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

The Effectiveness and Cost-effectiveness of Implementing Evidence-based Depression Treatment Within the TB Care Platform in South Africa: A Hybrid Effectiveness-implementation Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Tuberculosis
• Intervention / Treatment: Behavioral: Interpersonal Counseling; Behavioral: Enhanced treatment as usual

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.

• Study Type: Interventional
• Enrollment (Estimated): 1410
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annika C Sweetland, DrPH, MSW; Phone Number: 9175028690; Email: annika.sweetland@nyspi.columbia.edu

Study Locations

• South Africa
  • Cape Town, South Africa
    • Recruiting
    • Desmond Tutu HIV Foundation
    • Contact: Andrew Medina-Marino, PhD; Phone Number: 021-406-6966; Email: andrew.marino@hiv-research.org.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unable or unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Interpersonal Counseling for Depression; 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.	Behavioral: Interpersonal Counseling; 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.
Other: Control: Enhanced Treatment as Usual; 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.	Behavioral: Enhanced treatment as usual; Depression screening and referral (as needed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months, 6 months

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Columbia University; University of Cape Town; Desmond Tutu HIV Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Depression; effectiveness; Tuberculosis; South Africa; cost-effectiveness; implementation science; Hybrid Type I Trial
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Infections; Mood Disorders; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Depression; Depressive Disorder; Tuberculosis
• Other Study ID Numbers: 8217; R01AI148461 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No