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

July 10, 2025 updated by: University of California, San Francisco
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Infectious Diseases Research Collaboration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: P4P intervention
Peer-led PrEP/PEP intervention
Other: P4P intervention
The final Peers for PrEP (P4P) intervention components were refined based on stakeholder engagement, key informant interviews, and focus group discussions. Trained peers will deliver the following intervention with remote clinician support and ongoing mentorship: pre-exposure prophylaxis (PrEP) access and refills in community/at hotspots; HIV testing, with option for HIV self-testing (HIVST); Rapid post-exposure prophylaxis (PEP) access for unplanned exposures; Family planning integration; Phone/text messaging hotline for peer support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of delivery of the P4P intervention by peers
Time Frame: 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
6 months
Acceptability of the P4P intervention
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Catherine Koss, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

February 14, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-38098
  • CO-US-412-6436 (Other Grant/Funding Number: Gilead Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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