Leprosy Active Searching Trial in Brazil

NCT06761469 | Recruiting

• 1 other identifier: 78510724.3.0000.0070
• Study Type: interventional
• Target: 1,925
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Leprosy; Active-case finding; Cluster stepped-wedge; Clinical trial; Brazil

Outcome Measures

Primary Outcomes (1)

• New cases of leprosy

  Number of new cases of leprosy: incidence rate of leprosy per 100,000 inhabitants.

  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

  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.

Study Arms (2)

Multifaceted intervention

EXPERIMENTAL

Implementation of active-case finding strategies

Other: Implementing active-case finding strategies

Standard of care

NO INTERVENTION

Routine screening

Interventions

Implementing active-case finding strategies OTHER

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).

Multifaceted intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Hospital Alemão Oswaldo Cruz: lead

Study Sites (1)

Hospital Alemão Oswaldo Cruz

São Paulo, 01327-001, Brazil

RECRUITING

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Rosa C Lucchetta, PhD

  Hospital Alemão Oswaldo Cruz

  STUDY DIRECTOR

Central Study Contacts

Sebastian A Vernal, MD, PhD

CONTACT

+61 488 062 931; vernal.carranza@gmail.com

Katia C Braz

CONTACT

+55 11 99616 5496; katia.braz@haoc.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst (statistician)
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Cluster stepped-wedge

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BR (1)