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Evaluation of Community-based Mass Screening and Treatment for Malaria in Western Kenya (MSaT)

Primary Purpose

Malaria,Falciparum

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dihydroartemisinin-piperaquine
Sponsored by
Simon Kariuki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria,Falciparum focused on measuring mass screen and treat, malaria, asymptomatic infections, transmission reduction, infectious reservoir, kenya

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Cohort study- pregnant at time of recruitment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mass screening and treatment

    Control arm

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of malaria infection
    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

    Secondary Outcome Measures

    Prevalence of malaria infection
    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
    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
    Sporozoite and oocyst rates were compared in malaria vectors captured during pyrethrum spray catches and aspirations after year 1 and after year 2.

    Full Information

    First Posted
    December 6, 2016
    Last Updated
    December 8, 2016
    Sponsor
    Simon Kariuki
    Collaborators
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02987270
    Brief Title
    Evaluation of Community-based Mass Screening and Treatment for Malaria in Western Kenya
    Acronym
    MSaT
    Official Title
    Evaluation of Community-based Screening and Treatment for Malaria in the KEMRI/CDC Health and Demographic Surveillance System (HDSS) in Western Kenya
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Simon Kariuki
    Collaborators
    Centers for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria,Falciparum
    Keywords
    mass screen and treat, malaria, asymptomatic infections, transmission reduction, infectious reservoir, kenya

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mass screening and treatment
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Dihydroartemisinin-piperaquine
    Other Intervention Name(s)
    Eurartesim
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of malaria infection
    Description
    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
    Time Frame
    After year 1 and after year 2
    Secondary Outcome Measure Information:
    Title
    Prevalence of malaria infection
    Description
    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.
    Time Frame
    After year 1 and after year 2
    Title
    Incidence of clinical malaria
    Description
    Incidence of clinical malaria as determined by passive surveillance in the ten study health facilities, after year 1 and after year 2.
    Time Frame
    After year 1 and after year 2
    Title
    Entomological indices of transmission
    Description
    Sporozoite and oocyst rates were compared in malaria vectors captured during pyrethrum spray catches and aspirations after year 1 and after year 2.
    Time Frame
    After year 1 and after year 2

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Cohort study- pregnant at time of recruitment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meghna R Desai, PhD
    Organizational Affiliation
    Centers for Disease Control and Prevention
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Simon K Kariuki, PhD
    Organizational Affiliation
    Kenya Medical Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26852227
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32324850
    Citation
    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.
    Results Reference
    derived

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

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