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CompletedNCT06761469LAST•BrUpdated Aug 4, 2026

Leprosy Active Searching Trial in Brazil

An interventional study of Implementing active-case finding strategies in Leprosy, sponsored by Hospital Alemão Oswaldo Cruz. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Hospital Alemão Oswaldo Cruz · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
323
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Leprosy

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Keywords

  • Leprosy
  • Active-case finding
  • Cluster stepped-wedge
  • Clinical trial
  • Brazil
03

In context

Leprosy

52 studies on the registry are indexed under Leprosy; 13 are open to participants now.

This study's enrollment of 323 is above the median of 70 across 41 interventional studies indexed under Leprosy.

Browse Leprosy studies →

Lead sponsor

Hospital Alemão Oswaldo Cruz is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
323 participants (actual)

Study arms

  • Experimental
    Multifaceted intervention

    Implementation of active-case finding strategies

    Other: Implementing active-case finding strategies

  • No intervention
    Standard of care

    Routine screening

Interventions

  • OtherImplementing 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).

06

What researchers measure

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.

07

Study locations

1 site
  • Hospital Alemão Oswaldo Cruz
    São Paulo, São Paulo 01327-001, Brazil
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06761469
Lead sponsor
Hospital Alemão Oswaldo Cruz
Responsible party
Sebastian Andres Vernal Carranza (Medical Doctor, Hospital Alemão Oswaldo Cruz) — Principal investigator
First posted
Jan 7, 2025
Start date
Jun 1, 2025
Primary completion
May 31, 2026
Completion
May 31, 2026
Last update
Aug 4, 2026

Study contacts

Rosa C Lucchetta, PhD
study director · Hospital Alemão Oswaldo Cruz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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