Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- New cases of leprosy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
盲法说明
Data analyst (statistician)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Multifaceted intervention
Implementation of active-case finding strategies
干预措施: Implementing active-case finding strategies (Other)
Standard of care
Routine screening
结局指标
主要结局
New cases of leprosy
时间窗: 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.
次要结局
- 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.)
研究者
Sebastian Andres Vernal Carranza
Medical Doctor
Hospital Alemão Oswaldo Cruz