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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Epidemiology; Tuberculosis (TB); Prisoners; TB Infection
• Intervention / Treatment: Diagnostic test: Type 1 - Intensive Intervention; Diagnostic test: Type 2 - Optimized intervention; Diagnostic test: Type 3. Control.

• Study Type: Interventional
• Enrollment (Estimated): 4500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Caaguazú Department
    • Coronel Oviedo, Caaguazú Department, Paraguay
      • Universidad Nacional de Caaguazú

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be a person deprived of liberty (PDL) residing in one of the participating penitentiary centers during the study period.
2. Be 18 years of age or older at the time of enrollment.
3. Be present in the penitentiary facility at the time of a screening round or enter the facility during the study period.
4. Provide informed consent to participate in the study.

Exclusion Criteria:

1. Are currently undergoing treatment for active tuberculosis at the time of the screening round.
2. Have a medical condition that, in the opinion of the clinical staff, prevents the safe performance of the planned diagnostic procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.; 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; 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.
Active Comparator: Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases; 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; 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.
Sham Comparator: Prison 3. Control intervention. Mass screening once a year and TPT to specific cases; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Continuously assessed between rounds up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months
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.	Up to 24 months

Collaborators and Investigators

• Sponsor: Universidad Nacional de Caaguazu
• Investigators: Principal Investigator: Guillermo Sequera, PhD, MD, Universidad Nacional de Caaguazú

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: PRESMAP-TB-Estr01-34; Estr01-34 (Other Identifier: CONACYT-PARAGUAY)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data underlying the results reported in this study will be shared after de-identification. Shared data will include demographic characteristics, incarceration-related variables, screening participation, diagnostic test results for active tuberculosis and latent tuberculosis infection, treatment initiation and completion for tuberculosis preventive therapy, and follow-up outcomes across screening rounds. Data will be provided in a coded format with removal of direct identifiers to protect participant confidentiality.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No