Novel mHealth Platform to Ensure Quality of Community-based Malaria Diagnosis

Not Applicable

Completed

• Conditions: Quality Assurance of Malaria Diagnosis
• Interventions: Device: mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis

• Registration Number: NCT02504593
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Community health volunteers	mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis	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.

Primary Outcome Measures

Name	Time	Method
Percent of RDTs with correct administration and interpretation by CHVs compared across the first and tenth tests	6 months (during which each consenting CHV of the 200 eligible will conduct 10 tests)	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.

Secondary Outcome Measures

Name	Time	Method
Percent of RDTs with a false negative reading by CHVs compared across the first and tenth tests	6 months	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.
Percent of RDTs with a false positive reading by CHVs compared across the first and tenth tests	6 months	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.
Overall specificity (measured as the proportion of negative tests as determined by the DR which the CHVs correctly identify).	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.
Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests	6 months	Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests read with the Deki Reader for each CHV.
Percent of RDTs that CHVs performed with an improper test procedure compared across the first and tenth tests.	6 months	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.
Overall sensitivity (measured as the proportion of positive tests as determined by the DR which the CHVs correctly identify).	6 months	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.

Trial Locations

Locations (1)

Duke University; 🇰🇪 Eldoret, Kenya