Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-04 @ 5:53 PM
Study NCT ID:
NCT00623051
Status:
COMPLETED
Last Update Posted:
2013-07-17
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012725', 'term': 'Sexual Behavior'}], '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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002944', 'term': 'Circumcision, Male'}], 'ancestors': [{'id': 'D046289', 'term': 'Body Modification, Non-Therapeutic'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-16', 'studyFirstSubmitDate': '2008-02-11', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV prevalence in population', 'timeFrame': 'at the end of the study'}], 'secondaryOutcomes': [{'measure': 'Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision', 'timeFrame': 'at the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['male circumcision', 'HIV', 'sexual behavior', 'HIV prevention', 'HIV Seronegativity'], 'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.anrs.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed at demonstrating whether or not Male Circumcision can be used as an effective public health prevention tool that will have an impact on HIV prevalence in the South African population.', 'detailedDescription': "A randomized, controlled trial (ANRS 1265) conducted in Orange Farm (South Africa) has demonstrated that male circumcision (MC) can reduce the risk of HIV acquisition by more than 50% among young men. This result has been confirmed by two similar studies conducted in Uganda and in Kenya.\n\nGiving these findings, the next logical step is to demonstrate whether or not MC can be used as an effective public health prevention tool that will have an impact on HIV in populations as well as among individuals.\n\nThis research study aims to establish a MC intervention in the community where the first randomized controlled trial of the impact of MC on men's risk of acquiring HIV infection was carried out in order to evaluate its impact on:\n\n1. knowledge, attitudes and practice regarding MC\n2. existing means of prevention (sexual behavior change, condom use, STI treatment-seeking behavior and VCT (voluntary counseling and testing) attendance)\n3. the spread of HIV and HSV-2\n\nThis research will be carried out over a period of 60 months and will have three major components: (1) the delivery of the intervention, (2) quantitative studies (cross-sectional surveys), and (3) qualitative studies."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being uncircumcised\n* living in Orange Farm (South Africa) for more than 3 months\n* agreeing to follow the instructions given by doctors, nurses and/or staff, and in particular to abstain from sex for 6-weeks after being circumcised\n* having understood and sign a consent form written in their own language\n* for those younger than 18 years of age having a written authorization from one parent or guardian and having signed an assent form.\n\nExclusion Criteria:\n\n* subjects with contraindications for male circumcision\n* allergy to anesthesia\n* hemophilia or bleeding disorders\n* genital ulceration or other symptoms of sexually transmitted infections\n* signs of infections or AIDS\n* abnormal genital anatomy\n* history of diabetes'}, 'identificationModule': {'nctId': 'NCT00623051', 'acronym': 'ORANGE FARM 2', 'briefTitle': 'Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)', 'orgStudyIdInfo': {'id': 'ANRS 12126 ORANGE FARM 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Male circumcision by experimented doctor or nurse', 'interventionNames': ['Procedure: Male Circumcision']}], 'interventions': [{'name': 'Male Circumcision', 'type': 'PROCEDURE', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Orange Farm', 'state': 'Johannesburg', 'country': 'South Africa', 'facility': 'Male Circumcision Centre', 'geoPoint': {'lat': -26.48333, 'lon': 27.86667}}], 'overallOfficials': [{'name': 'Bertran Auvert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Versailles, INSERM U687, France'}, {'name': 'David Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NICD, Johannesburg'}, {'name': 'Mohamed Haffejee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wits Medical School, Urology Department, Johannesburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}