Introduction: Tuberculosis (TB) remains an ongoing public health and socioeconomic challenge worldwide, especially in low- and middle-income countries such as Vietnam. Despite improvements in healthcare, TB still causes significant problems to those infected, especially within marginalized populations, including financial hardship, stigma, and mental health issues. This study aims to assess the effectiveness of a psycho-socioeconomic support intervention intended to improve treatment outcomes and reduce financial hardship faced by TB-affected households in Vietnam, measured through catastrophic costs.
Methods: A hybrid type II effectiveness implementation study using a randomized control trial study design will be employed to evaluate the effectiveness and implementation of the intervention. The study will be conducted in 12 Vietnamese provinces across Northern, Central, and Southern regions, targeting areas with lower TB treatment success rates. Participants will be randomly assigned to either a control group, which will receive standard care, or an intervention group, which will receive cash transfers conditioned on participation in TB Club peer-support meetings. Data will be collected on the individual, household and district levels. Individual outcomes will include treatment success, health-related quality of life, TB-related stigma, and anxiety and depression. Household outcomes will include catastrophic cost incurrence, changes in financial capital and livelihoods, and TB service and universal health coverage (UHC) uptake. Implementation outcomes, by district, will include fidelity, satisfaction, participation, acceptability, and quality.
Hypothesis: The study hypothesizes that providing financial and enhanced psychosocial support to people with TB will improve their treatment success and reduce the financial burden on TB-affected households.
Diagnosed with drug-sensitive, pulmonary, new, or relapse TB
Initiated on TB treatment and reported/notified in VITIMES
Residing in one of the implementation districts for the past 1 month
First member of the household to enroll in the study
Not enrolled in VITIMES within 1 month of treatment initiation
Household registration in another province
Plans to relocate in the next 6 months
Additional family members living in the same household with someone enrolled in the study
Parallel
Intervention
BehavioralIntervention participants will receive cash transfers on the condition of their participation in peer-led TB support meetings (TB Clubs). Two monthly TB Club meetings will be held in each participating district. Each will aim to provide enhanced education about the TB treatment process, as well as to improve treatment engagement and adherence, foster social support and mitigate TB-related stigma. Participants will be eligible for a maximum of three cash transfers, amounting to a total of 3,000,000 VND. The first payment of 1,000,000 VND will be made after a participant joins one TB Club, the second payment will be completed after attending a second TB Club, and the third payment will be provided after attendance at their 6th TB Club.
TB Treatment Success
Difference in the proportion of those cured or completing treatment between the two study arms
Catastrophic costs
Difference in the proportion of households where the combined direct and indirect costs of TB treatment-after accounting for any financial support received-amount to ≥20% of their estimated pre-treatment household income.
Composite fidelity score
Level of adherence to the design of the intervention components (cash transfers conditioned on TB Club participation) including the content, coverage, frequency, and duration, by district. The composite fidelity score has been structured according to Carroll et al. (2007) A conceptual framework for implementation fidelity.
Health-Related Quality of Life
Difference in the health-related quality of life of study participants between the two arms, as measured by EuroQoL's EQ-5D-5L.
TB-Related Stigma
Difference in the perceived TB-related stigma reported by participants between the two study arms, as measured by the Redwood scale for TB-related stigma in Vietnam.
Financial Capital
Changes in financial capital such as dissavings, asset sales, borrowing and social support, between the two study arms. The definition of financial capital will be taken from Timire et al. (2023) Use of a Sustainable Livelihood Framework-Based Measure to Estimate Socioeconomic Impact of Tuberculosis on Households.
Sustainable Livelihood
Difference in livelihood impacts such as food insecurity and educational disruptions, between the two study arms. The definition of this outcome will be taken from Timire et al. (2023) Use of a Sustainable Livelihood Framework-Based Measure to Estimate Socioeconomic Impact of Tuberculosis on Households.
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Freundeskreis Für Internationale Tuberkulosehilfe e.V
Lead sponsor
Karolinska Institutet
Collaborator
Liverpool School of Tropical Medicine
Collaborator
Vietnam National Lung Hospital
Collaborator
Korea International Cooperation Agency (KOICA)
Collaborator
Stop TB
Collaborator
