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) has 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 an implementation trial to understand men’s choices for HIV prevention and how to deliver a PrEP service to them.
Overall Objectives
1: Understand the catalysts/barriers across local and regional contexts that could influence uptake of new PrEP options by mobile men in Uganda and South Africa.
2: Assess implementation effectiveness of oral and injectable PrEP in men who travel for work by comparison of retention in care, effective use, PrEP choice and cost effectiveness.
3. Asses the implementation of PrEP for mobile men amongst service providers to inform scale-up
4. Determine the cost and cost effectiveness of oral and injectable PrEP using HIV synthesis model
This 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.
The programme is mixed methods and involves social and implementation science working within and external to an open-label randomised study of 400 HIV uninfected men from mobile groups in South Africa and Uganda randomised to oral TDF-FTC or CAB-LA over 9 months, then followed by a further 9 -months of PrEP Choice.