[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646716":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":73,"collaborators":76,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":38,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":109,"whyStopped":38,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation","OTHER",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Model A: PrEP referrals","EXPERIMENTAL","Model A: PrEP Referrals - Pharmacies in CRPS assigned to this implementation model will conduct behavioral screening for PrEP eligibility for young women (see Box 1, Section A). Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the CTC health facility for clinical screening, PrEP dispensation and required laboratory testing (i.e., HIV and creatinine testing, a component of clinical screening).\n\nPharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW.",[13,14],"Behavioral: Pharmacy-based PrEP services","Behavioral: Distribution of HIV self-test kits",{"label":16,"type":10,"description":17,"interventionNames":18},"Model B: PrEP screening and PrEP refills","Model B: PrEP Refills - In addition to behavioral screening for PrEP eligibility for young women, pharmacies in CRPS assigned to this implementation model will offer PrEP refills to study participants. Pharmacies will first conduct the behavioral screening for PrEP eligibility for young women. Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the health facility CTC for PrEP dispensation, further clinical screening and required laboratory testing. Young women will then be able to return to the pharmacy to receive PrEP refills. Refill provision includes rescreening for PrEP eligibility at each visit (Box 1); repeat HIV testing is required at the CTC at Month 1 and then every three months thereafter.\n\nPharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to YW.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Model C: PrEP screening, PrEP refills, and PrEP initiation","Model C: PrEP Initiation - Pharmacies in CRPS assigned to this implementation model will offer PrEP initiation services for young women enrolled in the study. Pharmacies in CRPS assigned to this implementation model will first conduct the behavioral and clinical screenings and refer participants to the health facility lab for required laboratory testing. Participants who are HIV negative will return to the pharmacy for dispensation of 30 days of PrEP medication, adherence and side effects counseling, and scheduling a next appointment for a PrEP refill in 30 days.\n\nPharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator","Model D: Peer Navigator - Pharmacies in CRPS assigned to this implementation model will offer to link young women utilizing PrEP services to a PrEP peer navigator. This is in addition to PrEP screening, PrEP initiation, and refill services for young women.\n\nPeer navigators are current or former young female PrEP users (age 18 or older, not considered study participants) who are willing to provide periodic advice, guidance, and referrals to the health facility for study participants. The role of the peer navigator is to enhance the pharmacy's protocols for linkage to health facilities for various SRH services, antenatal care, long-acting reversible contraceptives, STI screening, and\u002For PrEP consultations (e.g., side effects, safely stopping PrEP). There will be a minimum of one and a maximum of three peer navigators assigned to support each pharmacy in this implementation model.\n\nPharmacies will also implement the girl-friendly loyalty program, Mwotaji.",[13,14],{"label":28,"type":29,"description":30,"interventionNames":31},"Comparison","ACTIVE_COMPARATOR","Comparison: No PrEP services will be provided in pharmacies during phase I of the study; young women will receive PrEP from health facilities per the current standard of care. If young women go to a pharmacy and express interest in PrEP, they will be referred to the health facility for more information and PrEP access. In phase II of the study (cost-sharing), pharmacies assigned to the comparison group will provide pharmacy-based PrEP services corresponding to the best performing PrEP model determined at the end of phase I.",[14],[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BEHAVIORAL","Pharmacy-based PrEP services","Provision of PrEP services to AGYW in pharmacies.",[9,16,20,24],null,{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Distribution of HIV self-test kits","Provision of free HIV self-test kits to AGYW in pharmacies.",[28,9,16,20,24],[44],{"name":45,"affiliation":46,"role":47},"Mackfallen I Anasel, PhD","Mzumbe University","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":38,"email":53},"Mackfallen G Anasel, PhD","CONTACT","+255784705072","mganasel@mzumbe.ac.tz",{"name":55,"role":51,"phone":38,"phoneExt":38,"email":56},"Lila A Sheira, PhD MPH","Lila.sheira@ucsf.edu",[58],{"facility":59,"status":38,"city":60,"state":38,"zip":38,"country":61,"countryCode":38,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Health for a Prosperous Nation","Dar es Salaam","Tanzania",{"type":63,"coordinates":64},"Point",[65,66],39.26951,-6.82349,{"lat":66,"lon":65},[69],{"name":70,"role":51,"phone":71,"phoneExt":38,"email":72},"Emmanuel Katabaro, MD","+255 765 360 090","manuelkatabaro@gmail.com",{"type":47,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Mackfallen Giliadi Anasel","Head of Department of Health Systems Management and Centre of Excellence in Health Monitoring and Evaluation, Mzumbe University",[77,80,82],{"name":78,"class":79},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":81,"class":6},"University of California, Berkeley",{"name":83,"class":6},"University of California, San Francisco","100646716","pharmacy-based-provision-of-pre-exposure-prophylaxis-prep-for-adolescent-girls-and-young-women-in-tanzania-100646716",false,"NCT07687888","Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania","MWOTAJI: Making Women's Options for HIV Prevention In Tanzania Accessible, and Joining in Implementation Science Capacity Building","MWOTAJI","Inclusion Criteria (Parent study: YW cohort study):\n\n1. Female sex;\n2. Age 18-24 at the baseline visit;\n3. Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania with no known plans to move;\n4. Interested in starting PrEP;\n5. Access to a mobile phone (either own phone or borrowed phone); and\n6. Eligible for PrEP based on Tanzania National PrEP Guidelines behavioral screening criteria\n\nExclusion Criteria: Currently taking PrEP (refilled a PrEP prescription within the past 28 days at enrollment).\n\nInclusion Criteria (Sub-study: YW household survey):\n\n1. Female sex;\n2. Age 18-24; and\n3. Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania.\n\nExclusion Criteria (Sub-study: YW household survey): N\u002FA\n\nInclusion Criteria (Study pharmacies):\n\n1. Geographically located within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania;\n2. Located within 4 km of at least 1 health facility that provides PrEP services and whose lab conducts creatinine and hepatitis B testing;\n3. Has no planned extended closures over the next 24 months.\n\nExclusion Criteria (Study pharmacies): N\u002FA\n\nInclusion Criteria (Sub-study: Pharmacy staff):\n\n1. Pharmacy owners and staff affiliated with study pharmacies; and\n2. ≥18 years of age.\n\nExclusion Criteria (Sub-study: Pharmacy staff): N\u002FA\n\nInclusion Criteria (Sub-study: Stakeholders):\n\n1. Staff employed at referral health facilities within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania or local, regional, or national government officials;\n2. ≥18 years of age.\n\nExclusion Criteria (Sub-study: Stakeholders): N\u002FA",true,"FEMALE","18 Years","24 Years",{"count":97,"type":98},2818,"ESTIMATED","INTERVENTIONAL",[101],"NA","Implementation study comparing standard pre-exposure prophylaxis (PrEP) services to four models of pharmacy-based PrEP access for young women aged 18-24 (YW) in Tanzania. At 9 months, all sites converge to one pharmacy-based PrEP model and are randomly allocated to one of two cost sharing models to increase the program's potential for sustainability.",[104,105],"HIV","PrEP",[105,107,108],"young women","pharmacies","NOT_YET_RECRUITING","2026-07-20",{"date":112,"type":113},"2026-07-22","ACTUAL",{"date":115,"type":98},"2026-09",{"date":117,"type":98},"2028-02",{"name":5,"class":6},1]