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

NCT05091580 | Suspended DMC

• 2 other identifiers: 8217R01AI148461
• Study Type: interventional
• Target: 1,410
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Tuberculosis

Keywords

effectiveness; cost-effectiveness; implementation science; Hybrid Type I Trial; South Africa; Depression; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depression remission rate

  2 months, 6 months

Study Arms (2)

Intervention: Interpersonal Counseling for Depression

EXPERIMENTAL

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

Control: Enhanced Treatment as Usual

OTHER

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

Interventions

Interpersonal Counseling BEHAVIORAL

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: Interpersonal Counseling for Depression

Enhanced treatment as usual BEHAVIORAL

Depression screening and referral (as needed)

Control: Enhanced Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unable or unwilling to provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

Desmond Tutu HIV Foundation

Cape Town, South Africa

Location

MeSH Terms

Conditions

Depression; Tuberculosis

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped-wedge cluster-randomized hybrid type I effectiveness-implementation trial

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 25, 2021
• Study Start: March 24, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

ZA (1)