Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-28 @ 10:03 AM
Study NCT ID:
NCT03745495
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2018-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants starting PrEP among those who use and do not use HIVST', 'timeFrame': '3 years'}, {'measure': 'Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Men or Transgender Women Who Have Sex With Men']}, 'descriptionModule': {'briefSummary': 'This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.', 'detailedDescription': 'All eligible participants will be followed up at month 3, 6, 9, and 12; month 6 and 12 will be mandatory clinic visits, while month 3 and 9 will be either clinic or a virtual visits. For participants accepting PrEP, additional follow-up visit at month 1, 2, 4, and 5 will be appointed; all visits will be either clinic or virtual visits.\n\nStudy Sites\n\nThe study will take place at the following community-based clinics:\n\n1. SWING DIC, Bangkok, Thailand\n2. RSAT DIC, Bangkok, Thailand\n3. SWING DIC, Chonburi, Thailand\n4. Sister DIC, Chonburi, Thailand\n5. Caremat DIC, Chiang Mai, Thailand\n6. MPlus DIC, Chiang Mai, Thailand\n7. RSAT DIC, Songkhla, Thailand'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 600 older adolescent MSM and TGW', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Thai nationality\n2. Age 15-19 years old\n3. Men or transgender women who have sex with men\n4. HIV-negative at the time of screening\n5. Have at least one of the following risks for HIV acquisition in the past 6 months:\n\n 1. Any unprotected receptive anal sex with a male partner\n 2. More than 5 male partners, regardless of condom use and serostatus\n 3. Has had a bacterial sexually transmitted infection (STI)\n 4. Any injected drug use\n6. Calculated creatinine clearance (CrCl) ≥ 75 mL/min, as estimated by the Cockcroft- Gault equation\n7. Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n8. Have signed the informed consent form\n\nExclusion Criteria:\n\n1. HIV-positive\n2. Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening\n3. Known allergy/sensitivity to tenofovir or emtricitabine'}, 'identificationModule': {'nctId': 'NCT03745495', 'briefTitle': 'HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW', 'organization': {'class': 'OTHER', 'fullName': 'Thai Red Cross AIDS Research Centre'}, 'officialTitle': 'Study to Determine the Effect of HIV Self-testing on the Uptake of and Retention in Pre-exposure Prophylaxis Service Among Older Adolescent Men Who Have Sex With Men and Transgender Women', 'orgStudyIdInfo': {'id': 'STANDUP-TEEN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '300 To determine the effect of HIVST on PrEP uptake among older adolescent MSM and TGW'}, {'label': 'Group 2', 'description': '300 To determine the effect of HIVST on retention of older adolescent MSM and TGW in HIV service'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': '1.Swing Dic,', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': '2. Rsat Dic,', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'facility': '5. Caremat DIC,', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'facility': '6. MPlus DIC,', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Chon Buri', 'country': 'Thailand', 'facility': '3. Swing Dic,', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}, {'city': 'Chon Buri', 'country': 'Thailand', 'facility': '4. Sister DIC,', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}, {'city': 'Songkhla', 'country': 'Thailand', 'facility': '7. Rsat Dic,', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thai Red Cross AIDS Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}