DepressionNCT05006625
Implementation of a Collaborative Care Model to Manage Depression Among Adolescents and Young Adults in HIV Services in Thailand
An observational study of Depression and HIV, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to investigate the acceptability and feasibility of the implementation of a collaborative care model (CCM) to screen and treat depression. This model will includes cognitive behavioral therapy (CBT) and useof a task-shifting model to address depression among adolescents and young adults (AYA) who are… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression, HIV
- What is being tested?
- Collaborative Care Model
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2021to 24 Feb 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Service users aged 15-24 starting or currently receiving HIV treatment and prevention services, which includes any individual or combination receipt of the following services: ART, PrEP, HIV testing, receipt of condoms, HIV risk counselling 2. Staff providing care at the adolescent HIV treatment and prevention services, with any active patient interface, such as physicians, nurses, peer navigators, psychologists and psychiatrists
Who may be able to join
- Aged 15-24 years of age
- Starting or currently receiving HIV treatment and prevention services, which includes any individual or combination receipt of the following services: ART, PrEP, HIV testing, receipt of condoms, HIV risk counselling
- Thai Nationality
- Current staff providing care at the CU Buddy Clinic with any active patient interface, such as physicians, nurses, peer navigators, psychologists and psychiatrists
Who cannot join
- Individuals with a history of, or are currently receiving, mental healthcare at the CU psychiatric clinic or elsewhere
- Service providers at CU Buddy Clinic
- Staff with less than 3 months duration of service at the CU Buddy Clinic
- Staff who are not affiliated with the CU Buddy Clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Collaborative Care Model to Screen and Treat Depression Among Adolescents and Young Adults Ages 15-24 Years Seeking HIV Treatment and Prevention Services in Bangkok, Thailand
This study aims to investigate the acceptability and feasibility of the implementation of a collaborative care model (CCM) to screen and treat depression. This model will includes cognitive behavioral therapy (CBT) and useof a task-shifting model to address depression among adolescents and young adults (AYA) who are seeking HIV treatment and prevention services at a hospital in Bangkok, Thailand. Analyses will be guided by the consolidated framework for implementation research (CFIR), which will include the identification of facilitators and barriers to implementation of this CCM.
In the last 3 years, 10-20% of AYA patients at King Chulalongkorn Memorial Hospital (KCMH) who seek HIV treatment or prevention services suffer from mental health disorders. As a result, CCM integration for depression screening and treatment was implemented at the 'CU Buddy Clinic' KCMH with the ultimate goal of increasing access to and engagement in mental healthcare with a goal to improve the overall quality of life for Thai AYA. This project will inform a future implementation science study that will focus on how the optimization of integrated mental healthcare into routine AYA HIV treatment and prevention services can impact health outcomes for patients, including ART adherence and long-term viral suppression (AYA living with HIV) and HIV acquisition risk behaviors and PrEP adherence (AYA at risk for HIV).
- Conditions
- Depression, HIV
- Being tested
- Collaborative Care Model
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care ModelOther
Use of the collaborative care model to screen and deliver care for depression in adolescents and young adults aged 15-24 years seeking HIV prevention and treatment services
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and Young Adults | Adolescents and Young Adults Seeking HIV Treatment and Prevention Receives: Other: Collaborative Care Model | |
| Service Providers | Service Providers for Adolescents and Young Adults Seeking HIV Treatment and Prevention Receives: Other: Collaborative Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using the collaborative care model integration to routine HIV care services
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the feasibility of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Measured: 1 year
Acceptability of using the collaborative care model integration to routine HIV care services
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the acceptability of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Measured: 1 year
Facilitators of using the collaborative care model integration to routine HIV care services
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the facilitators of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Measured: 1 year
Barriers of using the collaborative care model integration to routine HIV care services
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the barriers of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Oct 2021
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research
- Responsible party
- Principal investigator, Wipaporn Natalie Songtaweesin, MD., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006625
- Sponsor's protocol ID
- CHIMERA
- Status last verified
- Feb 2023
- First submitted
- 20 Apr 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Collaborative Care Model to Screen and Treat Depression Among Adolescents and Young Adults Ages 15-24 Years Seeking HIV Treatment and Prevention Services in Bangkok, Thailand
- ClinicalTrials.gov ID
- NCT05006625
- Acronym / sponsor ID
- CHIMERA
- Conditions
- Depression, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the acceptability and feasibility of the implementation of a collaborative care model (CCM) to screen and treat depression. This model will includes cognitive behavioral therapy (CBT) and useof a task-shifting model to address depression among adolescents and young adults (AYA) who are seeking HIV treatment and prevention services at a hospital in Bangkok, Thailand. Analyses will be guided by the consolidated framework for implementation research (CFIR), which will include the identification of facilitators and barriers to implementation of this CCM.
In the last 3 years, 10-20% of AYA patients at King Chulalongkorn Memorial Hospital (KCMH) who seek HIV treatment or prevention services suffer from mental health disorders. As a result, CCM integration for depression screening and treatment was implemented at the 'CU Buddy Clinic' KCMH with the ultimate goal of increasing access to and engagement in mental healthcare with a goal to improve the overall quality of life for Thai AYA. This project will inform a future implementation science study that will focus on how the optimization of integrated mental healthcare into routine AYA HIV treatment and prevention services can impact health outcomes for patients, including ART adherence and long-term viral suppression (AYA living with HIV) and HIV acquisition risk behaviors and PrEP adherence (AYA at risk for HIV).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents and Young Adults | – | Other: Collaborative Care ModelAdolescents and Young Adults Seeking HIV Treatment and Prevention |
| Service Providers | – | Other: Collaborative Care ModelService Providers for Adolescents and Young Adults Seeking HIV Treatment and Prevention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Service users aged 15-24 starting or currently receiving HIV treatment and prevention services, which includes any individual or combination receipt of the following services: ART, PrEP, HIV testing, receipt of condoms, HIV risk counselling 2. Staff providing care at the adolescent HIV treatment and prevention services, with any active patient interface, such as physicians, nurses, peer navigators, psychologists and psychiatrists
Key inclusion criteria (4 listed)
- Aged 15-24 years of age
- Starting or currently receiving HIV treatment and prevention services, which includes any individual or combination receipt of the following services: ART, PrEP, HIV testing, receipt of condoms, HIV risk counselling
- Thai Nationality
- Current staff providing care at the CU Buddy Clinic with any active patient interface, such as physicians, nurses, peer navigators, psychologists and psychiatrists
Key exclusion criteria (4 listed)
- Individuals with a history of, or are currently receiving, mental healthcare at the CU psychiatric clinic or elsewhere
- Service providers at CU Buddy Clinic
- Staff with less than 3 months duration of service at the CU Buddy Clinic
- Staff who are not affiliated with the CU Buddy Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Care ModelUse of the collaborative care model to screen and deliver care for depression in adolescents and young adults aged 15-24 years seeking HIV prevention and treatment services | Other | Adolescents and Young Adults, Service Providers |
Primary outcome
Feasibility of using the collaborative care model integration to routine HIV care services
Time frame: 1 year
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the feasibility of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Acceptability of using the collaborative care model integration to routine HIV care services
Time frame: 1 year
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the acceptability of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Facilitators of using the collaborative care model integration to routine HIV care services
Time frame: 1 year
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the facilitators of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Barriers of using the collaborative care model integration to routine HIV care services
Time frame: 1 year
Qualitative assessment - in-depth interviews using semi-structured interview guides individually asking service providers and adolescent service users the barriers of using the collaborative care model on integration of screening and treatment for depression (including CBT) for standard AYA HIV treatment and prevention services, audio recorded, transcripted and coded for qualitative analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and HIV, run by Chulalongkorn University 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 4 inclusion and 4 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 9 Feb 2023. 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?
Feasibility of using the collaborative care model integration to routine HIV care services (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2023.