Evaluation of Community-based Mass Screening and Treatment for Malaria in Western Kenya
NCT ID: NCT02987270
Last Updated: 2016-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90000 participants
INTERVENTIONAL
2013-04-30
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mass screening and treatment
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).
Dihydroartemisinin-piperaquine
Dihydroartemisinin-piperaquine is an antimalarial in the artemisinin-based combination therapy class of drugs. It is the Kenya Ministry of Health second-line treatment for malaria in Kenya.
Control arm
Members of the control arm received standard of care, which includes universal (LLIN) coverage and standard malaria case management (laboratory confirmation prior to antimalarial treatment) at the study health facilities.
No interventions assigned to this group
Interventions
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Dihydroartemisinin-piperaquine
Dihydroartemisinin-piperaquine is an antimalarial in the artemisinin-based combination therapy class of drugs. It is the Kenya Ministry of Health second-line treatment for malaria in Kenya.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
ALL
Yes
Sponsors
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Centers for Disease Control and Prevention
FED
Simon Kariuki
OTHER
Responsible Party
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Simon Kariuki
Malaria Branch Chief
Principal Investigators
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Meghna R Desai, PhD
Role: PRINCIPAL_INVESTIGATOR
Centers for Disease Control and Prevention
Simon K Kariuki, PhD
Role: PRINCIPAL_INVESTIGATOR
Kenya Medical Research Institute
References
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Shuford K, Were F, Awino N, Samuels A, Ouma P, Kariuki S, Desai M, Allen DR. Community perceptions of mass screening and treatment for malaria in Siaya County, western Kenya. Malar J. 2016 Feb 6;15:71. doi: 10.1186/s12936-016-1123-y.
Samuels AM, Odero NA, Odongo W, Otieno K, Were V, Shi YP, Sang T, Williamson J, Wiegand R, Hamel MJ, Kachur SP, Slutsker L, Lindblade KA, Kariuki SK, Desai MR. Impact of Community-Based Mass Testing and Treatment on Malaria Infection Prevalence in a High-Transmission Area of Western Kenya: A Cluster Randomized Controlled Trial. Clin Infect Dis. 2021 Jun 1;72(11):1927-1935. doi: 10.1093/cid/ciaa471.
Other Identifiers
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2380
Identifier Type: -
Identifier Source: org_study_id