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

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

NCT Number	NCT06133686
Lead Sponsor	MRC/UVRI and LSHTM Uganda Research Unit Collaborators: King's College London, London School of Hygiene and Tropical Medicine, Africa Health Research Institute, Wits Health Consortium (Pty) Ltd, University College, London, Ministry of Health, Uganda, Desmond Tutu HIV Foundation, Assistance Publique - Hôpitaux de Paris
Conditions	HIV
Enrollment	400 participants
Start Date	2024-04-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2027-04-01 (estimated)
Updated on ClinicalTrials.gov	2023-11-15