Clinical Trial

Prevention and Mass Screening of TB in Prisons in Paraguay

Study acronym: PRESMAP-TB
Not Yet Recruiting
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Summary
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: * Which strategy is more effective for reducing the incidence rate of active TB? * Which strategy is more effective for reducing the TB infection rate? * Are these strategies safe, feasible, and cost-effective in prison settings? Researchers 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). Participants will: * undergo informed consent and clinical evaluation * receive TB screening through symptom assessment, chest digital X-ray with CAD, and rapid molecular testing, depending on site strategy * undergo IGRA testing and preventive therapy assessment, depending on the assigned strategy * be followed for 18 months, with screening rounds every 6 months or annually depending on the prison
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-02.
Trial Details
NCT Number NCT07520448
Lead Sponsor Universidad Nacional de Caaguazu
Conditions Tuberculosis (TB), TB Infection, Prisoners, Epidemiology
Enrollment 4,500 participants
Start Date 2026-08-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-14