Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-06 @ 3:56 AM
Study NCT ID:
NCT07089966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Stepped-wedge cluster randomized trial of 20 public health clinics implementing the intervention of HTS counselor-led PrEP care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP screening', 'timeFrame': 'Up to 42 months', 'description': 'Using individual client-level data at clinics, compare proportion of clients completing PrEP eligibility screening in usual care (control) versus intervention time points'}, {'measure': 'PrEP initiation', 'timeFrame': 'Up to 42 months', 'description': 'Using individual client-level data at clinics, compare PrEP initiation in usual care (control) versus intervention time points. PrEP initiation will be measured as the proportion of eligible clients starting PrEP use documented on ministry of health (MOH) tools.'}, {'measure': 'PrEP continuation', 'timeFrame': 'Up to 42 months', 'description': 'Using individual client-level data at clinics, compare PrEP continuation in usual care (control) versus intervention time points. PrEP continuation among clients initiating PrEP will be determined by clinic visit attendance and pharmacy PrEP refill records obtained by abstraction of MOH clinic records.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'HIV Prevention'], 'conditions': ['Human Immunodeficiency Virus (HIV)', 'HIV Pre-exposure Prophylaxis']}, 'descriptionModule': {'briefSummary': 'This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥15 years of age\n* Accessing health services at participating public health facilities.\n* Not known to be living with HIV prior to the visit when their clinical data is first abstracted'}, 'identificationModule': {'nctId': 'NCT07089966', 'acronym': 'HTS PrEP', 'briefTitle': 'HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project', 'orgStudyIdInfo': {'id': 'STUDY00022678'}, 'secondaryIdInfos': [{'id': 'R01MH136842-01', 'link': 'https://reporter.nih.gov/quickSearch/R01MH136842-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control (Usual care)', 'description': 'The control period (usual care) will be when the clinics are still implementing the usual care model, prior to implementing the intervention. Prior to launching the intervention, all facilities will have a baseline phase of 3 months. That time, in conjunction with other periods when the clinics are implementing usual care will serve as the control period.'}, {'type': 'EXPERIMENTAL', 'label': 'HTS counselor-led PrEP care model', 'description': 'During the intervention period, all core components of PrEP delivery - including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills will be conducted by existing facility HTS counselor as part of standard of care.', 'interventionNames': ['Other: HTS counselor-led PrEP care model']}], 'interventions': [{'name': 'HTS counselor-led PrEP care model', 'type': 'OTHER', 'otherNames': ['HTS-led PrEP'], 'description': 'PrEP delivery ,including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills, provided by an HTS counselor', 'armGroupLabels': ['HTS counselor-led PrEP care model']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'contacts': [{'name': 'Daniel Matemo', 'role': 'CONTACT', 'email': 'dmatemo@uw.edu', 'phone': '+254 722 322378'}], 'facility': 'Kenyatta National Hospital', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Siaya', 'country': 'Kenya', 'contacts': [{'name': 'Daniel Matemo', 'role': 'CONTACT', 'email': 'dmatemo@uw.edu', 'phone': '+254 722 322378'}], 'facility': 'Kenyatta National Hospital', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}], 'centralContacts': [{'name': 'Laura Drown', 'role': 'CONTACT', 'email': 'ldrown@uw.edu', 'phone': '803-403-5487'}], 'overallOfficials': [{'name': 'Kenneth Mugwanya, MBChB, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor: School of Medicine, Global Health', 'investigatorFullName': 'Kenneth K Mugwanya', 'investigatorAffiliation': 'University of Washington'}}}}