Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote d'Ivoire
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,650
- 试验地点
- 1
- 主要终点
- malaria case incidence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
研究概览
简要总结
The investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte d'Ivoire.
The primary objective of the project is to evaluate the efficacy of chlorfenapyr-pyrethroid and piperonyl-butoxide (PBO) synergist-pyrethroid LLINs on malaria case incidence in children aged 6 months to 10 years compared to standard pyrethroid-only LLINs. The secondary objectives are to evaluate the efficacy of the two intervention LLINs compared to the standard LLIN on a) malaria infection prevalence in the general population (both children and adults), b) vector density and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, changes in phenotypic resistance intensity and selection for molecular resistance mechanisms at baseline and 12 months post-LLIN distribution, in sentinel villages in each treatment arm will be investigate.
It is vital to demonstrate that these next generation LLINs which are becoming the standard of care in Sub Saharan AFRICA, are superior to standard py-LLIN in the most extreme resistance areas as this is likely where alternative interventions will be most needed to keep malaria control on track. The trial will generate the first epidemiological evidence on the efficacy of PBO nets compared to py-LLIN in West Africa.
UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
详细描述
Background: The massive scale-up of long-lasting insecticidal nets (LLIN) has led to a major reduction in malaria burden in many sub-Saharan African (SSA) countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors.
Study site: The study will be conducted in the department of Tiebissou (Gbeke Region in Lac district) Southern Bouake city, central Côte d'Ivoire. The Lac district is characterized by intense indoor malaria transmission with a prevalence of malaria reaching 51.3% in 2021 in children of under 5 years of age and extremely high pyrethroid resistance intensity in the main malaria vectors Anopheles gambiae s.s. and An. coluzzii.
Study design: Three-arm superiority, single blinded, cluster-randomised trial with village as the unit of randomisation. The arms consist of; 1/ Veeralin LLIN, a net combining the synergist PBO and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, a mixture LLIN incorporating two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ the control arm: MAGNet LLIN, an alpha-cypermethrin-only LLIN.
UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
Activities/Sample size:
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
- Double (Participant, Outcomes Assessor)
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 adults: willing to participate and provide consent
- •For children: Having a parents/adult caregiver willing to provide written consent for the household and clinical survey and assent for children over 10
- •Residing in the village over the last 3 months
- •Be aged 6 months to 9 years old at time of recruitment (for the cohort)
排除标准
- •Children who are expected to be non-resident over the period of study will be excluded (for the cohort)
- •Dwelling not found or vacant during the survey (for prevalence and entomological surveys)
- •No adult caregiver capable to give informed consent (All activities)
- •Habitants/selected participants severely ill
研究组 & 干预措施
Py LLIN with school-based top ups in years 2 and 3
Our original arms from year 1 were split to either receive top ups or not
干预措施: Alpha-cypermethrin only LLIN (Other)
Py-PBO LLIN
Veeralin is a long-lasting net of 130 deniers containing the pyrethroid insecticide alpha-cypermethrin 6.0 g/kg (216 mg/m2) and the synergist piperonyl butoxide (PBO) 2.2 g/kg (79.2 mg/m2) and manufactured by VKA polymers.
干预措施: Alpha-cypermethrin and PBO LLIN (Other)
Py-CFP LLIN
Interceptor® G2 is a long-lasting dual insecticide treated nets of 100 deniers combining Alpha-cypermethrin 2.4 g/kg (100 mg/m2) and Chlorfenapyr 4.8 g/kg (200 mg/m2) manufactured by BASF
干预措施: Alpha-cypermethrin and Clorfenapyr LLIN (Other)
Py LLIN
MAGNet® is a long-lasting net of 150 deniers containing the pyrethroid insecticide alpha-cypermethrin 5.8 g/kg (261 mg/m2) only and manufactured by VKA polymers.
干预措施: Alpha-cypermethrin only LLIN (Other)
Py-PBO LLIN with school-based top ups in years 2 and 3
Our original arms from year 1 were split to either receive top ups or not
干预措施: Alpha-cypermethrin and PBO LLIN (Other)
Py-PBO LLIN with school-based top ups in years 2 and 3
Our original arms from year 1 were split to either receive top ups or not
干预措施: School-based net top ups in year 2 and year 3 (Other)
Py-CFP LLIN with school-based top ups in years 2 and 3
Our original arms from year 1 were split to either receive top ups or not
干预措施: Alpha-cypermethrin and Clorfenapyr LLIN (Other)
Py-CFP LLIN with school-based top ups in years 2 and 3
Our original arms from year 1 were split to either receive top ups or not
干预措施: School-based net top ups in year 2 and year 3 (Other)
Py LLIN with school-based top ups in years 2 and 3
Our original arms from year 1 were split to either receive top ups or not
干预措施: School-based net top ups in year 2 and year 3 (Other)
结局指标
主要结局
malaria case incidence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
时间窗: Over one year follow up (UPDATE: over 3 years)
Incidence of malaria cases (fever above 37.5C or history of a fever in the last 48 hours and a positive RDT) in children aged 6 months to 10 years.
次要结局
- Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan](12 months post intervention)
- Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan](Baseline)
- Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan](6 months post intervention)
- Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan](18 months post intervention)
- Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan](24 months post intervention)
- Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan](30 months post intervention)
- Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan](36 months post intervention)
- Vector Density per person per night using human indoor and outdoor landing catches(Over one year follow up (UPDATE: over three years))
- Sporozoite rate in Anopheles detected using Enzyme Linked Immuno-Sorbent Assay (ELISA) circumsporozoite protein technique. landing catches(Over one year follow up (UPDATE: over three years))
- Mean number of Plasmodium spp infective malaria vectors collected per person per night(Over one year follow up (UPDATE: over three years))