Improving TB care through psychosocial and financial support in Vietnam

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

This study tests whether providing financial help and support to people with tuberculosis in Vietnam can improve their treatment outcomes and reduce the costs they face.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1324 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Freundeskreis Für Internationale Tuberkulosehilfe e.V (other)
• Locations: 12 sites (Ba Ria Vung Tau and 11 other locations)
• Trial ID: NCT06916962 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a psycho-socioeconomic support intervention aimed at improving treatment outcomes for tuberculosis (TB) patients in Vietnam. It employs a randomized control trial design across 12 provinces, focusing on marginalized populations facing financial hardship and stigma. The intervention includes cash transfers and enrollment in Vietnam's social health insurance scheme, targeting those with the greatest need. The study aims to measure the impact on catastrophic costs associated with TB treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with drug-sensitive, pulmonary TB who have recently initiated treatment and reside in the designated implementation districts.

Not a fit: Patients who are not enrolled in the TB treatment registry within one month of starting treatment or those planning to relocate in the near future may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the financial burden and improve treatment adherence for TB patients in low- and middle-income countries.

How similar studies have performed: Previous studies have shown promising results with similar socioeconomic interventions for TB, indicating potential for success in this approach.

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

Where this trial is running

Ba Ria Vung Tau and 11 other locations

• Long Dien District TB Unit — Ba Ria Vung Tau, Vietnam (RECRUITING)
• O Mon District TB Unit — Can Tho, Vietnam (RECRUITING)
• Lien Chieu District TB Unit — Da Nang, Vietnam (RECRUITING)
• Son Tra District TB Unit — Da Nang, Vietnam (RECRUITING)
• Phuc Tho District TB Unit — Hanoi, Vietnam (RECRUITING)
• Binh Chanh District TB Unit — Ho Chi Minh City, Vietnam (RECRUITING)
• District 04 District TB Unit — Ho Chi Minh City, Vietnam (RECRUITING)
• District 5 District TB Unit — Ho Chi Minh City, Vietnam (RECRUITING)
• Hoc Mon District TB Unit — Ho Chi Minh City, Vietnam (RECRUITING)
• Can Duoc District TB Unit — Long An, Vietnam (RECRUITING)
• Tan Hung District TB Unit — Long An, Vietnam (RECRUITING)
• Thang Binh District TB Unit — Điện Bàn, Vietnam (RECRUITING)

Study contacts

• Study coordinator: Rachel Forse, PhD

Conditions: Tuberculosis, Low- and Middle-income Countries, Treatment support, Catastrophic costs, Psychosocial support, Cash transfers, Health-related quality of life, Social protection