HIV/AIDS
Conditions
Keywords
Biomedical HIV Prevention, Peer Mentor Intervention, Uganda, Dynamic Choice HIV Prevention
Brief summary
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.
Detailed description
The overall goal of this study is to refine and pilot test a Peer-led Dynamic Choice HIV Prevention intervention tailored to women at elevated HIV risk in southwestern Uganda. We will conduct a single-arm pilot trial of the intervention enrolling approximately 60 women to assess the feasibility, acceptability, and preliminary effectiveness of the Peer-led Dynamic Choice Prevention intervention.
Interventions
The 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
Sponsors
University of California, San Francisco
National Institute of Mental Health (NIMH)
Infectious Diseases Research Collaboration, Uganda
University of California, Berkeley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-arm pilot trial to refine and pilot test the Peer-led DCP intervention.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age \>=18 years or mature or mature minor \>=15 years; 2. Female sex at birth; 3. HIV negative by country-standard testing algorithm 4. 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
Exclusion criteria
* Contraindication to country-recommended PrEP regimen per national guidelines * Participation in another HIV prevention study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomedical HIV prevention coverage | 24 weeks | Percentage of follow-up months that a participant uses a biomedical HIV prevention product |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| At-risk biomedical HIV prevention coverage | 24 weeks | 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 | 24 weeks | Proportion of participants with Peer-led DCP intervention services delivered by peer mentor |
Countries
Uganda
Contacts
CONTACTCatherine Koss, MD
CONTACTLisa Georgetti Gomez, MSPH
PRINCIPAL_INVESTIGATORCatherine Koss, MD
University of California, San Francisco
PRINCIPAL_INVESTIGATORJane Kabami, MPH, PhD(c)
Infectious Diseases Research Collaboration
Outcome results
None listed