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 trials, these 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.

Avac Event

Innovations in GPP

This webinar will feature site-level, national, and funders from across the globe who have non-traditional approaches to GPP. Examples multiple perspectives – sponsor to site-level, will illustrate the evolution of GPP from CABs and town hall meetings to more innovative and partnership-based approaches.

Moderator and Presenter:

  • Ntando Yola, Desmond Tutu Health Foundation

Presenters:

  • Sarah Read, National Institute of Allergy and Infectious Diseases
  • Clever Chilende, Treatment Advocacy & Literacy Campaign (TALC)
  • Chilufya Kasanda, Treatment Advocacy & Literacy Campaign (TALC)

Impact of the Anti-Homosexuality Act on PrEP Uptake Rates in Uganda Compared to Other Countries

Oral PrEP initiations in Uganda were among the highest in the region, with sizable increases each quarter, until the enactment of the Anti-Homosexuality Act (AHA) in March 2023. Since then, the number of new PrEP initiations plummeted, and have since struggled to sustain rates seen in 2023. Public policies clearly matter.

Avac Event

HIVR4P 2024

The HIV Research for Prevention Conference is the only global scientific conference focused exclusively on the challenging and fast-growing field of HIV prevention research. This conference fosters interdisciplinary knowledge exchange on HIV vaccines, microbicides, PrEP, treatment as prevention and biomedical interventions, as well as their social and behavioural implications.

Click here for registration and more information (including program) here.

African Networks of People Living with HIV Seek Resource Commitments in the Fight to End HIV

A coalition of African People Living and Affected with HIV released a statement during the 25th International AIDS Conference to extend gratitude to the international community for their contributions in ending the epidemic globally, but also highlighted several concerns including the need for sustained investment, efforts to push for a 5-year PEPFAR reauthorization, and advocating for key populations as they face increased discrimination.

Read the full statement here.

Avac Event

2024 IUSTI World Congress

The International Union Against Sexually Transmitted Infections (IUSTI) and ASHM are pleased to invite you to the 25th IUSTI World Congress, which will this year incorporate the Australasian Sexual and Reproductive Health Conference.

Taking place 17-20 September 2024 at the International Convention Centre in Gadigal Country, Australia, this conference will provide an opportunity to meet, discuss and learn about the latest research and innovation in sexual and reproductive health. The program will incorporate a range of world leading speakers and presentations, providing an opportunity to expand your professional knowledge through local and international insight.

Click here for registration and more info.

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 Alliance, SMART4TB, 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.

Avac Event

AIDS 2024: New Ways for the Next Wave: Innovative R&D for the future of women’s prevention

This session will be 9:30AM to 11:00AM Munich time.

Women need a range of HIV prevention options to meet different needs, preferences and life circumstances. Currently available pills, rings and injectables are necessary but insufficient. How might we accelerate the delivery of methods we have while developing additional ones – including systemic and non-systemic methods, short-acting and on-demand products, to complement longer-acting ones? Product developers and advocates are collaborating on new approaches to expedite R&D of additional HIV prevention options. Notably, MATRIX is taking a unique approach, endorsed by the CASPR network of advocates, that aims to improve the odds of success of new products – through development, delivery and use.

This session will focus on new efforts to identify and develop promising options, strategically engage all stakeholders, decolonize R&D and involve potential users in all their diversities throughout the process.

Speakers:

  • Jeanne Marrazzo, National Institute of Allergy and Infectious Diseases
  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Thesla Palanee-Phillips, Wits RHI

Followed by a moderated panel with:

  • Chimwemwe Chamdimba, African Medicines Regulatory Harmonization (AMRH) initiative- AUDA/NEPAD
  • Kelly Chibale, Holistic Drug Discovery and Development Centre -H3D, University of Cape Town
  • Nyaradzo Mgodi, University of Zimbabwe- Harare Health Research Centre
  • Jerop Ruth Limo, Ambassador for Youth and Adolescents Reproductive Health Program (AYARHEP)

Moderators:

  • Navita Jain, AVAC
  • Kenneth Ngure, Jomo Kenyatta University of Agriculture and Technology

Session Chairs:

  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Imelda Mahaka, Pangaea Zimbabwe

This satellite session will be co-hosted by CASPR and MATRIX, with support from USAID and PEPFAR.

Avac Event

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

The data we collect on a program determines its path and priorities. This webinar covered the current state of PrEP M&E and efforts to improve and simplify the data we collect, allowing our data to better reflect how people are using PrEP, support PrEP choice amongst the growing array of PrEP methods, and enhance the stories we can tell about PrEP program implementation.

Presenters:

  • Katharine Kripke, Avenir Health, MOSAIC
  • Jessica Williamson, Avenir Health, MOSAIC

Panelists:

  • Omolabake Ekundayo, Ministry of Health Nigeria
  • Dr. Herbert Kadama, Ministry of Health Uganda
  • Ramatsoai Soothoane, Jhpiego, MOSAIC Project Lesotho

Moderator:

  • Adaobi Olisa, FHI360, MOSAIC Project Nigeria

This webinar offered live French and Portuguese translation, courtesy of the South-to-South Learning Network in Africa.

Co-sponsors:

  • BioPIC
  • South-to-South Learning Network
  • The MOSAIC Project

Recording in English / French Audio Recording / Portuguese Audio Recording / Webinar Slides / Strengthening and Harmonising PrEP Indicators