Clinical trial NCT06353295: Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study
Official title: Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: Biomedical HIV Prevention
Peer Mentor Intervention
Women Engaged in Sex Work
Uganda
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2024-04-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of biomedical prevention
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of delivery of the P4P intervention by peers
timeFrame: 6 months
measure: Acceptability of the P4P intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Research Collaboration
Study officials:
affiliation: University of California, San Francisco
name: Catherine Koss, MD
role: PRINCIPAL_INVESTIGATOR
References: