NCT06761469

Leprosy Active Searching Trial in Brazil

Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,925 (estimated)
• Sponsor: Hospital Alemão Oswaldo Cruz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Leprosy

Interventions

Type	Name	Description
OTHER	Implementing active-case finding strategies	Implementation of a multifactorial active-case finding strategy, including: (1) raising awareness among the population about leprosy; (2) theoretical and practical educational training for healthcare workers; (3) georeferencing of historical and existing cases in the municipality (from 2012 to 2023) and of new cases diagnosed throughout the study (dynamic changes); (4) screening tools for signs/symptoms of the disease (application of Leprosy Suspicion Questionnaire); and (5) serological profile (rapid test) of patients with reported signs/symptoms (positive answers Leprosy Suspicion Questionnaire).

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-03-31
• Completion: 2026-05-31
• First posted: 2025-01-07
• Last updated: 2025-07-02

Locations

1 site across 1 country: Brazil