Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil
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.
⁃ (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.