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Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand (CHIMERA)

Primary Purpose

Depressive Symptoms

Status

Active

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Depression Screening Intervention

About this trial

This is an interventional screening trial for Depressive Symptoms focused on measuring Depression, Transgender women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Thai nationality
Transgender women ≥18 years
Attending the Tangerine Clinic for routine care visits during the intervention period.
Can be a new or returning clients.

Exclusion Criteria:

1. Transgender women currently receiving care for a mental health diagnosis will be excluded from participating in this study.

Inclusion Criteria for healthcare providers:

Currently working at the Tangerine Clinic
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.

Exclusion criteria for healthcare providers

1. Not willing to participate in this study

Sites / Locations

Institute of HIV Research and Innovation

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Depression Screening Intervention

Arm 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).

Outcomes

Primary Outcome Measures

Intervention Acceptability: Number of participants who accepted intervention

Acceptability will be measured by the number of clients who were offered and accepted the intervention.

Intervention Acceptability: Participants' perspective of the intervention through in-depth interviews

Acceptability will be assessed qualitatively through post-intervention in-depth interviews.

Intervention Acceptability: Participants' perspective of the intervention through focus group discussion

Acceptability will be assessed qualitatively through post-intervention focus group discussion.

Intervention Feasibility: Number of intervention completed

Feasibility will be measured by number of intervention completed. Point estimates of >50% of participants completed is considered as the minimum criteria for feasibility.

Intervention Feasibility: Participants' perspective of the intervention through in-depth interviews

Feasibility will be assessed qualitatively through post-intervention in-depth interviews.

Intervention Feasibility: Participants' perspective of the intervention through focus group discussion.

Feasibility will be assessed qualitatively through post-intervention focus group discussion.

Number of participants screening positive for depression

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05323695

First Posted

July 8, 2021

Last Updated

February 15, 2023

Sponsor

Thai Red Cross AIDS Research Centre

Collaborators

amfAR, The Foundation for AIDS Research, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health

1. Study Identification

Unique Protocol Identification Number

NCT05323695

Brief Title

Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand

Acronym

CHIMERA

Official Title

Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

February 15, 2023 (Actual)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thai Red Cross AIDS Research Centre

Collaborators

amfAR, The Foundation for AIDS Research, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Symptoms

Keywords

Depression, Transgender women

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

329 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Depression Screening Intervention

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Depression Screening Intervention

Intervention 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.

Primary Outcome Measure Information:

Title

Intervention Acceptability: Number of participants who accepted intervention

Description

Acceptability will be measured by the number of clients who were offered and accepted the intervention.

Time Frame

Day 1

Title

Intervention Acceptability: Participants' perspective of the intervention through in-depth interviews

Description

Acceptability will be assessed qualitatively through post-intervention in-depth interviews.

Time Frame

Day 1

Title

Intervention Acceptability: Participants' perspective of the intervention through focus group discussion

Description

Acceptability will be assessed qualitatively through post-intervention focus group discussion.

Time Frame

Day 1

Title

Intervention Feasibility: Number of intervention completed

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.

Time Frame

Day 1

Title

Intervention Feasibility: Participants' perspective of the intervention through in-depth interviews

Description

Feasibility will be assessed qualitatively through post-intervention in-depth interviews.

Time Frame

Day 1

Title

Intervention Feasibility: Participants' perspective of the intervention through focus group discussion.

Description

Feasibility will be assessed qualitatively through post-intervention focus group discussion.

Time Frame

Day 1

Title

Number of participants screening positive for depression

Description

Time Frame

Day 1

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Thai nationality Transgender women ≥18 years Attending the Tangerine Clinic for routine care visits during the intervention period. Can be a new or returning clients. Exclusion Criteria: 1. Transgender women currently receiving care for a mental health diagnosis will be excluded from participating in this study. Inclusion Criteria for healthcare providers: Currently working at the Tangerine Clinic 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. Exclusion criteria for healthcare providers 1. Not willing to participate in this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rena Janamnuaysook

Organizational Affiliation

Institute of HIV Research and Innovation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of HIV Research and Innovation

City

Pathum Wan

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

28158952

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.

Results Reference

background

PubMed Identifier

31078203

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.

Results Reference

background

PubMed Identifier

14583691

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.

Results Reference

background

PubMed Identifier

27429185

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.

Results Reference

background

PubMed Identifier

28134236

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.

Results Reference

background

PubMed Identifier

33844767

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.

Results Reference

background

PubMed Identifier

23679953

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.

Results Reference

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Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand

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