NCT07520448

Prevention and Mass Screening of TB in Prisons in Paraguay

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,500 (estimated)
• Sponsor: Universidad Nacional de Caaguazu · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tuberculosis (TB)
• TB Infection
• Prisoners
• Epidemiology

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-04-09
• Last updated: 2026-04-14

Locations

1 site across 1 country: Paraguay