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

NCT02987270 | Completed Phase 3

• 1 other identifier: 2380
• Study Type: interventional
• Target: 90,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria,Falciparum

Keywords

mass screen and treat; malaria; asymptomatic infections; transmission reduction; infectious reservoir; kenya

Outcome Measures

Primary Outcomes (1)

• 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

  After year 1 and after year 2

Secondary Outcomes (3)

• 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

Study Arms (2)

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).

Drug: Dihydroartemisinin-piperaquine

Control arm

NO INTERVENTION

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.

Interventions

Dihydroartemisinin-piperaquine DRUG

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.

Also known as: Eurartesim

Mass screening and treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cohort study- pregnant at time of recruitment

Sponsors & Collaborators

• Simon Kariuki: lead
• Centers for Disease Control and Prevention: collaborator

Related Publications (2)

• 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.

  PMID: 26852227 BACKGROUND

• 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.

  PMID: 32324850 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum; Malaria; Asymptomatic Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meghna R Desai, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Simon K Kariuki, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Malaria Branch Chief

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: April 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 9, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share