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临床试验/NCT04419766
NCT04419766进行中(未招募)不适用

Evaluation of IR3535 As a Spatial Repellent for Malaria Control. (Avaliação Da Eficácia Do Repelente Ambiental 3-(n-acetyl-n-butyl) Aminopropionic Acid Ethyl Ester (IR3535) Como Ferramenta Para O Controlo Da Malária).

Universidade Nova de Lisboa1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2021年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
166
试验地点
1
主要终点
Change from Baseline in Knowledge, attitudes and practices - KAP score at 1st year

研究概览

简要总结

Mozambique contributes with 5% of global malaria cases, and despite control efforts the Sofala province continues to experience a high burden of malaria. The resistance to insecticides and changes in vector habits can compromise the use of common vector control tools. The use of spatial repellents is thus an interesting alternative, as it does not exert selective pressure on resistance genes or eliminate other insects with impact on biodiversity. IR3535 is a non-toxic repellent and if used at community level can extend protection to outdoor biting.

Hypothesis: Using the IR3535 repellent for indoor and outdoor spraying will reduce the prevalence of malaria and reduce vector density and infection.

An experimental Before-After-Control-Intervention will be carried out with two groups: a) Intervention (Tambai Q2 and Q6): with intra and extra-household spraying with IR3535 and b) Control (Tambai Q3 and Q4): without spraying. Tambai is acommunity of Bebedo, Nhamatanda, Sofala, Mozambique. The mosquito distribution, diversity, density and sporozoite rate will be monitored indoors and outdoors in both communities for 2 years. The prevalence of malaria will be determined in under five years old children at the beginning, the end of the 1st year and at the end of the study. Additionally, cross-sectional studies with a mixed approach assessing the community knowledge, attitudes and practices (KAP) will be carried out to detect gaps that persist at the community level. Heads of households and health professionals will be interviewed at the beginning of the study, the end of 1st year and at the end of the study. The data will be analyzed using SPSS and R software packages. For matching situations (before and after), the McNemar test will be used to ascertain statistical significance. Generalized Linear Models (GLM) will be used to jointly analyze several explanatory variables. Linear Mixed Models (LMM) and Generalized Estimation Equation (GEE) models will be used to compare longitudinal data. The prevalence of malaria and entomological indices relevant for transmission are expected to decrease with the intervention while community knowledge on malaria and its control are expected to increase.

详细描述

Study area and population

The study will be carried out in the communities of Tambai, locality of Bebedo, district of Nhamatanda, Sofala province, Mozambique. The community is covered by the Mutondo Health Center.

Study design

A prospective experimental Before-After-Control-Intervention test will be carried out with two groups: a) Intervention (community of Tambai quarters 2 (Q2) and 6 (Q6)): with indoors and outdoors spraying with IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester) and b) Control (community of Tambai quarters 3 (Q3) and 4 (Q4)): without spraying. This longitudinal study will last for 2 years. Mosquitoes will be captured indoors and outdoors to determine entomological indicators relevant to transmission. Mosquito breeding sites in the communities will be mapped using "Participatory Mapping". The prevalence of malaria in children under five will be determined in the control and in the intervention communities, at the beginning, middle and end of study. A KAP survey on malaria to Tambai householders (Q2, Q3, Q4; Q6) and health professionals and key community actors.

Population interventions and procedures

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for children:
  • •aged 6 to 59 months
  • •resident in the communities under study
  • •to give informed consent for participation by parents or legal representatives
  • •availability on the day of the study.

排除标准

  • •for children:
  • •aged below 6 months and older than 59 months
  • •being infected with or having undergone malaria treatment for up to one month
  • •lack of consent from parents or legal representatives.
  • •Inclusion Criteria for heads of household and health professionals:
  • •Be the head of household or someone appointed by her/him and a resident at the place of study
  • •Be a health professional in the area of Vinho health center
  • •Be available on the day of the interview
  • •Have consented to participate in the study
  • •Exclusion Criteria for heads of household and health professionals:
  • •Having a mental illness or having a change in behavior

研究组 & 干预措施

intervention

Experimental

Community of Tambai: Indoors and outdoors spraying with IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester)

干预措施: IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester) house spraying (Other)

Control

No Intervention

Community of Micheu 1: Without spraying.

结局指标

主要结局

Change from Baseline in Knowledge, attitudes and practices - KAP score at 1st year

时间窗: Month 1, Month 12

An evaluation scale will be defined with the attribution of points for correct answers, and whoever has \<50% will be considered a participant with a bad level of knowledge, attitudes and practices and whoever has 50% -74% and ≥75% will be considered medium and high level of knowledge, attitudes or practices respectively

Changes from baseline in malaria prevalence in children under 5 years at 1st year

时间窗: Month 1, Month 12

Malaria cases in children aged 6 to 59 months

Changes from baseline in malaria prevalence in children under 5 years at 2nd year

时间窗: Month 1, Month 24

Malaria cases in children aged 6 to 59 months

Monthly changes of Anopheles mosquito sporozoite rate

时间窗: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 19, 20, 21, 22, 23, 24 Months

Number of infected mosquitoes determined by PCR

Monthly changes of outdoor Anopheles mosquito density from baseline to month 24

时间窗: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 19, 20, 21, 22, 23, 24 Months

Outside mosquitoes collected overnight using CDC-light traps

Change from Baseline in Knowledge, attitudes and practices - KAP score at 2nd

时间窗: Month 1, Month 24

An evaluation scale will be defined with the attribution of points for correct answers, and whoever has \<50% will be considered a participant with a bad level of knowledge, attitudes and practices and whoever has 50% -74% and ≥75% will be considered medium and high level of knowledge, attitudes or practices respectively

Monthly changes of indoor Anopheles mosquito density from baseline to month 24

时间窗: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 19, 20, 21, 22, 23, 24 Months

Mosquitoes resting inside the houses will be collected by aspiration

次要结局

  • Mosquito breeding sites mapping(continuous for the 2 years)
  • Prevalence of symptomatic malaria cases in the area covered by the Vinho health center(continuous for the 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henrique Silveira

Professor

Universidade Nova de Lisboa

研究点 (1)

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