Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

The primary user effectiveness outcome will be the persistent use of PrEP in the randomised period and throughout the full follow-up period.,The primary implementation outcome will be PrEP adoption,The primary implementation outcome will be PrEP adoption

Title: Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis
 (PrEP) in mobile men in Sub-Saharan Africa
 
 Design: A mixed method, multi-setting, multi-country, phase 3b, open-label, hybrid type 2
 implementation and effectiveness randomized controlled trial (RCT). The trial will be carried
 out in 400 HIV negative men aged 18+ years in South Africa and Uganda. Men will be randomized
 1:1 to either Group A: oral Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) PrEP
 (event-driven or daily) or Group B: Long-acting injectable cabotegravir (CAB-LA) over
 9-months. After 9-months participants from both groups will be offered choice of PrEP (oral
 TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required.
 Various strategies to support PrEP adoption, initiation, and persistence will be implemented,
 monitored, and reported on using a RE-AIM (Reach, Effectiveness, Adoption, Implementation,
 and Maintenance) implementation science framework.
 
 Treatment: CAB-LA or oral TDF-FTC Duration: 18 months