Leprosy Active Searching Trial in Brazil (LAST•Br)

April 26, 2026 updated by: Sebastian Andres Vernal Carranza, Hospital Alemão Oswaldo Cruz

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1925

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01327-001
        • Recruiting
        • Hospital Alemao Oswaldo Cruz
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian A Vernal, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multifaceted intervention
Implementation of active-case finding strategies
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).
No Intervention: Standard of care
Routine screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New cases of leprosy
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leprosy Suspicion Questionnaire usefulness
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.
Estimation of the diagnostic utility of positive LSQ and positive LSQ plus rapid test
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Alemão Oswaldo Cruz

Investigators

  • Study Director: Rosa C Lucchetta, PhD, Hospital Alemao Oswaldo Cruz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78510724.3.0000.0070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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