Status:
RECRUITING
Leprosy Active Searching Trial in Brazil
Lead Sponsor:
Hospital Alemão Oswaldo Cruz
Conditions:
Leprosy
Eligibility:
All Genders
Phase:
NA
Brief 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 que...
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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
1925 Patients enrolled
Trial Details
Trial ID
NCT06761469
Start Date
June 1 2025
End Date
May 31 2026
Last Update
July 2 2025
Active Locations (1)
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1
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil, 01327-001