Leprosy Active Searching Trial in Brazil

Hospital Alemão Oswaldo Cruz1,925 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

1,925

Conditions

Leprosy

Interventions

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

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

New cases of leprosy

Number of new cases of leprosy: incidence rate of leprosy per 100,000 inhabitants.

Time frame: From the date of identification of at least one positive response in the Leprosy Suspicion Questionnaire until the date of confirmation or ruling out leprosy, assessed up to 2 months.

Secondary Outcomes

Leprosy Suspicion Questionnaire usefulness

Estimation of the diagnostic utility of positive LSQ and positive LSQ plus rapid test

Time frame: From the application date of the Leprosy Suspicion Questionnaire and the rapid test until the date of confirmation or ruling out leprosy, it is assessed for up to 2 months.