protocolSection identificationModule nctId: NCT06374758, orgStudyIdInfo id: MU-2096449, briefTitle: Accelerated ART Initiation for PWHIV Who Are Out of Care, acronym: ACCELERATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Missouri-Columbia, class: OTHER, collaborators name: Gilead Sciences, descriptionModule briefSummary: The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care., conditionsModule conditions: HIV Infections, conditions: ART, conditions: Noncompliance, Patient, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: The Accelerate model of care, interventions name: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg, outcomesModule primaryOutcomes measure: The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24., primaryOutcomes measure: To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants., primaryOutcomes measure: To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants, primaryOutcomes measure: To study the change over time in feasibility of the ACCELERATE model of care in patient and staff participants, primaryOutcomes measure: To study the change over time in sustainability of the ACCELERATE model of care in patient and staff participants, primaryOutcomes measure: Qualitative data, secondaryOutcomes measure: To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care., secondaryOutcomes measure: To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care, secondaryOutcomes measure: To assess change in health-related quality of life (HRQoL), secondaryOutcomes measure: To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF, secondaryOutcomes measure: To measure Retention in Care, secondaryOutcomes measure: To assess the adherence to the study treatment, secondaryOutcomes measure: To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care., secondaryOutcomes measure: To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care., secondaryOutcomes measure: To assess staff impact of ACCELERATE model of care on staff satisfaction, secondaryOutcomes measure: To assess staff impact of ACCELERATE model of care on staff burnout, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Missouri-Columbia, status: RECRUITING, city: Columbia, state: Missouri, zip: 65212, country: United States, contacts name: Dima Dandachi, MD, role: CONTACT, phone: 573-884-8728, email: dandachid@health.missouri.edu, geoPoint lat: 38.95171, lon: -92.33407, hasResults: False