Our new issue of PxWire is here and shares the latest PrEP updates including new data from the PrEP Tracker, the HIV prevention pipeline, the prevention playlist and more! Check out the full issue here.
New Issue of Px Wire: Latest product approvals, PrEP data and more
PEPFAR: Celebrating its past and ensuring its future
As the US President’s Emergency Plan for AIDS Relief (PEPFAR) marks its 20th year as one of America’s most effective global programs in history, advanced with bipartisan support, the US Congress will be considering its reauthorization this year.
Yesterday, US President Joe Biden singled out the success of PEPFAR in his State of the Union address. Countless others including Bill Gates, former PEPFAR head Debbi Birx, former AVACer Emily Bass and Friends of the Global Fight’s Mark Lagon, have written about its impact in recent days – and the opportunities and challenges for its future. PEPFAR has to date saved 25 million lives by delivering life-saving antiretrovirals; it is credited with keeping 5.5 million babies HIV free and contributing to a 68 percent decline in AIDS-related deaths globally since their peak in 2004, just to highlight a few statistics that tell the story: PEPFAR’s impact has been monumental. Now what?
AVAC appreciates the Biden Administration’s recent promise to continue support for PEPFAR, as other presidential administrations have since its inception. However, it’s imperative that such promises are fulfilled through Congress’s unwavering, fully-funded support for the reauthorization of PEPFAR for the next five years – see these important principles to guide this process from the Global AIDS Policy Partnership (GAPP).
As the world begins to deliver on the commitment to end AIDS as a public health threat AND grapple with how best to build a platform for pandemic prevention, preparedness and response (PPPR), a strong PEPFAR will be critical. AVAC Senior Program Manager for Policy John Meade, Jr. spelled out some crucial connections in his recent blog, Global Fund and PEPFAR’s Essential Collaboration.
PEPFAR’s decades of experience using data and building systems, programs, and infrastructure to confront HIV, and instilling community trust, are unmatched as a global model for pandemic preparedness. Staying on track in the fight against HIV, through PEPFAR and other investments, secures a foundation for facing down future health threats, as a number of our colleagues just wrote in PLOS Global Public Health: Leveraging the HIV response to strengthen pandemic preparedness. Fulfilling this role depends on providing new money, policy-setting authority, and clearly defined leadership to PEPFAR. Without these measures, instead of building on and extending PEPFAR’s strength, decision-makers risk serious damage to what has been singular success in global health.
As PEPFAR marks its groundbreaking accomplishments in this anniversary year, we will be applauding its successes, tracking the process toward reauthorization, and keeping advocates connected to opportunities to add their voices to the process.
A Resource Roundup – Including a Recent Webinar on Trans Inclusion!
We are only a month into the New Year and so much has happened in HIV prevention. Below are links to important resources on the latest developments.
Opinion Piece: The Fight to Decriminalize Sex Work in South Africa
South Africa-based AVAC Fellow, Liyema Somnono published an opinion piece in Health-e News, Decriminalization of sex work can help prevent HIV, which unpacks the reasons for reforming South Africa’s outdated legislation that criminalizes “sex work” and legitimizing and recognizing sex work as work. AVAC’s Cindra Feuer then authored a blog post sharing AVAC’s support of possible reform: Decriminalization of Sex Work Prevents HIV: South Africa could overturn its outdated laws.
Publication: New Lancet HIV Publication Evaluates the Future of Injectable CAB for PrEP
The HIV Modelling Consortium along with representatives of AVAC and a number of partners recently published modelling study in The Lancet HIV. The new study, Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: a modelling study here, analyzes the potential benefits and risks from scaling up CAB for PrEP, with important implications for advocacy.
Mosaico Trial and What’s Next in HIV Vaccine Research
AVAC co-hosted with the HVTN the webinar, Where Are We Now and What’s Next in HIV Vaccine R&D. A link to the recording is here. On the webinar, the group shared details about the Mosaico HIV vaccine trial, which found no efficacy, including characteristics of the 3,800 participants, Mosaico’s approach to its PrEP, and community input throughout the trial. For more insights, check out these articles: The Only Late-Stage HIV Vaccine Study (Mosaico) Just Tanked. What’s Next? in The Body and Why inventing a vaccine for AIDS is tougher than for COVID in NPR’s Goats and Soda.
Webinar: Trans Inclusion and TG Scorecard
The Choice Agenda hosted its first webinar of 2023, Trans Inclusion: Charting HIV Research into the Future: A Manifesto and Scorecard for Advocates and Researchers with Leigh Ann van der Merwe, Brian Minalga, and AVAC’s own Cindra Feuer joined by over 80+ participants. Panelists unpacked the No Data No More manifesto and discussed preliminary findings from the TG scorecard, which looked at transgender representation in clinical trials over time. Watch the full recording of the webinar and check out the slides and resources here.
P.S. As a reminder, there are three upcoming webinars this month:
• The Power Of PrEP: Pleasure and Prevention In The Black Community on Tuesday, February 7 at 2:00 PM ET from the PrEP in Black America Coalition on National Black HIV/AIDS Awareness Day
• Ready, Set, CROI 2023 – Prepare for the 30th Year of CROI on Monday, February 13 at 9:00 AM ET / 2:00 PM GMT
• Decolonizing Global Public Health – What Will it Take to Dismantle Racism and White Supremacy? on Thursday, February 16 at 9:00am ET / 2:00 pm GMT
Decriminalization of Sex Work Prevents HIV: South Africa could overturn its outdated laws
South Africa could possibly reform its outdated and misguided criminal legislation that punishes consenting adults who offer or procure sexual services for money. AVAC supports the move toward decriminalization as evidence shows that its social, legal and economic injustices create a perfect storm for sex workers’ increased HIV risk. South African HIV and human rights activists deserve credit for their advocacy in bringing the Sexual Offenses Act of 1957 and its follow-on Amendment Act of 2007 up for a repeal vote.
AVAC Fellow, Liyema Somnono, authored an opinion in Health-e News (Jan 27), Decriminalization of sex work can help prevent HIV, unpacking the reasons for legitimizing and recognizing sex work as work, rather than as a stigmatizing crime with broad, negative effects that exacerbate an environment of social exclusion, violence and HIV. Liyema lays out a powerful case for repeal:
- Sex work is work. It’s an income-generating activity. Sex workers are not criminals, victims, vectors of disease, or sinners.
- Sex workers support between five and eight other people with their earnings.
- Under the current punitive laws, sex workers face human rights violations in their treatment by police officers, health practitioners, clients, and other members of society.
- Stigma and discrimination prevent most sex workers from accessing quality HIV prevention and HIV care services.
- Criminalization deems it difficult to negotiate safer sex or report abuse from clients, partners, police or health providers.
- Repeal of the legislation that punishes sex workers would have a profound impact on the course of HIV epidemics across all settings. A third to half of HIV infections would be averted in a decade.
For those residing in South Africa, please voice your opinion in favor of the Criminal Law Amendment Bill of 2022 at [email protected]. The comment period is open through 31 January.
Liyema is a 2022 Fellow, hosted by Passionate Unlimited Peers in Action, in South Africa where she partners closely with SWEAT and Sisonke, a national movement of sex workers working towards a South Africa where people who choose sex work are able to enjoy freedom, rights and human dignity. As part of her rights-based advocacy, Liyema works to integrate access to HIV prevention choices for sex workers and other women in the rural Eastern Cape.
This Week! Webinars on Mosaico Study and Trans Manifesto
AVAC has two webinars this week you won’t want to miss!
Tomorrow, January 25, at 9 AM PST/12 PM EST/6 PM CET, AVAC and HIV Vaccine Trials Network (HVTN) will host a webinar called Where Are We and Next Steps. As the field explores what the ending of the Mosaico study means for vaccine research, we’ll be joined by study investigators and community representatives to further interrogate what a post Mosaico trial looks like, key takeaways from the study, and ways to remain hopeful for an HIV vaccine. Register here.
On Thursday, January 26 at 10:00 AM EST / 3:00 PM GMT, The Choice Agenda is hosting its first webinar of 2023, Trans Inclusion: Charting HIV Research into the Future: A Manifesto and Scorecard for Advocates and Researchers. The webinar will explore why trans-inclusive and trans-centered research is not only the right the thing to do for equity in the global response, but also necessary to end the epidemic. Register here and join our growing community of HIV prevention advocates (Over 1,000 and counting!) with The Choice Agenda listserv.
We look forward to virtually connecting soon!
What’s Next for HIV Vaccines? Mosaico Study Webinar on Jan 25
On the heels of Wednesday’s announcement from Janssen Pharmaceutical Company that the Mosaico HIV vaccine trial is ending for lack of efficacy, there’s much to learn and discuss.
Please join AVAC and the HIV Vaccine Trials Network (HVTN) for a webinar on January 25th at 9am PST/12pm EST/6pm CET. The webinar will include study investigators and community representatives as we all discuss the outcome of the Mosaico study, what these results mean and next steps. Register here.
The Mosaico study, also known as HVTN 706/HPX3002, was the third large-scale vaccine efficacy study to conclude early for non-efficacy since 2020. Uhambo/HVTN 702 and Imbokodo/HVTN 705 were stopped in 2020 and 2021 respectively. One large-scale, Phase 2b trial known as PrEPVacc is continuing, studying two vaccine regimens and two daily oral PrEP regimens (F/TAF and TDF/FTC) in men and women; expected completion in late 2024. In addition, several early phase trials using mRNA technology have launched. It’s a field in transition.
This latest announcement raises critical questions about the direction of the essential work to develop an HIV vaccine. Understanding the results of the Mosaico study is central to this task. A vaccine strategy is vital for a durable end to the epidemic but a clear path is not in sight, and new longer-acting PrEP options, which hold promise to bring the world closer to controlling the epidemic, add to the complexity, the opportunities and challenges for HIV vaccine development.
To help navigate all of this, see our updated resources on the issue:
● AVAC’s statement on the Mosaico trial
● Years Ahead in Biomedical HIV Prevention Research (Detailed)
● Years Ahead in HIV Prevention Research (Simple)
● A Review of Pipeline of New HIV Prevention Options
We look forward to hearing from you on the 25th and working with you going forward.
Mosaico HIV Vaccine Study Stopped Early for Non-Efficacy
Today, the Mosaico study, a large-scale HIV vaccine efficacy study also known as HVTN 706/HPX3002, was stopped early for non-efficacy. The study took place in several countries in North and South America and Europe to test the safety and efficacy of the adenovirus26-based vaccine regimen among 3,900 cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals. An independent data and safety monitoring board, at a scheduled review of the trial data, found the regimen to be safe, but that it did not meet the pre-defined criteria for efficacy and recommended that the study be stopped and trial participants informed.
The Mosaico study used a similar version of the vaccine regimen in its companion study, the Imbokodo trial, which was stopped in August 2021 as it also did not significantly reduce the overall risk of HIV acquisition among over 2,600 cis-gender women in five sub-Saharan African countries.
● Read the Janssen Pharmaceutical Company press release.
● Read the HVTN press release.
● Read the AVAC press release.
● The HVTN and AVAC will host a global webinar on Wednesday, January 25 to reflect on this news and how it may impact HIV vaccine R&D and prevention globally. Stay tuned for registration details soon.
“The hard truth is the science of HIV vaccine development is extremely challenging,” AVAC said in its statement. “HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to provide a durable end to the pandemic. At the same time, we now have more proven HIV prevention options than ever before, but they are not reaching everyone who needs and wants them. Even as researchers continue the necessary work of accelerating HIV vaccine research, the broader HIV response must act as if we may never have a vaccine and prioritize the roll out of existing prevention options and research for additional ones. Ending this pandemic requires simultaneous action on multiple fronts of research, development and delivery.”
We hope you join us on January 25 with your questions and comments to discuss the ways forward.
AVAC Launches the Advocacy Navigator!
AVAC is excited to launch the Advocacy Navigator, an extension of our Advocacy Fellows program, which has involved more than 90 advocates and dozens of civil society organizations in 15 countries to drive groundbreaking advocacy on HIV prevention research, rollout, and human rights. AVAC now seeks applications from early-career professionals from Eastern and Southern Africa interested in strengthening their skills in HIV prevention advocacy. Applications for the Advocacy Navigator program are now being accepted through 13 February 2023.
Find details about the Advocacy Navigator program and application process here.
The Advocacy Navigator combines training and mentorship to young and emerging advocates in the field of HIV prevention advocacy. The program will mobilize a cohort of ambitious individuals and empower them with the knowledge, skills, and confidence to meaningfully advance HIV prevention advocacy. 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 of implementation, when advocates implement their plans.
Since 2009 and the beginning of the Advocacy Fellows program, AVAC has recognized the imperative to invest in mobilizing a growing cadre of HIV prevention advocates. They represent a global movement of seasoned veterans and passionate newcomers, who call out neglect, insist on equity, monitor commitments and identify solutions. This movement has been and will continue to be absolutely essential to the fight against HIV and progress in global health. See the 2019 evaluation of the Fellows program and highlights of what the current class of Fellows did last World AIDS Day.
Now the Advocacy Navigator Program is leveraging the strength of this extraordinary alumni community to sustainably expand this model to a larger number of people, continue to support and engage mentors, and prepare future Fellows for long-term projects.
Find the application and additional information at AVAC.org/navigator.
A Year of Action in 2023
At AVAC we saw tremendous work to accelerate HIV prevention and invest in global health resilience in 2022, and the year ahead will require critical advocacy to keep the field on track. What does this mean?
Our year-end letter, HIV Prevention and Equity in 2022 & Beyond, explores in depth the many initiatives, resources and collaborations that powered advocacy in 2022 — a historic juncture for HIV and global health. The field is facing a turning point where the right commitments in funding, policy and programming in 2023 could put the world on track to hit 2025 targets, end HIV as a public health threat by 2030, and lay a solid foundation for global health security against future pandemics.
The world finds itself at this moment because of the convergence of the approval of two new biomedical options for HIV prevention—the dapivirine vaginal ring (DVR, or the ring) and injectable cabotegravir for PrEP (CAB for PrEP)— with the launch of critical new strategies to advance HIV prevention from PEPFAR, the Global Fund, the Global HIV Prevention Coalition, and The Coalition to Accelerate Access to Long-Acting PrEP. All this in the context of a growing consensus and commitments to invest in pandemic preparedness and strengthening health systems.
In 2023, advocacy must meet the moment. Here’s just a sample of what AVAC’s preparing for in the weeks and months ahead.
Access Access Access
• Accelerated planning and engagement with the Coalition to Accelerate Access to Long-Acting PrEP and pushing key action steps for comprehensive and effective delivery of injectable CAB everywhere it’s needed.
• Taking action across our partnerships to establish the policies, budgets and programs that will deliver the ring to women who need it and want it.
Funding: Innovation and Expansion
• Defining a robust advocacy agenda for PEPFAR’s multi-year reauthorization starting in 2023.
• Supporting partners to help shape priorities for the Global Fund, the Pandemic Fund, PEPFAR country operational plans (COPs).
The Research Pipeline
• Tracking the trials on injectable lenacapavir as PrEP and the Dual Prevention Pill, and engaging in the development of next-generation PrEP options.
• Translating developments in research on and HIV vaccines and broadly neutralizing antibodies, including possible results from the Mosaico vaccine trial, the application of mRNA technology and new approaches to research and trial design.
People Centered Advocacy
• Advancing the reach of the GPP guidelines by compiling a body of evidence on GPP’s value, impact, and best practices as a key resource for partners and for clinical research broadly.
• Watch-dogging the status of the HIV research agenda for: trans and gender diverse people, pregnant and breastfeeding populations, and other key populations.
• Engaging with new leadership at the National Institutes of Health and National Institutes of Allergy and Infectious Diseases to deepen collaboration with civil society, community and advocacy leadership.
Key Dates for January and February
Pull out your calendars for the first three months of 2023, these convenings will help shape your advocacy for the rest of the year.
● Jan 26: The Choice Agenda webinar: Trans Inclusion: Charting HIV Research into the Future: A Manifesto and Scorecard for Advocates and Researchers, at 10 am. Register
● Feb 13: CROI is coming! Join The Choice Agenda and partners for the February 13 webinar “Ready, Set, CROI 2023 – Prepare for the 30th Year of CROI”
● Stay tuned for the Margarita Breakfast Club series of three webinars highlighting the latest in science presented at CROI, open to all, held during the CROI conference, Feb 20 – 22.
● Feb 19-22: Whether or not you are attending CROI, AVAC will have you covered as we track the research and the advocacy. Plus, we’ll have recordings from the Margarita Breakfast Club, for a curated discussion with CROI researchers.
Buckle up and lean in, let’s make 2023 an unforgettable year of collaboration and solutions.
Translating, Advocating and Catalyzing for HIV Prevention and Equity in 2022 & Beyond
This year was an incredible one of reflection, engagement, opportunity, and action. More than 40 years into the HIV epidemic – and in the midst of multiple other pandemics and persistent inequities – AVAC and its partners continue to reshape, reimagine and fight for effective HIV prevention.
We began 2022 with a new strategy reflecting an evolving field and critical opportunities for HIV prevention and for global health:
- Research is accelerating, with more options available than ever before. But progress toward crucial targets has been far too slow, and these biomedical options are not yet real choices for the people who need them.
- COVID accelerated science, but significant gaps in access underscored the necessity for smart, equitable, and people-centered pandemic preparedness, prevention AND response.
- And a global movement for social justice continues to demand that we all reexamine critical questions of equity, including health equity.
As we close out the year, we’ve been asking ourselves, how have we done? And the answer, we hope, lays the foundation for bold action in 2023 and beyond.
Thanks to an incredible partnership network and committed donors and collaborators, I am proud to say that we’ve made significant progress. But, as Tony Fauci reminded us all last month when he and I had a chance to chat about history AND the future, “much accomplished; much more to do.”
In all that we do at AVAC, we keep three aims in mind. Track and translate the science so the research enterprise and the communities who need prevention most are working hand in hand. Advocate for evidence-based, high-impact, community-centered programs, products and policies. And catalyze the relationships, partnerships, coalitions, advocacy agendas, joint commitments and action plans that get it all done.
Here’s a look at just some of the work we’ve done to advance all three in 2022.
We served as a bridge between the scientific field and communities where research happens.
- Published new evidence on a wide range of critical topics:
- Correlations Between Oral Pre-Exposure Prophylaxis (PrEP) Initiations and Policies that Enable the Use of PrEP to Address HIV Globally in PLOS
- JIAS Viewpoint on HIV vaccines in 2022: where to from here?
- Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment in Global Health Action
- “It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do’…”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement? in the Journal of Empirical Research on Human Research Ethics
- Safety data needed for concurrent use of ARV-based PrEP in Lancet HIV
- Convened critical conversations to reframe and re-energize the search for an HIV vaccine; created a snapshot of Phase 1 mRNA HIV Vaccine Trials that are underway and a backgrounder on experimental medicine vaccine trials (EMVTs) that are driving the field forward.
- Spoke with advocates and global leaders on our PxPulse podcasts about all forms of HIV prevention and what needs to happen next to ensure equitable access.
- Redesigned PrEPWatch.org, a one-stop clearinghouse for the latest PrEP data on implementation and uptake, resources, and information on PrEP policies, programs and products, approved and in development.
- Created STIWatch.org, the first and only resource on all things STI vaccine development.
- Tracked and translated new developments: created and shared more than 17 accessible, up-to-date resources on the full spectrum of biomedical HIV prevention products from research to rollout and real-time analysis of emerging developments.
We deepened our investment in supporting the next generation of skilled and informed advocates with the belief that advocacy and action must be founded on principles of power-sharing.
- Developed and continuously track our Plan for Accelerating Access and Introduction of Injectable CAB for PrEP to ensure time is not wasted and opportunity is not squandered, and importantly, that civil society plays a meaningful role.
- Supported the African Women’s HIV Prevention Accountability Board and our CASPR and COMPASS partners in meeting with global leaders, including Winnie Byanyima of UNAIDS, Amb. John Nkengasong of PEPFAR and Atul Gawande and Han Kang of USAID, to make the urgent case for faster and more equitable access to both the dapivirine vaginal ring (DVR) and injectable cabotegravir – and to listening to and engaging with civil society before making decisions.
- Welcomed the 12th class of the flagship Fellows Program with 8 new Advocacy Fellows working on access to the DVR, U=U campaigns, and integrating SRH with HIV services.
- Established CureROAR to support a cadre of advocates to gain knowledge in the science and process of cure research, and to develop an advocacy agenda to ethically advance cure research.
- Introduced The Choice Agenda (TCA), a global forum for advocacy on HIV prevention, with agenda-setting conversations, deep-dive webinars on key issues in the field and moderated passionate, highly-informed discussions with 1,000 advocates and experts across the field.
- Launched an advocacy campaign with PrEP4All and other partners to ensure the US National PrEP Program reaches those who need prevention most – with a huge year-end victory this week when the US Congress included as part of its fiscal year 2023 budget a call for the Centers for Disease Control and Prevention (CDC) to expand equitable national PrEP access in order to end the HIV epidemic!
We expanded our work to cultivate and sustain dynamic partnerships that set a bold and innovative agenda for HIV prevention.
- Launched The Coalition to Accelerate Access to Long-Acting PrEP, a new initiative to ensure an accelerated, equitable, sustainable and collaborative approach to making longer-acting PrEP options accessible as quickly and as equitably as possible.
- Co-hosted the first Africa Health R&D Week and launched the Domestic Resource Mobilization (DRM) Learning Collaborative.
- Joined a wide range of partners in urging a comprehensive approach to Pandemic Preparedness, Prevention and Response, outlining a funding agenda for the Pandemic Fund and articulating key needs for future global health governance.
- Hosted 20+ virtual and in-person think tanks and consultations to update and gather feedback on the latest developments related to the Dual Prevention Pill (DPP) market introduction, injectable CAB for PrEP, and the MATRIX pipeline of new HIV prevention and multipurpose prevention options.
- Hosted with Wits RHI and CASPR a GPP Symposium exploring innovation in Good Participatory Practice (GPP) and strategizing for expansion of GPP in 2023.
- Convened 3,000+ participants on 28 webinars to explore issues key to the future of the AIDS response, HIV prevention and global health equity.
Yes, together we’ve been able to do so much this year. But there remains a long, unfinished agenda for all of us in 2023 and beyond, that no one organization can address alone. The challenges ahead can only be defeated by building global solidarity, sharing responsibility and accountability, and mobilizing a response that leaves no one behind.
Thank you to all of our partners, AVAC staff, board, donors, and the remarkable individuals and organizations around the world who allow us to continue this critical work as part of a comprehensive and integrated pathway to global health equity.
In solidarity and with enormous gratitude,
Mitchell Warren and all of us at AVAC
P.S. We are grateful for all forms of support and partnership. If you can, please do consider a financial contribution to AVAC to help keep this work moving, together.