protocolSection identificationModule nctId: NCT06319105, orgStudyIdInfo id: 775736, briefTitle: PathToScale: An Implementation Evaluation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Georgetown University, class: OTHER, collaborators name: AIDS Vaccine Advocacy Coalition, collaborators name: Centers for Disease Control and Prevention, collaborators name: Center for the Development of People, collaborators name: Cooper/Smith, collaborators name: Elizabeth Glaser Pediatric AIDS Foundation, collaborators name: Family Health Services, collaborators name: Healthqual, collaborators name: Johns Hopkins Research Project, Malawi, collaborators name: Johns Hopkins Bloomberg School of Public Health, collaborators name: Kamuzu University of Health Sciences, collaborators name: Blantyre District Health Office, Malawi, collaborators name: Lilongwe District Health Office, Malawi, collaborators name: Lighthouse Trust, collaborators name: Ministry of Health, Malawi, collaborators name: National AIDS Commission, Malawi, collaborators name: Pakachere Institute of Health and Development Communication, collaborators name: Partners in Hope, collaborators name: Population Services International, collaborators name: University of North Carolina, collaborators name: United States Agency for International Development (USAID), collaborators name: United States President's Emergency Plan for AIDS Relief, collaborators name: Quantitative Engineering Design, collaborators name: Clinton Health Access Initiative-Malawi, descriptionModule briefSummary: The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels., conditionsModule conditions: Oral Pre-exposure Prophylaxis (PrEP), conditions: Long-acting Injectable Cabotegravir for PrEP, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 9900, type: ESTIMATED, armsInterventionsModule interventions name: Standard intervention: Offer PrEP choice, outcomesModule primaryOutcomes measure: Pre-exposure prophylaxis uptake by modality, primaryOutcomes measure: Pre-exposure prophylaxis uptake by delivery channel, primaryOutcomes measure: Pre-exposure prophylaxis uptake by population, primaryOutcomes measure: Pre-exposure prophylaxis continuation by modality, primaryOutcomes measure: Pre-exposure prophylaxis continuation by delivery channel, primaryOutcomes measure: Pre-exposure prophylaxis continuation by population, primaryOutcomes measure: Rates of switching between oral and injectable pre-exposure prophylaxis, secondaryOutcomes measure: Implementation readiness, secondaryOutcomes measure: Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users, secondaryOutcomes measure: Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 110 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Community Health Science Unit, status: RECRUITING, city: Lilongwe, country: Malawi, contacts name: W Ozituosauka, role: CONTACT, geoPoint lat: -13.96692, lon: 33.78725, hasResults: False