The PrEPared to Choose (PtC) study seeks to describe patterns of persistence on HIV pre-exposure prophylaxis (PrEP) products, individually and overall, amongst a cohort of South African adolescents and youth when offered a choice between PrEP products in real-world public health facility and mobile clinic settings. The study will further seek to understand implementation barriers and enablers in PrEP adoption (decision to use any PrEP product), initiation (first dose of any PrEP product), and persistence amongst both PrEP users (adolescents and youth) and PrEP providers (healthcare providers).
This study will utilise a prospective cohort design that recruits 1800 adolescents and young people, specifically adolescent girls and young women, including pregnant and lacting women (15-29 years), young male key populations including men who have sex with men and male sex workers (15-29 years), and their collective intimate male partners (any age).
Participants will be invited to choose to initiate on one of three types of PrEP (injectable, oral, or vaginal ring PrEP). Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point. Participants will be followed for 7 months to meet the primary outcome of short-term persistence and for a further 18 months to meet the secondary outcome of long-term persistence. Persistence will be defined as the continuous use of the selected product as intended with (a) \<7 day gap and (b) \<28 day gap in PrEP availability for daily dosing (oral PrEP), vaginal ring insertion, or subsequent injection. The 7-day window aligns with previous trial definitions of on-time dosing while the 28-day window aligns with pragmatic definitions of on-time dosing for PrEP in the South African context.
The three products available will include: (1) a Tenofovir-based oral tablet that needs to be taken daily and is provided as a 30-day supply of oral tablets; (2) a intra-vaginal silicone ring containing slow-release Dapivirine that provides HIV protection for up to 28 days; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. The study will aim to recruit up to 900 participants that initiate on injectable PrEP, up to 600 participants that initiate on oral PrEP, and up to 300 participants that initiate on vaginal ring PrEP.
PrEP choice counselling will be co-created with PrEP providers and young PrEP users (members of an existing PrEP-orientated youth reference group) and delivered by trained, adolescent-friendly HIV counsellors. PrEP will be administered by NIMART trained (Nurse Initiated Management of Anti-Retroviral Therapy) nurses at two clinical sites: a stationary government primary health care facility and a mobile clinic service that rotates on a fixed schedule through the study area. Participants will initiate at a single site but remain eligible to receive subsequent product refills/doses at the other site if desired.
