Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial
NCT ID: NCT06916962
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1324 participants
INTERVENTIONAL
2025-03-14
2026-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
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.
No interventions assigned to this group
Intervention
Intervention participants will receive the psycho-socioeconomic intervention.
Intervention
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.
Interventions
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Intervention
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Liverpool School of Tropical Medicine
OTHER
Vietnam National Lung Hospital
UNKNOWN
Korea International Cooperation Agency (KOICA)
UNKNOWN
Stop TB
UNKNOWN
Freundeskreis Für Internationale Tuberkulosehilfe e.V
OTHER
Responsible Party
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Rachel Forse
Program Director
Locations
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Long Dien District TB Unit
Ba Ria Vung Tau, , Vietnam
O Mon District TB Unit
Can Tho, , Vietnam
Lien Chieu District TB Unit
Da Nang, , Vietnam
Son Tra District TB Unit
Da Nang, , Vietnam
Phuc Tho District TB Unit
Hanoi, , Vietnam
Binh Chanh District TB Unit
Ho Chi Minh City, , Vietnam
District 04 District TB Unit
Ho Chi Minh City, , Vietnam
District 5 District TB Unit
Ho Chi Minh City, , Vietnam
Hoc Mon District TB Unit
Ho Chi Minh City, , Vietnam
Can Duoc District TB Unit
Long An, , Vietnam
Tan Hung District TB Unit
Long An, , Vietnam
Thang Binh District TB Unit
Điện Bàn, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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DTU Officer
Role: primary
References
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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.
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.
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.
Related Links
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Related Info
Other Identifiers
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21/25/CN-HDDD-BVPTU
Identifier Type: -
Identifier Source: org_study_id
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