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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: Depression Screening Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 329
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Institute of HIV Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Thai nationality
2. Transgender women ≥18 years
3. Attending the Tangerine Clinic for routine care visits during the intervention period.
4. 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:

1. Currently working at the Tangerine Clinic
2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Depression Screening Intervention; 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).	Behavioral: Depression Screening Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability: Number of participants who accepted intervention	Acceptability will be measured by the number of clients who were offered and accepted the intervention.	Day 1
Intervention Acceptability: Participants' perspective of the intervention through in-depth interviews	Acceptability will be assessed qualitatively through post-intervention in-depth interviews.	Day 1
Intervention Acceptability: Participants' perspective of the intervention through focus group discussion	Acceptability will be assessed qualitatively through post-intervention focus group discussion.	Day 1
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.	Day 1
Intervention Feasibility: Participants' perspective of the intervention through in-depth interviews	Feasibility will be assessed qualitatively through post-intervention in-depth interviews.	Day 1
Intervention Feasibility: Participants' perspective of the intervention through focus group discussion.	Feasibility will be assessed qualitatively through post-intervention focus group discussion.	Day 1
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.	Day 1

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: National Institutes of Health (NIH); amfAR, The Foundation for AIDS Research; Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Rena Janamnuaysook, Institute of HIV Research and Innovation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 15, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Transgender women
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: IHRI008; D43TW011302 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No