Clinical trial NCT02987270: Evaluation of Community-based Mass Screening and Treatment for Malaria in Western Kenya
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria,Falciparum
Keywords: mass screen and treat
malaria
asymptomatic infections
transmission reduction
infectious reservoir
kenya
Lead sponsor: Kenya Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2016-12-08
Enrollment: 90000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of malaria infection
timeFrame: After year 1 and after year 2
Secondary outcomes:
measure: Prevalence of malaria infection
timeFrame: After year 1 and after year 2
measure: Incidence of clinical malaria
timeFrame: After year 1 and after year 2
measure: Entomological indices of transmission
timeFrame: After year 1 and after year 2
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Meghna R Desai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Simon K Kariuki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.