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

Not Applicable

Active, not recruiting

• Conditions: HIV/AIDS
• Interventions: Other: P4P intervention

• Registration Number: NCT06353295
• Lead Sponsor: University of California, San Francisco

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).

Study Timeline

• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-09
• Study Start: 2024-04-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P4P intervention	P4P intervention	Peer-led PrEP/PEP intervention

Primary Outcome Measures

Name	Time	Method
Uptake of biomedical prevention	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 Outcome Measures

Name	Time	Method
Feasibility of delivery of the P4P intervention by peers	6 months	Feasibility of the P4P intervention will be assessed based on number of participants with services delivered by a peer divided by the number of participants
Acceptability of the P4P intervention	6 months	The acceptability of the P4P intervention will be assessed based on participant responses to a post-intervention survey on the acceptability of the intervention

Trial Locations

Locations (1)

Infectious Diseases Research Collaboration; 🇺🇬 Kampala, Uganda