Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-28 @ 7:29 PM
Study NCT ID:
NCT05323695
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2021-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Acceptability: Number of participants who accepted intervention', 'timeFrame': 'Day 1', 'description': 'Acceptability will be measured by the number of clients who were offered and accepted the intervention.'}, {'measure': "Intervention Acceptability: Participants' perspective of the intervention through in-depth interviews", 'timeFrame': 'Day 1', 'description': 'Acceptability will be assessed qualitatively through post-intervention in-depth interviews.'}, {'measure': "Intervention Acceptability: Participants' perspective of the intervention through focus group discussion", 'timeFrame': 'Day 1', 'description': 'Acceptability will be assessed qualitatively through post-intervention focus group discussion.'}, {'measure': 'Intervention Feasibility: Number of intervention completed', 'timeFrame': 'Day 1', 'description': 'Feasibility will be measured by number of intervention completed. Point estimates of \\>50% of participants completed is considered as the minimum criteria for feasibility.'}, {'measure': "Intervention Feasibility: Participants' perspective of the intervention through in-depth interviews", 'timeFrame': 'Day 1', 'description': 'Feasibility will be assessed qualitatively through post-intervention in-depth interviews.'}, {'measure': "Intervention Feasibility: Participants' perspective of the intervention through focus group discussion.", 'timeFrame': 'Day 1', 'description': 'Feasibility will be assessed qualitatively through post-intervention focus group discussion.'}, {'measure': 'Number of participants screening positive for depression', 'timeFrame': 'Day 1', 'description': 'Screening positive is defined as scoring 7 or greater on PHQ-9. The total possible score for PHQ-9 is 27, with 0-6 being minimum and indicating no depressive symptoms, 7-12 mild depression, 13-18 moderate depression, and 19-27 severe depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Transgender women'], 'conditions': ['Depressive Symptoms']}, 'referencesModule': {'references': [{'pmid': '28158952', 'type': 'BACKGROUND', 'citation': 'Anand T, Nitpolprasert C, Kerr SJ, Muessig KE, Promthong S, Chomchey N, Hightow-Weidman LB, Chaiyahong P, Phanuphak P, Ananworanich J, Phanuphak N. A qualitative study of Thai HIV-positive young men who have sex with men and transgender women demonstrates the need for eHealth interventions to optimize the HIV care continuum. AIDS Care. 2017 Jul;29(7):870-875. doi: 10.1080/09540121.2017.1286288. Epub 2017 Feb 3.'}, {'pmid': '31078203', 'type': 'BACKGROUND', 'citation': 'Schulman JK, Erickson-Schroth L. Mental Health in Sexual Minority and Transgender Women. Med Clin North Am. 2019 Jul;103(4):723-733. doi: 10.1016/j.mcna.2019.02.005.'}, {'pmid': '14583691', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.'}, {'pmid': '27429185', 'type': 'BACKGROUND', 'citation': 'Poteat T, Scheim A, Xavier J, Reisner S, Baral S. Global Epidemiology of HIV Infection and Related Syndemics Affecting Transgender People. J Acquir Immune Defic Syndr. 2016 Aug 15;72 Suppl 3(Suppl 3):S210-9. doi: 10.1097/QAI.0000000000001087.'}, {'pmid': '28134236', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Munoz MF, Castelao Legazpi PC, Olivares Crespo ME, Soto Balbuena C, Izquierdo Mendez N, Ferrer Barrientos FJ, Huynh-Nhu L. [PHQ-2 as First Screening Instrument of Prenatal Depression in Primary Health Care, Spain]. Rev Esp Salud Publica. 2017 Jan 30;91:e201701010. Spanish.'}, {'pmid': '33844767', 'type': 'BACKGROUND', 'citation': 'Martinez P, Soto-Brandt G, Brandt S, Guajardo V, Rojas G. [Validation of patient health Questionnaire-2 to detect depressive symptoms in diabetic or hypertensive patients]. Rev Med Chil. 2020 Nov;148(11):1614-1618. doi: 10.4067/S0034-98872020001101614. Spanish.'}, {'pmid': '23679953', 'type': 'BACKGROUND', 'citation': 'Baral S, Logie CH, Grosso A, Wirtz AL, Beyrer C. Modified social ecological model: a tool to guide the assessment of the risks and risk contexts of HIV epidemics. BMC Public Health. 2013 May 17;13:482. doi: 10.1186/1471-2458-13-482.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to develop and implement a depression screening intervention into routine HIV and sexual health service provision at a transgender health clinic in Thailand, and to explore the facilitators, barriers, feasibility and acceptability of the screening implementation.', 'detailedDescription': 'The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components. Aim 1 will involve the development and implementation of depression screening intervention at Tangerine Clinic. Aim 2 will involve semi-structured interviews with a purposive subset of participants who received the intervention and healthcare providers to explore the multilevel facilitators, barriers, feasibility and acceptability of the screening implementation. Aim 3 will evaluate the proportion of participants who are offered, accept, and receive the peer-led depression screening intervention, and the proportion who screen positive.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Thai nationality\n2. Transgender women ≥18 years\n3. Attending the Tangerine Clinic for routine care visits during the intervention period.\n4. Can be a new or returning clients.\n\nExclusion Criteria:\n\n1\\. Transgender women currently receiving care for a mental health diagnosis will be excluded from participating in this study.\n\nInclusion Criteria for healthcare providers:\n\n1. Currently working at the Tangerine Clinic\n2. Can be medical doctors, nurses, peer counselors and other members of the clinic management team involved in the routine delivery of HIV and health services to Transgender women.\n\nExclusion criteria for healthcare providers\n\n1\\. Not willing to participate in this study'}, 'identificationModule': {'nctId': 'NCT05323695', 'acronym': 'CHIMERA', 'briefTitle': 'Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand', 'organization': {'class': 'OTHER', 'fullName': 'Thai Red Cross AIDS Research Centre'}, 'officialTitle': 'Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand', 'orgStudyIdInfo': {'id': 'IHRI008'}, 'secondaryIdInfos': [{'id': 'D43TW011302', 'link': 'https://reporter.nih.gov/quickSearch/D43TW011302', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Depression Screening Intervention', 'description': 'All eligible participants will be screened using the Patient Health Questionnaire-2 (PHQ-2) for depression. If screened positive, participants will be further screened with Patient Health Questionnaire-9 (PHQ-9).', 'interventionNames': ['Behavioral: Depression Screening Intervention']}], 'interventions': [{'name': 'Depression Screening Intervention', 'type': 'BEHAVIORAL', 'description': 'All participants will be screened for depression using PHQ-2 and PHQ-9. Those screened positive for PHQ-2 but decline further screening with PHQ-9 will be assisted for further assessment or care. Those with mild to severe symptoms (score of 7 or higher on PHQ-9) will be assisted for further assessment or care with a psychiatrist.', 'armGroupLabels': ['Depression Screening Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Institute of HIV Research and Innovation', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'overallOfficials': [{'name': 'Rena Janamnuaysook', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of HIV Research and Innovation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thai Red Cross AIDS Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'amfAR, The Foundation for AIDS Research', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}