Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-16 @ 3:31 PM
Study NCT ID:
NCT02383602
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2015-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Feasibility of Community-based Test and Treat Strategies Among Men Who Have Sex With Men and Transgender Women to Increase the Uptake of HIV Testing and Treatment Services in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the uptake of HIV testing among MSM and TG as a result of the community-based Test and Treat approach', 'timeFrame': '36 months', 'description': '1. Increase in the number of individuals tested who have not previously had an HIV test\n2. Increase in the number of HIV-positive individuals tested who did not previously know their HIV status\n3. Increase in the proportion of HIV-negative individuals who are retested at least twice a year, every six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['6,000 Thai MSM and TG from study sites in Bangkok, Chiang Mai, Chonburi and Songkhla'], 'conditions': ['HIV Test and Treat']}, 'descriptionModule': {'briefSummary': 'HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants Same-day result HIV testing along with pre-test and post-test counseling, including risk reduction counseling, will be provided according to the standard practice at each study site at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can also access non-occupational post-exposure prophylaxis service and symptomatic STD service if these are available at study sites. HIV-positive participants will also receive risk reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.', 'detailedDescription': 'This study is a prospective observational cohort study that will enroll up to 6,000 Thai MSM and TG from drop-in centers in Bangkok, Chiang Mai, Chonburi and Songkhla. Each participant will have HIV testing at baseline and will be followed up for 18 months.\n\nHIV-negative participants will be asked to have HIV re-testing every 6 months. HIV-positive participants will have POC CD4 testing and ART initiation regardless of CD4 count will be offered. Those who accept ART will be followed up at week 2, week 4, month 2, month 3 and every 3 months thereafter. Those who deny ART will be followed up every 3 months.\n\nUptake of HIV re-testing will be determined. Access to POC CD4 testing and acceptability of ART initiated at HIV diagnosis regardless of CD4 count along with ART adherence will also be determined.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. SWING Drop-In Center, Bangkok, Thailand\n2. RSAT Drop-In Center, Bangkok, Thailand\n3. Chiang Mai Buddy Station, Northern Thailand\n4. SWING Drop-In Center, Pattaya, Chonburi, Eastern Thailand\n5. Sisters Drop-In Center, Pattaya, Chonburi, Eastern Thailand\n6. RSAT Drop-In Center, Songkhla, Southern Thailand', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Thai national\n2. Age \\>18 years\n3. Men or transgender women who report unprotected anal intercourse with a man at least one time in the past 6 months\n4. Not known to be HIV-positive, i.e., never tested for HIV or previous HIV test(s) negative\n5. Willing to participate in the study\n6. Provide written informed consent\n\nExclusion Criteria:\n\n1\\. Known HIV-positive serostatus'}, 'identificationModule': {'nctId': 'NCT02383602', 'briefTitle': 'Study to Evaluate the Feasibility of Community-based Test and Treat Strategies Among Men Who Have Sex With Men and Transgender Women to Increase the Uptake of HIV Testing and Treatment Services in Thailand', 'organization': {'class': 'OTHER', 'fullName': 'Thai Red Cross AIDS Research Centre'}, 'officialTitle': 'Thai Red Cross AIDS Research Centre (TRC-ARC)', 'orgStudyIdInfo': {'id': 'Community-based Test and Treat'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retention strategies', 'description': 'In addition to telephone call(s) made within 1 week prior to scheduled visit, participants will receive at least biweekly communications from the study staff in order to establish and maintain a good relationship between participants and study sites. These communications will make use of various social networking tools (for example, Grindr, LINE and/or WhatsApp and/or SMS and/or Facebook and/or electronic mail).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Ratchaburi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'The Thai Red Cross AIDS Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thai Red Cross AIDS Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Ministry of Health, Thailand', 'class': 'OTHER_GOV'}, {'name': 'The Government Pharmaceutical Organization', 'class': 'OTHER_GOV'}, {'name': 'National Health Security Office, Thailand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}