Prevention and Mass Screening of TB in Prisons in Paraguay
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorUniversidad Nacional de Caaguazu
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Type 1 - Intensive Intervention
- Type 2 - Optimized intervention
- Type 3. Control.
Treatment groups
4,500 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov