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

• Status: Not yet recruiting
• Trial end date: 2027-04-01

Summary

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

• Phase: Phase 3

Details

• Lead Sponsor: MRC/UVRI and LSHTM Uganda Research Unit
• Collaborators: Africa Health Research Institute; Assistance Publique - Hôpitaux de Paris; Desmond Tutu HIV Foundation; King's College London; London School of Hygiene and Tropical Medicine; Ministry of Health, Uganda; University College, London; Wits Health Consortium (Pty) Ltd
• Treatments: Cabotegravir; Emtricitabine; Tenofovir