NCT05006625

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

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

April 20, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2022

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

April 20, 2021

Last Update Submit

February 7, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    1 year

Study Arms (2)

Adolescents and Young Adults

Adolescents and Young Adults Seeking HIV Treatment and Prevention

Other: Collaborative Care Model

Service Providers

Service Providers for Adolescents and Young Adults Seeking HIV Treatment and Prevention

Other: Collaborative Care Model

Interventions

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

Adolescents and Young AdultsService Providers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with a history of, or are currently receiving, mental healthcare at the CU psychiatric clinic or elsewhere
  • Service providers at CU Buddy Clinic
  • Current staff providing care at the CU Buddy Clinic with any active patient interface, such as physicians, nurses, peer navigators, psychologists and psychiatrists
  • Staff with less than 3 months duration of service at the CU Buddy Clinic
  • Staff who are not affiliated with the CU Buddy Clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2021

First Posted

August 16, 2021

Study Start

October 1, 2021

Primary Completion

February 24, 2022

Study Completion

February 24, 2022

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations