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Clinical Trials/NCT06353295
NCT06353295
Active, not recruiting
Not Applicable

Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study

University of California, San Francisco1 site in 1 country140 target enrollmentApril 24, 2024
ConditionsHIV/AIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
University of California, San Francisco
Enrollment
140
Locations
1
Primary Endpoint
Uptake of biomedical prevention
Status
Active, not recruiting
Last Updated
9 months ago

Overview

Brief Summary

The overall goal of the P4P: Peers for PrEP (pre-exposure prophylaxis) study is to pilot test a peer-led and delivered intervention for biomedical HIV prevention that is tailored to women who engage in sex work in southwestern Uganda. This study will evaluate whether this intervention is feasible, acceptable, and increases uptake of biomedical prevention.

Detailed Description

The investigators have collaborated with key stakeholders to develop a community-based, peer-led intervention to provide biomedical prevention products (e.g. pre-exposure prophylaxis \[PrEP\] and post-exposure prophylaxis \[PEP\]) for women who engage in sex work in southwestern Uganda. A single-arm pilot trial will evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention. The intervention is designed to reduce stigma associated with attending clinics (via community-based delivery by peers), leverage peer support to foster adherence, and reduce barriers to prevention services (through access to PrEP, HIV self-testing, and PEP from trusted peers).

Registry
clinicaltrials.gov
Start Date
April 24, 2024
End Date
June 30, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female sex at birth
  • Self-identified as commercial sex worker; exchange of sex for goods or money in last 3 months; or work or live in setting associated with sex work
  • Age \>=18 years (or mature minor \>=15 years)
  • HIV-negative by country-standard rapid testing algorithm

Exclusion Criteria

  • Contraindication to country-recommended PrEP regimen per national guidelines
  • Unable or unwilling to provide informed consent
  • Participation in another HIV prevention study

Outcomes

Primary Outcomes

Uptake of biomedical prevention

Time Frame: 6 months

Number of participants receiving biomedical prevention (e.g., oral pre-exposure prophylaxis \[PrEP\] or post-exposure prophylaxis \[PEP\]) divided by the number of participants

Secondary Outcomes

  • Feasibility of delivery of the P4P intervention by peers(6 months)
  • Acceptability of the P4P intervention(6 months)

Study Sites (1)

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