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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
4,500
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.
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.
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.
Universidad Nacional de Caaguazú
Coronel Oviedo, Caaguazú Department, Paraguay
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.
Time frame: At baseline and every 6 months up to 24 months
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.
Time frame: Continuously assessed between screening rounds over 24 months
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.
Time frame: Every 6 months up to 24 months
Progression from latent tuberculosis infection to active tuberculosis
Proportion of participants diagnosed with LTBI who develop active tuberculosis during follow-up.
Time frame: Up to 24 months
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.
Time frame: Baseline, 6, 12, 18, and 24 months
Cumulative yield of repeated mass screening
Total number and proportion of active tuberculosis cases identified through sequential mass screening rounds over the study period.
Time frame: Up to 24 months
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.
Time frame: Continuously assessed between rounds up to 24 months
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