[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656537":3},{"organization":4,"outcomesModule":7,"designInfo":87,"detailedDescription":59,"studyPopulation":59,"armGroups":94,"interventions":105,"overallOfficials":110,"centralContacts":115,"locations":120,"responsibleParty":137,"collaborators":139,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":152,"minAge":153,"maxAge":59,"enrollmentInfo":154,"targetDuration":59,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":170,"whyStopped":59,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":59,"otherOutcomes":60},[9,13,16,19,22,25,28,31,34,37,40,43,46,50,53,56],{"measure":10,"description":11,"timeFrame":12},"Uptake of HIV\u002FSTI 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.","From enrollment to study follow up at 3 months post-enrollment.",{"measure":14,"description":15,"timeFrame":12},"Uptake of HIV testing","Completion of HIV testing among those not known to be living with HIV at enrollment.",{"measure":17,"description":18,"timeFrame":12},"Completion of confirmatory HIV testing","Completion of confirmatory HIV testing among those with positive HIV self tests.",{"measure":20,"description":21,"timeFrame":12},"HIV diagnosis","New diagnosis of HIV among those not known to be living with HIV at enrollment.",{"measure":23,"description":24,"timeFrame":12},"HIV treatment linkage","Registered in the Zambian national HIV program (of those with HIV).",{"measure":26,"description":27,"timeFrame":12},"HIV prevention linkage","Registered in the national HIV program (of those not living with HIV).",{"measure":29,"description":30,"timeFrame":12},"Uptake of self-collected STI testing","Completed self-collected STI testing (of those offered testing through the strategy).",{"measure":32,"description":33,"timeFrame":12},"Uptake of self-collected syphilis testing","Completed self-collected syphilis testing (of those offered testing through the strategy).",{"measure":35,"description":36,"timeFrame":12},"Uptake of self-collected gonorrhea\u002Fchlamydia testing","Completed self-collected gonorrhea\u002Fchlamydia testing (of those offered testing through the strategy).",{"measure":38,"description":39,"timeFrame":12},"STI diagnosis","Diagnosed with one or more microbiologically confirmed STIs (of those participating at intervention sites).",{"measure":41,"description":42,"timeFrame":12},"STI syndromic diagnosis","Diagnosed with one or more STI syndromes (of those participating at SOC sites)",{"measure":44,"description":45,"timeFrame":12},"STI treatment linkage","Received STI treatment (of those diagnosed with STIs and\u002For STI syndromes).",{"measure":47,"description":48,"timeFrame":49},"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.","At enrollment and at study follow up 3 months post-enrollment.",{"measure":51,"description":52,"timeFrame":49},"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.",{"measure":54,"description":55,"timeFrame":49},"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.",{"measure":57,"description":58,"timeFrame":12},"Strategy costs","Variable and fixed costs associated with the strategy and expressed per participant.",null,[61,65,69,72,75,78,81,84],{"measure":62,"description":63,"timeFrame":64},"HIV incidence","New HIV diagnoses among those with negative HIVST at enrollment and no known history of HIV prior to enrollment at intervention sites.","Between enrollment and study follow up at 3 months post-enrollment.",{"measure":66,"description":67,"timeFrame":68},"HIV prevalence","Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.","At enrollment.",{"measure":70,"description":71,"timeFrame":68},"Syphilis prevalence","Diagnosed with syphilis at enrollment (of those participating at intervention sites).",{"measure":73,"description":74,"timeFrame":64},"Syphilis incidence","Diagnosed with syphilis at\u002Fbefore the 3-month study follow up visit (among those with negative syphilis testing at enrollment or those who were diagnosed with syphilis at enrollment and completed syphilis treatment at intervention sites).",{"measure":76,"description":77,"timeFrame":68},"Gonorrhea prevalence","Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).",{"measure":79,"description":80,"timeFrame":64},"Gonorrhea incidence","Diagnosed with gonorrhea at\u002Fbefore the 3-month study follow up visit (among those with negative gonorrhea testing at enrollment or who completed gonorrhea treatment at enrollment at intervention sites).",{"measure":82,"description":83,"timeFrame":68},"Chlamydia prevalence","Diagnosed with chlamydia at enrollment (of those participating at intervention sites).",{"measure":85,"description":86,"timeFrame":64},"Chlamydia incidence","Diagnosed with chlamydia at\u002Fbefore the 3-month study follow up visit (among those with negative chlamydia testing at enrollment or who completed chlamydia treatment at enrollment at intervention sites).",{"allocation":88,"interventionModel":89,"interventionModelDescription":90,"primaryPurpose":91,"observationalModel":59,"timePerspective":59,"maskingInfo":92},"RANDOMIZED","PARALLEL","The investigators will utilize a parallel pilot cohort study design to pilot the strategy at two purposively selected venues (i.e., sites where FSW socialize and meet new sex partners) in Lusaka, Zambia, and compare to standard of care (SOC, syndromic treatment for symptomatic FSW) at two SOC sites.","HEALTH_SERVICES_RESEARCH",{"masking":93,"maskingDescription":59,"whoMasked":59},"NONE",[95,101],{"label":96,"type":97,"description":98,"interventionNames":99},"Intervention Arm","EXPERIMENTAL","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 3 months post-enrollment. At enrollment, participants will complete a one-time 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\u002For 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\u002FDICs\u002Fhealth facilities per participant preference. HIVST and self-collected STI testing and questionnaires repeated 3 months after enrollment.",[100],"Other: Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing",{"label":102,"type":103,"description":104,"interventionNames":59},"Standard-of-Care Arm","NO_INTERVENTION","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.",[106],{"type":6,"name":107,"description":108,"armGroupLabels":109,"otherNames":59},"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\u002For 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.",[96],[111],{"name":112,"affiliation":113,"role":114},"Stephanie F Sweitzer, MSPH, MD","University of North Carolina","PRINCIPAL_INVESTIGATOR",[116],{"name":112,"role":117,"phone":118,"phoneExt":59,"email":119},"CONTACT","+260572003688","Stephanie.Sweitzer@unchealth.unc.edu",[121],{"facility":122,"status":59,"city":123,"state":124,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office","Lusaka","Lusaka Province","10101","Zambia","ZM",{"type":129,"coordinates":130},"Point",[131,132],28.28713,-15.40669,{"lat":132,"lon":131},[135],{"name":136,"role":117,"phone":118,"phoneExt":59,"email":119},"Stephanie Sweitzer, MSPH, MD",{"type":138,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[140],{"name":141,"class":142},"Fogarty International Center of the National Institute of Health","NIH","100656537","pilot-hiv-self-testing-and-self-collected-sti-testing-strategy-for-sex-worker-empowerment-study-100656537",false,"NCT07829133","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)","PHASES","FSW Inclusion Criteria:\n\n* Born biologically female\n* Identifies as a woman\n* Aged 18 years or older\n* Exchanged sex for money, goods, or services in the last 6 months\n* Lived and\u002For worked in Lusaka for at least the last 3 months\n* Planning to remain in Lusaka for at least the next 3 months\n* Willing and able to provide contact information, including a reachable telephone number\n* Willing and able to provide informed consent in Nyanja, Bemba, or English\n\nFSW Exclusion Criteria:\n\n* Under the age of 18 years\n* Does not identify as a woman\n* Unable and\u002For unwilling to provide contact information\n* Unable and\u002For unwilling to provide informed consent\n\nQueen Mother Eligibility Criteria:\n\n* Aged 18 years or older\n* Currently engaged as a sex work manager (\"queen mother\")\n* Lived and\u002For worked in Lusaka for at least the last 3 months\n* Planning to remain in Lusaka for at least the next 6 months\n* Willing and able to provide contact information, including a reachable telephone number\n* Willing and able to provide informed consent in Nyanja, Bemba, or English\n\nImplementer Focus Group Discussion Eligibility Criteria:\n\n* Aged 18 years old or older\n* Working as a queen mother OR civil society organization\u002FMinistry of Health\u002Fnon-governmental organization clinician or peer navigator OR member of a civil society or implementing partner organization serving FSW\n* Willing and able to provide verbal informed consent in English, Nyanja, or Bemba",true,"FEMALE","18 Years",{"count":155,"type":156},232,"ESTIMATED","INTERVENTIONAL",[159],"NA","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:\n\n* Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services?\n* Can this approach increase STI diagnosis and connection to STI treatment services?\n* Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach?\n\nResearchers 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.\n\nFSW participants will:\n\n* Complete questionnaires when they join the study and again about three months later.\n* 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.\n* Agree to have their medical records reviewed.\n\nQueen mother participants will:\n\n* Complete questionnaires when they join the study and again about three months later.\n* 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).\n\nAdditionally, 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.",[162,163,164,165],"HIV","Syphilis","Gonorrhea","Chlamydia",[167,168,169,162],"Sexually transmitted infections","Female sex workers","Implementation science","NOT_YET_RECRUITING","2026-09-14",{"date":173,"type":174},"2026-09-18","ACTUAL",{"date":176,"type":156},"2026-10",{"date":178,"type":156},"2027-06",{"name":5,"class":6},1]