Leprosy Active Searching Trial in Brazil

Launched by HOSPITAL ALEMÃO OSWALDO CRUZ · Jan 5, 2025

Keywords

ClinConnect Summary

The Leprosy Active Searching Trial in Brazil is studying a new approach to find and diagnose people with leprosy, a disease that affects the skin and nerves. The aim is to see if actively searching for cases through community awareness and specific screening tools can help detect more cases compared to the usual methods. Participants will be educated about leprosy, screened using a special questionnaire in targeted areas, and evaluated by trained healthcare professionals. If someone is diagnosed, they will undergo additional tests.

To be eligible, participants need to be in certain municipalities recognized by health authorities, including children and adults who have symptoms of leprosy. Those who are already diagnosed or have a history of leprosy won't be included. During the trial, healthcare providers will receive training on leprosy, and researchers will track how many new cases are found over a year. This study aims to better understand how leprosy is diagnosed and the health profiles of those affected, ultimately improving the care for individuals with this condition.

Gender

ALL

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.