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).
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
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
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
Henrique Silveira
Professor
Universidade Nova de Lisboa
