NCT06916962 Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial
| NCT ID | NCT06916962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Freundeskreis Für Internationale Tuberkulosehilfe e.V |
| Condition | Tuberculosis (TB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,324 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,324 participants in total. It began in 2025-03-14 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06916962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculosis (TB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06916962 currently recruiting?
Yes, NCT06916962 is actively recruiting participants. Contact the research team at rachel.forse@tbhelp.org for enrollment information.
Where is the NCT06916962 trial being conducted?
This trial is being conducted at Ba Ria Vung Tau, Vietnam, Can Tho, Vietnam, Da Nang, Vietnam, Da Nang, Vietnam and 8 additional locations.
Who is sponsoring the NCT06916962 clinical trial?
NCT06916962 is sponsored by Freundeskreis Für Internationale Tuberkulosehilfe e.V. The trial plans to enroll 1,324 participants.