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 studyof 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.

Upcoming Webinars and a Roundup of New Resources

Last week’s interim result of the PURPOSE 1 HIV prevention study of injectable lenacapavir is captivating headlines. Check out AVAC’s statement here and one from the PURPOSE 1 Global Community Accountability Board and the African Women’s Prevention Community Accountability Board here. But there are LOTS of other things also happening in HIV prevention, and we’re delighted to share this roundup.

Upcoming Webinars

Responding to Project 2025’s Threats to Science, Rights and Resources

Project 2025 is part of an ongoing multi-pronged backlash to the sexual and reproductive health, gender and LGBTQ+ movements. Building on the experience of the HIV movement in fighting these same far-right forces, join this Choice Agenda webinar discussing potential responses through the lens of HIV affected communities and programs. Register here

You Get What You Measure: Why Monitoring for PrEP Choice Helps Tell Our Story

The data collected on a program determines its path and priorities. This Choice Agenda webinar will cover the current state of PrEP monitoring and evaluation, and efforts to improve and simplify data-gathering to better reflect how people use PrEP and to support choice amongst the growing array of PrEP methods. And the discussion will also focus on how data can be used to enhance the stories we tell about PrEP program implementation. Register here

Recordings and Resources

From The Lab To The Jab Webinar and Issue Briefs

Earlier this month, AVAC hosted a webinar highlighting our series of issue briefs, From The Lab To The Jab, covering research and development, mRNA technology, vaccine production, issues relevant to equitable global access to vaccines. The webinar featured panelists from the International Vaccine Institute, International Treatment Preparedness Coalition, and æqua, a think tank focused on equity and economic justice for health. Panelists discussed international initiatives for vaccine development, the current state of vaccine research and access, and how they can be improved. Read more

The GPP Body of Evidence: GPP Monitoring and Evaluation Frameworks, REAL and REAL2

GPP is an essential part of clinical trials research, and an ethical imperative to creating equitable and effective clinical trials. GPP is created by and for communities, so it looks different and takes multiple forms in different cultural contexts. This kind of responsiveness is inherent to GPP, but it also makes it difficult to measure and evaluate. In this webinar, participants will learn from the Realist Review of Community Engagement and the REAL2 review of participatory research. Each examined frameworks for evaluating community engagement efforts. We’ll also learn about the Global Health Network’s new course on evaluation, and other efforts in the field to evaluate the impact of GPP. View the recording

It’s Not Just about the Trial: GPP from discovery to delivery in TB research

GPP enhances every stage of the research lifecycle. In this webinar, our partners at TB AllianceSMART4TB, and THINK shared experiences, lessons learned, and innovative approaches in integrating GPP at the organizational, network and situational level, from drug development through delivery. View the recording

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP)

Doxycycline, an oral antibiotic, can be used as a post-exposure prophylaxis, commonly referred to as DoxyPEP, when used to prevent the acquisition of some bacterial STIs after sex. Doxycycline is inexpensive, easily tolerated, and widely available. However, questions remain regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access and minimize antimicrobial resistance. This guide seeks to explore and address these critical questions. Read the guide

Episode 3: The Promising Science

Our Mitchell Warren speaks to ViiV’s Kimberly Smith in this episode of the Foreign Policy podcast series ‘can we end epidemics?’ about the future of HIV science and the challenges we need to overcome on our journey to finding a cure. Listen

We hope these conversations and resources are helpful in your advocacy. Stay tuned for our upcoming advocates’ primer on lenacapavir and our roadmap to the AIDS 2024 conference in Munich.

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 [email protected]


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. 

Pride and a Transnational Anti-LGBTQ+ Reaction

For five decades LGBTQ+ communities and their allies have come together in June to celebrate Pride, to demand recognition of our human rights, and to honor Queer lives. It was movement that ignited out of a climate of fear and ignorance, one that de-humanized trans people and same-gender loving people and made possible their continual persecution.   

As we mark the 54th anniversary of the New York City Stonewall Uprising of 1969, we celebrate the diversity and resilience of LGBTQ+ communities around the world and we must call out the transnational anti-LGBTQ+ reaction that is propelling gay-hate legislation, systemic violations of human rights, and violence against Queer people in countries across Africa, Asia and the US.  

Read on for details on an important advocacy movement against the anti-LGBTQ+ legislation in Uganda, a new podcast capturing the highlights and personal story of one advocate’s work, and the work of a cross-country collaboration strengthening advocacy for key populations.  

New Report

UNWANTED, OUTLAWED AND ILLEGAL: THE CRY OF LGBTIQ+ UGANDANS

It’s been one year since the Ugandan legislature passed one of the most draconian gay-hate laws in the world, the Anti Homosexuality ACT (AHA), which has since been approved by a Ugandan court ruling, now on appeal. The AHA intensifies the criminalization of LGBTQ+ people, including up to life imprisonment for consensual same-sex conduct, and even the death penalty in certain circumstances. A new report by the Strategic Response Team (SRT), UNWANTED, OUTLAWED AND ILLEGAL: THE CRY OF LGBTIQ+ UGANDANS, documents evictions, arrests, imprisonment, forced anal exams, and community violence against LGBTQ+ people since the passage of AHA. 

New Podcast

PxPulse: The Advocacy Chronicles

In a new edition of PxPulse: The Advocacy Chronicles, Allan Mwasa of SMUG International in Uganda discusses the Anti-Homosexuality Act (AHA), rising violence against LGBTQ+ communities in Uganda, how advocates are organizing, and what allies can do now. A donation to SMUG supports the work of the Strategic Response Team documenting civil rights violations and intensifying persecution of LGBTQI+ Ugandans. Click here to donate to SMUG

On the Radar

The Key Population Trans National Collaboration (KP-TNC)

And follow the work of the Key Population Trans National Collaboration (KP-TNC), a cross country collaboration strengthening advocacy for key populations. Working in Ghana, Kenya, Malawi, Nigeria, South Sudan, Tanzania, Zambia and Zanzibar, the KP-TNC strengthens relationships between KP-led organizations and development partners, regional organizations, the African Union, PEPFAR, The Global Fund and country governments, and develops strategies to advance advocacy for global health equity at large, and for HIV prevention and treatment among key populations. 

This moment requires global solidarity to push back against the lies, prejudice and discrimination that imperil LGBTQ+ people everywhere. Here’s to a powerful Pride! 

Announcing the Next Class of Advocacy Navigators

We are thrilled to announce AVAC’s 3rd class of Advocacy Navigators! This group of 12 emerging advocates from nine countries was selected from 100s of interested applicants. They will be paired with six mentors, seasoned advocates who are alumni of AVAC’s Advocacy Fellows program. These mentors provide support and guidance as the Navigators strengthen and expand their skills in HIV prevention advocacy. 

Meet the 2024 Advocacy Navigators

Elizabeth Zahabu, Tanzania; Gcebile Yvette Dlamini, Eswatini; Jessica Booysen, South Africa; Joseph Robert Linda, Uganda; Nawanyaga Gloria, Uganda; Rita Nyaguthii Gatonye, Kenya; Renny Mulala, Zambia; Madalitso Juwayeyi, Malawi; Rumbidzai Munhanzi, Zimbabwe; Takunda Clement Chanetsa, Zimbabwe; Nicole Ondisa Oduya, Kenya; Sharon Ramantele, Botswana.

Following the model of the AVAC Advocacy Fellows program, Navigators tackle curated coursework, focused networking, and personalized mentorship over six months.

Meet the 2024 Mentors

Anna Miti, Zimbabwe; Chilufya Hampongo, Zambia; Cleopatra Makura, Zimbabwe; Eric Mcheka, Malawi; Dr. Lilian Benjamin Mwakyosi, Tanzania; Simon K’Ondiek, Kenya.

And a big congratulations to the graduating cohort of Advocacy Navigators who recently completed the 2023 program. Nine Navigators implemented new advocacy projects in their communities on the rollout of CAB for PrEP and DVR, meaningful engagement of adolescent girls and young women (AGYW) in HIV prevention, changing the age of consent, and advocacy for accessible HIV prevention for people with disabilities, sex workers and other key populations.

About the Advocacy Navigators Program

Since 2009 with the establishment of the AVAC Advocacy Fellows program, AVAC has recognized the imperative to support HIV prevention advocates with the knowledge and skills they desire. The Fellows Network represents a global movement of seasoned veterans and passionate newcomers, who call out neglect, insist on equity, monitor commitments and identify solutions. Now the Advocacy Navigator program, which is part of the Coalition to Accelerate & Support Prevention Research (CASPR), is leveraging the strength of this extraordinary program and its alumni community to expand and strengthen the network and continue to support and engage advocates for the long-term. 

The Advocacy Navigator program combines training and mentorship to young and emerging advocates in the field of HIV prevention advocacy. The program mobilizes a cohort of ambitious individuals and provides them with resources to build their knowledge, skills and confidence to meaningfully advance HIV prevention advocacy in their communities and countries. The program includes online coursework, personalized mentorship, and opportunities to directly apply learning through a community advocacy project. The program begins with three months of coursework and project development, followed by three months when advocates implement their plans. 

Keep up to date with this year’s Navigators and stay tuned for updates on their upcoming advocacy projects!