Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial

Freundeskreis Für Internationale Tuberkulosehilfe e.V

Status: Enrolling

Conditions: Tuberculosis (TB)

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06916962

21/25/CN-HDDD-BVPTU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,324 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,324 participants in 2 patient groups

Control

No Intervention group

Description:

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

Experimental group

Description:

Intervention participants will receive the psycho-socioeconomic intervention.

Treatment:

Behavioral: Intervention