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RECRUITING

NCT06761469

Leprosy Active Searching Trial in Brazil

Sponsor: Hospital Alemão Oswaldo Cruz

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are: \- 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.

Official title: Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1925

Start Date

2025-06-01

Completion Date

2026-05-31

Last Updated

2025-07-02

Healthy Volunteers

Yes

Conditions

Leprosy

Interventions

OTHER

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).

Inclusion Criteria: (I) Municipalities * 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: (I) Municipalities * 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.

Locations (1)

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil