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NCT06916962Recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1324 (estimated)
First submitted
12 Mar 2025
Start date
Mar 2025
Primary completion date
Mar 2026
Lead sponsor
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Diseases
Tuberculosis
NCT number
NCT06916962

What you commit to

  • Study type: Interventional
  • Planned participants: 1324
  • From Mar 2025 to the primary completion date, Mar 2026
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Long Dien District TB Unit
Coordinator of this site? Confirm its status
Ba Ria Vung TauVietnamRecruiting
O Mon District TB Unit
Coordinator of this site? Confirm its status
Can ThoVietnamRecruiting
Son Tra District TB Unit
Coordinator of this site? Confirm its status
Da NangVietnamRecruiting
Lien Chieu District TB Unit
Coordinator of this site? Confirm its status
Da NangVietnamRecruiting
Thang Binh District TB Unit
Coordinator of this site? Confirm its status
Điện BànVietnamRecruiting
Phuc Tho District TB Unit
Coordinator of this site? Confirm its status
HanoiVietnamRecruiting
Binh Chanh District TB Unit
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting
Hoc Mon District TB Unit
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting
District 5 District TB Unit
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting
District 04 District TB Unit
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting
Tan Hung District TB Unit
Coordinator of this site? Confirm its status
Long AnVietnamRecruiting
Can Duoc District TB Unit
Coordinator of this site? Confirm its status
Long AnVietnamRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.