Quality Assurance of Malaria DiagnosisNCT02504593
Novel mHealth Platform to Ensure Quality of Community-based Malaria Diagnosis
A study testing mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis in people with Quality Assurance of Malaria Diagnosis, run by Duke University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality Assurance of Malaria Diagnosis
- What is being tested?
- mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any person not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis
- Keywords
- Quality Assurance, Monitoring & Evaluation, Malaria rapid diagnostic test (RDT), Community-based malaria diagnosis, Community health workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Community health volunteers | Other | 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. Receives: Device: mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of RDTs with correct administration and interpretation by CHVs compared across the first and tenth 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.
Measured: 6 months (during which each consenting CHV of the 200 eligible will conduct 10 tests)
Secondary outcomes (6)
Percent of RDTs with a false negative reading by CHVs compared across the first and tenth tests
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.
Measured: 6 months
Percent of RDTs with a false positive reading by CHVs compared across the first and tenth tests
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.
Measured: 6 months
Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests
Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests read with the Deki Reader for each CHV.
Measured: 6 months
Percent of RDTs that CHVs performed with an improper test procedure compared across the first and tenth tests.
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.
Measured: 6 months
Overall sensitivity (measured as the proportion of positive tests as determined by the DR which the CHVs correctly identify).
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.
Measured: 6 months
Overall specificity (measured as the proportion of negative tests as determined by the DR which the CHVs correctly identify).
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality Assurance of Malaria DiagnosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy O'Meara, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504593
- Sponsor's protocol ID
- Pro00063521
- Status last verified
- Apr 2016
- First submitted
- 2 Jul 2015
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel mHealth Platform to Ensure Quality of Community-based Malaria Diagnosis
- ClinicalTrials.gov ID
- NCT02504593
- Acronym / sponsor ID
- Pro00063521
- Conditions
- Quality Assurance of Malaria Diagnosis
- Keywords
- Quality Assurance, Monitoring & Evaluation, Malaria rapid diagnostic test (RDT), Community-based malaria diagnosis, Community health workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community health volunteers | Other | Device: mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosisThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any person not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosisThe 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. | Device | Community health volunteers |
Primary outcome
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)
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.
6 secondary outcomes
Percent of RDTs with a false negative reading by CHVs compared across the first and tenth tests
Time frame: 6 months
Percent of RDTs with a false positive reading by CHVs compared across the first and tenth tests
Time frame: 6 months
Percent of invalid RDTs not properly identified by CHVs compared across the first and tenth tests
Time frame: 6 months
Percent of RDTs that CHVs performed with an improper test procedure compared across the first and tenth tests.
Time frame: 6 months
Overall sensitivity (measured as the proportion of positive tests as determined by the DR which the CHVs correctly identify).
Time frame: 6 months
Overall specificity (measured as the proportion of negative tests as determined by the DR which the CHVs correctly identify).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy O'Meara, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis in people with Quality Assurance of Malaria Diagnosis, run by Duke University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.