Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-29 @ 7:38 PM
Study NCT ID:
NCT00080093
Status:
UNKNOWN
Last Update Posted:
2008-09-26
First Post:
2004-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Condom Use in People at Risk for HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 534}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-25', 'studyFirstSubmitDate': '2004-03-23', 'studyFirstSubmitQcDate': '2004-03-23', 'lastUpdatePostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of condom use', 'timeFrame': 'At 30 days and 2 months before each assessment'}, {'measure': 'Number of occurances of unprotected sex', 'timeFrame': 'At 30 days before each assessment'}, {'measure': 'Stage of change for condom use with main and nonmain partners, and men and women', 'timeFrame': 'Throughout study'}], 'secondaryOutcomes': [{'measure': 'Frequency of condom use with main and nonmain partners, and men and women', 'timeFrame': 'Throughout Study'}, {'measure': 'Number and ratios of protected sex occasions with main and nonmain partners, and men and women', 'timeFrame': 'Throughout study'}, {'measure': 'Stage of change for condom use with main and nonmain partners, and men and women', 'timeFrame': 'Throughout Study'}]}, 'conditionsModule': {'keywords': ['Condom', 'HIV Seronegativity', 'HIV Prevention', 'Behavioral Intervention'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Cho S, Harlow L, Morokoff P, Redding C, Rossi J, Mayer K, Koblin B. Predicting 3-Wave LGCM of Condom Use in High-Risk Community Sample. Annual Meeting of the American Psychological Association, San Francisco, CA, 2007.'}, {'type': 'RESULT', 'citation': 'Cho S, Morokoff P, Redding C, Harlow L, Rossi J, Mayer K, Koblin B. Empirically Investigating Gender in a Multifaceted Model of HIV Risk. 19th Annual Meeting of the American Psychological Society, Washington, DC, 2007.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate a new program designed to increase condom use in both women and men.', 'detailedDescription': 'As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.\n\nParticipants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.\n\nAssessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* HIV uninfected\n* Sexually active\n* At risk for HIV (as determined by study officials)\n* Speaks English\n* Seen at a participating clinic\n\nExclusion Criteria\n\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT00080093', 'briefTitle': 'Increasing Condom Use in People at Risk for HIV Infection', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Increasing Condom Use With a Stage-Matched Intervention', 'orgStudyIdInfo': {'id': 'R01AI041323', 'link': 'https://reporter.nih.gov/quickSearch/R01AI041323', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01AI041323', 'link': 'https://reporter.nih.gov/quickSearch/R01AI041323', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4', 'interventionNames': ['Behavioral: Individual feedback and specially-tailored manuals']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4', 'interventionNames': ['Behavioral: General HIV information feedback and the best-available information']}], 'interventions': [{'name': 'Individual feedback and specially-tailored manuals', 'type': 'BEHAVIORAL', 'description': 'Individual feedback and specially-tailored manuals', 'armGroupLabels': ['1']}, {'name': 'General HIV information feedback and the best-available information', 'type': 'BEHAVIORAL', 'description': 'General HIV information feedback and the best-available information', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Patricia Morokoff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rhode Island'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Patricia Morokoff, PhD', 'oldOrganization': 'University of Rhode Island'}}}}