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

November 22, 2024 updated by: Thai Red Cross AIDS Research Centre
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
317

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention Acceptability: Number of participants who accepted intervention
Time Frame: Day 1
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
Time Frame: Day 1
Acceptability will be assessed qualitatively through post-intervention in-depth interviews.
Day 1
Intervention Acceptability: Participants' perspective of the intervention through focus group discussion
Time Frame: Day 1
Acceptability will be assessed qualitatively through post-intervention focus group discussion.
Day 1
Intervention Feasibility: Number of intervention completed
Time Frame: Day 1
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
Time Frame: Day 1
Feasibility will be assessed qualitatively through post-intervention in-depth interviews.
Day 1
Intervention Feasibility: Participants' perspective of the intervention through focus group discussion.
Time Frame: Day 1
Feasibility will be assessed qualitatively through post-intervention focus group discussion.
Day 1
Number of participants screening positive for depression
Time Frame: Day 1
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thai Red Cross AIDS Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
amfAR, The Foundation for AIDS Research
Fogarty International Center of the National Institute of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rena Janamnuaysook, Institute of HIV Research and Innovation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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