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

April 1, 2025 updated by: Rachel Forse, Freundeskreis Für Internationale Tuberkulosehilfe e.V

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

1324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ba Ria Vung Tau, Vietnam
      • Can Tho, Vietnam
        • Recruiting
        • O Mon District TB Unit
        • Contact:
      • Da Nang, Vietnam
        • Recruiting
        • Lien Chieu District TB Unit
        • Contact:
      • Da Nang, Vietnam
      • Hanoi, Vietnam
        • Recruiting
        • Phuc Tho District TB Unit
        • Contact:
      • Ho Chi Minh City, Vietnam
      • Ho Chi Minh City, Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • District 5 District TB Unit
        • Contact:
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • Hoc Mon District TB Unit
        • Contact:
          • DTU Officer
      • Long An, Vietnam
        • Recruiting
        • Can Duoc District TB Unit
        • Contact:
      • Long An, Vietnam
        • Recruiting
        • Tan Hung District TB Unit
        • Contact:
      • Quang Nam, Vietnam
        • Recruiting
        • Thang Binh District TB Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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 the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants in this arm will receive standard care TB treatment delivered by Vietnam's National TB Program (NTP), which includes routine counseling, support, and materials. Highly vulnerable individuals will be eligible to access existing government financial assistance through established mechanisms and eligibility criteria. No cash transfers will be received by control group participants, nor will they be invited to participate in TB Clubs.
Experimental: Intervention
Intervention participants will receive the psycho-socioeconomic intervention.
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.

Other Names:
  • Psycho-socioeconomic support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TB Treatment Success
Time Frame: Through study completion, an average of 6 months.
Difference in the proportion of those cured or completing treatment between the two study arms
Through study completion, an average of 6 months.
Catastrophic costs
Time Frame: The period from the onset of TB symptoms through study completion, an average of 9 months.
Difference in the proportion of households where the combined direct and indirect costs of TB treatment-after accounting for any financial support received-amount to ≥20% of their estimated pre-treatment household income.
The period from the onset of TB symptoms through study completion, an average of 9 months.
Composite fidelity score
Time Frame: 1 year
Level of adherence to the design of the intervention components (cash transfers conditioned on TB Club participation) including the content, coverage, frequency, and duration, by district. The composite fidelity score has been structured according to Carroll et al. (2007) A conceptual framework for implementation fidelity.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life
Time Frame: Through study completion, an average of 6 months.
Difference in the health-related quality of life of study participants between the two arms, as measured by EuroQoL's EQ-5D-5L.
Through study completion, an average of 6 months.
TB-Related Stigma
Time Frame: Through study completion, an average of 6 months.
Difference in the perceived TB-related stigma reported by participants between the two study arms, as measured by the Redwood scale for TB-related stigma in Vietnam.
Through study completion, an average of 6 months.
Financial Capital
Time Frame: The period from the onset of TB symptoms through study completion, an average of 9 months.
Changes in financial capital such as dissavings, asset sales, borrowing and social support, between the two study arms. The definition of financial capital will be taken from Timire et al. (2023) Use of a Sustainable Livelihood Framework-Based Measure to Estimate Socioeconomic Impact of Tuberculosis on Households.
The period from the onset of TB symptoms through study completion, an average of 9 months.
Sustainable Livelihood
Time Frame: The period from the onset of TB symptoms through study completion, an average of 9 months.
Difference in livelihood impacts such as food insecurity and educational disruptions, between the two study arms. The definition of this outcome will be taken from Timire et al. (2023) Use of a Sustainable Livelihood Framework-Based Measure to Estimate Socioeconomic Impact of Tuberculosis on Households.
The period from the onset of TB symptoms through study completion, an average of 9 months.
TB Service and UHC Uptake
Time Frame: Through study completion, an average of 6 months.
Difference in the proportion of household members screened for TB, initiating preventive therapies or purchasing social health insurance, between the two study arms.
Through study completion, an average of 6 months.
Implementation quality score
Time Frame: 1 year
During two-week time windows, implementation districts will be scored with up to 5 points for implementation quality, and quality scores for each window and district will be averaged to obtain an intervention quality score by district, province and region. Quality will be defined as timeliness of intervention delivery and participant satisfaction with the intervention at each district.
1 year
Participation
Time Frame: 1 year
Average number of TB Clubs attended per participant, within each district.
1 year
Acceptability
Time Frame: 1 year
Acceptability of the intervention as measured by district. Acceptability will be defined by Sekhon et al. (2022) Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Freundeskreis Für Internationale Tuberkulosehilfe e.V

Collaborators

Karolinska Institutet
Liverpool School of Tropical Medicine
Vietnam National Lung Hospital
Korea International Cooperation Agency (KOICA)
Stop TB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Estimated)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/25/CN-HDDD-BVPTU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tuberculosis (TB)

Clinical Trials on Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe