Implementing oral (event-driven and daily) and long-acting pre-exposure prophylaxis in mobile men in sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)

作者：Sylvia Kusemererwa, Bernadette Nayiga, Limakatso Lebina, Linda‐Gail Bekker, A. Philips, Loveleen Bansi- Matharu, Darshini Govindasamy, Gesine Meyer‐Rath, Geofrey Kimbugwe, Eugene Ruzagira, Maryam Shahmanesh, Janet Seeley, Emily L. Webb, Julie Fox · 发表于：Trials · 年份：2025 · DOI：10.1186/s13063-025-09138-5 · 被引用次数：1 · 研究领域：HIV/AIDS Research and Interventions、HIV, Drug Use, Sexual Risk、HIV Research and Treatment

BACKGROUND: Men who are mobile for work are a key population at high risk of acquiring HIV. Flexible pre-exposure prophylaxis (PrEP) options, including event-driven (ED) oral PrEP and long-acting injectable cabotegravir (CAB-LA), may offer increased access and acceptability for these men. However, limited data exist on the effectiveness and implementation of CAB-LA and ED PrEP among mobile men in Africa. Our study aims to assess the effectiveness and implementation of CAB-LA and oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (both daily and ED) through comparison of uptake, retention in care, coital coverage, and participant choice. METHODS: We will conduct a mixed0method, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomised controlled trial (RCT). The trial will be carried out in 400 HIV-negative men aged 18 years or older in South Africa and Uganda. Men will be randomised 1:1 to either Group A: oral TDF/FTC PrEP (ED or daily) or Group B: CAB-LA over 9 months. After 9 months, participants from both groups will be offered a choice of PrEP (oral TDF/FTC or CAB-LA) for a further 9 months, with the ability to change their 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. DISCUSSION: This study will provide critical data to inform scalable...