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Completed
NCT06761469
Leprosy Active Searching Trial in Brazil
Conditions: Leprosy
Sex: All
Healthy volunteers: Yes
Phase: NA
Enrollment: 323
Sponsor: Hospital Alemão Oswaldo Cruz
Location: Hospital Alemão Oswaldo Cruz São Paulo São Paulo
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.
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.
Source: ClinicalTrials.gov (NCT06761469). StuddyBuddy aggregates publicly available trial information.