[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Freundeskreis Für Internationale Tuberkulosehilfe e.V\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100586560","examining-psycho-socioeconomic-linkages-in-tb-care-the-uplift-trial-100586560",false,"NCT06916962","Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial","Understanding Psycho-socioeconomic Linkages Through an Intervention Providing Enhanced Financial and Social Support During Tuberculosis Treatment","UPLIFT","Inclusion Criteria:\n\n* Diagnosed with drug-sensitive, pulmonary, new, or relapse TB\n* Initiated on TB treatment and reported\u002Fnotified in VITIMES\n* Residing in one of the implementation districts for the past 1 month\n* First member of the household to enroll in the study\n\nExclusion Criteria:\n\n* Not enrolled in VITIMES within 1 month of treatment initiation\n* Household registration in another province\n* Plans to relocate in the next 6 months\n* Additional family members living in the same household with someone enrolled in the study","ALL","18 Years",{"count":20,"type":21},1324,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nMethods: 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.\n\nHypothesis: 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.",[27],"Tuberculosis (TB)",[29,30,31,32,33,34,35],"Low- and Middle-income Countries","Treatment support","Catastrophic costs","Psychosocial support","Cash transfers","Health-related quality of life","Social protection","RECRUITING","2025-04-01",{"date":39,"type":40},"2025-04-08","ACTUAL",{"date":42,"type":40},"2025-03-14",{"date":44,"type":21},"2026-03-31",{"name":46,"class":47},"Freundeskreis Für Internationale Tuberkulosehilfe e.V","OTHER",12,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100530815","phase-3-1hp-versus-3hr-in-the-treatment-of-tuberculosis-infection-in-vietnam-100530815","NCT06191692","1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam","An Open-label, Randomized Controlled Trial of the New One-month Regimen Versus the Current Three-month Regimen for the Treatment of Tuberculosis Infection in Vietnam","Inclusion Criteria:\n\n* Household contacts of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiated treatment with residence in the intervention areas;\n* Positive QFT-Plus or TST results (TST induration of at least 5mm)\n* Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designed area for the duration of the study;\n* Age ≥ 18 years;\n* Capable of providing signed informed consent;\n* Willing to participate in the study visits and procedures\n\nExclusion Criteria:\n\n* Indeterminate results on QFT-Plus;\n* Clinical or radiographic suspicions or history of previous active TB;\n* Known hypersensitivity or contraindication to any components of the regimens;\n* Weight \\<30kg;\n* Acute or chronic liver failure with elevated liver enzymes or evidence of liver dysfunction such as jaundice or a history of liver failure caused by isoniazid or rifampicin; History of liver cirrhosis at any time before study entry;\n* Infection with suspected or confirmed tuberculosis strains resistant to isoniazid or rifampicin;\n* Porphyria- Porphyrin metabolism disorder;\n* Polyneuropathy (self-reported\u002F confirmed);\n* Pregnant or planning to become pregnant within 120 days of enrollment;\n* Any other severe underlying condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial;\n* Participation in other clinical intervention trials or research protocols (participation in other studies that do not involve an intervention may be allowed, but this must be discussed and approved by the Chief Investigator).",{"count":57,"type":21},350,[59],"PHASE3","Introduction: Tuberculosis (TB) infection is a key driver of the TB pandemic, with over 10.6 million people fell ill with TB disease in 2022. About one-quarter of the global population is estimated to be infected with TB bacteria. Around 5-10% of people with TB infection will develop active and contagious TB disease, which could be largely avoided if TB infection is identified and given effective preventative treatment, before progression to active disease. The long treatment of TB infection with regimens lasting from three to nine months is a significant barrier to treatment completion in individuals with a confirmed diagnosis of TB infection. Adapting a shorter regimen than the current regimens could lead to a higher treatment completion rate and increased uptake of preventative therapy for TB, as well as reduced side effects.\n\nMethods and analysis: An open-label, randomized clinical trial (1:1) will be performed in two study sites in Ha Noi, Vietnam (Vietnam National Lung Hospital and Ha Noi Lung Hospital). Adult household contacts (n=350) of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiate treatment will be invited to participate.\n\nAim: To compare the TB preventive therapy completion rates and adverse event incidence between a new one-month regimen (1HP) versus the current three-month regimen (3HR)\\*.\n\n\\*1HP= one month of daily isoniazid (H\u002FINH) and rifapentine (P\u002FRPT) 3HR= three months of daily isoniazid (H\u002FINH) and rifampicin (R\u002FRIF)",[62],"Tuberculosis Infection",[64,65,66,67,68,69],"Tuberculosis","TB preventive therapy","Tuberculosis infection","Latent TB infection","LTBI","TBI","NOT_YET_RECRUITING","2025-03-17",{"date":73,"type":40},"2025-03-19",{"date":75,"type":21},"2025-08-01",{"date":77,"type":21},"2027-12-01",{"name":46,"class":47},""]