Prevention and Mass Screening of TB in Prisons in Paraguay

NCT07520448 | Not Yet Recruiting DMC

• 2 other identifiers: PRESMAP-TB-Estr01-34Estr01-34
• Study Type: interventional
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 24 months

Secondary Outcomes (3)

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

  Baseline, 6, 12, 18, and 24 months

• Cumulative yield of repeated mass screening

  Up to 24 months

• Interval tuberculosis diagnoses between screening rounds

  Continuously assessed between rounds up to 24 months

Other Outcomes (2)

• Comparative performance of diagnostic tests for LTBI and active tuberculosis

  Up to 24 months

• Cost-effectiveness of sequential mass tuberculosis screening

  Up to 24 months

Study Arms (3)

Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.

ACTIVE COMPARATOR

Arm 1. Prison One. 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 1 - Intensive Intervention

Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases

ACTIVE COMPARATOR

This is the "optimized" intervention arm. Mass screening for active and latent TB will be conducted at months 0, 6, 12, and 18. The TPT test will only be performed on cases of latent TB infection in HIV-positive individuals and other immunocompromised patients.

Diagnostic Test: Type 2 - Optimized intervention

Prison 3. Control intervention. Mass screening once a year and TPT to specific cases

SHAM COMPARATOR

This is the "control" intervention arm. Mass screenings for active and latent TB will be conducted at month 0 and 12 months. The TB test will only be performed on cases of latent infection in HIV-positive individuals and other immunocompromised patients. It is the usual NTP intervention.

Diagnostic Test: Type 3. Control.

Interventions

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.

Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.

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.

Prison 3. Control intervention. Mass screening once a year and TPT to specific cases

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.

Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Caaguazu: lead

Study Sites (1)

Universidad Nacional de Caaguazú

Coronel Oviedo, Caaguazú Department, Paraguay

Location

Related Publications (2)

• da Silva Peres Bezerra W, Jung E, Croda MG, de Oliveira RD, da Silva Santos A, Tsuha DH, Dos Santos PCP, Cunha EAT, Croda J, Andrews JR. The role of tuberculosis symptoms in transmission risk to cell contacts in prisons. medRxiv [Preprint]. 2025 May 27:2025.05.27.25328413. doi: 10.1101/2025.05.27.25328413.

  PMID: 40492062 BACKGROUND

• Pivetta de Araujo RC, Martinez L, da Silva Santos A, Ferreira Lemos E, Dias de Oliveira R, Croda M, Porto Batestin Silva D, Lemes IBG, Cunha EAT, Goncalves TO, Pereira Dos Santos PC, Oliveira da Silva B, Cavalheiro Maymone Goncalves C, Andrews J, Croda J. Serial Mass Screening for Tuberculosis Among Incarcerated Persons in Brazil. Clin Infect Dis. 2024 Jun 14;78(6):1669-1676. doi: 10.1093/cid/ciae055.

  PMID: 38324908 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Guillermo Sequera, PhD, MD

  Universidad Nacional de Caaguazú

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, Caaguazú National University

Model Details: There are three different intervention branches (each intervention cluster is a prison). Each branch will have a different sequence of screening for active and latent TB, every 6 months (Prisons 1 \& 2) y every 12 months (Prison 3), and one of them will perform mass TB preventive therapy treatment (3HP regimen), while the other two (Prison 2 \& 3) will perform TB preventive therapy treatment (3HP) only in immunocompromised cases.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication. Supporting documents, including the study protocol and statistical analysis plan, will be available at the time of publication.
• Access Criteria: De-identified individual participant data and supporting documents will be available to qualified researchers who provide a methodologically sound proposal. Requests must be submitted to the study investigators and will be reviewed by the study steering committee and relevant ethical oversight bodies. Data will be shared under a data use agreement that ensures confidentiality, prohibits re-identification, and limits use to the approved research objectives. Access will be provided through secure electronic transfer.

Locations

PA (1)