Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-28 @ 4:51 AM
Study NCT ID:
NCT02775357
Status:
UNKNOWN
Last Update Posted:
2016-05-17
First Post:
2016-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of HIV Risk to Create Demand for Safe Male Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 968}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circumcision status as reported on a questionnaire and confirmed by examination', 'timeFrame': '6 months', 'description': 'Circumcision status of men ascertained using a questionnaire and confirmed by examination'}], 'secondaryOutcomes': [{'measure': 'Condom use at last non-marital relationship as reported on a questionnaire', 'timeFrame': '6 months', 'description': 'Condom use at last non-marital sex ascertained using questionnaire self reports'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The study is aimed at testing whether use of a new index to measure risk for HIV in the context of HIV testing and counseling will increase demand for safe male circumcision (SMC) services among HIV-negative non-muslim men in Rakai. We will also study whether use of the index leads to positive sexual behavioral modifications among men. The study will also measure acceptability of the index among men.', 'detailedDescription': 'Three randomized trials, one of which was conducted in Rakai, Uganda, have shown that safe male circumcision (SMC) reduces HIV acquisition in men by approximately 60%. Recommendations from the World Health Organization (WHO) and the Joint United Nations Programme (UNAIDS) emphasize that SMC should be considered an efficacious intervention for HIV prevention in countries and regions with heterosexual epidemics, high HIV and low male circumcision prevalence.\n\nIn Sub Saharan Africa, 14 countries including Uganda have been selected to scale up SMC, for these countries the target is to achieve 80% circumcision prevalence by 2015 and maintain it till 2025. The scale up would avert more than 20 percent of new infections among men and women. However SMC programs are faced with the challenge of low uptake of SMC by older sexually active men who might be at higher risk of HIV. The need to increase SMC coverage among men at high risk of HIV requires tools to measure individual HIV risk.\n\nRakai Health Sciences Program has received funding to carry out an individual randomized, unblinded, two-arm 1:1 trial comprising a total of 968 men (484 men per study arm) from Rakai Community Cohort Study (RCCS) to assess whether HIV Counseling and Testing (HCT), enhanced with measurement and communication of HIV risk (eHCT), increases uptake of SMC and leads to behavior modification among HIV-negative sexually active men aged 15-49 years in Rakai District, Uganda.\n\nThe study is using a risk nomogram developed from the Rakai Community Cohort Study data to measure individual HIV risk in the intervention group and standard HCT in the control arm. All men enrolled will be followed at six months to ascertain circumcision status and collect brief information on sexual behaviors such as number of sex partners, use of alcohol with sex, detailed data on their sexual partners etc.The study will also measure acceptability of the index among men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncircumcised, non-muslim, HIV-negative, sexually active in the previous 12 months\n\nExclusion Criteria:\n\n* Refuses HIV testing, not willing to stay in Rakai for at least 6 months following enrollment or unwilling to be traced'}, 'identificationModule': {'nctId': 'NCT02775357', 'briefTitle': 'Measurement of HIV Risk to Create Demand for Safe Male Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'Rakai Health Sciences Program'}, 'officialTitle': 'Using the Rakai HIV Risk Index to Measure and Communicate HIV Risk to Create Demand for Safe Male Circumcision: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OPP1118591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced HIV counseling and testing', 'description': 'In addition to standard HIV testing and counseling,men randomized to this arm received Measurement and communication of HIV risk from the HIV counselors using an index developed and validated through the Rakai community cohort study. Their risk was communicated to them and subsequent HIV risk reduction counseling including male circumcision was given.', 'interventionNames': ['Behavioral: Measurement and communication of HIV risk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard HIV testing and counseling', 'description': 'Men randomized to this arm were given standard HIV testing and counseling following the current Uganda Ministry of Health guidelines. Following the counseling HIV risk reduction counseling including male circumcision was given.', 'interventionNames': ['Behavioral: Standard HIV testing and counseling']}], 'interventions': [{'name': 'Measurement and communication of HIV risk', 'type': 'BEHAVIORAL', 'description': 'Measurement and communication of HIV risk in the context of HIV testing and counseling to inform HIV risk reduction counseling', 'armGroupLabels': ['Enhanced HIV counseling and testing']}, {'name': 'Standard HIV testing and counseling', 'type': 'BEHAVIORAL', 'description': 'Participants received HIV testing and counseling following standard Ministry of Health guidelines', 'armGroupLabels': ['Standard HIV testing and counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '256', 'city': 'Kalisizo', 'state': 'Rakai', 'country': 'Uganda', 'facility': 'Rakai Health Sciences Program', 'geoPoint': {'lat': -0.53639, 'lon': 31.62139}}], 'overallOfficials': [{'name': 'Joseph Kagaayi, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rakai Health Sciences Program'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be published in peer-reviewed journals and at scientific conferences.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rakai Health Sciences Program', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}