Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT06761469
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06761469
Study Brief:
Protocol Section:
NCT06761469