Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa - Trial NCT06133686
Access comprehensive clinical trial information for NCT06133686 through Pure Global AI's free database. This Phase 3 trial is sponsored by MRC/UVRI and LSHTM Uganda Research Unit and is currently Not yet recruiting. The study focuses on HIV. Target enrollment is 400 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
MRC/UVRI and LSHTM Uganda Research Unit
Timeline & Enrollment
Phase 3
Apr 01, 2024
Apr 01, 2027
Primary Outcome
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
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
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06133686
Non-Device Trial