[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632958":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":49,"studyPopulation":49,"armGroups":52,"interventions":70,"overallOfficials":84,"centralContacts":49,"locations":89,"responsibleParty":101,"collaborators":49,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":49,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":49,"overallStatus":127,"whyStopped":49,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Universidad Nacional de Caaguazu","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":37},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Point prevalence of active tuberculosis at each screening round","Proportion of participants diagnosed with microbiologically or clinically confirmed active tuberculosis during each 6-month mass screening round in participating prisons.","At baseline and every 6 months up to 24 months",{"measure":14,"description":15,"timeFrame":16},"Incidence of active tuberculosis between screening rounds","Number of new active tuberculosis cases identified between consecutive screening rounds among participants without active TB at the previous round.","Continuously assessed between screening rounds over 24 months",{"measure":18,"description":19,"timeFrame":20},"Incidence of latent tuberculosis infection (LTBI conversion) between screening rounds","Proportion of participants with negative LTBI test at a prior round who convert to positive at a subsequent screening round.","Every 6 months up to 24 months",{"measure":22,"description":23,"timeFrame":24},"Progression from latent tuberculosis infection to active tuberculosis","Proportion of participants diagnosed with LTBI who develop active tuberculosis during follow-up.","Up to 24 months",[26,30,33],{"measure":27,"description":28,"timeFrame":29},"Point prevalence of latent tuberculosis infection (LTBI) at each screening round","Proportion of participants with LTBI at each screening round. Proportion of screened participants with a positive LTBI test result during each mass screening round conducted every 6 months in participating prisons.","Baseline, 6, 12, 18, and 24 months",{"measure":31,"description":32,"timeFrame":24},"Cumulative yield of repeated mass screening","Total number and proportion of active tuberculosis cases identified through sequential mass screening rounds over the study period.",{"measure":34,"description":35,"timeFrame":36},"Interval tuberculosis diagnoses between screening rounds","Number and proportion of active tuberculosis cases identified between scheduled mass screening rounds through routine clinical evaluation or passive case detection.","Continuously assessed between rounds up to 24 months",[38,41],{"measure":39,"description":40,"timeFrame":24},"Comparative performance of diagnostic tests for LTBI and active tuberculosis","Comparison of performance metrics between screening diagnostic tests used for detection of latent tuberculosis infection and active tuberculosis.",{"measure":42,"description":43,"timeFrame":24},"Cost-effectiveness of sequential mass tuberculosis screening","Incremental cost-effectiveness ratio (ICER). Cost per tuberculosis case detected and cost per infection prevented associated with sequential mass screening compared with routine practice.",{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":49,"timePerspective":49,"maskingInfo":50},"NON_RANDOMIZED","PARALLEL","There are three different intervention branches (each intervention cluster is a prison). Each branch will have a different sequence of screening for active and latent TB, every 6 months (Prisons 1 \\& 2) y every 12 months (Prison 3), and one of them will perform mass TB preventive therapy treatment (3HP regimen), while the other two (Prison 2 \\& 3) will perform TB preventive therapy treatment (3HP) only in immunocompromised cases.","DIAGNOSTIC",null,{"masking":51,"maskingDescription":49,"whoMasked":49},"NONE",[53,59,64],{"label":54,"type":55,"description":56,"interventionNames":57},"Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.","ACTIVE_COMPARATOR","Arm 1. Prison One. This is the branch with the highest intervention intensity. Mass screenings for active and latent TB will be conducted at months 0, 6, 12, and 18. Mass TB testing will be performed on the entire prison population.",[58],"Diagnostic Test: Type 1 - Intensive Intervention",{"label":60,"type":55,"description":61,"interventionNames":62},"Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases","This is the \"optimized\" intervention arm. Mass screening for active and latent TB will be conducted at months 0, 6, 12, and 18. The TPT test will only be performed on cases of latent TB infection in HIV-positive individuals and other immunocompromised patients.",[63],"Diagnostic Test: Type 2 - Optimized intervention",{"label":65,"type":66,"description":67,"interventionNames":68},"Prison 3. Control intervention. Mass screening once a year and TPT to specific cases","SHAM_COMPARATOR","This is the \"control\" intervention arm. Mass screenings for active and latent TB will be conducted at month 0 and 12 months. The TB test will only be performed on cases of latent infection in HIV-positive individuals and other immunocompromised patients. It is the usual NTP intervention.",[69],"Diagnostic Test: Type 3. Control.",[71,76,80],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":49},"DIAGNOSTIC_TEST","Type 1 - Intensive Intervention","Type 1. This is the branch with the highest intervention intensity. Mass screenings for active and latent TB will be conducted at months 0, 6, 12, and 18. Mass TB testing will be performed on the entire prison population.",[54],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":49},"Type 2 - Optimized intervention","Type 2. This is the intervention with mass screenings for active and latent tuberculosis that will be carried out in months 0, 6, 12 and 18. TPT treatment will only be given to groups of people with HIV+ and other immunocompromised individuals.",[60],{"type":72,"name":81,"description":82,"armGroupLabels":83,"otherNames":49},"Type 3. Control.","Type 3. This intervention involves mass screening for active and latent tuberculosis, to be conducted in months 0 and 12. TPT treatment will be administered only to HIV-positive and other immunocompromised individuals. This intervention is similar to that of the NTP.",[65],[85],{"name":86,"affiliation":87,"role":88},"Guillermo Sequera, PhD, MD","Universidad Nacional de Caaguazú","PRINCIPAL_INVESTIGATOR",[90],{"facility":87,"status":49,"city":91,"state":92,"zip":49,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":49},"Coronel Oviedo","Caaguazú Department","Paraguay","PY",{"type":96,"coordinates":97},"Point",[98,99],-56.43928,-25.44613,{"lat":99,"lon":98},{"type":88,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Guillermo Sequera","PhD, MD, Caaguazú National University","100632958","prevention-and-mass-screening-of-tb-in-prisons-in-paraguay-100632958",false,"NCT07520448","Prevention and Mass Screening of TB in Prisons in Paraguay","Prevention and Mass Screening of TB in Prisons in Paraguay (PRESMAP-TB)","PRESMAP-TB","Inclusion Criteria:\n\n1. Be a person deprived of liberty (PDL) residing in one of the participating penitentiary centers during the study period.\n2. Be 18 years of age or older at the time of enrollment.\n3. Be present in the penitentiary facility at the time of a screening round or enter the facility during the study period.\n4. Provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Are currently undergoing treatment for active tuberculosis at the time of the screening round.\n2. Have a medical condition that, in the opinion of the clinical staff, prevents the safe performance of the planned diagnostic procedures.","MALE","18 Years","65 Years",{"count":116,"type":117},4500,"ESTIMATED","INTERVENTIONAL",[120],"NA","The goal of this interventional study is to evaluate three tuberculosis (TB) screening and prevention strategies in prisons in Paraguay. The main questions it aims to answer are:\n\n* Which strategy is more effective for reducing the incidence rate of active TB?\n* Which strategy is more effective for reducing the TB infection rate?\n* Are these strategies safe, feasible, and cost-effective in prison settings?\n\nResearchers will compare three cluster-based, non-randomized programmatic strategies implemented in three prisons. These strategies differ in the frequency of screening, the diagnostic methods used, and the approach to tuberculosis preventive therapy (TPT).\n\nParticipants will:\n\n* undergo informed consent and clinical evaluation\n* receive TB screening through symptom assessment, chest digital X-ray with CAD, and rapid molecular testing, depending on site strategy\n* undergo IGRA testing and preventive therapy assessment, depending on the assigned strategy\n* be followed for 18 months, with screening rounds every 6 months or annually depending on the prison",[123,124,125,126],"Tuberculosis (TB)","TB Infection","Prisoners","Epidemiology","NOT_YET_RECRUITING","2026-04-08",{"date":130,"type":131},"2026-04-14","ACTUAL",{"date":133,"type":117},"2026-08-01",{"date":135,"type":117},"2028-12-31",{"name":5,"class":6},1]