Key stakeholders’ perspectives on providing oral pre-exposure prophylaxis as HIV-prevention standard of care in clinical trials in South Africa

Abstract

Introduction: HIV-prevention and endpoint-driven clinical trials enrol individuals at substantial risk of HIV. Recently, these trials have  provided oral pre-exposure prophylaxis (PrEP) as HIV-prevention standard of care; however, data on PrEP uptake and use during the trial and post-trial access are lacking.
Methods: We conducted once-off, telephonic, in-depth interviews from August 2020 to March 2021, with 15 key stakeholders (including  site directors/leaders, principal investigators and clinicians), purposively recruited from research sites across South Africa that are known  to conduct HIV-prevention and endpoint-driven clinical trials. The interview guide probed for facilitators and barriers to PrEP uptake and  use during the trial, and post-trial PrEP access. Interviews were audio recorded and transcribed. Coding was facilitated using NVivo and  emergent themes were identified.
Results: Most stakeholders reported incorporating PrEP as part of the HIV-prevention package in HIV-prevention and endpoint-driven  clinical trials. Stakeholders identified multiple barriers to PrEP uptake and use, including difficulties with daily pill taking, side effects,  stigma, a lack of demand creation and limited knowledge and education about PrEP in communities. Facilitators of PrEP uptake and use  included demand-creation campaigns and trial staff providing quality counselling and education. Post-trial PrEP access was frequently  challenging as facilities were located a considerable distance from research sites, had long queues and inconvenient operating hours.
Conclusions: Strategies to address barriers to PrEP uptake and use during trials and post-trial access, such as PrEP demand creation,  education and counselling, addressing stigma, support for daily pill-taking and increased post-trial access, are urgently needed.