September 8, 2026
Ethical conduct of HIV clinical trial research improves as product developers, researchers, and other stakeholders become increasingly intentional about community partnership and engagement. When AVAC and UNAIDS developed the Good Participatory Practice (GPP) guidelines, the goal was to create a framework for trial funders, sponsors and implementers to engage communities across the HIV prevention research continuum. From trial design and implementation to results dissemination and access planning, GPP provides a guide for ensuring prevention products are responsive to community priorities and accessible to the people they aim to serve. For almost 20 years of GPP implementation, AVAC has collaborated with partners around the world to embed the principles within advocacy strategies and partnerships and cultivating a diverse network of advocates, civil society organizations, journalists, researchers, and implementers who champion GPP and are equipped to engage with, question, and influence HIV clinical trial research.
The Good Participatory Practice Guidelines, developed by AVAC and UNAIDS
Promoting Transparency and Accountability in Gilead’s PURPOSE Program
Gilead’s PURPOSE program is comprised of six clinical trials investigating long-acting injectable lenacapavir (LEN) for PrEP among diverse populations. PURPOSE 1, one of the two efficacy trials in the program, was conducted among cisgender women in South Africa and Uganda, while PURPOSE 2 expanded the reach to include men who have sex with men (MSM), transgender men and women, and gender non-binary people. Both trials found LEN highly safe and effective among participants. Beyond the clinical findings, the trials also demonstrated that embedding GPP principles promotes accountability, transparency, and meaningful community engagement throughout trial design and conduct.
A case study of GPP implementation in PURPOSE 1 highlights how GPP strengthens ethical conduct and inclusion. AVAC staff and partners participated as members of the Global Community Accountability Group (GCAG), a formal mechanism for providing community perspectives on the trial. GCAG members provided community recommendations on trial design, including protocol considerations, participant recruitment and retention, and trial implementation to Gilead and researchers. Advocacy by the GCAG contributed to expansion of the inclusion criteria to enroll adolescents and to allow pregnant and breastfeeding people to remain in PURPOSE 1 after re-consent, reinforcing the principle that communities should help shape research that directly affects them and allowing the study to gather critical data on the safety and efficacy of LEN in populations often excluded from research.
Nombeko Mpongo of the Desmond Tutu Health Foundation and a member of the African Women’s Prevention Community Accountability Board served on the GCAG for PURPOSE 1 and describes how early involvement translated into influence and accountability:
“What was important was that communities were involved from the beginning. We received the protocol early, before the study began, and had the opportunity to scrutinize it and identify what we thought needed to change. One of the issues we raised was ensuring that women who became pregnant during the study would not automatically be excluded, so we could better understand prevention during pregnancy. We were not there as tokens—we took ownership of our role in the GCAG. We made sure Gilead was accountable to us, and we were also accountable to our communities. It was a flow of accountability in both directions.”
Through this structured forum and sustained engagement, community concerns were heard, researchers and the developer remained responsive, and the priorities of women and young girls remained central to decision making.
Members of the PURPOSE-1 GCAG
Championing Good Participatory Practice
Impactful community engagement in clinical trials requires sustained investment in community leadership, scientific literacy, and trusted partnerships. Years before PURPOSE 1, AVAC and partners established the Coalition to Accelerate and Support Prevention Research (CASPR), an Africa-led advocacy coalition of civil society organizations working to advance biomedical HIV prevention research and equitable access to proven HIV prevention products. CASPR supported a network of advocates with the knowledge and relationships to engage with emerging HIV prevention research. Many of these advocates went on to serve on the PURPOSE 1 GCAG while remaining connected to the broader communities and networks they worked with through CASPR. This helped extend engagement and understanding of the trial beyond the GCAG, and strengthened the pathway from engaging in research to product introduction and access planning.
As Navita Jain, Senior Program Manager and Team Lead for AVAC’s Partnership Network Team explains, “CASPR provided the connective tissue that made meaningful engagement possible. Advocates weren’t starting from scratch when they joined the GCAG—they were already informed, connected and prepared to engage, and could bring that knowledge back to their communities well before conversations about rollout began.”
Because AVAC, CASPR partners, AWPCAB and the broader network of informed advocates were already equipped with the expertise, partnerships, and communities’ trust, they helped bridge the transition from research implementation to disseminating trial results and planning for access. This continued engagement with Gilead, funders and decision makers supported community confidence in the results and accelerated momentum toward equitable LEN rollout in comparison to the delivery of previous PrEP products. This contribution was recognized when Yvette Raphael, Executive Director of APHA, accepted the American Association for the Advancement of Science’s (AAAS) Mani L. Bhaumik Breakthrough of the Year Award on behalf of CASPR, AWPCAB, and the GCAG, affirming the critical role of community advocacy in LEN’s development.
Yvette Raphael, the Executive Director of APHA and a PURPOSE-1 GCAG member accepted the AAAS Breakthrough of the Year Award.
From Research to Rollout
GPP guided community engagement in PURPOSE 1, creating meaningful opportunities for advocates to influence the trial. However, the GPP guidelines recommend continued engagement to shape access and rollout once a product has been proven safe and effective, achieves regulatory approval, and becomes available. After the PURPOSE 1 results were announced, Gilead discontinued the GCAG, even though many of the decisions that would determine equitable access, including licensing, pricing, manufacturing, and product introduction, were still ahead. For HIV activist Saidy Brown, a member of CASPR’s Young Women’s HIV Prevention Council (YWHPC) and GCAG member, continuing the GCAG through product introduction would have been a natural extension of the partnership that began during research:
“We were there from the beginning, supporting the research, and it would have made sense for that partnership to continue through rollout. As much as communities supported the trial, there was also an opportunity to bring that support back to communities as LEN became available. Keeping GCAG members engaged through introduction would have helped create that continuity from research to rollout.”
While the GCAG was discontinued, the networks and relationships built through CASPR have provided a platform for advocates to continue pushing for equitable access, with demands including: a role in access planning, speed and equity in rollout, price transparency, and accelerated access to generics. As a result, donors and ministries of health are engaging with and investing in civil society partners to secure community buy-in, inform rollout planning and generate demand. While LEN rollout across early adopter countries reflects this community leadership, advocates remain vigilant in identifying and addressing challenges around equitable access.
Even so, global access has been far from perfect. Advocates’ demand that all PURPOSE efficacy trial countries be included in voluntary licensing agreements has not been met, reflecting that strong incorporation of GPP during a trial does not automatically translate into access once the trial is over; the work of and commitment to engagement must carry through. Nevertheless, the positive lessons from PURPOSE 1 are informing AVAC’s recent work in Merck’s EXPrESSIVE program assessing the efficacy of a new monthly oral PrEP pill. As new HIV prevention products advance through the research pipeline, AVAC and partners will continue to call for developers, donors and other stakeholders to apply the lessons and practice of GPP – strengthening community engagement throughout research & development, policy, and product introduction so that scientific innovation translates into equitable access and real-world impact.