NCT06133686Not yet recruitingPhase 3
Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa
Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa: a Phase 3b, Open-label, Hybrid Type 2 Implementation and Effectiveness Trial
Source: ClinicalTrials.gov · Last updated 15 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 19 Oct 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Diseases
- HIV
- NCT number
- NCT06133686
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 1 Apr 2024 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known HIV infection
- Confirmed HIV-positive test result, indeterminate HIV test result, and/or signs and symptoms of an acute HIV infection
- 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)
Other
- Body weight less than 35Kg at baseline
- Other reasons at the discretion of site investigator for unsuitability for study inclusion
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: Male · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.