Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-01-04 @ 6:57 PM
Study NCT ID:
NCT00691561
Status:
COMPLETED
Last Update Posted:
2010-03-11
First Post:
2008-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally-Tailored HIV Risk Reduction for African-American MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-10', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.', 'timeFrame': '3 months after completing intervention'}], 'secondaryOutcomes': [{'measure': 'The HCT-plus intervention will result in a smaller proportion of men who had an act of anal or vaginal intercourse without the use of a condom.', 'timeFrame': '3 months after completing the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV Prevention', 'African American', 'Black', 'gay', 'Men who have sex men', 'HIV Seronegativity'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of HIV testing and counseling risk reduction intervention (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men (AA-MSM).', 'detailedDescription': 'The HCT-plus intervention will consist of the HCT-only intervention, as well as 8 small group intervention sessions focused on HIV risk reduction. Small groups will consist of 10 men who will meet once-a-week for 8 consecutive weeks. Each meeting will last approximately 2 hours. In each small group session, staff will work with men to reassess their HIV risk behavior, re-prioritize their goals as appropriate, and provide motivational support for their risk reduction accomplishments. Participants will be asked to discuss ways they have successfully avoided HIV risk behavior since the previous session, as well as to discuss situations in which they found it difficult to avoid risk. Staff will reinforce successful risk avoidance, and problem-solve with men to overcome barriers to risk reduction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reside in Milwaukee county;\n* are at least 18 years of age;\n* self-identify as male;\n* self-identify as Black or African-American;\n* can provide informed consent;\n* report unprotected anal sex with a man in the past 3 months;\n* report at least two sexual partners with whom they have had unprotected anal or vaginal sex in the past 3 months;\n* are willing to be tested for HIV using rapid oral fluid procedures or willing to provide evidence of HIV seropositivity\n\nExclusion Criteria:\n\n* Under 18 years of age,\n* involvement in a HIV prevention study currently or in the past 6 months,\n* Participation in the pilot phase'}, 'identificationModule': {'nctId': 'NCT00691561', 'acronym': 'Project ABLE', 'briefTitle': 'Culturally-Tailored HIV Risk Reduction for African-American MSM', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment', 'orgStudyIdInfo': {'id': 'CDC-NCHHSTP-5394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.', 'interventionNames': ['Behavioral: Project ABLE']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Participants receive HIV counseling and testing only.'}], 'interventions': [{'name': 'Project ABLE', 'type': 'BEHAVIORAL', 'description': "Participants will receive HIV counseling and testing. Those selected for the intervention arm will attend small groups consisting of 10 men who meet once a week for 8 consecutive weeks. The weekly two hour discussion sessions will address HIV risk behavior within a framework of contextual influences that may moderate men's risk reduction motivation and behavior. The factors include identity, stigma, connections to community, and situation factors.", 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53202', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Diverse and Resilient', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'David Seal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'Diverse and Resilient', 'class': 'UNKNOWN'}, {'name': 'Charles D Productions', 'class': 'UNKNOWN'}, {'name': 'Milwaukee LGBT Community Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'David Seal, Principal Investigator', 'oldOrganization': 'Medical College of Wisconsin- Center for AIDS Intervention Research'}}}}