The field of HIV prevention research has two updated ethical guidance documents, one from the US National Institutes of Health-funded HIV Prevention Trials Network (HPTN) and the other jointly published by UNAIDS and WHO. Each of these documents updates prior versions, last published in 2009 for the HPTN and 2012 for UNAIDS/WHO. Here we explore the key similarities and differences in the two documents and their implications for the field.

Taken together, the HPTN’s Ethics Guidance for Research and UNAIDS/WHO’s Ethical Considerations in HIV prevention trials address the dominant issues in today’s world of HIV prevention research. They reflect the expanded array of prevention tools—including antiretroviral treatment as prevention for people living with HIV and a PrEP landscape that includes tenofovir-based oral PrEP today, with the Dapivirine Vaginal Ring (DVR) and injectable long-acting cabotegravir (CAB-LA)—and provide deeper guidance on critical decisions that come with trial operations and regulations.

The considerations and obligations put forward in these documents are not binding, but they are widely accepted by civil society, trial designers, product developers and researchers as crucial considerations for the design and execution of biomedical prevention trials.

The publications serve different primary audiences. The HPTN guidance is written specifically for the network’s researcher staff and partners and reflects US government policy and positions. The UNAIDS/WHO document is aimed at a global audience, including all research institutions as well as other decision-making bodies such as national ministries of health. Both set out principles that can be referenced by communities, researchers, policy makers, funders, regulators, and anyone engaging with a specific trial or with research overall.

In both cases, the authors were digesting major forces that affect HIV prevention research. The advent of oral PrEP, increasingly accessible since 2012, is making HIV prevention trials more complex. Participants must be offered this highly protective option—either in the “comparator” arm of a study where there’s no placebo, or as part of the standard package of prevention that participants receive when they are randomized to either a placebo product or an experimental one. (For more on issues in innovative trial design check out Bill Snow’s blog on AVAC, Designing a New Generation of HIV Prevention Efficacy Trials, and the May 2021 statement from the AVAC-convened Trial Design Academy on the future of HIV prevention trials.)

But providing PrEP involves a web of decisions about how to ethically fulfill this obligation, and how to design a trial that will be able to answer key questions in research. As new forms of PrEP move through the pipeline, this complexity will only grow. In addition, ethics bodies have been increasingly concerned with a number of other issues including: building lasting capacity to conduct research and respond to healthcare needs in the places where research takes place; addressing the social and political pressures faced by vulnerable populations as a factor in trial design; and expanding and deepening partnerships among host communities, populations that need prevention, and those who fund and conduct research.

Each of the 15 guidance points of HPTN’s Ethics Guidance for Research receives a designation as an “obligation” or an “aspiration” and names accountable entities, such as trial sponsors, researchers, community representatives, study teams and/or research sites.

Ethical Considerations in HIV prevention trials by UNAIDS/WHO tackles the ethics of trial design and conduct in 14 guidance points. Guidance Point 1 reasserts, in contemporary terms, why HIV prevention trials remain imperative. Despite the efficacy of PrEP and its increasing availability, transmission of HIV is outpacing current efforts to control the epidemic, and more choices for effective prevention are essential.

Many of the most significant changes in each publication echo each other, but there are some distinctions. This table (downloadable here) summarizes some of the key changes in both documents and their implications.

These two foundational documents set a standard that all HIV prevention stakeholders should seek to meet, and transparently. It’s important to note that they are intended and should be used as guides, not prescriptions. Where they leave off, the Good Participatory Practice Guidelines for biomedical HIV prevention trials (GPP) pick up. Developed by AVAC and UNAIDS, the GPP Guidelines look at how to involve stakeholders and build the partnerships that make research relevant and ensure results will lead to innovation that works for the people who need it. Researchers, sponsors, advocates, ministries of health, trial-site staff, regulators and anyone interested in HIV prevention research should know what’s in them all.

We’re taking a long look at two new guidance documents on ethics for HIV prevention trials, one by the HIV Prevention Trials Network (HPTN) and another from UNAIDS/WHO.

Check out Ethical Guidance in Focus, a blog by Jeanne Baron that spotlights what’s new, how the two publications contrast, and implications for advocacy.

And we hope you’ll join next week’s webinar New Ethical Guidelines for HIV prevention trials in people: What’s changed and Why Does it Matter? on Thursday, 5 August at 9am US EDT / 3-4pm Southern Africa / 4-5pm Eastern Africa.

Register here.

The webinar will explore the guidance documents in-depth, and offer a discussion on the changes and what they mean for HIV prevention research.

Panelists include:

• Catherine Slack, PhD. Head, HIV/AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Pietermaritzburg, South Africa
• Andreas Reis, MD, MSc. Co-Lead, Health Ethics & Governance Unit, WHO, Geneva
• Jeremy Sugarman, MD, MPH, MA. Professor of Bioethics and Medicine, Johns Hopkins University, Baltimore, US, and Chair of the HPTN Ethics Working Group

Looking forward to working with you all on a future for trial design that’s ready for next generation prevention.

Worldwide, trans and gender-diverse (TGD) people face a highly disproportionate burden of HIV but are frequently and often systematically left out of HIV prevention research and responses. That ongoing exclusion is a major barrier to efforts to end the global HIV pandemic, according to No Data No More, a new HIV prevention manifesto written by TGD advocates from South Africa, Europe and the United States, with support and solidarity from AVAC.

No Data No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities takes aim at an achilles heel in the global response to HIV: the neglect of trans and gender-diverse communities. Trans women bear a disproportionate burden of HIV globally with 19 percent living with HIV—49 times greater than the general population. HIV in trans men is woefully underreported and understudied and the absence of data leads to a false assumption that they bear little to no burden of the virus. Gender nonbinary people face even greater underrepresentation in HIV surveillance and research.

No Data No More analyzes how TGD communities are left out of HIV prevention research and responses through structural barriers such as discriminatory attitudes and punitive laws, non-inclusive language, failure to recognize the diverse and unique identities of different members of TGD communities and a lack of understanding of the role of gender-affirming hormone therapy (GAHT) in TGD health. And this manifesto provides a vision for a course-correction.

Addressing researchers, implementers, funders and advocates, highlights of manifesto demands include:

• Inclusion of the full range of the gender spectrum in clinical trials, with an emphasis on trans men.
• Efficacy and safety questions regarding on-demand oral PrEP for trans people on GAHT are resolved.
• Local research sites funded to recruit TGD participants and to follow the Good Participatory Practice.
• Guidelines, which must involve engaging with the local LGBTQ community, including transgender-led organizations.

No Data No More offers practical and essential priorities to ensure viable HIV interventions for TGD people. We encourage you to engage with these important insights, because the future must include peer-led HIV prevention research with true ownership and acceptability in TGD communities.

Watch this space for details on an upcoming webinar. And for more information and to advocate for TGD inclusion in HIV research, go here [email protected].

The latest episode of Px Pulse goes behind the scenes of the new HBO movie, The Legend of the Underground. The film documents the lives of AVACer Micheal Ighodaro and other LGBTQ Nigerians as they confront enormous risks to ‘live out loud’. As the movie unfolds, individual stories of resilience are woven together into a tapestry that portrays a revolution for cultural change in Nigeria.

In this special Px Pulse interview, Micheal reflects on what the movie means to him and how he sees himself in the young Nigerian activists at the forefront of the movement today. Micheal says, “change starts by people sharing their stories… Telling my story helps, hopefully, to give light to other stories that need to be told—that’s why I do it”.

AVAC applauds Micheal and the other Nigerian activists and their fight for freedom. The Legend of the Underground, directed by Nneka Onuorah and Giselle Bailey, is streaming now on HBO. For the full podcast episode, highlights and more resources, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

IAS 2021 is around the corner! This year’s virtual event covering advances in HIV research runs from Sunday, July 18 to Wednesday, July 21. AVAC will be tracking the landscape of prevention research to explain, frame, connect and contextualize what’s new, what’s next and what it all means for advocacy.

Below we’ve gathered some resources and highlights so you won’t miss a thing!

Resources

• Use AVAC’s Prevention Roadmap to find sessions where prevention is in the spotlight. You can download it as a sortable spreadsheet or pdf.
• AVAC’s Research Literacy Zone takes the conversation deeper with advocates and researchers exploring timely topics including: updates on rolling out the Dapivirine Vaginal Ring, updates on recent results and new trials, advances in vaccine and cure research and new approaches to understanding social factors that impact health. See the full schedule here.
• To follow events in real time, AVAC will offer comments and updates on Twitter, and our friends at NAM/AIDSMAP who will be reporting throughout the conference. Join the conversation using the conference hashtag, #IAS2021.

Satellites, sessions and panels featuring AVAC and partners

Sunday, July 18

Symposium – Pivoting HIV prevention during a parallel pandemic
Ch. 4 14:00-14:50 CEST / 8:00-8:50 EDT

This session explores how the COVID-19 pandemic has impacted HIV prevention services and some of the positive changes to how services are managed. Co-moderated by AVAC’s Micheal Ighodaro and Loice OMBAJO, University of Nairobi, Kenya.

Monday, July 19

Satellite – Paving the road for new PrEP products: The promise of differentiated, simplified, and decentralized delivery to maximize the potential of emerging PrEP products

Ch. 2 08:30-09:30 CEST / 2:30-3:30 EDT
PrEP uptake has increased over 100 percent since 2019, largely due to efforts to innovate and adapt PrEP delivery. The next generation of PrEP must learn from these experiences. Implementers, advocates and researchers discuss these models and others to scale up all forms of PrEP to reach those who need it. Chaired by AVAC’s Jessica Rodrigues, Anna Grimsrud of the International AIDS Society, Davina Canagasabey and Kim Green of PATH. Download the flyer.

Symposium – What is missing in the HIV response? Strengthening HIV programmes for trans populations in the Global South (CME)
Ch. 3 11:00-11:50 CEST / 5:00-5:50 EDT
There’s a serious dearth of information on health outcomes for trans populations in much of the world. Without this information how can HIV programmes effective? Join this session for a dialogue among academics, HIV service providers and trans community members on where research must expand and to engage the trans community in the development of this research agenda.

Symposium – Build it: But will they come? Prevention efficacy versus population effectiveness

Ch. 3 14:00-15:50 CEST / 8:00-9:50 EDT

Community uptake is crucial for the success of prevention interventions. This session will discuss how the field can better prepare for the delivery of effective prevention interventions and how communities can contribute to ensuring their success. Co-moderated by AVAC’s Manju Chatani-Gada and Moses R. Kamya of Makerere University, Kampala, Uganda.

Satellite – Bringing the Dual Prevention Pill to Market: Opportunities for HIV and Pregnancy Prevention and Implications for Future Multipurpose Prevention Technologies

Ch. 1 21:00-22:30 CEST / 15:00-16:30 EDT
The Dual Prevention Pill (DPP), a tablet containing oral PrEP and combined oral contraceptive, is likely to be the first MPT with PrEP to go to market. This combination, preventing both pregnancy and HIV, may transform challenges related to stigma that women face taking PrEP alone. Using the DPP as a case study, this session will highlight practical considerations for future MPTs such as: What are best practices with end users and providers? How do different financing sources for family planning and HIV shape next steps? What approaches can be used to estimate impact?

Tuesday July 20

Satellite – An HIV vaccine: who needs it?

Ch. 3 19:00-20:30 CEST / 13:00-14:30 EDT
The response to the HIV epidemic, now in its fourth decade, has marked tremendous progress in developing effective treatments and prevention options, but the challenge of developing a safe and effective HIV vaccine persists. Co-sponsored by the Global HIV Vaccine Enterprise at IAS and UNAIDS, this satellite offers. A panel discussion, including AVAC’s Daisy Ouya and others, will explore critical questions that will come when an HIV vaccine is discovered, such as who should be immunized, what will be the benefits, the costs, and who will pay?

Access these resources, conference highlights and more at AVAC’s dedicated IAS 2021 event page. And watch this space for further updates. Hope to see you in the virtual halls!

The latest episode of Px Pulse takes a deep dive into PEPFAR, The President’s Emergency Plan for AIDS Relief, looking at its pioneering successes and its challenges. In this episode, AVAC’s former Director of Strategy and Content, Emily Bass, discusses her new book, To End a Plague: America’s fight to end AIDS in Africa.

Emily began reporting this comprehensive history of PEPFAR not long after George W. Bush launched the program in 2003. Since its creation, PEPFAR had an enormous impact and radically changed expectations of what a foreign aid program should be.

But the program has also faced challenges. Emily covers it all in her new book, including questions related to health equity, drug costs, patents, and the best ways to design and implement a foreign aid program and address pandemics.

This podcast episode is bittersweet for us at AVAC. After nearly 16 years with AVAC, Emily is taking on new challenges in the larger field of global health as part of the new Pandemic Prevention Institute. Her leadership at AVAC has provided a legacy of passionate, far-sighted advocacy and she will be deeply missed. Congratulations, Emily, on this book, and we look forward to our continued collaborations with you in fighting against pandemics and for global health equity.

Happy Listening!

Carlos del Rio is professor of medicine at Emory University School of Medicine and professor of global health and epidemiology at Emory’s Rollins School of Public Health. He is also chair at the PEPFAR scientific advisory board. Mitchell Warren is AVAC’s Executive Director and a member of the PEPFAR scientific advisory board. This piece first appeared on Devex.

US President Joe Biden has repeatedly praised the United States’ leadership in the global effort to end HIV/AIDS. Early this month, in marking the 40th anniversary of the start of the AIDS pandemic, the White House noted the “heartbreaking human toll” of nearly 35 million global AIDS deaths, the ongoing, high rate of new HIV infections worldwide, and the enormous progress being made against the epidemic by the US President’s Emergency Plan for AIDS Relief, or PEPFAR.

But surprisingly, more than five months into the new administration, PEPFAR remains with an acting global AIDS coordinator and, thus, effectively leaderless, for far longer than at any point in its history.

The silence on who will run US efforts to control and reverse the AIDS pandemic is a source of increasing anxiety and frustration for advocates, public health officials, PEPFAR partners around the world, and members of the PEPFAR scientific advisory board, on which we both sit.

PEPFAR is the largest single-nation effort to address a disease in history and is one of the few examples of a highly effective and truly bi-partisan government program, garnering both Presidential and Congressional support for almost 20 years.

Since its creation, PEPFAR has enabled more than 18 million people to receive life saving antiretroviral treatment, and provided HIV testing for 50 million people.

As members of PEPFAR’s scientific advisory board … we know that the best-intended efforts by committed staff and capable advisers still require clear and consistent leadership.

PEPFAR’s DREAMS initiative has reduced new infections among adolescent girls and young women who are particularly vulnerable to HIV in several sub-Saharan African countries.

Moreover, the HIV policy, programmatic, and laboratory infrastructure that PEPFAR has helped to build over the past 18 years is the strongest foundation for an equitable global response to COVID-19 and future pandemics. To put it simply, PEPFAR is US global leadership at its best.

PEPFAR’s impact is so enormous, and its leadership is seen as so important to US efforts to advance global health and security, that its program director holds the title of ambassador — unique among US global health employees, and its activities are coordinated by the US Department of State. Of all of the vacant ambassadorships in Washington, PEPFAR’s vacant leadership is one that causes global health advocates the most alarm.

Of course, this multibillion-dollar global initiative continues to function, even without clear leadership. But the lack of a Presidentially-appointed and Senate-approved PEPFAR director is beginning to take its toll on efforts, such as those approved at the 2016 United Nations High-level Meeting on HIV/AIDS, to end the global AIDS epidemic by 2030, where US leadership was necessary to secure global commitments.

PEPFAR-supported infrastructure is also critical to ending COVID-19 globally, an effort that must be coordinated between a permanent PEPFAR director and the recently appointed Gayle Smith, the State Department’s coordinator for global COVID-19 response and health security.

As US Representatives and HIV/AIDS Caucus co-chairs, Barbara Lee and Jenniffer González-Colón noted in a recent letter to the White House, PEPFAR’s strategic plan, which lays out its global AIDS-control vision for the next five years, is currently being developed with no leader in place.

Daily decisions on efforts to ensure the delivery of critical PEPFAR services, now severely tested by COVID-19, are being made without the benefit of a director with a clear line to the highest levels of the US government.

That situation could have been understandable in the early weeks of a new presidency, but more than five months into the Biden-Harris administration, it’s past time to give PEPFAR leadership the priority it deserves. The administration’s failure to have named PEPFAR leader to work with member states at the recent UN High-Level Meeting, and to represent the program at the upcoming International AIDS Conference next month sends a message that HIV is no longer a priority for the administration.

Few doubt this administration’s commitments to a robust response to HIV/AIDS. The recent appointment of Harold Phillips as the director of the White House Office of HIV/AIDS Policy — a position left vacant since 2017 — will strengthen efforts to control and reduce the US’s own entrenched national HIV epidemic, which disproportionately impacts people from racial and ethnic minorities, men who have sex with men, heterosexual women, people who inject drugs, transgender people, and people from other marginalized communities.

As members of PEPFAR’s scientific advisory board, however, we know that the best-intended efforts by committed staff and capable advisers still require clear and consistent leadership from a director who brings the demonstrated confidence of the President, Secretary of State, and Congress to the table.

The world has just commemorated the solemn anniversary of 40 years of AIDS. Now it’s time for the President to nominate a strong PEPFAR leader with the vision and commitment to help lead global efforts to control and eliminate AIDS in the years ahead.

Check out the new resources and events available on avac.org, plus a new site for global AIDS policy resources!

An “HIV Prevention Buffet” and a DJ

The AIDS Foundation of Chicago, in partnership with AVAC, the Black AIDS Institute, Desmond Tutu Health Foundation and SisterLove, is hosting a June 29 webinar, What’s Your Pleasure? Expanding Your Choices on the HIV Prevention Buffet. The event will feature global HIV prevention research experts, spoken word artistry and a smokin’ DJ (yes, a DJ!). The focus of the webinar will be on the HIV prevention research pipeline, including a wide array of molecules and modalities. Speakers include Desmond Tutu Health Foundation’s Dr. Linda-Gail Bekker, Dazon Dixon Diallo of SisterLove and the Black AIDS Institute’s Rob Newells-Newton. Register here.

Monitoring Progress Towards PrEP-FP Integration

Authors from the OPTIONS, PROMISE and CHOICE consortia, including AVAC’s Jessica Rodrigues, recently published an article, “Integrating oral PrEP into family planning services for women in sub-Saharan Africa: findings from a multi-country landscape analysis” in Frontiers in Reproductive Health. In the piece they share their desk review to develop a PrEP-FP integration framework—as integration of HIV and family planning services sees a renewed focus for national policy makers, donors, and implementers in sub-Saharan Africa. In the authors’ analysis, none of the countries included had made substantial progress toward integrated PrEP-FP service delivery. Check out the article for a road map for policy makers, program implementers, and health care providers to assess and monitor progress toward PrEP-FP integration. This work complements AVAC’s ongoing SRH/HIV integration work. Read more.

PrEP “Cycling”: The dance of oral PrEP

The landscape for PrEP is in the midst of transformation, with opportunities to understand and improve HIV prevention. With increasing numbers taking oral PrEP and new products on the horizon, such as the Dapivirine Vaginal Ring and long-acting cabotegravir, the world must get rollout right. There are vital lessons to learn from how people use oral PrEP and critical questions to answer. AVACer Jeanne Baron’s blog, PrEP “Cycling”: The dance of oral PrEP explores one key lesson from today’s PrEP users that could mean a new definition of success with PrEP. Read more.

A New Look for the GAPP

The Global AIDS Policy Partnership (GAPP) is a coalition of over 70 organizations committed to expanding and improving US global HIV/AIDS programming, and they’ve got a new website! Visit globalaidspolicy.org for information on member organizations, global AIDS policy resources and a calendar of events. AVAC is a long-time member of the GAPP and hosts the staff secretariat for the partnership. Read more.

UN HLM: Civil society says “Yes — AND” to the 2021 political declaration

A special HLM page on avac.org recaps some of the events at the HLM earlier in June and includes an editorial from AVAC’s Maureen Luba, published in Science Speaks, which puts the Political Declaration in context and sharpens the focus on the need to eliminate punitive laws and structures that result in discrimination and stigma. Read more.