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

NCT02504593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-05-25

No results posted yet for this study

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.

Conditions

  • Quality Assurance of Malaria Diagnosis

Interventions

DEVICE

mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis

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.

Sponsors & Collaborators

Principal Investigators

  • Wendy O'Meara, PhD · Duke University

Study Design

Allocation
NA
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504593 on ClinicalTrials.gov