leprosy active searching trial in brazil

Conditions: Leprosy

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 diagnosed patients.


Eligibility criteria:
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.

Keywords: leprosy active-case finding cluster stepped-wedge clinical trial brazil