protocolSection identificationModule nctId: NCT06274060, orgStudyIdInfo id: 135399, secondaryIdInfos id: R01MH121161, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MH121161, secondaryIdInfos id: IRB00012628, type: OTHER, domain: JHSPH IRB, briefTitle: Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins Bloomberg School of Public Health, class: OTHER, collaborators name: TB/HIV Care, collaborators name: Unity Health Toronto, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa., conditionsModule conditions: Pre-exposure Prophylaxis, conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. The design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 304, type: ESTIMATED, armsInterventionsModule interventions name: Case management, interventions name: Food vouchers, interventions name: PrEP support buddy, interventions name: Community-based PrEP pickup points, outcomesModule primaryOutcomes measure: PrEP persistence at 7 months after PrEP initiation, primaryOutcomes measure: PrEP adherence at 7 months after PrEP initiation among all trial participants, secondaryOutcomes measure: PrEP persistence at 1 month after PrEP initiation, secondaryOutcomes measure: PrEP persistence at 4 months after PrEP initiation, secondaryOutcomes measure: PrEP persistence at 13 months after PrEP initiation, secondaryOutcomes measure: PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TB HIV Care, status: RECRUITING, city: Pietermaritzburg, state: KwaZulu Natal, zip: 3200, country: South Africa, contacts name: Chitra Singh, MSocSci, role: CONTACT, phone: +27721516828, email: chitra.singh@tbhivcare.org, contacts name: Joel Steingo, MBChB, MPH, role: CONTACT, phone: +27833009377, email: joel@tbhivcare.org, contacts name: Harry Hausler, MD, PhD, MPH, role: PRINCIPAL_INVESTIGATOR, contacts name: Mfezi Mcingana, BA, role: SUB_INVESTIGATOR, contacts name: Jenny Mcloughlin, RN, role: SUB_INVESTIGATOR, contacts name: Joel Steingo, MBChB, MPH, role: SUB_INVESTIGATOR, geoPoint lat: -29.61679, lon: 30.39278, hasResults: False