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RECRUITING
NCT06916962
NA

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

Sponsor: Freundeskreis Für Internationale Tuberkulosehilfe e.V

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1324

Start Date

2025-03-14

Completion Date

2026-03-31

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Intervention

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