Implementing oral and long acting Pre-exposure prophylaxis in mobile men in Sub-Saharan Africa [MOBILE MEN]

Reducing HIV is key 2030 SDG target.

In Africa, HIV prevention research has focused on young women yet heterosexual men, vulnerable due to their mobility, remain WHO priority.

Long-acting injectable cabotegravir (CAB-LA) and on-demand, oral pre-exposure prophylaxis (PrEP) have not been evaluated in such men who are not in-line to receive either. Building on our EU studies men want on-demand PrEP and CAB-LA (referred to as new PrEP options).

This project using RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance), uses rapid assessment followed by implementation trial.

Objectives1: Catalysts/barriers across local and regional contexts that could influence uptake of new PrEP options by mobile mena.Qualitative assessment mobility patterns of men, knowledge/ perceptions of PrEP effectivenessb.Policy analysis at local and national level2: Assess implementation effectiveness of new PrEP options by comparison of retention in care, effective use and expressed choiceOpen-label study of 400 men from mobile groups in South Africa and Uganda randomised to oral TDF-FTC or CAB-LA over 9 months, then access to both to 18months3: Preferences of mobile men amongst new PrEP options a.Adoption of new PrEP options b.Barriers in non PrEP acceptorsc.Patterns of PrEP use d.Participant/ staff / community reflections 4: Reach and implementation of PrEP for mobile men amongst service providers to inform scale-upa.Reach of PrEP b.Feasibility of delivering PrEP in different settings c.Fidelity of PrEP delivery in practice d.Service-level needs and adaptations to implement PrEP Objectives 3 and 4 use mixed methods in users and service providers.Objective 5: Affordability, cost and cost effectiveness of new PrEP options using HIV synthesis modelThis first multi-country study of on-demand PrEP and CAB-LA in men in Africa provides evidence for guidelines change, inform scalability, and provide operational tools for PrEP implementation.