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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFreundeskreis Für Internationale Tuberkulosehilfe e.V

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intervention

Treatment groups

1,324 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Freundeskreis Für Internationale Tuberkulosehilfe e.V

Lead sponsor

Karolinska Institutet

Collaborator

Liverpool School of Tropical Medicine

Collaborator

Vietnam National Lung Hospital

Collaborator

Korea International Cooperation Agency (KOICA)

Collaborator

Stop TB

Collaborator