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

HIV/AIDS Clinical Trial

— P4P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353295
• Other study ID #: 22-38098
• Secondary ID: CO-US-412-6436
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Catherine Koss, MD
• Phone: +1 415-476-4082
• Email: catherine.koss[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

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

Locations

Country	Name	City	State
Uganda	Infectious Diseases Research Collaboration	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Gilead Sciences

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of delivery of the P4P intervention by peers	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
Secondary	Acceptability of the P4P intervention	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