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

Last updated: April 1, 2025
Sponsor: Freundeskreis Für Internationale Tuberkulosehilfe e.V
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Hiv

Treatment

Intervention

Clinical Study ID

NCT06916962
21/25/CN-HDDD-BVPTU
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thestudy

Study Design

Total Participants: 1324
Treatment Group(s): 1
Primary Treatment: Intervention
Phase:
Study Start date:
March 14, 2025
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Long Dien District TB Unit

    Ba Ria Vung Tau,
    Vietnam

    Active - Recruiting

  • O Mon District TB Unit

    Can Tho,
    Vietnam

    Active - Recruiting

  • Lien Chieu District TB Unit

    Da Nang,
    Vietnam

    Active - Recruiting

  • Son Tra District TB Unit

    Da Nang,
    Vietnam

    Active - Recruiting

  • Phuc Tho District TB Unit

    Hanoi,
    Vietnam

    Active - Recruiting

  • Binh Chanh District TB Unit

    Ho Chi Minh City,
    Vietnam

    Active - Recruiting

  • District 04 District TB Unit

    Ho Chi Minh City,
    Vietnam

    Active - Recruiting

  • District 5 District TB Unit

    Ho Chi Minh City,
    Vietnam

    Active - Recruiting

  • Hoc Mon District TB Unit

    Ho Chi Minh City,
    Vietnam

    Active - Recruiting

  • Can Duoc District TB Unit

    Long An,
    Vietnam

    Active - Recruiting

  • Tan Hung District TB Unit

    Long An,
    Vietnam

    Active - Recruiting

  • Thang Binh District TB Unit

    Quang Nam,
    Vietnam

    Active - Recruiting

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