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Depressive SymptomsCHIMERANCT05323695

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

A study testing Depression Screening Intervention in people with Depressive Symptoms, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms
What is being tested?
Depression Screening Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
1 siteThailand
Study dates
11 Oct 2021to 2 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Institute of HIV Research and Innovation

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

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.

Read the 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.

Being tested
Depression Screening Intervention
Keywords
Depression, Transgender women
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Depression Screening InterventionBehavioural

    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.

Study groups in NCT05323695
Study groupRoleWhat they receive
Depression Screening InterventionOtherAll 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).
Receives: Behavioral: Depression Screening Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention Acceptability: Number of participants who accepted intervention

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

    Measured: Day 1

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

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

    Measured: Day 1

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

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

    Measured: Day 1

  4. 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.

    Measured: Day 1

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

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

    Measured: Day 1

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

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

    Measured: Day 1

  7. 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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start11 Oct 2021
  3. Primary completion15 Feb 2023
  4. Study completion2 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323695
Sponsor's protocol ID
IHRI008
Other IDs
D43TW011302
Acronym
CHIMERA
Status last verified
Nov 2024
First submitted
8 Jul 2021
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28158952

  • 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.

    PubMed 31078203

  • 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.

    PubMed 14583691

  • 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.

    PubMed 27429185

  • 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.

    PubMed 28134236

  • 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.

    PubMed 33844767

  • 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.

    PubMed 23679953

Questions about this trial

What is this clinical trial studying?

A study testing Depression Screening Intervention in people with Depressive Symptoms, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Acceptability: Number of participants who accepted intervention (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323695, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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