Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-29 @ 6:53 PM
Study NCT ID:
NCT00886561
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2009-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2009-04-22', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consistent condom use', 'timeFrame': '3 and 6 months post intervention'}], 'secondaryOutcomes': [{'measure': 'Condom application', 'timeFrame': '3 and 6 months post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV prevention, female sex workers', 'HIV seronegativity'], 'conditions': ['HIV Prevention', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'This pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia.', 'detailedDescription': 'The purpose of this pilot study is to evaluate the efficacy of an intervention to reduce sexual risk behaviors and enhance HIV-preventive behaviors among female sex workers (FSWs) in Yerevan, Armenia. The study design is a randomized controlled trial of 120 FSWs aged 18 and over recruited through Hope and Help NGO. Participants will complete an interviewer administered questionnaire collected at baseline, 3- and 6-month follow-up.\n\nSubsequently, participants will be randomly assigned to either the intervention condition or a wait-list control. Those randomized to the intervention condition will receive a 2-hour one-on-one intervention session emphasizing HIV knowledge, self-efficacy, and condom use behaviors. They will also receive a 10-15 minute booster session at 3-month follow-up. The comparison condition is wait-listed, but have the choice of participating in the intervention program upon completion of the study.\n\nThe main outcome measure includes consistent condom use, defined as condom use during every episode of vaginal intercourse with clients. Other outcome measures are condom application by FSW and HIV- preventive behaviors such as condom use self-efficacy, knowledge of HIV transmission dynamics,perceived barriers to condom use and condom use errors.\n\nResults from this pilot study are expected to inform a larger trial to be implemented with FSWs in Armenia, in an effort to devise gender and culturally relevant intervention programs to prevent HIV transmission in this vulnerable population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* traded sex for money in the past 7 days\n* cognitive ability to participate in assessment and intervention\n\nExclusion Criteria:\n\n* younger than 18 years of age\n* did not trade sex for money in the past 7 days\n* cognitively unable to participate in assessment and intervention'}, 'identificationModule': {'nctId': 'NCT00886561', 'briefTitle': 'HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia', 'orgStudyIdInfo': {'id': '0126-2005'}, 'secondaryIdInfos': [{'id': 'ARX1-2719-YE-06', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV risk reduction intervention', 'description': 'Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia', 'interventionNames': ['Behavioral: HIV risk reduction intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wait list control', 'description': 'Will receive behavioral intervention after completion of study upon request.', 'interventionNames': ['Behavioral: HIV risk reduction intervention']}], 'interventions': [{'name': 'HIV risk reduction intervention', 'type': 'BEHAVIORAL', 'description': 'Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia', 'armGroupLabels': ['HIV risk reduction intervention', 'Wait list control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'state': 'Yerevan', 'country': 'Armenia', 'facility': 'Hope and Help NGO', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'overallOfficials': [{'name': 'Ralph J DiClemente, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American University of Armenia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ralph J. DiClemente', 'investigatorAffiliation': 'Emory University'}}}}