- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02504593
Novel mHealth Platform to Ensure Quality of Community-based Malaria Diagnosis
May 24, 2016 updated by: Duke University
The investigators propose to implement a new mobile interface that automatically reads and troubleshoots malaria rapid diagnostic test (RDT) cassettes.
This device, called a Deki reader (DR), will allow the investigators to establish an extensive quality assurance program of malaria diagnosis performed by trained community health volunteers (CHVs).
The study will lease 10 DRs and rotate them amongst 200 CHVs performing community-based malaria diagnosis through rapid diagnostic testing.
The study setting is Bungoma East subcounty and Kiminini subcounty in Kenya.
The overall goal is to measure and improve the quality of malaria diagnosis by CHVs using malaria RDTs.
The investigators aim for every CHW to exceed 90% sensitivity and specificity and zero operator errors within six months.
There are no appreciable risks to the CHV associated with evaluation by the DR device.
The investigators' analysis will focus on descriptive statistics of RDT use and accuracy amongst all participating CHVs.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Eldoret, Kenya
- Duke University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All community health volunteers in 10 community units in Bungoma East and 6 community units in Kiminini that have been trained to provide community-based malaria diagnosis through rapid diagnostic testing are eligible.
Exclusion Criteria:
- Any person not meeting the inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Community health volunteers
The study subjects are all community health volunteers in community units in Kenya (10 community units in Bungoma East and 6 community units in Kiminini) that have been trained to provide community-based malaria diagnosis through rapid diagnostic testing.
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The investigators propose to implement a new mobile interface that automatically reads and troubleshoots malaria rapid diagnostic test (RDT) cassettes.
This device, called a Deki reader (DR), will allow the investigators to establish an extensive quality assurance program of malaria diagnosis performed by trained community health volunteers (CHVs).
To ensure high-quality diagnosis by CHVs, the study team will deploy 10 Fionet DRs and rotate them amongst 200 CHVs who have been trained to do RDTs.
In the first phase, each CHV will use the device for 10 successive clients presenting themselves for malaria diagnosis to the CHV, and then the device will be rotated to another CHV.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of RDTs with correct administration and interpretation by CHVs compared across the first and tenth tests
Time Frame: 6 months (during which each consenting CHV of the 200 eligible will conduct 10 tests)
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The percent of RDTs that were properly conducted and interpreted by CHVs, according to Deki Reader results, comparing across the first and tenth RDTs read with the Deki Reader for each CHV.
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6 months (during which each consenting CHV of the 200 eligible will conduct 10 tests)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of RDTs with a false negative reading by CHVs compared across the first and tenth tests
Time Frame: 6 months
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Percent of RDTs with a false negative reading by CHVs compared across the first and tenth tests read with the Deki Reader for each CHV.
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6 months
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Percent of RDTs with a false positive reading by CHVs compared across the first and tenth tests
Time Frame: 6 months
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Percent of RDTs with a false positive reading by CHVs compared across the first and tenth tests read with the Deki Reader for each CHV.
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6 months
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Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests
Time Frame: 6 months
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Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests read with the Deki Reader for each CHV.
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6 months
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Percent of RDTs that CHVs performed with an improper test procedure compared across the first and tenth tests.
Time Frame: 6 months
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Percent of RDTs that CHVs performed with an improper test procedure compared across the first and tenth tests read with the Deki Reader for each CHV.
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6 months
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Overall sensitivity (measured as the proportion of positive tests as determined by the DR which the CHVs correctly identify).
Time Frame: 6 months
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Overall sensitivity of RDTs performed by CHVs compared to the Deki Reader results.
Sensitivity will be measured as the proportion of positive tests as determined by the DR which the CHVs correctly identify.
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6 months
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Overall specificity (measured as the proportion of negative tests as determined by the DR which the CHVs correctly identify).
Time Frame: 6 months
|
Overall specificity of RDTs performed by CHVs compared to the Deki Reader results.
Specificity will be measured as the proportion of negative tests as determined by the DR which the CHVs correctly identify.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wendy O'Meara, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
July 2, 2015
First Submitted That Met QC Criteria
July 20, 2015
First Posted (Estimate)
July 22, 2015
Study Record Updates
Last Update Posted (Estimate)
May 25, 2016
Last Update Submitted That Met QC Criteria
May 24, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00063521
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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