Clinical trial NCT06916962: Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial
Official title: Understanding Psycho-socioeconomic Linkages Through an Intervention Providing Enhanced Financial and Social Support During Tuberculosis Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tuberculosis (TB)
Keywords: Low- and Middle-income Countries
Treatment support
Catastrophic costs
Psychosocial support
Cash transfers
Health-related quality of life
Social protection
Lead sponsor: Freundeskreis Für Internationale Tuberkulosehilfe e.V
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Liverpool School of Tropical Medicine
name: Vietnam National Lung Hospital
name: Korea International Cooperation Agency (KOICA)
name: Stop TB
First posted: 2025-04-08
Enrollment: 1324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background - Previous Studies on Social Protection for TB in Vietnam

This study has been designed based on the results of previous formative research on the preferences, acceptability, and feasibility of TB-specific social protection interventions in the Vietnamese context. This body of research found that people with TB and healthcare providers prefer cash transfers and enrollment in Vietnam's social health insurance scheme, especially when targeted to those with the greatest financial need and severe illness. A pilot study was conducted that provided cash transfers and social health insurance to economically vulnerable people starting TB treatment. The intervention was found broadly acceptable, but stakeholders felt that cash-transfers should be subject to limited forms of conditionality. Findings from this pilot indicated that future socioeconomic interventions in Vietnam should consider both conditional and unconditional cash transfers to be feasible.

Following this pilot, a non-randomized social assistance intervention was conducted under programmatic conditions. Among the group receiving financial support, it was found that a combination of transport vouchers, cash transfers and health insurance enrollment, combined with existing government and social network support could reduce catastrophic costs by 37.8%.

Finally, a one-year consultative process was conducted in 2023 to co-prioritize challenges and solutions with Vietnam's TB Program. This process found that an intervention supplementing the existing social safety net with TB-specific support was the priority.

Methods - Sample Size Two sample sizes were calculated to determine the effectiveness of the intervention. The larger sample will be used to recruit individuals undergoing TB treatment to measure changes in TB treatment success, while a subset of these same individuals will be recruited to assess catastrophic cost incurrence in the household, which will utilize a modified, longitudinal WHO TB Patient Cost Survey tool. A total of 1,324 participants (662 per study arm) will be recruited for the treatment success sample, while 450 (225 per study arm) will be recruited for the household costing sample.

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

Primary outcomes:
measure: TB Treatment Success
timeFrame: Through study completion, an average of 6 months.
measure: Catastrophic costs
timeFrame: The period from the onset of TB symptoms through study completion, an average of 9 months.
measure: Composite fidelity score
timeFrame: 1 year
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Through study completion, an average of 6 months.
measure: TB-Related Stigma
timeFrame: Through study completion, an average of 6 months.
measure: Financial Capital
timeFrame: The period from the onset of TB symptoms through study completion, an average of 9 months.
measure: Sustainable Livelihood
timeFrame: The period from the onset of TB symptoms through study completion, an average of 9 months.
measure: TB Service and UHC Uptake
timeFrame: Through study completion, an average of 6 months.
measure: Implementation quality score
timeFrame: 1 year
measure: Participation
timeFrame: 1 year
measure: Acceptability
timeFrame: 1 year
Other outcomes:
Locations:
city: Ba Ria Vung Tau
country: Vietnam
facility: Long Dien District TB Unit
city: Can Tho
country: Vietnam
facility: O Mon District TB Unit
city: Da Nang
country: Vietnam
facility: Lien Chieu District TB Unit
city: Da Nang
country: Vietnam
facility: Son Tra District TB Unit
city: Hanoi
country: Vietnam
facility: Phuc Tho District TB Unit
city: Ho Chi Minh City
country: Vietnam
facility: Binh Chanh District TB Unit
city: Ho Chi Minh City
country: Vietnam
facility: District 04 District TB Unit
city: Ho Chi Minh City
country: Vietnam
facility: District 5 District TB Unit
city: Ho Chi Minh City
country: Vietnam
facility: Hoc Mon District TB Unit
city: Long An
country: Vietnam
facility: Can Duoc District TB Unit
city: Long An
country: Vietnam
facility: Tan Hung District TB Unit
city: Quang Nam
country: Vietnam
facility: Thang Binh District TB Unit
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.