Next Generation Trial Design for HIV Prevention Research

As clinical trials in HIV prevention grow in complexity, advocacy for future trial design is more important than ever.

Since AVAC’s founding, we’ve understood—and advocated—that the people most impacted by HIV must be involved in the design and implementation of clinical trials. Even as prevention options grow, trials to test new HIV prevention methods remain crucial as high rates of new infections persist in communities all over the world. As proven products roll out, including oral PrEP now and other options in the near future, innovative trial design is a focus and challenge for the field. Advocates and communities must play a central role in shaping future trial design. Their input is essential for both community acceptance of clinical trials and for trial results that advance the field. As trial designs grow more complex, this need is greater than ever.

AVAC’s Evolving Designs for HIV Prevention Trials is a two-page introduction to the issue. It features a table describing key trial designs under discussion, links to background material, and a table on four trials testing next-generation PrEP options, including: monthly oral PrEP with islatravir from Merck; a new form of daily oral PrEP with F/TAF from Gilead; and six-monthly injectable PrEP with lenacapavir from Gilead.

The Trial Design Academy

Launched in September of 2019, AVAC’s Trial Design Academy convenes HIV prevention advocates from across the globe to confront the technical challenges, engage with researchers, statisticians, product developers and regulators, and help shape the decisions to move the research agenda forward. Resources generated from the academy are featured below.

Resources

Context and Advocacy

• A Statement on the Future of HIV Prevention Trials — In May 2021, members of the Trial Design Academy updated this consensus statement on key priorities for future trial design and community engagement
• A webinar with biostatistician Dr. Deborah Donnell outlines new clinical trial designs: Next-Generation Trial Design
• Designing a New Generation of HIV Prevention Efficacy Trials — This blog post by Bill Snow, AVAC co-founder and senior advisor, lays out basic concepts in innovations in trial design and an analysis of the implications for advocacy
• Advocates’ Perspectives on Next-Generation HIV Prevention Trial Design — Presented at AIDS 2020 Virtual, this poster encapsulates the evolution of HIV prevention trial design and lays out advocacy priorities

Ethical Guidance

• Updated Guidance Documents on HIV Prevention Trials: The HPTN’s Ethics Guidance for Research and UNAIDS/WHO’s Ethical Considerations in HIV prevention trials
• Ethical Guidance in Focus — This blog post by AVAC’s Jeanne Baron highlights and compares what’s new in two updated guidance documents, from UNAIDS/WHO and the HPTN, both addressing where PrEP fits in HIV prevention trials
• New Ethical Guidelines for HIV prevention Trials in People: What’s changed and Why Does it Matter? — In this August 2021 webinar, AVAC hosted advocates and bioethicists to discuss the new guidance documents and the role of PrEP, community engagement, equity and more in future trial design