Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT03559595
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2018-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing PrEP Among African Americans in Louisville KY
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': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP uptake', 'timeFrame': '12 months', 'description': 'Reported use of PrEP'}], 'secondaryOutcomes': [{'measure': 'PrEP intentions', 'timeFrame': '12 months', 'description': 'Intention to use PrEP'}, {'measure': 'PrEP prescription', 'timeFrame': '12 months', 'description': 'Prescription of PrEP to eligible individuals by medical personnel'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS PREVENTION']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of a multifaceted strategy to increase pre-exposure prophylaxis (PrEP; a medication regimen to reduce HIV risk) uptake among high risk African Americans in Louisville, KY. We will do this by 1) implementing a media campaign to raise awareness about PrEP, 2) providing PrEP education to medical personnel who can prescribe PrEP, and 3) partnering with AIDS service organizations to improve outreach and linkage to PrEP services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages 18-29 years old\n* Self-identifies as African American or Black\n* Resident of Louisville, KY\n* Member of a priority group for PrEP HIV prevention (Men who have sex with men, people who inject drugs, trans women, high risk heterosexuals, people in serodiscordant relationships).\n* Not diagnosed with HIV\n\nExclusion Criteria:\n\n* Older than 29 and younger than 18 years old\n* Does not identify as African American or Black\n* Does not reside in Louisville, KY\n* Not a member of a priority group\n* Diagnosed with HIV'}, 'identificationModule': {'nctId': 'NCT03559595', 'briefTitle': 'Increasing PrEP Among African Americans in Louisville KY', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Increasing Pre-exposure Prophylaxis Among High-Risk African Americans in Louisville KY', 'orgStudyIdInfo': {'id': '18.0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'All study participants will be exposed to the intervention', 'interventionNames': ['Behavioral: Project Prevent']}], 'interventions': [{'name': 'Project Prevent', 'type': 'BEHAVIORAL', 'description': 'The Project Prevent intervention entails 1) a media campaign to raise PrEP awareness, 2) geographically targeted education initiatives with medical personnel to increase access to consumers, and 3) programming with AIDS service organizations to improve service delivery around PrEP.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jelani Kerr', 'investigatorAffiliation': 'University of Louisville'}}}}