Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 4:04 PM
Study NCT ID:
NCT01895556
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2013-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012725', 'term': 'Sexual Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-03', 'studyFirstSubmitDate': '2013-06-28', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Condom use', 'timeFrame': 'One year after baseline survey', 'description': 'frequency of reported condom use across all sexual acts (never, sometimes, always)'}], 'secondaryOutcomes': [{'measure': 'Male circumcision', 'timeFrame': 'One year after baseline survey', 'description': 'Circumcision, willingness to circumcise, circumcision of son'}, {'measure': 'Condom purchases', 'timeFrame': 'one year after baseline survey', 'description': 'number of condoms purchased'}, {'measure': 'number of sexual partners', 'timeFrame': 'one year after baseline survey', 'description': 'number of partners over last year with which individual has engaged in vaginal, anal, oral intercourse'}]}, 'conditionsModule': {'keywords': ['Malawi', 'Risk Compensation', 'Male Circumcision', 'Demand'], 'conditions': ['Sexual Behavior', 'Dis-inhibition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the behavioral effects of learning information about male circumcision and HIV risk on sexual behavior and the demand for male circumcision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will involve men between the ages of 25 and 40\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01895556', 'briefTitle': 'Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Study of the Effect of Information About the Relationship Between HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision Among Circumcised and Uncircumcised Men in Malawi, Africa.', 'orgStudyIdInfo': {'id': 'FSG09-Thornton'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Information', 'description': 'Information about male circumcision and HIV risk', 'interventionNames': ['Other: Information']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Information', 'type': 'OTHER', 'armGroupLabels': ['Information']}, {'name': 'Control', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rebecca Thornton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Susan Godlonton, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rebecca Thornton', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rebecca Thornton', 'investigatorAffiliation': 'University of Michigan'}}}}