Tuberculosis (TB)UPLIFTNCT06916962
Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial
A study testing Intervention in people with Tuberculosis (TB), run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 12 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,324 participants
- Where
- 12 sitesVietnam
- Study dates
- 14 Mar 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trang Nghiem, MPH contact
12 sites in 1 country
Vietnam12 sites, 12 recruiting
- Recruiting
Long Dien District TB Unit
Ba Ria Vung Tau
DTU Officer, +84911898939, Huyengau101989@gmail.com
- Recruiting
O Mon District TB Unit
Can Tho
DTU Officer, +84329956958, dqt7779@gmail.com
- Recruiting
Lien Chieu District TB Unit
Da Nang
DTU Officer, +84905770796, dkhanh.291@gmail.com
- Recruiting
Son Tra District TB Unit
Da Nang
DTU Officer, +84969671550, phamthuyanyhst@gmail.com
- Recruiting
Thang Binh District TB Unit
Điện Bàn
DTU Officer, +84777456618, lethidieu.a536@gmail.com
- Recruiting
Phuc Tho District TB Unit
Hanoi
DTU Officer, +84948392466, pkdk.ngoctao@gmail.com
- Recruiting
Binh Chanh District TB Unit
Ho Chi Minh City
DTU Officer, +84704620255, nguyenthanhan15079898@gmail.com
- Recruiting
District 04 District TB Unit
Ho Chi Minh City
DTU Officer, +84908254049, lethihongle1982@gmail.com
- Recruiting
District 5 District TB Unit
Ho Chi Minh City
DTU Officer, +84909170398, TranTran3035@gmail.com
- Recruiting
Hoc Mon District TB Unit
Ho Chi Minh City
DTU Officer
- Recruiting
Can Duoc District TB Unit
Long An
DTU Officer, +84348195988, ysducnguyen@gmail.com
- Recruiting
Tan Hung District TB Unit
Long An
DTU Officer, +84964152033, tochonglao@gmail.com
About this study
Official title: Understanding Psycho-socioeconomic Linkages Through an Intervention Providing Enhanced Financial and Social Support During Tuberculosis Treatment
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.
Read the 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.
- Conditions
- Tuberculosis (TB)
- Being tested
- Intervention
- Keywords
- Low- and Middle-income Countries, Treatment support, Catastrophic costs, Psychosocial support, Cash transfers, Health-related quality of life, Social protection
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Psycho-socioeconomic support
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB Treatment Success
Difference in the proportion of those cured or completing treatment between the two study arms
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (8)
Health-Related Quality of Life
Difference in the health-related quality of life of study participants between the two arms, as measured by EuroQoL's EQ-5D-5L.
Measured: Through study completion, an average of 6 months.
TB-Related Stigma
Difference in the perceived TB-related stigma reported by participants between the two study arms, as measured by the Redwood scale for TB-related stigma in Vietnam.
Measured: Through study completion, an average of 6 months.
Financial Capital
Changes in financial capital such as dissavings, asset sales, borrowing and social support, between the two study arms. The definition of financial capital will be taken from Timire et al. (2023) Use of a Sustainable Livelihood Framework-Based Measure to Estimate Socioeconomic Impact of Tuberculosis on Households.
Measured: The period from the onset of TB symptoms through study completion, an average of 9 months.
Sustainable Livelihood
Difference in livelihood impacts such as food insecurity and educational disruptions, between the two study arms. The definition of this outcome will be taken from Timire et al. (2023) Use of a Sustainable Livelihood Framework-Based Measure to Estimate Socioeconomic Impact of Tuberculosis on Households.
Measured: The period from the onset of TB symptoms through study completion, an average of 9 months.
TB Service and UHC Uptake
Difference in the proportion of household members screened for TB, initiating preventive therapies or purchasing social health insurance, between the two study arms.
Measured: Through study completion, an average of 6 months.
Implementation quality score
During two-week time windows, implementation districts will be scored with up to 5 points for implementation quality, and quality scores for each window and district will be averaged to obtain an intervention quality score by district, province and region. Quality will be defined as timeliness of intervention delivery and participant satisfaction with the intervention at each district.
Measured: 1 year
Participation
Average number of TB Clubs attended per participant, within each district.
Measured: 1 year
Acceptability
Acceptability of the intervention as measured by district. Acceptability will be defined by Sekhon et al. (2022) Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start14 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Liverpool School of Tropical Medicine, Vietnam National Lung Hospital, Korea International Cooperation Agency, Stop TB
- Responsible party
- Principal investigator, Rachel Forse, Freundeskreis Für Internationale Tuberkulosehilfe e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916962
- Sponsor's protocol ID
- 21/25/CN-HDDD-BVPTU
- Acronym
- UPLIFT
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38566224Forse 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.
PubMed 38055709Smith 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.
PubMed 37612116
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Psycho-socioeconomic Linkages Through an Intervention Providing Enhanced Financial and Social Support During Tuberculosis Treatment
- ClinicalTrials.gov ID
- NCT06916962
- Acronym / sponsor ID
- UPLIFT / 21/25/CN-HDDD-BVPTU
- Conditions
- Tuberculosis (TB)
- Keywords
- Low- and Middle-income Countries, Treatment support, Catastrophic costs, Psychosocial support, Cash transfers, Health-related quality of life, Social protection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,324 participants (estimated)
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.VUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Liverpool School of Tropical Medicine, Vietnam National Lung Hospital, Korea International Cooperation Agency, Stop TB
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: InterventionIntervention participants will receive the psycho-socioeconomic intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Psycho-socioeconomic supportIntervention 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. | Behavioural | Intervention |
Primary outcome
TB Treatment Success
Time frame: Through study completion, an average of 6 months.
Difference in the proportion of those cured or completing treatment between the two study arms
Catastrophic costs
Time frame: The period from the onset of TB symptoms through study completion, an average of 9 months.
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.
Composite fidelity score
Time frame: 1 year
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.
8 secondary outcomes
Health-Related Quality of Life
Time frame: Through study completion, an average of 6 months.
TB-Related Stigma
Time frame: Through study completion, an average of 6 months.
Financial Capital
Time frame: The period from the onset of TB symptoms through study completion, an average of 9 months.
Sustainable Livelihood
Time frame: The period from the onset of TB symptoms through study completion, an average of 9 months.
TB Service and UHC Uptake
Time frame: Through study completion, an average of 6 months.
Implementation quality score
Time frame: 1 year
Participation
Time frame: 1 year
Acceptability
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 38566224Forse 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.
- Background: PubMed 38055709Forse 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.
- Background: PubMed 37612116Smith 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trang Nghiem, MPH contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Tuberculosis (TB), run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 12 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Forse, PhD (+19294337337, rachel.forse@tbhelp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB Treatment Success (time frame: Through study completion, an average of 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06916962, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.