An interventional study of Type 1 - Intensive Intervention and Type 2 - Optimized intervention in Tuberculosis (TB), TB Infection and Prisoners, sponsored by Universidad Nacional de Caaguazu. Not yet recruiting at 1 site in Paraguay. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Universidad Nacional de Caaguazu · Not applicable, Interventional, and Diagnostic
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:
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:
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Universidad Nacional de Caaguazu is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Type 1 - Intensive 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.
Diagnostic Test: Type 2 - Optimized intervention
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.
Diagnostic Test: Type 3. Control.
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. 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. 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.
Point prevalence of active tuberculosis at each screening round
Proportion of participants diagnosed with microbiologically or clinically confirmed active tuberculosis during each 6-month mass screening round in participating prisons.
Time frame: At baseline and every 6 months up to 24 months
Incidence of active tuberculosis between screening rounds
Number of new active tuberculosis cases identified between consecutive screening rounds among participants without active TB at the previous round.
Time frame: Continuously assessed between screening rounds over 24 months
Incidence of latent tuberculosis infection (LTBI conversion) between screening rounds
Proportion of participants with negative LTBI test at a prior round who convert to positive at a subsequent screening round.
Time frame: Every 6 months up to 24 months
Progression from latent tuberculosis infection to active tuberculosis
Proportion of participants diagnosed with LTBI who develop active tuberculosis during follow-up.
Time frame: Up to 24 months
Point prevalence of latent tuberculosis infection (LTBI) at each screening round
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.
Time frame: Baseline, 6, 12, 18, and 24 months
Cumulative yield of repeated mass screening
Total number and proportion of active tuberculosis cases identified through sequential mass screening rounds over the study period.
Time frame: Up to 24 months
Interval tuberculosis diagnoses between screening rounds
Number and proportion of active tuberculosis cases identified between scheduled mass screening rounds through routine clinical evaluation or passive case detection.
Time frame: Continuously assessed between rounds up to 24 months
Comparative performance of diagnostic tests for LTBI and active tuberculosis
Comparison of performance metrics between screening diagnostic tests used for detection of latent tuberculosis infection and active tuberculosis.
Time frame: Up to 24 months
Cost-effectiveness of sequential mass tuberculosis screening
Incremental cost-effectiveness ratio (ICER). Cost per tuberculosis case detected and cost per infection prevented associated with sequential mass screening compared with routine practice.
Time frame: Up to 24 months
Plan to share: Yes — Individual participant data underlying the results reported in this study will be shared after de-identification. Shared data will include demographic characteristics, incarceration-related variables, screening participation, diagnostic test results for active tuberculosis and latent tuberculosis infection, treatment initiation and completion for tuberculosis preventive therapy, and follow-up outcomes across screening rounds. Data will be provided in a coded format with removal of direct identifiers to protect participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication. Supporting documents, including the study protocol and statistical analysis plan, will be available at the time of publication.
Access criteria: De-identified individual participant data and supporting documents will be available to qualified researchers who provide a methodologically sound proposal. Requests must be submitted to the study investigators and will be reviewed by the study steering committee and relevant ethical oversight bodies. Data will be shared under a data use agreement that ensures confidentiality, prohibits re-identification, and limits use to the approved research objectives. Access will be provided through secure electronic transfer.
Data sharing details ↗ · osf.io
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's planned 16 months is below that.
Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Universidad Nacional de Caaguazu