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临床试验/NCT07009613
NCT07009613已完成不适用

Integration of Strongyloides Stercoralis Public Health Control Into the Soil-transmitted Helminths Control Programme in Rwanda - The SCAN Study

IRCCS Sacro Cuore Don Calabria di Negrar1 个研究点 分布在 1 个国家目标入组 1,415 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,415
试验地点
1
主要终点
Evaluation of the tests based on technicians' perception (through questionnaire) and costs

研究概览

简要总结

The World Health Organization (WHO) recently issued guideline for the public health control of Strongyloides stercoralis in endemic areas. We aimed to evaluate the feasibility of implementing the WHO recommendations in Rwanda, specifically to intergrate the activities for the public health control of strongyloidiasis in the ongoing national programme for the control of the other soil-transmitted helminths and schistosomiasis, that has been in place for several years. As additional objective, we aimed to estimate the prevalence of S. stercoralis in two districts of Rwanda (Gisagara and Rubavu). To evaluate the feasibility, we asked lab technicians to evaluate challenges emerged during the implementation of the laboratory procedures with a structured questionnaire. Also, we evaluated the costs needed to perform these tests. We estimated the prevalence of S. stercoralis by calculating the number of positive cases out of all people tested. The lab technicians participated to a training session, where they were taught the S. stercoralis-specific lab techniques, and to a two-day pilot study where they could practice. The tests used were parasitological techniques (agar stool culture, (APC) and Baermann method) and an antibody rapid diagnostic test (RDT). Duration of training, with a specific focus on larvae differentiation, was identified as pivotal for a successful implementation of the parasitological techniques. The use of the RDT was instead considered easy to apply at all evaluation time points. Raw cost (i.e. not including staff salaries and transport costs) of materials and equipment was below 2 euros/test for each assay. In both districts, Strongyloides prevalence was below the threshold recommended by the WHO for the implementation of mass treatment, hence this aspect was not evaluated.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People living in the selected districts and households
  • Obtainment of written informed consent (for children's participation, consent was sought from parents/guardians).

排除标准

  • Inability to supply an adequate stool sample

结局指标

主要结局

Evaluation of the tests based on technicians' perception (through questionnaire) and costs

时间窗: The data will be collected at baseline, during the pilot study (two - three days from baseline) and during field work (after two to three weeks from baseline)

Technicians' previous experience with each S. stercoralis-specific assay, along with their perceptions regarding the ease of each of the procedural steps and associated safety concerns were assessed using a structured questionnaire. Each procedural step was rated as "Very easy", "Easy", "Neutral", "Difficult" and "Very difficult". For the steps marked "difficult" or "very difficult", respondents could specify the reasons for the difficulty from a predefined non-mutually-exclusive list of options. The per-test costs were calculated from the procurement records of each S. stercoralis-specific assay.

次要结局

  • Prevalence(through study completion)

研究者

发起方
IRCCS Sacro Cuore Don Calabria di Negrar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dora Buonfrate

Head of infectious disease Clinical Research Unit

IRCCS Sacro Cuore Don Calabria di Negrar

研究点 (1)

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