Prevention and Mass Screening of TB in Prisons in Paraguay (PRESMAP-TB)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- Point prevalence of active tuberculosis at each screening round
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Type 1 - Intensive Intervention (Diagnostic Test)
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.
干预措施: Type 2 - Optimized intervention (Diagnostic Test)
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.
干预措施: Type 3. Control. (Diagnostic Test)
结局指标
主要结局
Point prevalence of active tuberculosis at each screening round
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to 24 months
Proportion of participants diagnosed with LTBI who develop active tuberculosis during follow-up.
次要结局
- 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)
研究者
Guillermo Sequera
PhD, MD, Caaguazú National University
Universidad Nacional de Caaguazu