Recruitment of disproportionately affected populations in the PURPOSE 5 study evaluating lenacapavir for PrEP in France and the UK
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Authors
Molina J.M.
Clarke A.
Lacombe K.
Yager J.
Carter C.C.
Tittle V.
Ghosn J.
Orkin, C.
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2025
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Purpose: Daily oral pre-exposure prophylaxis (PrEP) is effective when taken as directed and has contributed to fewer HIV diagnoses worldwide, including in France and the UK. However, PrEP uptake and persistence are suboptimal among some disproportionately-affected populations. This study aims to prioritize inclusion of these affected populations, which have been historically underrepresented in PrEP clinical trials. We describe our inclusive recruitment processes in PURPOSE 5 (NCT06513312), which evaluates the potential benefit of twice-yearly subcutaneous lenacapavir among people not currently benefiting from daily oral PrEP. Method(s): PURPOSE 5 is an ongoing, Phase 2, multicenter, randomized study evaluating persistence on twiceyearly subcutaneous lenacapavir versus daily oral emtricitabine/ tenofovir disoproxil fumarate for PrEP in France and the UK over 1 year. Persistence is defined as consistent and continuous adherence over time. Our recruitment approaches were informed by feedback from key stakeholders obtained before and during study initiation. The PURPOSE 5 study team engaged with community advisory groups to review and provide feedback on the study protocol, informed consent forms, and supporting documents. Result(s): When selecting sites, we considered geographic location, expertise in providing care for individuals from disproportionately affected populations, and experience working with community-based organizations. We developed study recruitment goals to ensure most participants were from high-priority populations (cisgender women, gender-diverse individuals, individuals from minoritized ethnic groups, and sex workers). As enrollment has progressed, the study team have actively reviewed enrollment metrics and worked with sites to focus recruitment efforts. Preliminary assessment of demographics with ~90% of the study enrolled indicates ~50% of participants represent high-priority populations (complete enrollment demographic data will be presented). Conclusion(s): By leveraging intentional outreach and thoughtful research-site engagement, we demonstrate the feasibility of enrolling disproportionately affected populations not currently benefitting from PrEP in a study of twice-yearly lenacapavir for PrEP in France and the UK.
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HIV.Med.