Tuberculosis (TB)
Conditions
Keywords
Low- and Middle-income Countries, Treatment support, Catastrophic costs, Psychosocial support, Cash transfers, Health-related quality of life, Social protection
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.
Interventions
BEHAVIORALIntervention
Intervention 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.
Sponsors
Karolinska Institutet
Liverpool School of Tropical Medicine
Vietnam National Lung Hospital
Korea International Cooperation Agency (KOICA)
Stop TB
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be individually randomized using a non-blinded stratified randomization approach to allocate sub-groups of participants (by gender and recruitment site) into the intervention or control group, in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TB Treatment Success | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Sustainable Livelihood | The period from the onset of TB symptoms through study completion, an average of 9 months. | 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. |
| TB Service and UHC Uptake | Through study completion, an average of 6 months. | Difference in the proportion of household members screened for TB, initiating preventive therapies or purchasing social health insurance, between the two study arms. |
| Health-Related Quality of Life | Through study completion, an average of 6 months. | Difference in the health-related quality of life of study participants between the two arms, as measured by EuroQoL's EQ-5D-5L. |
| Participation | 1 year | Average number of TB Clubs attended per participant, within each district. |
| Acceptability | 1 year | Acceptability of the intervention as measured by district. Acceptability will be defined by Sekhon et al. (2022) Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. |
| Implementation quality score | 1 year | During two-week time windows, implementation districts will be scored with up to 5 points for implementation quality, and quality scores for each window and district will be averaged to obtain an intervention quality score by district, province and region. Quality will be defined as timeliness of intervention delivery and participant satisfaction with the intervention at each district. |
| TB-Related Stigma | Through study completion, an average of 6 months. | 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 | The period from the onset of TB symptoms through study completion, an average of 9 months. | 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. |
Countries
Vietnam
Contacts
Primary ContactRachel Forse, PhD
Backup ContactTrang Nghiem, MPH
Outcome results
None listed