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

What this Trial Is About

Researchers are evaluating whether a multifactorial active case-finding strategy can improve the detection of leprosy cases in Brazil compared to standard screening methods. The study aims to find out if this intervention increases the number of new leprosy cases identified and to better understand underdiagnosis as well as the clinical profiles of diagnosed patients. Healthcare professionals will also receive training to enhance leprosy detection in primary care units. The intervention includes raising community awareness about leprosy, training health workers, using georeferencing tools to identify priority areas, and applying a Leprosy Suspicion Questionnaire to screen people in these areas. Those with positive questionnaire responses will undergo clinical evaluation by a trained medical team. If leprosy is diagnosed, additional laboratory tests will be collected. The study compares this active case-finding approach to routine screening practices. Participants will be involved through community screening and clinical evaluations, with data monitored over a 12-month period using Brazil's national notification system. Researchers will assess new leprosy cases from the time of a positive questionnaire until confirmation or ruling out of leprosy within two months. They will also evaluate the usefulness of the Leprosy Suspicion Questionnaire and rapid test during this period. The study will provide important insights into leprosy detection and diagnosis in affected communities.

Leprosy Active Searching Trial in Brazil