Tuberculosis (TB)PRESMAP-TBNCT07520448
Prevention and Mass Screening of TB in Prisons in Paraguay
A study testing Type 1 - Intensive Intervention and Type 2 - Optimized intervention in people with Tuberculosis (TB) and TB Infection, run by Universidad Nacional de Caaguazu at 1 site in Paraguay.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Tuberculosis (TB), TB Infection, Prisoners
- What is being tested?
- Type 1 - Intensive Intervention and Type 2 - Optimized intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,500 participants
- Where
- 1 siteParaguay
- Study dates
- 1 Aug 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paraguay1 site
Universidad Nacional de Caaguazú
Coronel Oviedo, Caaguazú Department
About this study
Official title: Prevention and Mass Screening of TB in Prisons in Paraguay (PRESMAP-TB)
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?
Read more
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
- Conditions
- Tuberculosis (TB), TB Infection, Prisoners, Epidemiology
- Being tested
- Type 1 - Intensive Intervention, Type 2 - Optimized intervention, Type 3. Control.
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 1 - Intensive InterventionDiagnostic 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.
Type 2 - Optimized interventionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Type 1 - Intensive Intervention |
| 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. Receives: Diagnostic Test: Type 2 - Optimized intervention |
| 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. Receives: Diagnostic Test: Type 3. Control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Continuously assessed between rounds up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Caaguazu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Sequera, Universidad Nacional de Caaguazu
- Investigators
- Guillermo Sequera, PhD, MD, Principal investigator, Universidad Nacional de Caaguazú
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520448
- Sponsor's protocol ID
- PRESMAP-TB-Estr01-34
- Other IDs
- Estr01-34
- Acronym
- PRESMAP-TB
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 40492062Pivetta 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.
PubMed 38324908