Research Engagement Series: Trial Design Basics with Deborah Donnell

CASPR, BAI, & TAG presented a limited research engagement series discussing foundational concepts in next-generation clinical trial designs. This webinar with Deborah Donnell discussed the rationale for exploring new clinical trial designs for HIV prevention. Dr. Donnell discussed the different trial design approaches currently being pursued and answers questions on what advocates need to know.

Watch here.

Dive into the AMP Trials

Results from the AMP Trials, studying a broadly neutralizing antibody (bNAb) known as VRC01, were complex, with still unfolding implications for the field.

The AMP Trials, two Phase IIb studies, tested the safety and efficacy of an infusion of VRC01 received every eight weeks. HVTN 703/HPTN 081 enrolled 1,900 women in sub-Saharan Africa, and HVTN 704/HPTN 085 enrolled 2,700 men who have sex with men and transgender people in North and South America and in Europe.

The overall efficacy demonstrated in the trials was not protective. But when VRC01 was fighting strains of HIV that were highly sensitive to it, the antibody did provide partial protection. So what does that mean for the field, and what other questions have been raised by these pioneering trials?

In this episode of Px Pulse, AVACers Jeanne Baron and Daisy Ouya talk to leading bNAb researcher, IAVI’s Devin Sok; a veteran HIV research advocate Mark Hubbard who served on AMP’s protocol team; and a senior member of the HVTN’s community engagement team, a chief explainer of the AMP trails, Gail Broder. Together we explore why these findings point to the need for combination antibodies, the need for a better understanding of the types of HIV that are circulating in a community, the complicated implications of a key lab test, the TZM-bl assay and more.

Hosted and produced by Jeanne Baron.

Highlights

Resources

Research Work Group of the Federal AIDS Policy Partnership’s response to the NIH Request for Information (RFI)

This letter is the Research Work Group of the Federal AIDS Policy Partnership’s response to the NIH Request for Information (RFI) inviting comments and suggestions to advance and strengthen racial equity, diversity and inclusion in the biomedical research workforce and advance health disparities and health equity research.

Advocates’ Guide to Multipurpose Prevention Technologies

A resource to support advocacy for multipurpose prevention technologies (MPTs). The Guide calls out four areas ripe for advocate involvement. It also provides a snapshot on the status of MPT research and development and data on investments—critical information that can support evidence-based advocacy.

Updated Recommendations on HIV Prevention, Infant Diagnosis, Antiretroviral Initiation And Monitoring

A 2021 update to the WHO recommendations on HIV clinical and service delivery of prevention and treatment.

The Well Project

Founded in 2002, The Well Project is a non-profit organization whose mission is to change the course of the HIV/AIDS pandemic through a unique and comprehensive focus on women and girls. Their website is a global online resource of information, support and advocacy for women living with HIV and their allies.

Access their resources, additional information and strong partner network at thewellproject.org.

The Evolution of Oral PrEP Access

A presentation on global trends in PrEP uptake since 2016, prepared for R4P. See breakdowns by country and analysis of lessons learned and continued use.

Ethical considerations in HIV prevention trials

UNAIDS and the World Health Organization have published this updated guidance on ethical considerations in HIV prevention trials. The new guidance is the result of a year-long process that saw more than 80 experts and members of the public give inputs and is published 21 years after the first edition appeared.

Breaking the cycle of transmission: A human-centered approach to increase adoption and sustained use of HIV prevention among high-risk adolescent girls and young women (AGYW) in South Africa

Download findings from Breaking the Cycle of Transmission, a research effort to better understand AGYW decisions and behaviors related to HIV prevention; identify different segments to better tailor outreach; and how to reach each segment more effectively. The project uses user-centered research and human-centered design and piloting.

The HIV Prevention Market Manager (PMM), co-led by AVAC and CHAI and funded by the Bill & Melinda Gates Foundation, leads the research in partnership with behavioral research firm Final Mile, user-centered design firm Upstream Innovation and market research group Ask AfriKa, with the Surgo Foundation providing strategic guidance.

Broadly Neutralizing Antibody Combinations

Overview of the combinations of broadly neutralizing antibodies (bNAbs) under investigation in early clinical studies for HIV prevention.