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| ID | Type | Description | Link |
|---|---|---|---|
| Estr01-34 | Other Identifier | CONACYT-PARAGUAY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prison 1. Intensive intervention. Mass screening twice a year and massive TPT. | Active Comparator | 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. |
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| Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases | Active Comparator | 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. |
|
| Prison 3. Control intervention. Mass screening once a year and TPT to specific cases | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type 1 - Intensive Intervention | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6, 12, 18, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| Cost-effectiveness of sequential mass tuberculosis screening |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Sequera, PhD, MD | Universidad Nacional de Caaguazú | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Nacional de Caaguazú | Coronel Oviedo | Caaguazú Department | Paraguay |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40492062 | Background | 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. | |
| 38324908 | Background |
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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.
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.
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.
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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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.
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| Type 2 - Optimized intervention | Diagnostic Test | 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. Control. | Diagnostic Test | 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. |
|
| Cumulative yield of repeated mass screening |
Total number and proportion of active tuberculosis cases identified through sequential mass screening rounds over the study period. |
| 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. | Continuously assessed between rounds up to 24 months |
Incremental cost-effectiveness ratio (ICER). Cost per tuberculosis case detected and cost per infection prevented associated with sequential mass screening compared with routine practice. |
| Up to 24 months |
| 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/ciae055. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |