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

NCT06353295 | Active Not Recruiting

• 2 other identifiers: 22-38098CO-US-412-6436
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

Biomedical HIV Prevention; Peer Mentor Intervention; Women Engaged in Sex Work; Uganda

Outcome Measures

Primary Outcomes (1)

• Uptake of biomedical prevention

  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 Outcomes (2)

• Feasibility of delivery of the P4P intervention by peers

  6 months

• Acceptability of the P4P intervention

  6 months

Study Arms (1)

P4P intervention

OTHER

Peer-led PrEP/PEP intervention

Other: P4P intervention

Interventions

P4P intervention OTHER

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

P4P intervention

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Female sex at birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Gilead Sciences: collaborator

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Catherine Koss, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm pilot trial to evaluate a community-based, peer-led and delivered 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. This study will test whether the intervention is feasible, acceptable, and increases biomedical prevention uptake.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 9, 2024
• Study Start: April 24, 2024
• Primary Completion: February 14, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)