Clinical Trial: Evaluation of Community-based Mass Screening and Treatment for Malaria in Western Kenya

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

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



Original Primary Outcome: Incidence of malaria infection [ Time Frame: Two years ]

Incidence of malaria infection as determined by malaria blood smear microscopy in members of the cohort over the two years of mass screening and treatment


Current Secondary Outcome:

  • Prevalence of malaria infection [ Time Frame: After year 1 and after year 2 ]
    Prevalence of malaria infections diagnosed by blood smear microscopy were determined during three cross-sectional studies at baseline, after year 1, and after year 2.
  • Incidence of clinical malaria [ Time Frame: After year 1 and after year 2 ]
    Incidence of clinical malaria as determined by passive surveillance in the ten study health facilities, after year 1 and after year 2.
  • Entomological indices of transmission [ Time Frame: After year 1 and after year 2 ]
    Sporozoite and oocyst rates were compared in malaria vectors captured during pyrethrum spray catches and aspirations after year 1 and after year 2.


Original Secondary Outcome:

  • Prevalence of malaria infection [ Time Frame: Two years ]
    Prevalence of malaria infections diagnosed by blood smear microscopy were determined during three cross-sectional studies at baseline, after year 1, and after year 2.
  • Incidence of clinical malaria [ Time Frame: Two years ]
    Incidence of clinical malaria as determined by passive surveillance in the ten study health facilities.
  • Entomological indices of transmission [ Time Frame: Two years ]
    Sporozoite and oocyst rates were compared in malaria vectors captured during pyrethrum spray catches and aspirations.


Information By: Kenya Medical Research Institute

Dates:
Date Received: December 6, 2016
Date Started: April 2013
Date Completion:
Last Updated: December 8, 2016
Last Verified: December 2016