Recruitment of Adolescent Girls and Young Women into an Early Oral PrEP Open- Label Study in Southern Africa: Lessons Learned from HPTN 082.

Background: Adolescent girls and young women (AGYW) in southern Africa who are at high risk for HIV acquisition can mitigate this risk by using daily oral pre-exposure prophylaxis (PrEP) consistently. Using reflections from the community engagement teams in an early oral PrEP trial, this paper presents lessons learned from recruiting AGYW into the trial. It highlights experiences and strategies employed during the planning, readiness, and implementation phases of the trial. Methods: The HIV Prevention Trials Network (HPTN) 082 was an open-label study of PrEP uptake and adherence conducted between October 2016 and October 2018 among 16- to 25-year-old women without HIV in Cape Town and Johannesburg, South Africa, and Harare, Zimbabwe. A joint community team meeting with team members from all three HPTN 082 sites garnered and synthesized team experiences by analysing fieldwork reflections, HPTN 082 study-led workshop summaries, project records, and Community Advisory Board (CAB) meeting minutes about lessons for stakeholder engagement that are relevant for PrEP introduction and service delivery. Results: Using the Good Participatory Practice (GPP) framework, thighlighted the value of PrEP education, engagement with stakeholders during the formative phase, and the importance of peers and family as sources of information, support, and referral for adolescent study participants. In the first year of recruitment for HPTN 082, study participants reported they needed support for consistent daily oral PrEP use from parents and other adults, and efforts were intensified to engage parents and community stakeholders. Conclusions: The introduction of daily oral PrEP, a novel HIV prevention for young African AGYW, required multiple strategies that were culturally sensitive, age-appropriate, and included peers, partners, parents, and other adults who influence health behaviours in AGYW. Trial registration: Clinicaltrials.gov NCT02732730, 13 November 2018.