Engagement of adolescent girls and young women into an early oral PrEP open-label study in Southern Africa: lessons learned from HPTN 082

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BACKGROUND: Adolescent girls and young women (AGYW) in southern Africa face a high risk of HIV acquisition. Consistent use of daily oral pre-exposure prophylaxis (PrEP) can significantly mitigate this risk. We used the Good Participatory Practice Framework (GPP) to summarize lessons learned from engaging AGYW in an open-label PrEP trial, highlighting successful strategies that enhanced trial engagement. METHODS: The HIV Prevention Trials Network (HPTN) 082 was an open-label study conducted from 2016 to 2018 that evaluated PrEP uptake and adherence in AGYW 16- to 25-year-old without HIV living in Cape Town and Johannesburg, South Africa, and Harare, Zimbabwe. Overall, 646 AGYW were screened for eligibility and 416 were enrolled. Fieldwork reflections, meeting summaries, Community Advisory Board (CAB) meeting minutes, and other project records were analyzed to synthesize lessons for stakeholder engagement relevant to PrEP introduction and service delivery. RESULTS: Using the GPP framework, several key lessons were identified. Early and comprehensive engagement with a broad range of stakeholders throughout the trial was crucial. Youth stakeholders played a significant role in shaping communication materials, clinic design, the package of HIV and non-HIV care, and referral pathways for supportive services. Identifying myths and misconceptions during early stakeholder engagements allowed for tailored PrEP education materials and approaches for PrEP-naïve communities. Parents and caregivers emerged as an essential group to engage to ensure support, even when adolescents were of legal age to provide consent. Peers were identified as important sources of information, support and referral for screening during the trial. Innovations to enhance engagement and results dissemination included the development of youth-led videos and peer support clubs. CONCLUSIONS: Introducing daily oral PrEP for young African AGYW required multiple strategies that were culturally sensitive, age-appropriate, and inclusive of peers, partners, parents, and other influential adults. These strategies were essential for fostering a supportive environment for PrEP use and enhancing engagement in the trial. Lessons learned from PrEP introduction to AGYW in southern Africa have relevance for future trials and HIV prevention programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02732730, 13 November 2018.

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