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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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HIV/AIDS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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P4P intervention

Peer-led PrEP/PEP intervention

Group Type OTHER

P4P intervention

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes