An interventional study of Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing in HIV, Syphilis and Gonorrhea, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in Zambia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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:
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:
Queen mother participants will:
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.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 232 is below the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
FSW Inclusion Criteria:
FSW Exclusion Criteria:
Queen Mother Eligibility Criteria:
Implementer Focus Group Discussion Eligibility Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At intervention sites, the investigators will consecutively enroll 50 female sex workers (FSW) per site and follow them for 3 months, with questionnaire administration, HIV self-testing (HIVST), and self-collected STI testing performed at enrollment, and questionnaire administration repeated 3 months post-enrollment. At enrollment, participants will complete a questionnaire on sociodemographic data, sexual history, medical history, and strategy acceptability and appropriateness, as well as HIVST and self-collected STI testing, with the assistance of queen mothers. 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 facilities per participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues/DICs/health facilities per participant preference. Questionnaires will be repeated 3 months after enrollment.
Other: Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing
At standard-of-care (SOC) sites, the investigators will enroll 50 FSW at each site for completion of study questionnaires at enrolment and at 3-month follow up. These FSW will continue receiving routine syndromic STI management and HIV screening and treatment as recommended by Zambian guidelines.
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.
Uptake of HIV/STI testing through the strategy
Completion of HIV self-testing and self-collected STI testing among those offered HIV self-testing and self-collected STI testing through the strategy.
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Uptake of HIV testing
Completion of HIV testing among those not known to be living with HIV at enrollment.
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Completion of confirmatory HIV testing
Completion of confirmatory HIV testing among those with positive HIV self tests.
Time frame: From enrollment to study follow up at 3 months post-enrollment.
HIV diagnosis
New diagnosis of HIV among those not known to be living with HIV at enrollment.
Time frame: From enrollment to study follow up at 3 months post-enrollment.
HIV treatment linkage
Registered in the Zambian national HIV program (of those with HIV).
Time frame: From enrollment to study follow up at 3 months post-enrollment.
HIV prevention linkage
Registered in the national HIV program (of those not living with HIV).
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected STI testing
Completed self-collected STI testing (of those offered testing through the strategy).
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected syphilis testing
Completed self-collected syphilis testing (of those offered testing through the strategy).
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected gonorrhea/chlamydia testing
Completed self-collected gonorrhea/chlamydia testing (of those offered testing through the strategy).
Time frame: From enrollment to study follow up at 3 months post-enrollment.
STI diagnosis
Diagnosed with one or more microbiologically confirmed STIs (of those participating at intervention sites).
Time frame: From enrollment to study follow up at 3 months post-enrollment.
STI syndromic diagnosis
Diagnosed with one or more STI syndromes (of those participating at SOC sites)
Time frame: From enrollment to study follow up at 3 months post-enrollment.
STI treatment linkage
Received STI treatment (of those diagnosed with STIs and/or STI syndromes).
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Strategy acceptability
Acceptability of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers, using the Acceptability of Intervention Measure.
Time frame: At enrollment and at study follow up 3 months post-enrollment.
Strategy appropriateness
Appropriateness of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers using the Intervention Appropriateness Measure.
Time frame: At enrollment and at study follow up 3 months post-enrollment.
Strategy feasibility
Feasibility of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among implementers using the Feasibility of Intervention Measure.
Time frame: At enrollment and at study follow up 3 months post-enrollment.
Strategy costs
Variable and fixed costs associated with the strategy and expressed per participant.
Time frame: From enrollment to study follow up at 3 months post-enrollment.
HIV prevalence
Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.
Time frame: At enrollment.
Syphilis prevalence
Diagnosed with syphilis at enrollment (of those participating at intervention sites).
Time frame: At enrollment.
Gonorrhea prevalence
Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).
Time frame: At enrollment.
Chlamydia prevalence
Diagnosed with chlamydia at enrollment (of those participating at intervention sites).
Time frame: At enrollment.
Plan to share: No — Given the concern that sharing identifiable data could violate participant privacy around potentially stigmatizing information, this data will not be shared outside of the study team.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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