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

NCT06916962 | Recruiting DMC

• 1 other identifier: 21/25/CN-HDDD-BVPTU
• Study Type: interventional
• Target: 1,324
• Locations: 1 country
• Sites: 12

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.

Conditions

Tuberculosis (TB)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• TB Treatment Success

  Difference in the proportion of those cured or completing treatment between the two study arms

  Through study completion, an average of 6 months.

• Catastrophic costs

  Difference in the proportion of households where the combined direct and indirect costs of TB treatment-after accounting for any financial support received-amount to ≥20% of their estimated pre-treatment household income.

  The period from the onset of TB symptoms through study completion, an average of 9 months.

• Composite fidelity score

  Level of adherence to the design of the intervention components (cash transfers conditioned on TB Club participation) including the content, coverage, frequency, and duration, by district. The composite fidelity score has been structured according to Carroll et al. (2007) A conceptual framework for implementation fidelity.

  1 year

Secondary Outcomes (8)

• Health-Related Quality of Life

  Through study completion, an average of 6 months.

• TB-Related Stigma

  Through study completion, an average of 6 months.

• Financial Capital

  The period from the onset of TB symptoms through study completion, an average of 9 months.

• Sustainable Livelihood

  The period from the onset of TB symptoms through study completion, an average of 9 months.

• TB Service and UHC Uptake

  Through study completion, an average of 6 months.

Study Arms (2)

Control

NO INTERVENTION

Participants in this arm will receive standard care TB treatment delivered by Vietnam's National TB Program (NTP), which includes routine counseling, support, and materials. Highly vulnerable individuals will be eligible to access existing government financial assistance through established mechanisms and eligibility criteria. No cash transfers will be received by control group participants, nor will they be invited to participate in TB Clubs.

Intervention

EXPERIMENTAL

Intervention participants will receive the psycho-socioeconomic intervention.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

Intervention participants will receive cash transfers on the condition of their participation in peer-led TB support meetings (TB Clubs). Two monthly TB Club meetings will be held in each participating district. Each will aim to provide enhanced education about the TB treatment process, as well as to improve treatment engagement and adherence, foster social support and mitigate TB-related stigma. Participants will be eligible for a maximum of three cash transfers, amounting to a total of 3,000,000 VND. The first payment of 1,000,000 VND will be made after a participant joins one TB Club, the second payment will be completed after attending a second TB Club, and the third payment will be provided after attendance at their 6th TB Club.

Also known as: Psycho-socioeconomic support

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Freundeskreis Für Internationale Tuberkulosehilfe e.V: lead
• Karolinska Institutet: collaborator
• Liverpool School of Tropical Medicine: collaborator
• Vietnam National Lung Hospital: collaborator
• Korea International Cooperation Agency (KOICA): collaborator
• Stop TB: collaborator

Study Sites (12)

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

Related Publications (3)

• Forse R, Yoshino CA, Nguyen TT, Phan THY, Vo LNQ, Codlin AJ, Nguyen L, Hoang C, Basu L, Pham M, Nguyen HB, Van Dinh L, Caws M, Wingfield T, Lonnroth K, Sidney-Annerstedt K. Towards universal health coverage in Vietnam: a mixed-method case study of enrolling people with tuberculosis into social health insurance. Health Res Policy Syst. 2024 Apr 2;22(1):40. doi: 10.1186/s12961-024-01132-8.

  PMID: 38566224 BACKGROUND

• Forse R, Nguyen TT, Dam T, Vo LNQ, Codlin AJ, Caws M, Minh HDT, Nguyen LH, Nguyen HB, Nguyen NV, Lonnroth K, Annerstedt KS. A qualitative assessment on the acceptability of providing cash transfers and social health insurance for tuberculosis-affected families in Ho Chi Minh City, Vietnam. PLOS Glob Public Health. 2023 Dec 6;3(12):e0002439. doi: 10.1371/journal.pgph.0002439. eCollection 2023.

  PMID: 38055709 BACKGROUND

• Smith I, Forse R, Sidney Annerstedt K, Thanh NT, Nguyen L, Phan THY, Nguyen H, Codlin A, Vo LNQ, Nguyen NTT, Khan A, Creswell J, Pham Huy M, Basu L, Lonnroth K, Nguyen BH, Nguyen VN, Atkins S. What matters most? A qualitative study exploring priorities for supportive interventions for people with tuberculosis in urban Viet Nam. BMJ Open. 2023 Aug 23;13(8):e076076. doi: 10.1136/bmjopen-2023-076076.

  PMID: 37612116 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Tuberculosis

Interventions

Methods

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Rachel Forse, PhD

CONTACT

+19294337337; rachel.forse@tbhelp.org

Trang Nghiem, MPH

CONTACT

trang.nghiem@tbhelp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director

Model Details: Participants will be individually randomized using a non-blinded stratified randomization approach to allocate sub-groups of participants (by gender and recruitment site) into the intervention or control group, in a 1:1 ratio.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 8, 2025
• Study Start: March 14, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (12)