protocolSection identificationModule nctId: NCT06348069, orgStudyIdInfo id: 2022-11-15783, briefTitle: Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe, acronym: TOPAZ, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-03-11, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of California, Berkeley, class: OTHER, collaborators name: Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe), collaborators name: University of California, San Francisco, collaborators name: Liverpool School of Tropical Medicine, descriptionModule briefSummary: Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP., conditionsModule conditions: Adherence, Medication, conditions: HIV Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Groups (sites/clusters) are randomized to either the intervention (pharmacy-based PrEP refills plus gift card incentives) or the control (standard of care) and are followed and compared over time., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pharmacy-based PrEP refill and gift voucher, interventions name: Control (Standard of care), outcomesModule primaryOutcomes measure: PrEP retention at 6 months, otherOutcomes measure: PrEP retention at 6 months among FSW who are 18-24 years of age, otherOutcomes measure: : PrEP retention at 6 months among participants who have remained active in sex work, otherOutcomes measure: FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies, otherOutcomes measure: HIV tests, otherOutcomes measure: HIV care referrals, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CESHHAR Zimbabwe, status: RECRUITING, city: Harare, zip: 0000, country: Zimbabwe, contacts name: Oppah Kuguyo, role: CONTACT, email: oppah.kuguyo@ceshhar.co.zw, geoPoint lat: -17.82772, lon: 31.05337, hasResults: False