Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

April 1, 2027

Conditions
HIV
Interventions
DRUG

Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA)

Group A will receive oral TDF-FTC PrEP (using either event-driven or daily) for 9-months. After 9-months, participants will be offered choice of PrEP (either TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required. Those receiving oral PrEP will be able to choose between event-driven and daily PrEP with the emphasis on coital coverage by PrEP

DRUG

Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)

Group B will receive CAB-LA for 9-months. After 9-months participants will be offered choice of PrEP (either TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required. Those receiving oral PrEP will be able to choose between event-driven and daily PrEP with the emphasis on coital coverage by PrEP.

Sponsors
All Listed Sponsors
collaborator

King's College London

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

Africa Health Research Institute

OTHER

collaborator

Wits Health Consortium (Pty) Ltd

OTHER

collaborator

University College, London

OTHER

collaborator

Ministry of Health, Uganda

OTHER_GOV

collaborator

Desmond Tutu HIV Foundation

OTHER

collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

lead

MRC/UVRI and LSHTM Uganda Research Unit

OTHER