Understanding Psycho-socioeconomic Linkages Through an Intervention Providing Enhanced Financial and Social Support During Tuberculosis Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,324
- Locations
- 12
- Primary Endpoint
- TB Treatment Success
Study Overview
Brief Summary
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.
Detailed Description
Background - Previous Studies on Social Protection for TB in Vietnam
This study has been designed based on the results of previous formative research on the preferences, acceptability, and feasibility of TB-specific social protection interventions in the Vietnamese context. This body of research found that people with TB and healthcare providers prefer cash transfers and enrollment in Vietnam's social health insurance scheme, especially when targeted to those with the greatest financial need and severe illness. A pilot study was conducted that provided cash transfers and social health insurance to economically vulnerable people starting TB treatment. The intervention was found broadly acceptable, but stakeholders felt that cash-transfers should be subject to limited forms of conditionality. Findings from this pilot indicated that future socioeconomic interventions in Vietnam should consider both conditional and unconditional cash transfers to be feasible.
Following this pilot, a non-randomized social assistance intervention was conducted under programmatic conditions. Among the group receiving financial support, it was found that a combination of transport vouchers, cash transfers and health insurance enrollment, combined with existing government and social network support could reduce catastrophic costs by 37.8%.
Finally, a one-year consultative process was conducted in 2023 to co-prioritize challenges and solutions with Vietnam's TB Program. This process found that an intervention supplementing the existing social safety net with TB-specific support was the priority.
Methods - Sample Size Two sample sizes were calculated to determine the effectiveness of the intervention. The larger sample will be used to recruit individuals undergoing TB treatment to measure changes in TB treatment success, while a subset of these same individuals will be recruited to assess catastrophic cost incurrence in the household, which will utilize a modified, longitudinal WHO TB Patient Cost Survey tool. A total of 1,324 participants (662 per study arm) will be recruited for the treatment success sample, while 450 (225 per study arm) will be recruited for the household costing sample.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control
Participants in this arm will receive standard care TB treatment delivered by Vietnam's National TB Program (NTP), which includes routine counseling, support, and materials. Highly vulnerable individuals will be eligible to access existing government financial assistance through established mechanisms and eligibility criteria. No cash transfers will be received by control group participants, nor will they be invited to participate in TB Clubs.
Intervention
Intervention participants will receive the psycho-socioeconomic intervention.
Intervention: Intervention (Behavioral)
Outcomes
Primary Outcomes
TB Treatment Success
Time Frame: Through study completion, an average of 6 months.
Difference in the proportion of those cured or completing treatment between the two study arms
Catastrophic costs
Time Frame: The period from the onset of TB symptoms through study completion, an average of 9 months.
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
Time Frame: 1 year
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.
Secondary Outcomes
- Health-Related Quality of Life(Through study completion, an average of 6 months.)
- TB-Related Stigma(Through study completion, an average of 6 months.)
- Participation(1 year)
- Acceptability(1 year)
- Financial Capital(The period from the onset of TB symptoms through study completion, an average of 9 months.)
- Sustainable Livelihood(The period from the onset of TB symptoms through study completion, an average of 9 months.)
- TB Service and UHC Uptake(Through study completion, an average of 6 months.)
- Implementation quality score(1 year)
Investigators
Rachel Forse
Program Director
Freundeskreis Für Internationale Tuberkulosehilfe e.V