RecruitingNot ApplicableNCT06916962

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

Understanding Psycho-socioeconomic Linkages Through an Intervention Providing Enhanced Financial and Social Support During Tuberculosis Treatment


Sponsor

Freundeskreis Für Internationale Tuberkulosehilfe e.V

Enrollment

1,324 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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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.


Locations(12)

Long Dien District TB Unit

Ba Ria Vung Tau, Vietnam

O Mon District TB Unit

Can Tho, Vietnam

Lien Chieu District TB Unit

Da Nang, Vietnam

Son Tra District TB Unit

Da Nang, Vietnam

Phuc Tho District TB Unit

Hanoi, Vietnam

Binh Chanh District TB Unit

Ho Chi Minh City, Vietnam

District 04 District TB Unit

Ho Chi Minh City, Vietnam

District 5 District TB Unit

Ho Chi Minh City, Vietnam

Hoc Mon District TB Unit

Ho Chi Minh City, Vietnam

Can Duoc District TB Unit

Long An, Vietnam

Tan Hung District TB Unit

Long An, Vietnam

Thang Binh District TB Unit

Điện Bàn, Vietnam

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NCT06916962


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