- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02634450
Early Infant Diagnosis Point of Care Pilot
July 24, 2017 updated by: Instituto Nacional de Saúde, Mozambique
Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
In Mozambique, early infant HIV diagnosis (EID, i.e.
HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane.
However, test volumes are growing and many parts of the country do not have close access to laboratories.
Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country.
There are now new POC EID technologies becoming available that will enable diagnosis of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non technical staff and without laboratory infrastructure.
This protocol describes a plan to conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing technologies that are being considered for use in Mozambique, and to pilot those technologies in order to provide more effective diagnostics and clinical care to patients.
During this implementation pilot, sites are randomized to use either conventional or POC EID testing only before the inclusion of the patients in the study.
No consent will be asked to the parents or guardians.
A written permission will be asked to the Direção Provincial de Saúde of both provinces to implement the POC device as routine in those intervention sites.
All the information that will be analyzed will be collected from the routine care and it will be analyzed as a group.
Study Overview
Study Type
Interventional
Enrollment (Actual)
179
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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Maputo, Mozambique
- Centro de Saude de Machava II
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Maputo, Mozambique
- Centro de Saude Matola Gare
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Maputo, Mozambique
- Centro de Saúde de Khongolote
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Maputo
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Moamba, Maputo, Mozambique
- Centro de Saude Moamba
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Sofala
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Beira, Sofala, Mozambique
- Centro de Saude de Manga Loforte
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Beira, Sofala, Mozambique
- Centro de Saude de Ponta Gea
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Beira, Sofala, Mozambique
- Centro de Saude Munhava
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Beira, Sofala, Mozambique
- Centro de Saude NHACONJO
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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
4 weeks to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Born to HIV positive mother
- From 4 weeks to 18 months of age
- Came to CCR consultation for Early Infant Diagnosis
Exclusion Criteria:
- With a valid positive test by other center
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
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Current practice of Early Infant Diagnosis in Mozambique: using conventional system of collecting blood on Dried Blood Spot and sending it to central laboratory for PCR processing and receiving result by SMS printer.
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Active Comparator: Intervention
Point Of Care Device (Alere q) is used for Early Infant Diagnosis, with the sample collected and processed in the consultation room with the device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection
Time Frame: up to 6 months
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up to 6 months
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the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up.
Time Frame: 3 months after treatment initiation
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Patients were considered retained in care at 90 days if they had visited the health facility within the previous 30 days.
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3 months after treatment initiation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The median age at time of results received by patient
Time Frame: Up to 6 months
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Up to 6 months
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The median number of days between specimen collection and results received by patient
Time Frame: Up to 6 months
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Up to 6 months
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The median age at time of antiretroviral treatment initiation
Time Frame: Up to 6 months
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Up to 6 months
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The median number of days between specimen collection and initiation of antiretroviral treatment.
Time Frame: Up to 6 months
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Up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2015
Primary Completion (Actual)
September 30, 2016
Study Completion (Actual)
September 30, 2016
Study Registration Dates
First Submitted
December 5, 2015
First Submitted That Met QC Criteria
December 15, 2015
First Posted (Estimate)
December 18, 2015
Study Record Updates
Last Update Posted (Actual)
July 26, 2017
Last Update Submitted That Met QC Criteria
July 24, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- POC EID PILOT
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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