Early Infant Diagnosis Point of Care Pilot

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial

Conditions
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HIV

Intervention / Treatment
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* Device: Alere q


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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. | |
| Active Comparator: Intervention<br>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 | Device: Alere q<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection |  | up to 6 months | 
| the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up. | Patients were considered retained in care at 90 days if they had visited the health facility within the previous 30 days. | 3 months after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The median age at time of results received by patient |  | Up to 6 months | 
| The median number of days between specimen collection and results received by patient |  | Up to 6 months | 
| The median age at time of antiretroviral treatment initiation |  | Up to 6 months | 
| The median number of days between specimen collection and initiation of antiretroviral treatment. |  | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Diagnostic, children