About this trial
This study will refine and pilot test the Peer-led Dynamic Choice HIV Prevention (DCP) intervention in a single-arm pilot trial. The study will test the hypothesis that the Peer-led Dynamic Choice HIV Prevention intervention will be feasible and increase biomedical HIV prevention coverage in the 6 months after receipt of the Peer-led DCP intervention compared to the standard of care in the 6 months prior to intervention implementation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >=18 years or mature or mature minor >=15 years;
Female sex at birth;
HIV negative by country-standard testing algorithm
Elevated risk of HIV exposure, defined as at least 1 of the following: a) eligible for PrEP based on Uganda Ministry of Health Guidelines; b) exchange of sex for goods or money in last 6 months; or c) work in bar or guesthouse
Disqualifiers
Contraindication to country-recommended PrEP regimen per national guidelines
Participation in another HIV prevention study
Trial design
Single group
Treatments tested in this trial
Peer-led Dynamic Choice HIV Prevention (DCP) intervention
Other interventionThe intervention consists of peer mentor training on patient-centered choice counseling and Peer-led DCP services, and will be delivered by the peer mentor with clinician support: 1. HIV prevention product choice with option to switch over time 2. Rapid access to PEP from peer mentor for unplanned exposures 3. Integration of STI testing and treatment 4. Travel kit 5. Phone/SMS contact for peer support
Treatment groups
Trial outcomes
Primary outcomes
Biomedical HIV prevention coverage
Percentage of follow-up months that a participant uses a biomedical HIV prevention product
Secondary outcomes
At-risk biomedical HIV prevention coverage
Percentage of at-risk follow-up months that a participant uses a biomedical HIV prevention product
Feasibility of delivery of the Peer-Led DCP intervention by peers
Proportion of participants with Peer-led DCP intervention services delivered by peer mentor
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Infectious Diseases Research Collaboration, Uganda
Collaborator
University of California, Berkeley
Collaborator