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

NCT06133686 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: RGDER231010
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Mobile Men; HIV; Pre-exposure prophylaxis; Truvada; Cabotegravir

Outcome Measures

Primary Outcomes (3)

• 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.

  18 months

• 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.

  18 months

• 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

  18 Months

Study Arms (2)

Group A

OTHER

Oral Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) followed by choice of TDF-FTC or CAB-LA

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

Group B

OTHER

Long-acting injectable cabotegravir (CAB-LA) followed by choice of TDF-FTC or CAB-LA

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

Interventions

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

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

Group A

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

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.

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• In the past 6-months has travelled for work or to find work and spent at least one night away from home for work related purposes.
• Available for follow up for the duration of the study

You may not qualify if:

• 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
• Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
• Use of contraindicated medications: Medication for tuberculosis (Rifampin, rifapentine) or anticonvulsants (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin)

Sponsors & Collaborators

• MRC/UVRI and LSHTM Uganda Research Unit: lead
• 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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MeSH Terms

Interventions

Tenofovir; Emtricitabine; cabotegravir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Eugene Ruzagira, PhD

  MRC/UVRI and LSHTM Uganda Research Unit

  PRINCIPAL INVESTIGATOR

• Julie Fox, PhD

  King's College London

  STUDY CHAIR

Central Study Contacts

Berna Nayiga, MSc

CONTACT

0417704000; Berna.Kalanzi@mrcuganda.org

Sylvia Kusemererwa, MPH

CONTACT

0417704000; sylvia.kusemererwa@mrcuganda.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase 3b, open label, hybrid type 2 study with co-primary aims of effective use and implementation. This is a mixed method, multi-setting, multi-country randomized controlled trial, carried out in South Africa and Uganda to compare persistence in care for oral PrEP and CAB-LA in mobile men, which will inform PrEP implementation in men. Mobile men aged 18+ years, will be recruited from outreach settings in in South Africa and Uganda. Those testing HIV negative (target sample size, n=400) will be randomized into 2 groups: Group A will receive oral TDF-FTC PrEP (using either event-driven or daily) and Group B will receive CAB-LA over 9-months. After 9- months participants from both groups will be offered choice of PrEP for a further 9-months, with the ability to change choice as required. Switch PrEP options will be monitored. Those receiving oral PrEP will be able to choose between event-driven and daily PrEP with the emphasis on coital coverage by PrEP.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 15, 2023
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL