Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT07053527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Welcome to PrEP School Utilizing Peer Educators to Improve Uptake of Preexposure Prophylaxis for HIV at an HBCU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Welcome to PrEP School Utilizing Peer Educators to Improve Uptake of Pre-Exposure Prophylaxis for HIV at an HBCU Consortium', 'timeFrame': '12 months', 'description': 'The Primary endpoint will be increased awareness, acceptability and access of PrEP by measuring pre-post surveys after peer-educator/navigator educational intervention.'}], 'secondaryOutcomes': [{'measure': 'Welcome to PrEP School Utilizing Peer Educators to Improve Uptake of Pre-Exposure Prophylaxis for HIV at an HBCU Consortium', 'timeFrame': '12 months', 'description': 'The secondary endpoint will be measuring clinic data assessing the proportion of college students who initiated PrEP post educational intervention over a 12 months period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preexposure Prophylaxis', 'PrEP Awareness', 'PrEP Access', 'PrEP Uptake', 'HIV Prevention', 'Peer education', 'HBCU'], 'conditions': ['HIV Prevention Program']}, 'referencesModule': {'references': [{'pmid': '32960183', 'type': 'BACKGROUND', 'citation': 'Weber S, Lazar L, McCord A, Romero C, Tan J. Online Navigation for Pre-Exposure Prophylaxis via PleasePrEPMe Chat for HIV Prevention: Protocol for a Development and Use Study. JMIR Res Protoc. 2020 Sep 22;9(9):e20187. doi: 10.2196/20187.'}, {'pmid': '25967271', 'type': 'BACKGROUND', 'citation': "Truong HM, Pipkin S, O'Keefe KJ, Louie B, Liegler T, McFarland W, Grant RM, Bernstein K, Scheer S. Brief Report: Recent Infection, Sexually Transmitted Infections, and Transmission Clusters Frequently Observed Among Persons Newly Diagnosed With HIV in San Francisco. J Acquir Immune Defic Syndr. 2015 Aug 15;69(5):606-9. doi: 10.1097/QAI.0000000000000681."}, {'pmid': '36476363', 'type': 'BACKGROUND', 'citation': 'Pichon LC, Teti M, McGoy S, Murry VM, Juarez PD. Engaging Black men who have sex with men (MSM) in the South in identifying strategies to increase PrEP uptake. BMC Health Serv Res. 2022 Dec 7;22(1):1491. doi: 10.1186/s12913-022-08914-2.'}, {'pmid': '34006245', 'type': 'BACKGROUND', 'citation': 'Okeke NL, McLaurin T, Gilliam-Phillips R, Wagner DH, Barnwell VJ, Johnson YM, James O, Webb PB, Parker SD, Hill B, McKellar MS, Mitchell JT. Awareness and acceptability of HIV pre-exposure prophylaxis (PrEP) among students at two historically Black universities (HBCU): a cross-sectional survey. BMC Public Health. 2021 May 19;21(1):943. doi: 10.1186/s12889-021-10996-2.'}]}, 'descriptionModule': {'briefSummary': 'This study involves a peer-educator/navigation model targeting gaps in PrEP awareness, uptake, and access in priority populations.', 'detailedDescription': 'The study focuses on increasing awareness and uptake of Pre-Exposure Prophylaxis (PrEP) for HIV prevention among African American college students at a consortium of historically Black colleges and universities in Atlanta, GA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-26 years old\n* not currently on PrEP\n* English speaking\n* HIV negative\n* 5\\) Enrolled in the following universities: Spellman College, Morehouse College, Clark Atlanta University, Morehouse school of medicine\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Non-English speaking\n* HIV positive\n* Not currently enrolled any of the four colleges/universities'}, 'identificationModule': {'nctId': 'NCT07053527', 'acronym': 'PrEPSchool', 'briefTitle': 'Welcome to PrEP School Utilizing Peer Educators to Improve Uptake of Preexposure Prophylaxis for HIV at an HBCU', 'organization': {'class': 'OTHER', 'fullName': 'Morehouse School of Medicine'}, 'officialTitle': 'Welcome to PrEP School Utilizing Peer Educators to Improve Uptake of Preexposure Prophylaxis for HIV at an HBCU', 'orgStudyIdInfo': {'id': '2264597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Intervention Arm: African American College Students Receiving PrEP Awareness Sessions', 'description': 'Develop a peer-educator/navigation intervention to help decrease stigma and discrimination and foster knowledge around PrEP use, in the prevention of HIV', 'interventionNames': ['Behavioral: PrEP Awareness and Uptake Educational Program']}], 'interventions': [{'name': 'PrEP Awareness and Uptake Educational Program', 'type': 'BEHAVIORAL', 'description': 'This intervention targets African American college students aged 18-26 using a tailored, community participatory approach. It is delivered by trained peer educators and focuses on increasing PrEP awareness, access, and uptake through interactive, behaviorally focused sessions. Developed with input from focus groups to ensure relevance, the program includes a 6-month follow-up to assess sustained impact, distinguishing it from general PrEP education efforts.', 'armGroupLabels': ['Educational Intervention Arm: African American College Students Receiving PrEP Awareness Sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Kara Garretson, MPH', 'role': 'CONTACT', 'email': 'kgarretson@msm.edu', 'phone': '404-756-1258'}, {'name': 'Kara Garretson, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Morehouse School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Kara Garretson', 'role': 'CONTACT', 'email': 'kgarretson@msm.edu', 'phone': '14047561258'}, {'name': 'David Inwards-Breland', 'role': 'CONTACT', 'email': 'dinwardsbreland@luriechildrens.org', 'phone': '312-227-6800'}], 'overallOfficials': [{'name': 'Kara Garretson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Morehouse School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morehouse School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sr. Epidemiologist and Infection, Prevention & Control Safety Officer for AUCC Student Health Division', 'investigatorFullName': 'Kara Garretson, MPH', 'investigatorAffiliation': 'Morehouse School of Medicine'}}}}