Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1925 participants
INTERVENTIONAL
2025-06-01
2026-05-31
Brief Summary
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\- Does the intervention increase the number of new leprosy cases detected compared to standard care?
Participants will:
* Receive community awareness about leprosy.
* Be screened using the Leprosy Suspicion Questionnaire at priority areas identified by georeference tools.
* Undergo clinical evaluation by a trained medical team.
* If leprosy is diagnosed, affected patients will collect complementary laboratory exams
Healthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of patients who have been diagnosed.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SCREENING
NONE
Study Groups
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Multifaceted intervention
Implementation of active-case finding strategies
Implementing active-case finding strategies
Implementation of a multifactorial active-case finding strategy, including: (1) raising awareness among the population about leprosy; (2) theoretical and practical educational training for healthcare workers; (3) georeferencing of historical and existing cases in the municipality (from 2012 to 2023) and of new cases diagnosed throughout the study (dynamic changes); (4) screening tools for signs/symptoms of the disease (application of Leprosy Suspicion Questionnaire); and (5) serological profile (rapid test) of patients with reported signs/symptoms (positive answers Leprosy Suspicion Questionnaire).
Standard of care
Routine screening
No interventions assigned to this group
Interventions
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Implementing active-case finding strategies
Implementation of a multifactorial active-case finding strategy, including: (1) raising awareness among the population about leprosy; (2) theoretical and practical educational training for healthcare workers; (3) georeferencing of historical and existing cases in the municipality (from 2012 to 2023) and of new cases diagnosed throughout the study (dynamic changes); (4) screening tools for signs/symptoms of the disease (application of Leprosy Suspicion Questionnaire); and (5) serological profile (rapid test) of patients with reported signs/symptoms (positive answers Leprosy Suspicion Questionnaire).
Eligibility Criteria
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Inclusion Criteria
* Municipality recognized by the Brazilian Institute of Geography and Statistics as part of the Brazilian Federation.
* Municipality with operational epidemiological classification by the Ministry of Health (BMoH) as: 'municipalities with cases in the period from 2015 to 2019'.
* Municipality with authorization/consent from the government to participate in the study.
(II) Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.
(III) Participants
• Patients with positive Leprosy Suspicion Questionnaire (LSQ): children under five years old with Free and Informed Consent Form (ICF) signed by parents/guardians, 5-17 years old with ICF signed by parents/guardians and Free and Informed Assent Form (IAF) signed by the minor, and patients over 18 years old with ICF signed for: rapid test collection, comorbidity questionnaire and clinical evaluation; and if leprosy diagnosis is confirmed, collection of complementary exams.
Exclusion Criteria
* Municipality with extreme population size (municipalities with a number of inhabitants lower than the 10th percentile and higher than the 90th percentile).
* Municipality with operational epidemiological classification by the BMoH as: 'municipalities without cases in the period 2015 to 2019'.
* Municipalities with active or recent participation (less than one year) in other active-finding strategies, in addition to the usual ones: ministerial, Non-Governmental Organizations (NGOs), academic, among others.
(II) Primary Health Units
* UBS with limited multidisciplinary team (absence of physicians, nurse and/or community health agents).
* UBS with difficult access (no access by land, i.e. riverside populations).
* UBS with territorial coverage exclusively of indigenous populations.
(III) Participants
* LSQ negative.
* Patients with a previous diagnosis or history of treated leprosy.
* Patients residing/registered outside the selected municipality.
ALL
Yes
Sponsors
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Hospital Alemão Oswaldo Cruz
OTHER
Responsible Party
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Sebastian Andres Vernal Carranza
Medical Doctor
Principal Investigators
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Rosa C Lucchetta, PhD
Role: STUDY_DIRECTOR
Hospital Alemão Oswaldo Cruz
Locations
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Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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78510724.3.0000.0070
Identifier Type: -
Identifier Source: org_study_id
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