Clinical trial NCT05091580: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Tuberculosis
Keywords: effectiveness
cost-effectiveness
implementation science
Hybrid Type I Trial
South Africa
Depression
Tuberculosis
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Desmond Tutu HIV Foundation
name: University of Cape Town
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-10-25
Enrollment: 1410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge cluster-randomized hybrid type I effectiveness-implementation trial
Primary purpose: TREATMENT

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.

Recruitment was temporarily paused on September 1, 2024 due to an interruption in funding.

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

Primary outcomes:
measure: TB treatment success rate
timeFrame: 6 months
Secondary outcomes:
measure: Depression remission rate
timeFrame: 2 months, 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
Study officials:
References: