Prevention and Mass Screening of TB in Prisons in Paraguay

Официальное название

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

Обзор

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

Вмешательства

• Диагностический тест 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.
• Диагностический тест 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.
• Диагностический тест 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.

Первичные конечные точки

• Point prevalence of active tuberculosis at each screening round [Срок оценки: At baseline and every 6 months up to 24 months]
• Incidence of active tuberculosis between screening rounds [Срок оценки: Continuously assessed between screening rounds over 24 months]
• Incidence of latent tuberculosis infection (LTBI conversion) between screening rounds [Срок оценки: Every 6 months up to 24 months]
• Progression from latent tuberculosis infection to active tuberculosis [Срок оценки: Up to 24 months]

Вторичные конечные точки (3)

• Point prevalence of latent tuberculosis infection (LTBI) at each screening round [Срок оценки: Baseline, 6, 12, 18, and 24 months]
• Cumulative yield of repeated mass screening [Срок оценки: Up to 24 months]
• Interval tuberculosis diagnoses between screening rounds [Срок оценки: Continuously assessed between rounds up to 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Paraguay · 1 центр

• Universidad Nacional de Caaguazú — Coronel Oviedo

Публикации

• 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/ciae PMID 38324908

Идентификаторы

NCT: NCT07520448 · PRESMAP-TB-Estr01-34 · Estr01-34

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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