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

NCT06916962 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1324

Last updated 2025-04-08

No results posted yet for this 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.

Conditions

  • Tuberculosis (TB)

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.

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER
  • Liverpool School of Tropical Medicine

    collaborator OTHER
  • Vietnam National Lung Hospital

    collaborator UNKNOWN
  • Korea International Cooperation Agency (KOICA)

    collaborator UNKNOWN
  • Stop TB

    collaborator UNKNOWN
  • Freundeskreis Für Internationale Tuberkulosehilfe e.V

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Vietnam

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06916962 on ClinicalTrials.gov