Avac Event

Lens on LEN

SAVE THE DATE: Join AVAC, Gilead and partners for a discussion of and comprehensive presentation on lenacapavir for PrEP data from the PURPOSE I and II trials, along with an update on where we are with global access and regulatory submissions.

More details, including registration, to come.

People’s Research Agenda

Community & Advocacy Priorities in HIV Prevention Research Development

Led by AVAC alongside a network of partners, the People’s Research Agenda puts forward recommendations to diversify and strengthen the HIV prevention pipeline, enhance investment and financial support for HIV prevention research and development, and guide an advocacy strategy that truly addresses the needs of communities across the prevention pipeline.

The PRA is a living document developed through intentional consultative processes that used multiple modalities, including surveys, focus groups, convenings, to gather insights about the processes and products needed to actualize HIV prevention justice.

In this summary of the People’s Research Agenda, you’ll find the PRA’s core insights into the processes involved in HIV prevention research and implementation, and the types of products that should be developed through these processes.

Download the Report

Avac Event

HIVR4P 2024

The 5th HIV Research for Prevention (R4P) conference is being held in Lima, Peru from 6 to 10 October. Held every two years, HIVR4P is the only global conference to focused exclusively on biomedical HIV prevention, including AIDS vaccines, microbicides, PrEP, treatment as prevention and other approaches. 

See below for conference highlights, recaps and announcements. 

Conference Highlights and Recaps

Announcements

Sexual and Reproductive Health Integration Advocacy Roadmap

This roadmap addresses the critical need for integrated sexual and reproductive health (SRH) and HIV services. This integration is essential for enhancing public health outcomes, socio-economic benefits, and individual health and rights. The Roadmap aims to revitalize and sustain advocacy efforts for SRH and HIV integration, empower communities to hold stakeholders accountable for implementation, increase political and program support to enable the shift from policy to practice, and foster dynamic partnerships across research, advocacy, implementation, and policy sectors.

It was developed by Copper Rose Zambia (CRZ) as part of the Coalition to Accelerate and Support Prevention Research (CASPR). It draws on extensive input, including desk reviews, interviews, focus group discussions, and a specialized workshop held at the 2023 International Conference on AIDS and STIs in Africa (ICASA).

Avac Event

The Road Ahead – SRH Integration Advocacy

Join Copper Rose Zambia, as a part of CASPR, for a webinar, The Road Ahead – SRH Integration Advocacy. The webinar will launch the SRH Integration Advocacy Roadmap, and feature healthcare providers, advocates, and more to discuss the future of sexual and reproductive health integration.

Explore STIWatch.org and get the latest resources to navigate the IUSTI & STI Prevention meetings!

Dear Advocate, 

AVAC is delighted to share its all-new STIWatch.org website just as advocates, clinicians, researchers and partners convene in Atlanta, GA for the Centers for Disease Control and Prevention STI Prevention Conference, and in Sydney, Australia for the 25th International Union Against Sexually Transmitted Infections (IUSTI) World Congress.  

Rates of sexually transmitted infections (STIs) continue to rise globally with too little public health intervention and investment. While many STIs are curable, they often go undiagnosed and untreated because they tend to cause few or no initial symptoms. Available diagnostics are often too costly to use for routine screening and testing in many low to middle-income countries (LMICs), and few vaccines exist to address the most common STIs. 

Discover STIWatch.org!

STIWatch.org is an updated platform designed to enhance understanding and advocacy for STI vaccine and diagnostics research, development, and rollout. It offers comprehensive information on common STIs, a clinical trials dashboard, advocacy priorities, and a range of resources and tools to support STI prevention and treatment efforts. 

Scroll down for more STI prevention resources advocates need to navigate these two conferences.

Resources

Follow the STI Prevention Conference events in real time in Atlanta on Twitter at #STIConf24 and on AVAC’s feed at @HIVpxresearch

STI Clinical Trial Dashboard: shares the latest STI research on diagnostics and vaccines

STIs: A Review of the 2022 Vaccine and Diagnostic R&D Pipeline and Investments: provides an annual analysis of global funding trends for STI prevention research

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP): explores and addresses the explore and address the critical questions around who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access. 


STIWatch.org is an initiative of AVAC with funding and support from the World Health Organization, the Bill & Melinda Gates Foundation and the National Institutes of Allergy and Infectious Diseases.  

Contact sti@avac.org for more information. To receive email updates from AVAC, signup here

New Peer-Reviewed Articles, Upcoming Webinars & More!

Dear Advocate,  

AVAC and partners authored three new peer-reviewed articles this month on a range of HIV prevention issues. From the potential and challenges of long-acting formulations in HIV care, to the benefits of delivering family planning AND PrEP using pharmacies, e-pharmacies and private sector clinics, to the necessity for gender-transformative approaches to ensure effective and equitable participation of women in biomedical prevention trialsthese are must-read pieces. Scroll down for more and mark your calendars for four webinars coming up, including this week!

The Long Wait for Long-Acting HIV Prevention and Treatment Formulations

This commentary in The Lancet HIV calls on WHO, financial donors, manufacturers, and governments to take coordinated action to make long-acting HIV prevention and treatment available at scale in lower- and middle-income countries.

Harnessing Private Sector Strategies for Family Planning to deliver the Dual Prevention Pill

The latest edition of the Journal of the International AIDS Society features newly published research by AVAC and partners on the benefits of delivering family planning and PrEP using pharmacies, e-pharmacies and telemedicine, in addition to private sector clinics. The research demonstrates why these delivery methods should be prioritized for rolling out the Dual Prevention Pill (DPP), a daily pill that combines oral PrEP with an oral contraceptive to prevent both unintended pregnancy and HIV. 

Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials

CASPR partners authored new research published in AIDS and Behaviorhighlighting the need for clinical trial teams to balance the goals of generating scientific evidence with participants’ fertility choices. The authors argue that to better support participants, trials should adopt strategies that accommodate changing fertility preferences, plan for pregnancies, and consider the ethical implications of allowing pregnant participants to continue in studies. This approach would contribute to a more gender-transformative approach to pregnancy in HIV prevention trials.

Mark Your Calendars: Upcoming Webinar

TOMORROW, August 27: Opportunities to Expand Equitable Access to HIV Prevention Services through Community Pharmacies 
Join The Choice Agenda and RxEACH, a national coalition effort working to expand and sustain access to HIV prevention and linkage to care services in community pharmacies for a webinar discussing the opportunity to expand equitable access to HIV prevention services, including PrEP, and what is needed to grow and sustain community-based HIV prevention service programs in pharmacies. 

August 29: Let’s Talk LEN: What global advances in HIV prevention mean for Black communities in the US
Join PrEP in Black America, Black Public Health, Federal AIDS Policy Partnership (FAPP), AVAC, and APHA, this webinar will explore the implications of the groundbreaking results from the PURPOSE 1 trial of Lenacapavir for US Black populations.
 
August 29: PrEP Your Booty
Join The Choice Agenda and HPTN 106 (REV UP), an innovative clinical trial from the HIV Prevention Trials Network that will investigate the safety and acceptability of a tenofovir-based rectal douche for HIV prevention, for a discussion with researchers leading the study.
 
September 11: Innovations in GPP
Join AVAC and champions of Good Participatory Practices (GPP) as they illustrate the evolution of GPPS from CABs and town hall meetings to more innovative and partnership-based approaches.

Pandemic Accord Priority for 2025

As members of the Coalition of Advocates for Global Health and Pandemic Preparedness, a group of organizations advocating for an integrated and holistic approach to preparedness that emphasizes equity, inclusion, and synergies of multiple global health programs in advancing preparedness, we share the following asks with regard to the ongoing Pandemic Accord negotiations after their extension past May 2024.

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.

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.