About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intervention
Treatment groups
Sponsors and collaborators
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