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
Able and willing to provide informed consent
Aged 18 years and above on the day of screening
Willing to have a HIV test and receive the test results
Male at birth
Known HIV infection
Confirmed HIV-positive test result, indeterminate HIV test result, and/or signs and symptoms of an acute HIV infection
Body weight less than 35Kg at baseline
Allergy to any of the study products
Parallel
Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA)
DrugGroup 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
Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)
DrugGroup 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.
The primary user effectiveness outcome will be the persistent use of PrEP in the randomised period and throughout the full follow-up period.
Persistence will be a binary outcome capturing whether a participant has used PrEP persistently or not. For participants receiving CAB-LA, this will be based on whether they received all injections as per schedule or not. For participants receiving TDF-FTC, this will be based on whether they have attended scheduled visits, had TDF-FTC dispensed, and have detectable TFV-DP levels in dried blood spots.
The primary implementation outcome will be PrEP adoption
PrEP adoption was assessed as uptake of PrEP in months 0-9. This is a binary variable that will capture whether or not a participant was offered and took up the offer of PrEP during the 9-month randomized period.
The primary implementation outcome will be PrEP adoption
PrEP adoption was assessed as the choice preference of PrEP in months 9-18. This is a categorical variable that will measure the proportions that choose and uptake each modality (daily or event-driven TDF-FTC or CAB-LA) captured at the start and the end of the subsequent 9-month choice period
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MRC/UVRI and LSHTM Uganda Research Unit
Lead sponsor
King's College London
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
Africa Health Research Institute
Collaborator
Wits Health Consortium (Pty) Ltd
Collaborator
University College, London
Collaborator
Ministry of Health, Uganda
Collaborator
Desmond Tutu HIV Foundation
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
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