NCT07829133Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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 as needed, 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 as needed (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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- HIV
- NCT number
- NCT07829133
What you commit to
- Study type: Interventional
- Planned participants: 232
- From Nov 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- FSW Inclusion Criteria:
- Born biologically female
- Identifies as a woman
- Aged 18 years or older
- Exchanged sex for money, goods, or services in the last 6 months
- Lived and/or worked in Lusaka for at least the last 3 months
- Planning to remain in Lusaka for at least the next 3 months
- Willing and able to provide contact information, including a reachable telephone number
- Willing and able to provide informed consent in Nyanja, Bemba, or English
- FSW Exclusion Criteria:
- Under the age of 18 years
- Does not identify as a woman
- Unable and/or unwilling to provide contact information
- Unable and/or unwilling to provide informed consent
- Queen Mother Eligibility Criteria:
- Aged 18 years or older
- Currently engaged as a sex work manager ("queen mother")
- Lived and/or worked in Lusaka for at least the last 3 months
- Planning to remain in Lusaka for at least the next 6 months
- Willing and able to provide contact information, including a reachable telephone number
- Willing and able to provide informed consent in Nyanja, Bemba, or English
- Implementer Focus Group Discussion Eligibility Criteria:
- Aged 18 years old or older
- Working as a queen mother OR civil society organization/Ministry of Health/non-governmental organization clinician or peer navigator OR member of a civil society or implementing partner organization serving FSW
- Willing and able to provide verbal informed consent in English, Nyanja, or Bemba
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.