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NCT Number: NCT06353295

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Infectious Diseases Research Collaboration

Kampala, Uganda

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Gilead Sciences

Registry information

Acronym: P4P

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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