Periodic Reporting for period 1 - MOBILE MEN (Implementing oral and long acting Pre-exposure prophylaxis in mobile men in Sub-Saharan Africa [MOBILE MEN])
Berichtszeitraum: 2023-07-01 bis 2024-12-31
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.
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.
The first rapid assessment was carried out June 2024 and results informed the recruitment and set up of the trial. The implementation trial opened in August 2024, initially in South Africa, followed by Uganda. Recruitment was rapid and completed in Oct 20204. The Randomised Phase completes in May 2025 and is followed by the 9-month CHOICE phase. The last participant visit is expected April 2026.
The initial time motion studies have been carried out at all three sites. Further time motion studies will be carried out during the choice phase. The HIV synthesis model is being updated to include MOBILE MEN.
The initial time motion studies have been carried out at all three sites. Further time motion studies will be carried out during the choice phase. The HIV synthesis model is being updated to include MOBILE MEN.
The study is now fully recruited but it is too soon to have results in order to show impact. Baseline results show a highly mobile population of men from fishing communities, taxi ranks and construction sites. Knowledge of and previous use of PrEP was low and HIV risk behaviour high. Initially uptake of PrEP was 99%.
We are contributing data on CAB-LA uptake to the dept of health South Africa so that planning for post-trial access can begin. The Randomised data will be analysed once this phase is complete, and we plan to publish this before the end of the trial. We are working with other CAB implementation programmes in Africa to maximise impact and ensure roll out once the programmes have ended.
We are contributing data on CAB-LA uptake to the dept of health South Africa so that planning for post-trial access can begin. The Randomised data will be analysed once this phase is complete, and we plan to publish this before the end of the trial. We are working with other CAB implementation programmes in Africa to maximise impact and ensure roll out once the programmes have ended.