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Effectiveness and Cost-Effectiveness of Depression Treatment for Individuals With TB in South Africa

Primary Purpose

Depression, Tuberculosis

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Interpersonal Counseling
Enhanced treatment as usual
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring effectiveness, cost-effectiveness, implementation science, Hybrid Type I Trial, South Africa, Depression, Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or over
  • initiating treatment for TB
  • ability to provide informed consent

Exclusion Criteria:

  • unable or unwilling to provide informed consent

Sites / Locations

  • Desmond Tutu HIV FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention: Interpersonal Counseling for Depression

Control: Enhanced Treatment as Usual

Arm Description

New adult TB patients with depressive symptoms (PHQ-9 > 10) will be offered 4-8 sessions of Interpersonal Counseling delivered by a trained lay counsellor.

New adult TB patients will be screened for depression and those with significant symptoms (PHQ-9 > 15 and/or suicidal ideation) will be referred to the clinic nurse for evaluation and referral to specialized mental health care as needed. Routine screening for depression is not a standard practice for TB patients; therefore assessment and referral is considered "enhanced" treatment as usual. Individuals will be interviewed at baseline and treatment completion.

Outcomes

Primary Outcome Measures

TB treatment success rate
Patient level TB treatment success (yes/no) will be extracted from clinic records and defined based on the South African National TB Control Guidelines as all smear-positive patients that were cured (negative smear in last month of treatment) and those that completed treatment but did not meet the criteria for cure or failure.

Secondary Outcome Measures

Depression remission rate
Patient level depression remission (yes/no) will be assessed using the Patient Health Questionnaire (PHQ-9) and defined as a score less than 10.

Full Information

First Posted
September 28, 2021
Last Updated
July 13, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, Desmond Tutu HIV Foundation, University of Cape Town, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05091580
Brief Title
Effectiveness and Cost-Effectiveness of Depression Treatment for Individuals With TB in South Africa
Official Title
The Effectiveness and Cost-effectiveness of Implementing Evidence-based Depression Treatment Within the TB Care Platform in South Africa: A Hybrid Effectiveness-implementation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, Desmond Tutu HIV Foundation, University of Cape Town, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This hybrid type I effectiveness-implementation trial will increase understanding of the effectiveness and cost-effectiveness of integrating a brief evidence-based treatment for major depressive disorder (MDD) within the tuberculosis (TB) care platform to improve TB and MDD. Findings from this R01 are likely to inform policy and treatment guidelines for the integrated management of TB and MDD in low- and middle-income countries globally.
Detailed Description
TB and depression are the leading infectious cause of death and the leading cause of disability, respectively. Furthermore, they are commonly co-occurring and negatively synergistic. TB and depression comorbidity is associated with a 2.85 greater chance of death and 8.70 higher risk for loss to follow up (LTFU) from treatment, which has a cascade of negative individual-, community-, societal-, and health system-level implications. As a treatable condition, depression is a remediable driver of the TB epidemic. The WHO has called for a global policy framework for TB and mental health integration, recommending brief psychological interventions to address mental disorders in primary care settings. Interpersonal counseling (IPC) is a brief version of one such evidence-based intervention that has demonstrated efficacy and effectiveness in treating depression when delivered by non-mental health specialists, including in South Africa. The purpose of this study is to assess the effectiveness and cost-effectiveness of integrating IPC (for depression) into the TB care platform to improve TB and depression outcomes, as well as mitigate TB-related catastrophic costs. As the country with the highest TB burden in the world, nearly 60% of whom are co-infected with HIV, South Africa is the ideal setting for this study. This 3-year hybrid type I effectiveness-implementation trial will be implemented in eight clinics (n~1410 individuals with TB/depression) in the Eastern and Western Capes of South Africa to integrate IPC to treat depression comorbidity within the TB care platform with the following aims: Aim 1) To evaluate the effectiveness and implementation outcomes of integrating IPC treatment for depression into the existing TB care platform to improve TB and depression outcomes; Aim 2) To determine the influence of theoretically based intervention mediators and moderators on TB treatment outcomes; Aim 3) To assess the cost-effectiveness of integrating depression treatment into the TB care platform from the patient and health system perspectives. This research will provide critical clinical, programmatic, and economic data to inform the WHO global policy framework for TB and mental health integration, and cost-effective clinical practice to improve TB outcomes, especially in low-resource settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Tuberculosis
Keywords
effectiveness, cost-effectiveness, implementation science, Hybrid Type I Trial, South Africa, Depression, Tuberculosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge cluster-randomized hybrid type I effectiveness-implementation trial
Masking
None (Open Label)
Masking Description
Since this is a stepped wedge design, masking will not be possible. Clinics will be randomized in terms of the order in which they're trained to deliver the behavioral intervention over time, but it will be obvious whether or not a clinic is implementing the intervention.
Allocation
Randomized
Enrollment
1410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Interpersonal Counseling for Depression
Arm Type
Experimental
Arm Description
New adult TB patients with depressive symptoms (PHQ-9 > 10) will be offered 4-8 sessions of Interpersonal Counseling delivered by a trained lay counsellor.
Arm Title
Control: Enhanced Treatment as Usual
Arm Type
Other
Arm Description
New adult TB patients will be screened for depression and those with significant symptoms (PHQ-9 > 15 and/or suicidal ideation) will be referred to the clinic nurse for evaluation and referral to specialized mental health care as needed. Routine screening for depression is not a standard practice for TB patients; therefore assessment and referral is considered "enhanced" treatment as usual. Individuals will be interviewed at baseline and treatment completion.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Counseling
Intervention Description
Interpersonal Counseling is a brief (4-8 sessions) psychological intervention that was developed to treat depression in primary care. In IPC, counselors provide psychoeducation about the connection of depressive symptoms to social triggers and support patients in leveraging social networks to address these stressors and reduce depressive symptoms. Since depressive symptoms are often a transient reaction to life stress (e.g. TB diagnosis), many individuals are able to achieve significant alleviation of symptoms in as few as four sessions. IPC focuses on reducing interpersonal conflict and improving social cohesion in families, which may have the advantage of strengthening the ability of families to support TB patients in completing treatment to achieve cure. All individuals will be offered 4-5 sessions (weekly), with up to 3 optional booster sessions (monthly) until TB treatment is completed.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced treatment as usual
Intervention Description
Depression screening and referral (as needed)
Primary Outcome Measure Information:
Title
TB treatment success rate
Description
Patient level TB treatment success (yes/no) will be extracted from clinic records and defined based on the South African National TB Control Guidelines as all smear-positive patients that were cured (negative smear in last month of treatment) and those that completed treatment but did not meet the criteria for cure or failure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression remission rate
Description
Patient level depression remission (yes/no) will be assessed using the Patient Health Questionnaire (PHQ-9) and defined as a score less than 10.
Time Frame
2 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or over initiating treatment for TB ability to provide informed consent Exclusion Criteria: unable or unwilling to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annika C Sweetland, DrPH, MSW
Phone
9175028690
Email
annika.sweetland@nyspi.columbia.edu
Facility Information:
Facility Name
Desmond Tutu HIV Foundation
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Medina-Marino, PhD
Phone
021-406-6966
Email
andrew.marino@hiv-research.org.za

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing of scientific findings with the research and clinical communities will be executed through the centralized NIH data repository, publications in peer reviewed journals, and presentations at scientific meetings. If requested, we will share our statistical code (SAS, Stata, R) for use with other investigators. We will also post the methods and analysis plan of this proposal on the Open Science Framework hosted by the Center for Open Science. Data to be shared will include all of the individual participant data collected during the trial, after de-identification.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.

Learn more about this trial

Effectiveness and Cost-Effectiveness of Depression Treatment for Individuals With TB in South Africa

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