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NOT YET RECRUITING
NCT07829133
NA

Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to find out if sex work managers (also called "queen mothers") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. This study will also find out if this approach helps link FSW to HIV and STI treatment and prevention services. The main questions it aims to answer are: * Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services? * Can this approach increase STI diagnosis and connection to STI treatment services? * Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach? Researchers will compare a venue-based, peer-supported strategy for HIV self-testing and self-collected STI testing among FSW to the current standard of care to see if the new approach helps to increase HIV and STI identification and linkage to HIV and STI treatment and prevention services. FSW participants will: * Complete questionnaires when they join the study and again about three months later. * Complete HIV self-testing and self-collected STI testing when they join the study and again about three months later (at intervention sites), with the help of queen mothers. * Agree to have their medical records reviewed. Queen mother participants will: * Complete questionnaires when they join the study and again about three months later. * Help FSW participant complete HIV self-testing and self-collected STI testing when they join the study and again three months later (at intervention sites). Additionally, some FSW participants will complete a one-time interview so that the investigators can learn more about their experiences with and views on HIV and STI services. The investigators will also be holding focus group discussions with queen mothers, clinicians, and others involved in study activities to understand their experiences with providing services through the study strategy.

Official title: Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

232

Start Date

2026-10

Completion Date

2027-06

Last Updated

2026-09-18

Healthy Volunteers

Yes

Interventions

OTHER

Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing

Sex work managers, known as "queen mothers", will act as peer champions and will store, distribute, and collect HIV self-tests and self-collected STI test kits at venues where sex is sold on-site. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health (MOH) health facilities based on participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues or DICs or health facilities based on participant preference.

Locations (1)

Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office

Lusaka, Lusaka Province, Zambia