Prevention and Mass Screening of TB in Prisons in Paraguay
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorUniversidad Nacional de Caaguazu
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be a person deprived of liberty (PDL) residing in one of the participating penitentiary centers during the study period.
Be 18 years of age or older at the time of enrollment.
Be present in the penitentiary facility at the time of a screening round or enter the facility during the study period.
Provide informed consent to participate in the study.
Disqualifiers
Are currently undergoing treatment for active tuberculosis at the time of the screening round.
Have a medical condition that, in the opinion of the clinical staff, prevents the safe performance of the planned diagnostic procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
Type 1 - Intensive Intervention
Diagnostic testType 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 - Optimized intervention
Diagnostic testType 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. Control.
Diagnostic testType 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.
Treatment groups
4,500 Participants
are divided into 3 treatment groupsGroup A: Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.Active comparator 1 intervention
Group B: Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific casesActive comparator 1 intervention
Group C: Prison 3. Control intervention. Mass screening once a year and TPT to specific casesSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsOther outcomes
1
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.
Time frame
Up to 24 months2
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.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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