Epidemiology, Prisoners, TB Infection, Tuberculosis (TB)
Conditions
Brief 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
Interventions
DIAGNOSTIC_TESTType 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.
DIAGNOSTIC_TESTType 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.
DIAGNOSTIC_TESTType 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.
Sponsors
Universidad Nacional de Caaguazu
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
There are three different intervention branches (each intervention cluster is a prison). Each branch will have a different sequence of screening for active and latent TB, every 6 months (Prisons 1 & 2) y every 12 months (Prison 3), and one of them will perform mass TB preventive therapy treatment (3HP regimen), while the other two (Prison 2 & 3) will perform TB preventive therapy treatment (3HP) only in immunocompromised cases.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Paraguay
Contacts
PRINCIPAL_INVESTIGATORGuillermo Sequera, PhD, MD
Universidad Nacional de Caaguazú
Outcome results
None listed