Status:
NOT_YET_RECRUITING
Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa
Lead Sponsor:
MRC/UVRI and LSHTM Uganda Research Unit
Collaborating Sponsors:
King's College London
London School of Hygiene and Tropical Medicine
Conditions:
HIV
Eligibility:
MALE
18-60 years
Phase:
PHASE3
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, o...
Detailed Description
BACKGROUND HIV prevention pre-exposure prophylaxis (PrEP) has not been evaluated in men who mainly have sex with women and who may be at high risk of HIV acquisition due to high HIV prevalence in part...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Other reasons at the discretion of site investigator for unsuitability for study inclusion
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06133686
Start Date
April 1 2024
End Date
April 1 2027
Last Update
November 15 2023
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