Leprosy Active Searching Trial in Brazil
ConditionLeprosy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital Alemão Oswaldo Cruz
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
UBS with limited multidisciplinary team (absence of physicians, nurse and/or community health agents).
Trial design
Design model
Sequential
Treatments tested in this trial
Implementing active-case finding strategies
Other interventionImplementation 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).
Treatment groups
1,925 Participants
are divided into 2 treatment groupsGroup A: Multifaceted interventionExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
New cases of leprosy
Number of new cases of leprosy: incidence rate of leprosy per 100,000 inhabitants.
Time frame
From the date of identification of at least one positive response in the Leprosy Suspicion Questionnaire until the date of confirmation or ruling out leprosy, assessed up to 2 months.Secondary outcomes
1
Leprosy Suspicion Questionnaire usefulness
Estimation of the diagnostic utility of positive LSQ and positive LSQ plus rapid test
Time frame
From the application date of the Leprosy Suspicion Questionnaire and the rapid test until the date of confirmation or ruling out leprosy, it is assessed for up to 2 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov