Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-31 @ 1:57 PM
Study NCT ID:
NCT06661356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-04
First Post:
2024-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer-led Community-based PrEP Delivery Among Youth in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding will not be possible for participants, peer lay workers, and health providers, but the data management and analysis teams will be blinded to the study arm.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP Uptake', 'timeFrame': 'Within 1 month of enrollment', 'description': 'Received at least one PrEP prescription'}], 'secondaryOutcomes': [{'measure': 'PrEP Adherence Biomarker', 'timeFrame': '1 month', 'description': 'Positive point of care urine tenofovir assay'}, {'measure': 'PrEP Adherence Self-Report', 'timeFrame': 'At 1, 5, 9, and 13 months', 'description': 'Number of pills taken in the past 30 days'}, {'measure': 'PrEP Persistence', 'timeFrame': '5 months and 13 months', 'description': 'Continuing to take PrEP at 5 months and 13 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'Pre-Exposure Prophylaxis', 'HIV', 'Peer lay workers', 'Youth'], 'conditions': ['Pre-Exposure Prophylaxis (PrEP)', 'HIV']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which youth will be integrated into health care teams and trained to deliver HIV pre-exposure prophylaxis (PrEP) to their peers. The study team will conduct a randomized trial to determine if peer delivery of PrEP to youth aged 15-24 in Brazil will increase PrEP uptake, persistence, and adherence compared to standard PrEP care provided in health facilities.', 'detailedDescription': 'HIV is declining in many parts of the world, but rising in Latin America, including Brazil. The HIV epidemic in Brazil, including the number of new infections, is concentrated among youth aged 15-24. Youth in Brazil face obstacles to HIV prevention. Use of HIV pre-exposure prophylaxis (PrEP) lags far behind PrEP need in Brazil. There is international momentum to promote PrEP as prevention and to increase access to low barrier care. Peer lay workers are a promising approach to address the unmet need for PrEP uptake and adherence among youth in Brazil.\n\nCOMPrEP is a multi-site randomized controlled trial designed to determine if peer delivery of PrEP to youth aged 15-24 in Brazil will increase PrEP uptake, persistence, and adherence compared to standard PrEP care provided in affirming health facilities. Eligible youth (N=1400) in two municipalities in Brazil (i.e., Salvador and São Paulo) will be randomized to 1:1 to either the COMPrEP intervention arm (PrEP access through peer lay workers in community venues) or the standard care arm (PrEP access through health providers at health facilities). It is anticipated that approximately 245 and 140 youth will initiate PrEP in intervention and standard care arms, respectively, and these will be followed for 12 months, facilitating measurement of PrEP adherence and persistence outcomes on this subset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility Criteria:\n\n* Aged 15-24 years\n* Candidate for HIV prevention\n* Sexually active\n* Not currently using PrEP\n* Willing to discuss oral PrEP\n* Agree to be randomized to either intervention or standard care arm\n\nExclusion Criteria:\n\n* HIV positive test result\n* Not currently sexually active\n* Currently using PrEP'}, 'identificationModule': {'nctId': 'NCT06661356', 'acronym': 'COMPrEP', 'briefTitle': 'Peer-led Community-based PrEP Delivery Among Youth in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Determining the Impact of Peer-led Community-based PrEP Delivery Among Youth in Brazil: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-300013551'}, 'secondaryIdInfos': [{'id': '1R01MH135769-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH135769-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care Arm', 'description': 'Participants randomized to the standard care arm will receive PrEP at a health facility from a physician or nurse.'}, {'type': 'EXPERIMENTAL', 'label': 'COMPrEP Intervention', 'description': 'Participants randomized to the COMPrEP intervention will receive PrEP from peer lay workers at private community locations.', 'interventionNames': ['Behavioral: COMPrEP']}], 'interventions': [{'name': 'COMPrEP', 'type': 'BEHAVIORAL', 'description': 'Participants will be paired with peer lay workers and will meet with peer lay workers at private community location. They will discuss options for oral PrEP with peer lay workers and be provided provide daily oral PrEP or event-driven (2-1-1) PrEP. Participants will take part in rapid HIV testing at each visit. They will also meet with peer lay workers at private community location for follow-up at 1, 5, 9, and 13 months.', 'armGroupLabels': ['COMPrEP Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'contacts': [{'name': 'Ines Dourado, PhD, MD', 'role': 'CONTACT', 'email': 'ines.dourado@gmail.com', 'phone': '+55 71 99975-4848'}], 'facility': 'Federal University of Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Alexandre Grangeiro', 'role': 'CONTACT', 'email': 'ale.grangeiro@gmail.com', 'phone': '+55 11 98230-0600'}], 'facility': 'University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Katia J Bruxvoort, PhD', 'role': 'CONTACT', 'email': 'kbruxvoort@uab.edu', 'phone': '(205) 975-8625'}, {'name': 'Mallie E Froehlich, MSW', 'role': 'CONTACT', 'email': 'mefroehl@uab.edu', 'phone': '205-478-1102'}], 'overallOfficials': [{'name': 'Katia J Bruxvoort, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with anyone outside of the study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'University of Sao Paulo', 'class': 'OTHER'}, {'name': 'Federal University of Bahia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katia J. Bruxvoort', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}