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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Long Dien District TB Unit Coordinator of this site? Confirm its status | Ba Ria Vung Tau | Vietnam | Recruiting |
| O Mon District TB Unit Coordinator of this site? Confirm its status | Can Tho | Vietnam | Recruiting |
| Son Tra District TB Unit Coordinator of this site? Confirm its status | Da Nang | Vietnam | Recruiting |
| Lien Chieu District TB Unit Coordinator of this site? Confirm its status | Da Nang | Vietnam | Recruiting |
| Thang Binh District TB Unit Coordinator of this site? Confirm its status | Điện Bàn | Vietnam | Recruiting |
| Phuc Tho District TB Unit Coordinator of this site? Confirm its status | Hanoi | Vietnam | Recruiting |
| Binh Chanh District TB Unit Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
| Hoc Mon District TB Unit Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
| District 5 District TB Unit Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
| District 04 District TB Unit Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
| Tan Hung District TB Unit Coordinator of this site? Confirm its status | Long An | Vietnam | Recruiting |
| Can Duoc District TB Unit Coordinator of this site? Confirm its status | Long An | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.