Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-07 @ 6:33 AM
Study NCT ID:
NCT02122094
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2014-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D013587', 'term': 'Syphilis'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance of testing', 'timeFrame': '2 hours', 'description': 'Participants in the clinic-based Sexual Health Promotion intervention will accept offer of testing for chlamydia, gonorrhea, syphilis, HIV, HBV and Hepatitis C Virus.'}, {'measure': 'Return for test results', 'timeFrame': 'two weeks', 'description': 'Participants in the clinic-based Sexual Health Promotion intervention will return for their test results'}, {'measure': 'Intention to access health services', 'timeFrame': 'two years', 'description': 'Participants who receive the community-based Sexual Health Promotion intervention will report intent to access health services for Sexually Transmitted Infection testing, treatment and vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV', 'Chlamydia', 'Gonorrhea', 'Syphilis', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study seeks to implement a sexual health promotion intervention for male sex workers in Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will increase testing, treatment and vaccination for sexually transmitted infections, including intentions of participants to engage in these services beyond the conclusion of the intervention. At the community level, the study hypothesis is that male sex workers will be more aware of sexual health care and more likely to access these services in the future.', 'detailedDescription': 'The intervention is administered in community and clinic settings. The full intervention consists of seven core modules: Sexual Health, Sexual Diversity, HIV/STI Transmission, Behavioral Risk and Risk Reduction, Alcohol and Drugs, Stigma, and HIV/STI and Health Seeking Practices. In the community, outreach is conducted by Health Educators to deliver the intervention modules that young men express and interest in, as well as to provide risk reduction materials including condoms and lubricant. Study interviewers conduct a cross-sectional interview of young male sex workers in community venues (the interviewers and health educators are never present in a venue at the same time), and a random sample of interviewees are invited to a local clinic, where they receive a more detailed interview, the full intervention (delivered one on one by a Health Educator and including all seven modules), a clinical exam, testing for HIV and other STIs (HBV, HCV, gonorrhea, syphilis, chlamydia), onsite treatment, vaccination and referral, and a post-intevention assessment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days\n\nExclusion Criteria:\n\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02122094', 'briefTitle': 'Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities', 'organization': {'class': 'OTHER', 'fullName': 'National Development and Research Institutes, Inc.'}, 'officialTitle': 'Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities', 'orgStudyIdInfo': {'id': 'R01DA033673', 'link': 'https://reporter.nih.gov/quickSearch/R01DA033673', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sexual Health Promotion Intervention', 'description': 'The SHP Intervention consists of seven core and five optional modules covering topics related to sexual health. It is delivered in both community (outreach) settings and i clinic-based settings.', 'interventionNames': ['Behavioral: Sexual Health Promotion Intervention']}], 'interventions': [{'name': 'Sexual Health Promotion Intervention', 'type': 'BEHAVIORAL', 'description': 'The seven core modules are 1) the Importance of Sexual Health, 2) Sexual Diversity, 3) HIV and other STIs, 4) Behavioral Risk and Risk Reduction, 5) Alcohol and Drugs, 6) Stigma and 7) Health Seeking Practices. The five optional modules are 1) HIV Treatment and Adherence, 2) Stress Reduction, 3) HIV Status Disclosure, 4) MSM/Gay Disclosure, and 5) Other Sexual Health Concerns', 'armGroupLabels': ['Sexual Health Promotion Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'state': 'Hanoi', 'country': 'Vietnam', 'facility': 'Hanoi Medical University', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Ho Chi Minh City', 'state': 'Ho Chi Minh CIty', 'country': 'Vietnam', 'facility': 'Center for Applied Research on Men and Health (CARMAH)', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Development and Research Institutes, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Hanoi Medical University', 'class': 'OTHER'}, {'name': 'University of Puerto Rico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}