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

Summary
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.

Objectives
1: Catalysts/barriers across local and regional contexts that could influence uptake of new PrEP options by mobile men
a. Qualitative assessment mobility patterns of men, knowledge/ perceptions of PrEP effectiveness
b. Policy analysis at local and national level
2: Assess implementation effectiveness of new PrEP options by comparison of retention in care, effective use and expressed choice
Open-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 18months
3: Preferences of mobile men amongst new PrEP options
a. Adoption of new PrEP options
b. Barriers in non PrEP acceptors
c. Patterns of PrEP use
d. Participant/ staff / community reflections
4: Reach and implementation of PrEP for mobile men amongst service providers to inform scale-up
a. 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 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.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/101103140
Start date: 01-07-2023
End date: 30-06-2026
Total budget - Public funding: 4 665 192,50 Euro - 4 665 192,00 Euro
Cordis data

Original description

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.

Objectives
1: Catalysts/barriers across local and regional contexts that could influence uptake of new PrEP options by mobile men
a. Qualitative assessment mobility patterns of men, knowledge/ perceptions of PrEP effectiveness
b. Policy analysis at local and national level
2: Assess implementation effectiveness of new PrEP options by comparison of retention in care, effective use and expressed choice
Open-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 18months
3: Preferences of mobile men amongst new PrEP options
a. Adoption of new PrEP options
b. Barriers in non PrEP acceptors
c. Patterns of PrEP use
d. Participant/ staff / community reflections
4: Reach and implementation of PrEP for mobile men amongst service providers to inform scale-up
a. 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 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.

Status

SIGNED

Call topic

HORIZON-JU-GH-EDCTP3-2022-CALL1-01-01

Update Date

12-03-2024
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Horizon Europe
HORIZON.2 Global Challenges and European Industrial Competitiveness
HORIZON.2.1 Health
HORIZON.2.1.0 Cross-cutting call topics
HORIZON-JU-GH-EDCTP3-2022-01
HORIZON-JU-GH-EDCTP3-2022-CALL1-01-01 Promoting implementation of research results into policy and practice
HORIZON-JU-GH-EDCTP3-2022-01
HORIZON-JU-GH-EDCTP3-2022-CALL1-01-01 Promoting implementation of research results into policy and practice