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NCT Number: NCT07520448

Prevention and Mass Screening of TB in Prisons in Paraguay

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

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Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Epidemiology Gram-Positive Bacterial Infections Infections Mycobacterium Infections Prisoners TB Infection Tuberculosis

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Nacional de Caaguazú

Coronel Oviedo, Caaguazú Department, Paraguay

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Type 1 - Intensive Intervention

Diagnostic Test

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 - Optimized intervention

Diagnostic Test

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. Control.

Diagnostic Test

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.

Primary outcomes

  1. Point prevalence of active tuberculosis at each screening round

    Time frame: At baseline and every 6 months up to 24 months

    Proportion of participants diagnosed with microbiologically or clinically confirmed active tuberculosis during each 6-month mass screening round in participating prisons.

  2. Incidence of active tuberculosis between screening rounds

    Time frame: Continuously assessed between screening rounds over 24 months

    Number of new active tuberculosis cases identified between consecutive screening rounds among participants without active TB at the previous round.

  3. Incidence of latent tuberculosis infection (LTBI conversion) between screening rounds

    Time frame: Every 6 months up to 24 months

    Proportion of participants with negative LTBI test at a prior round who convert to positive at a subsequent screening round.

  4. Progression from latent tuberculosis infection to active tuberculosis

    Time frame: Up to 24 months

    Proportion of participants diagnosed with LTBI who develop active tuberculosis during follow-up.

Secondary outcomes

  1. Point prevalence of latent tuberculosis infection (LTBI) at each screening round

    Time frame: Baseline, 6, 12, 18, and 24 months

    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.

  2. Cumulative yield of repeated mass screening

    Time frame: Up to 24 months

    Total number and proportion of active tuberculosis cases identified through sequential mass screening rounds over the study period.

  3. Interval tuberculosis diagnoses between screening rounds

    Time frame: Continuously assessed between rounds up to 24 months

    Number and proportion of active tuberculosis cases identified between scheduled mass screening rounds through routine clinical evaluation or passive case detection.

Other outcomes

  1. Comparative performance of diagnostic tests for LTBI and active tuberculosis

    Time frame: Up to 24 months

    Comparison of performance metrics between screening diagnostic tests used for detection of latent tuberculosis infection and active tuberculosis.

  2. Cost-effectiveness of sequential mass tuberculosis screening

    Time frame: Up to 24 months

    Incremental cost-effectiveness ratio (ICER). Cost per tuberculosis case detected and cost per infection prevented associated with sequential mass screening compared with routine practice.

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Caaguazu

Other

Registry information

Official study title

Prevention and Mass Screening of TB in Prisons in Paraguay (PRESMAP-TB)

Acronym: PRESMAP-TB

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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