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

Depressive Symptoms Clinical Trial

— CHIMERA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05323695
• Other study ID #: IHRI008
• Secondary ID: D43TW011302
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2022
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 329
• Est. completion date: December 1, 2024
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

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.

Locations

Country	Name	City	State
Thailand	Institute of HIV Research and Innovation	Pathum Wan	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	amfAR, The Foundation for AIDS Research, Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH)

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Intervention Acceptability: Participants' perspective of the intervention through in-depth interviews	Acceptability will be assessed qualitatively through post-intervention in-depth interviews.	Day 1
Primary	Intervention Acceptability: Participants' perspective of the intervention through focus group discussion	Acceptability will be assessed qualitatively through post-intervention focus group discussion.	Day 1
Primary	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
Primary	Intervention Feasibility: Participants' perspective of the intervention through in-depth interviews	Feasibility will be assessed qualitatively through post-intervention in-depth interviews.	Day 1
Primary	Intervention Feasibility: Participants' perspective of the intervention through focus group discussion.	Feasibility will be assessed qualitatively through post-intervention focus group discussion.	Day 1
Primary	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