Clinical trial NCT02504593: Novel mHealth Platform to Ensure Quality of Community-based Malaria Diagnosis
Official title: Novel mHealth Platform to Ensure Quality of Community-based Malaria Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality Assurance of Malaria Diagnosis
Keywords: Quality Assurance
Monitoring & Evaluation
Malaria rapid diagnostic test (RDT)
Community-based malaria diagnosis
Community health workers
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent of RDTs with correct administration and interpretation by CHVs compared across the first and tenth tests
timeFrame: 6 months (during which each consenting CHV of the 200 eligible will conduct 10 tests)
Secondary outcomes:
measure: Percent of RDTs with a false negative reading by CHVs compared across the first and tenth tests
timeFrame: 6 months
measure: Percent of RDTs with a false positive reading by CHVs compared across the first and tenth tests
timeFrame: 6 months
measure: Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests
timeFrame: 6 months
measure: Percent of RDTs that CHVs performed with an improper test procedure compared across the first and tenth tests.
timeFrame: 6 months
measure: Overall sensitivity (measured as the proportion of positive tests as determined by the DR which the CHVs correctly identify).
timeFrame: 6 months
measure: Overall specificity (measured as the proportion of negative tests as determined by the DR which the CHVs correctly identify).
timeFrame: 6 months
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Duke University
Study officials:
affiliation: Duke University
name: Wendy O'Meara, PhD
role: PRINCIPAL_INVESTIGATOR
References: