT+ people in Uganda access critical reproductive health services is the Children of the Sun Foundation (COSF). Thanks to donor funding, it operates a free clinic and shelter for LGBT+ people.

COSF Executive Director Henry Mukiibi says despite their constitutional protection, members of the LGBT+ community have been shamed and publicly castigated by health workers in some public and private health services.

Henry Mukiibi, founder of COSF

“One LGBT+ patient came here suffering from a hemorrhage and told us how a doctor shouted at him to get out of his clinic, accusing him of being gay and promoting bad sexual behavior,” Mukiibi narrates.

Even with the stringent law, Mukiibi says the COSF clinic has a permanent nurse and an on-call doctor to attend to the patients.

COSF premises

For HIV prevention, the clinic provides testing kits, condoms, and lubricants to the LGBT QI community. However, for HIV treatments, they are referred to licensed health centers that safely provide HIV treatment services to the community.

But COSF also does home delivery of drugs to members of the community who don’t feel safe going to health facilities to pick up their drugs for fear of stigma, discrimination, and even violence, Mukiibi reassures. To get the deliveries, patients in need call COSF or send a colleague to submit a request for them. Sometimes, through phone calls and home visits, the Foundation also follows up with the patients who fail to turn up for their medicine.

Sam, who prefers to be identified by his first name for fear of victimization, had his ARVs delivered to him for several weeks by COSF because he feared getting out of the house for several weeks. After the passage of the bad law, he was violently attacked and abused by some members of the village due to his sexual orientation.

“The home delivery of my HIV treatment drugs came in handy. It helped me adhere to treatment until I gained the confidence to get out and also shift to a new home,” says Sam.

 “For PEP and PrEP, we refer members of the community to organizations such as The Aids Support Organisation (TASO), a local NGO that has been supporting people living with HIV and also involved in the fight against HIV spread for over 30 years and REACH OUT, a Community Health initiative NGO providing HIV  services working mainly with urban and rural poor communities in Uganda where they get such services,” Mukiibi says.

He adds that for members who don’t feel safe moving to public spaces, the clinic partners with such organizations, which are then invited to provide outreach services to the community gathered at the clinic.

Dr. Nelson Musoba, Director General of Uganda Aids Commission, a government agency that coordinates the response to the country’s HIV/AIDS epidemic, rightly says preventive measures should be accessible to everyone who thinks they are at risk of contracting HIV.

“Everyone in Uganda should have access to all available HIV treatment services in Uganda without any kind of discrimination regardless of who they are,” he says, adding that the anti-homosexuality law doesn’t stop anyone from accessing HIV treatment.

However, Mukiibi disagrees. “When we have laws that discriminate against LBGT people, you increase the risk of violence and discrimination against them. We have seen them being stigmatized and discriminated against in health service centers because of their sexuality. The law increases and feeds the homophobia attitude even in the health practitioners,” he says.

The Situation in Kenya

In neighboring Kenya, although the situation isn’t better than in other countries where anti-homosexuality laws have been passed, the LGBT+ people are better off when it comes to access to health services, says Ishmael Bahati, the executive director of Persons Marginalised and Aggrieved Kenya (PEMA) and co-chair of Gay Bisexual Men (GBSM), network in Kenya that brings together all gay, bisexual men organizations working on health.

“In Mombasa County, for example, we have 14 government facilities which we have already sensitized the service providers to offer not only friendly services but also specific services needed for the gay and GBSMs.”

“PEMA does not have a distribution chain; we only do referrals. However, with our position on the national level, like at the coast, we do referrals and advocacy on health, mainly ensuring that the public/ government facilities can offer services to LGBTQI persons,” he emphasizes.

With the constitutional court having upheld the draconian anti-homosexuality law, eyes now turn to the Supreme Court to appeal, where the petitioners have filed an appeal to overturn the lower court’s impugned decision.

Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

AVAC Calls for Accelerated Regulatory Review and Ambitious Introduction Plans

AVAC welcomes the groundbreaking results of the PURPOSE 1 HIV prevention study among adolescent girls and young women in South Africa and Uganda. Preliminary safety and efficacy results were reported today by Gilead Sciences, the developer of the lenacapavir, one of the HIV prevention drugs that was being studied in the trial. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir. 

“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s executive director. “Adding additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit.” 

“We are incredibly excited about this result, especially about what it can mean for women in Africa,” says Nandisile Sikwana, Regional Stakeholder Engagement Manager for AVAC, and a member of the PURPOSE 1 Global Community Advisory Group. “We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies. While we wait for full data from the study, including adherence data of oral F/TAF, it is imperative that planning for rollout of lenacapavir be accelerated. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out,” says Sikwana.

The PURPOSE 1 study enrolled over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda. The study is evaluating injectable lenacapavir for PrEP and daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP. A companion trial, PURPOSE 2, is underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US, testing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary people. Results from PURPOSE 2 are expected by early 2025. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who use injection drugs, are also underway, and it will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.

Gilead’s plans for submission to regulatory agencies and future access, including the US Food and Drug Administration (FDA), are not yet clear. But the results reported today make this urgent. “We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review,” Warren said. “We also call on WHO to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices.”

“We now know that lenacapivir for PrEP is safe and highly effective among women,” Sikwana added. “Even as we await the results of the trial among other essential populations and for regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products – including oral PrEP – must be made feasible choices for all people who need and want HIV prevention options.”

Lessons learned from roll out of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP.

“AVAC and a cadre of international partners have been working together to plan for successful, accelerated introduction of lenacapavir. Since oral PrEP was first shown to be safe and effective 14 years ago, the global health community has failed in delivering PrEP at scale and with equity – and we have, therefore, not seen the impact that we need. The lessons from the past are clear, and we now must act on them and move with speed, scale and urgency. There can be no excuses and no delays,” said Warren. “We look forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option is made available as quickly as possible and that we don’t squander this opportunity to drive down new HIV infections.”

Advocates’ Guide to DoxyPEP

Earlier this month, the US Centers for Disease Control and Prevention released much-needed clinical guidelines on how and when to prescribe an oral antibiotic, doxycycline, as post-exposure prophylaxis to prevent acquisition of some bacterial sexually transmitted infections (STIs) after sex, so called “DoxyPEP”. 

Doxycycline is relatively inexpensive, easily tolerated, and widely available. It’s a promising tool to prevent bacterial STIs, including chlamydia and syphilis. However, many questions remain, including how DoxyPEP should be implemented equitably, if it is effective among cisgender women, and how it might impact the STI rates in low- and middle-income countries.

Read AVAC’s New Advocates’ Guide to DoxyPEP

AVAC’s new Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP) highlights the many DoxyPEP advocacy needs and considerations and covers an update on what the data do and don’t say, what we all need to know about this promising strategy for STI prevention and what critical questions remain that require advocacy and action.

Download the Advocates’ Guide.

DoxyPEP alone is not a complete solution to the escalating epidemic of STIs. But in a field with few recent innovations and limited investments in new prevention, detection, and treatment tools, DoxyPEP holds important potential. Today’s research, implementation, and policy decisions about DoxyPEP can shape the path for much-needed STI research and development in the future.  

We hope this new guide is helpful in our collective advocacy to ensure promising science is translated into public health impact. 

The Pandemic Accord

A Critical Fight in 2024

As the World Health Assembly concluded the 2024 session in Geneva last week, member states failed to reach an agreement on the Pandemic Accord. Aimed at formalizing global agreements that would improve pandemic preparedness, prevention and response (PPPR), negotiations for the Pandemic Accord faltered around commitments to key equity measures. Member States agreed to extend the negotiations through 2024. 

These issues are explained in AVAC’s updated Advocates’ Guide for PPPR in 2024, which covers what you need to know about still unresolved, but critical questions, such as agreements on sharing data and vaccines, and offers timelines in 2024 for strategic advocacy.

Additional Resources

The Coalition of Advocates for Global Health and Pandemic Preparedness, of which AVAC is a partner, issued a statement on the vulnerability and potential of the Pandemic Accord. 

“Without these commitments, we will fail to gain the necessary lead time to get ahead of rapidly spreading health emergencies and will have no chance of eliminating new viral threats once they emerge.” 

Fighting the Same Fight Again (blog)

Advocates must also seize opportunities to demand transparency and the comprehensive inclusion of civil society in the ongoing negotiations, an alarming deficiency in the Pandemic Accord process up to now. Find additional context on the role of civil society in global health initiatives in this blog.

What’s Next for the Pandemic Accord (recording)

And check out the recorded side event from Geneva where civil society came together and offered perspective on community priorities. And mark your calendars for the Independent Panel for Pandemic Preparedness and Response’s webinar June 18. 

AVAC’s PPPR Work (webpage)

Follow the work of the Coalition of Advocates for Global Health and Pandemic Preparedness and AVAC’s PPPR Work by contacting PPPR specialist Samantha Rick at Sam@avac.org. 

The Pandemic Accord is a once-in-a-generation opportunity to strategize in ‘peace time’ before the next pandemic hits. Civil Society priorities can and must lead this effort.