NCT05323695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

July 8, 2021

Last Update Submit

November 22, 2024

Conditions

Keywords

DepressionTransgender women

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

Depression Screening Intervention

OTHER

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

Interventions

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.

Depression Screening Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Transgender women currently receiving care for a mental health diagnosis will be excluded from participating in this study.
  • 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.
  • \. Not willing to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

Location

Related 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.

    PMID: 28158952BACKGROUND
  • 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: 31078203BACKGROUND
  • 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: 14583691BACKGROUND
  • 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: 27429185BACKGROUND
  • 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: 28134236BACKGROUND
  • 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: 33844767BACKGROUND
  • 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.

    PMID: 23679953BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Rena Janamnuaysook

    Institute of HIV Research and Innovation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

April 12, 2022

Study Start

October 11, 2021

Primary Completion

February 15, 2023

Study Completion

July 2, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Locations