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

Summary

Title: Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa

Design: A mixed method, multi-setting, multi-country, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomized controlled trial (RCT). The trial will be carried out in 400 HIV negative men aged 18+ years in South Africa and Uganda. Men will be randomized 1:1 to either Group A: oral Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) PrEP (event-driven or daily) or Group B: Long-acting injectable cabotegravir (CAB-LA) over 9-months. After 9-months participants from both groups will be offered choice of PrEP (oral TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required. Various strategies to support PrEP adoption, initiation, and persistence will be implemented, monitored, and reported on using a RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) implementation science framework.

Treatment: CAB-LA or oral TDF-FTC Duration: 18 months

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 & Collaborators

• King's College London

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Africa Health Research Institute

  collaborator OTHER

• Wits Health Consortium (Pty) Ltd

  collaborator OTHER

• University College, London

  collaborator OTHER

• Ministry of Health, Uganda

  collaborator OTHER_GOV

• Desmond Tutu HIV Foundation

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• MRC/UVRI and LSHTM Uganda Research Unit

  lead OTHER

Principal Investigators

• Eugene Ruzagira, PhD · MRC/UVRI and LSHTM Uganda Research Unit

• Julie Fox, PhD · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2025-12-31

Completion

2027-04-01