Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06916962

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

Led by Freundeskreis Für Internationale Tuberkulosehilfe e.V · Updated on 2025-04-08

1324

Participants Needed

12

Research Sites

54 weeks

Total Duration

On this page

Sponsors

F

Freundeskreis Für Internationale Tuberkulosehilfe e.V

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with drug-sensitive, pulmonary, new, or relapse TB
  • Started TB treatment and reported or notified in VITIMES
  • Living in one of the study districts for at least 1 month
  • First household member enrolling in the study
Not Eligible

You will not qualify if you...

  • Not enrolled in VITIMES within 1 month of starting treatment
  • Household registered in a different province
  • Plans to move away within the next 6 months
  • Other family members in the same household already enrolled in the study

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Long Dien District TB Unit

Ba Ria Vung Tau, Vietnam

Actively Recruiting

2

O Mon District TB Unit

Can Tho, Vietnam

Actively Recruiting

3

Lien Chieu District TB Unit

Da Nang, Vietnam

Actively Recruiting

4

Son Tra District TB Unit

Da Nang, Vietnam

Actively Recruiting

5

Phuc Tho District TB Unit

Hanoi, Vietnam

Actively Recruiting

6

Binh Chanh District TB Unit

Ho Chi Minh City, Vietnam

Actively Recruiting

7

District 04 District TB Unit

Ho Chi Minh City, Vietnam

Actively Recruiting

8

District 5 District TB Unit

Ho Chi Minh City, Vietnam

Actively Recruiting

9

Hoc Mon District TB Unit

Ho Chi Minh City, Vietnam

Actively Recruiting

10

Can Duoc District TB Unit

Long An, Vietnam

Actively Recruiting

11

Tan Hung District TB Unit

Long An, Vietnam

Actively Recruiting

12

Thang Binh District TB Unit

Điện Bàn, Vietnam

Actively Recruiting

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Research Team

R

Rachel Forse, PhD

CONTACT

T

Trang Nghiem, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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