Use of Rapid Diagnostic Tests for Malaria Case Management in Kenya

This study has been completed.
Sponsor:
Collaborators:
Kenya Medical Research Institute
Kenya Division of Malaria Control
KEMRI-Wellcome Trust Collaborative Research Program
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00336388
First received: June 10, 2006
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to investigate the impact of rapid diagnostic tests (RDTs) in the context of a newly implemented malaria case management guidelines using artemisinin-based combination therapy on the malaria prescribing practices of health care workers in Kenya.


Condition Intervention
Malaria
Device: Paracheck Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Introduction of Malaria Rapid Diagnostic Tests, Artemisinin-based Combination Therapy, and Malaria Case Management Guidelines at Health Facilities in Kenya: A Cluster Randomized Trial to Evaluate Adherence and Acceptance by Health Care Workers, Impact on Antimalarial Prescription Practices, and Patient Perceptions

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Sensitivity and specificity of malaria diagnosis 6 weeks after the introduction of malaria rapid diagnostic tests

Secondary Outcome Measures:
  • Adherence to malaria case management guidelines by health care workers
  • Cost effectiveness of malaria case management guidelines using malaria rapid diagnostic tests
  • Acceptability of malaria rapid diagnostic tests to health care workers
  • Acceptability of malaria rapid diagnostic tests to patients

Estimated Enrollment: 3600
Study Start Date: July 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All ill persons >5 years old attending health facilities in Bondo and Kericho Districts, Kenya
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336388

Locations
Kenya
Bondo and Kericho District Health Facilities
Kisumu, Nyanza Province, Kenya
Sponsors and Collaborators
Kenya Medical Research Institute
Kenya Division of Malaria Control
KEMRI-Wellcome Trust Collaborative Research Program
Investigators
Principal Investigator: Mary Hamel, MD Centers for Disease Control and Prevention
Principal Investigator: Alexandre Macedo De Oliveira, MD Centers for Disease Control and Prevention
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00336388     History of Changes
Other Study ID Numbers: CDC-NCID-4701
Study First Received: June 10, 2006
Last Updated: March 8, 2010
Health Authority: United States: Federal Government
Kenya: Kenya Medical Research Institute

Keywords provided by Centers for Disease Control and Prevention:
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on April 21, 2014