跳至主要内容
临床试验/NCT02987270
NCT02987270已完成3 期

Evaluation of Community-based Screening and Treatment for Malaria in the KEMRI/CDC Health and Demographic Surveillance System (HDSS) in Western Kenya

Simon Kariuki0 个研究点目标入组 90,000 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
90,000
主要终点
Incidence of malaria infection

研究概览

简要总结

This study is a cluster-randomized controlled trial to evaluate the efficacy of community-based mass screening with a malaria rapid diagnostic test, and treatment of participants with positive tests with an appropriate antimalarial for reducing malaria transmission indices.

详细描述

The investigators purposively selected ten health facilities in Siaya County, western Kenya based on malaria case loads. All villages whose midpoint was located within a 3 kilometer radius of each of the ten health facilities were included in the study. Contiguous villages were merged to form two clusters around each health facility. Clusters were randomly assigned to the control or intervention arm such that there was one control and one intervention cluster around each health facility. Approximately 30,000 and 60,000 people resided in intervention and control arms, respectively.

Once a year during the peak malaria transmission season in July, starting at baseline, the investigators selected a simple random sample of compounds within the study area for a cross-sectional survey to determine risk factors for malaria acquisition and parasite prevalence. Every person in each selected compound was consented into the cross-sectional survey. Community health volunteers (CHV) were trained to perform malaria rapid diagnostic tests, collect dried blood spots on filter papers, and provide treatment and referral recommendations for participants. Three times a year, in September, January, and April, for two years, CHVs visited every household in the intervention arm and tested and treated every consenting household member who was positive for malaria by rapid diagnostic test. Throughout the study period, malaria case counts from individuals located within the study clusters were recorded at each of the study health facilities. During the first two cross-sectional surveys we randomly selected 660 individuals to enter into an incidence cohort, 330 per arm. Cohort members were definitively treated for malaria at recruitment with artemether-lumefantrine, and were asked to visit a study health facility once a month for blood draws for malaria testing.

Every month, 18 households were randomly selected for entomological monitoring; 12 in the control arm, and 6 in the intervention arm. Pyrethrum spray catches were performed in each household. Live catches were performed one week in each month of the study. During live collection weeks, as many households were visited as possible, and prokopak aspirators were used to collect mosquitoes from the inner walls of houses.

Prior to the first round of mass screening and treatment and then again after the first round, 36 focus group discussions were conducted to evaluate community acceptance of community-based mass screening and treatment.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Cross sectional studies: Living within one of the study clusters, >1 month of age
  • Cohort: Living within one of the study clusters, ≥1 year of age
  • Passive surveillance: Living within one of the study clusters
  • Entomological surveillance- household in either control or intervention arm

排除标准

  • Cohort study- pregnant at time of recruitment

研究组 & 干预措施

Mass screening and treatment

Experimental

Each member (approximately 30,000 individuals) residing within the mass screening and treatment arm were visited three times a year and tested for malaria by rapid diagnostic test; those testing positive were treated with an appropriate antimalarial- dihydroartemisinin-piperaquine was the first-line therapy. Long-lasting insecticidal net (LLIN) coverage was topped up prior to the intervention to universal coverage (one bednet for every two household participants).

干预措施: Dihydroartemisinin-piperaquine (Drug)

结局指标

主要结局

Incidence of malaria infection

时间窗: After year 1 and after year 2

Incidence of malaria infection as determined by malaria blood smear microscopy in members of the cohort after year 1 and year 2 of mass screening and treatment

次要结局

  • Prevalence of malaria infection(After year 1 and after year 2)
  • Incidence of clinical malaria(After year 1 and after year 2)
  • Entomological indices of transmission(After year 1 and after year 2)

研究者

发起方
Simon Kariuki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Simon Kariuki

Malaria Branch Chief

Kenya Medical Research Institute

相似试验