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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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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
Are there results?: Not yet: the study is under way

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

Other trials in Paraguay

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?

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 groups in NCT07520448
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.

1 Aug 202631 Dec 2028

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)

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 40492062
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.
PubMed 38324908

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Tuberculosis (TB) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention and Mass Screening of TB in Prisons in Paraguay (PRESMAP-TB)
ClinicalTrials.gov ID: NCT07520448
Acronym / sponsor ID: PRESMAP-TB / PRESMAP-TB-Estr01-34
Conditions: Tuberculosis (TB), TB Infection, Prisoners, Epidemiology
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 4,500 participants (estimated)
Lead sponsor: Universidad Nacional de CaaguazuUniversity, hospital or other
Study start: 1 Aug 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 9 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

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

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.	Active comparator	Diagnostic Test: Type 1 - Intensive InterventionArm 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.
Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases	Active comparator	Diagnostic Test: Type 2 - Optimized interventionThis 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	Diagnostic Test: Type 3. Control.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.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Type 1 - Intensive InterventionType 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 test	Prison 1. Intensive intervention. Mass screening twice a year and massive TPT.
Type 2 - Optimized interventionType 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 test	Prison 2. Optimized intervention. Mass screening twice a year and TPT to specific cases
Type 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.	Diagnostic test	Prison 3. Control intervention. Mass screening once a year and TPT to specific cases

Primary outcome

Point prevalence of active tuberculosis at each screening round
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 24 months
Proportion of participants diagnosed with LTBI who develop active tuberculosis during follow-up.

3 secondary outcomes

Point prevalence of latent tuberculosis infection (LTBI) at each screening round
Time frame: Baseline, 6, 12, 18, and 24 months
Cumulative yield of repeated mass screening
Time frame: Up to 24 months
Interval tuberculosis diagnoses between screening rounds
Time frame: Continuously assessed between rounds up to 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Background: PubMed 40492062da 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.
Background: PubMed 38324908Pivetta 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.
Individual participant dataSharing planned: 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.

Related trials for Tuberculosis (TB)

RecruitingPhase 3
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Not yet recruitingEarly Phase 1
Silymarin Versus N-Acetylcysteine as Protective Effect Against Anti-tuberculosis Drugs Induced Liver Injury.
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RecruitingPhase 2
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Recruiting
Screening With Portable X-rays for Rapid Recognition of TB
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Guillermo Sequera, PhD, MD principal investigator

Universidad Nacional de Caaguazú

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Point prevalence of active tuberculosis at each screening round (time frame: At baseline and every 6 months up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07520448, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.