Prevention and Mass Screening of TB in Prisons in Paraguay

NCT07520448 — Not applicable, Not yet recruiting, 4500 participants, Universidad Nacional de Caaguazu

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

Registry	NCT07520448, acronym PRESMAP-TB
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, diagnostic
Enrollment	4500 (Estimated)
Sponsor	Universidad Nacional de Caaguazu (Other)
Conditions	Tuberculosis (TB), TB Infection, Prisoners, Epidemiology
Interventions	Type 1 - Intensive Intervention, Type 2 - Optimized intervention, Type 3. Control. (Diagnostic test)
Dates	start 2026-08-01 (estimated), primary completion 2027-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-04-09, last updated 2026-04-14
Locations	1 site in Paraguay

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.	Active comparator	Diagnostic Test: Type 1 - Intensive Intervention	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.
Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases	Active comparator	Diagnostic Test: Type 2 - Optimized intervention	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.
Prison 3. Control intervention. Mass screening once a year and TPT to specific cases	Sham comparator	Diagnostic Test: Type 3. Control.	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.

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.

+Outcome measures

Primary outcomes

Point prevalence of active tuberculosis at each screening round [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.
Incidence of active tuberculosis between screening rounds [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.
Incidence of latent tuberculosis infection (LTBI conversion) between screening rounds [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.
Progression from latent tuberculosis infection to active tuberculosis [Up to 24 months]: Proportion of participants diagnosed with LTBI who develop active tuberculosis during follow-up.

Secondary outcomes

Point prevalence of latent tuberculosis infection (LTBI) at each screening round [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.
Cumulative yield of repeated mass screening [Up to 24 months]: Total number and proportion of active tuberculosis cases identified through sequential mass screening rounds over the study period.
Interval tuberculosis diagnoses between screening rounds [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

Comparative performance of diagnostic tests for LTBI and active tuberculosis [Up to 24 months]: Comparison of performance metrics between screening diagnostic tests used for detection of latent tuberculosis infection and active tuberculosis.
Cost-effectiveness of sequential mass tuberculosis screening [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.

+Eligibility

Sex: Male, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
Universidad Nacional de Caaguazú	Coronel Oviedo, Caaguazú Department	Paraguay

+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. PMID 40492062
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

+Investigators

Guillermo Sequera, PhD, MD, Principal investigator, Universidad Nacional de Caaguazú