Active case-finding for leprosy in Brazil
Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil
This project will test whether actively screening people in high-risk Brazilian municipalities finds more leprosy cases than the usual approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1925 (estimated) |
| Sex | All |
| Sponsor | Hospital Alemão Oswaldo Cruz Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06761469 on ClinicalTrials.gov |
What this trial studies
The trial uses a cluster stepped-wedge approach to roll out a multifactorial active case-finding intervention across participating municipalities. Teams will run community awareness campaigns, use georeferenced tools to identify priority areas, administer a Leprosy Suspicion Questionnaire, and provide clinical evaluation and laboratory testing for suspected cases. Primary care workers at enrolled UBS units will receive leprosy training while researchers monitor changes in reported incidence using Brazil’s national notification system over 12 months. The study aims to quantify underdiagnosis and describe the clinical profiles of newly identified patients.
Who should consider this trial
Good fit: People living in participating Brazilian municipalities who are served by enrolled primary health units and screen positive on the Leprosy Suspicion Questionnaire are the intended participants.
Not a fit: People who live outside authorized municipalities, are not linked to participating UBS units, or do not meet the questionnaire or consent requirements are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could increase timely diagnoses and treatment, reducing transmission and disability from leprosy.
How similar studies have performed: Active case finding and contact screening have previously increased leprosy detection in Brazil and other endemic settings, supporting this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- Hospital Alemão Oswaldo Cruz — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Sebastian A Vernal, MD, PhD
- Email: vernal.carranza@gmail.com
- Phone: +61 488 062 931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.