An interventional study of Alere q in HIV, sponsored by Instituto Nacional de Saúde, Mozambique. Completed at 8 sites in Mozambique. Open to participants aged 4 Weeks to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-26.
Sponsored by Instituto Nacional de Saúde, Mozambique · Not applicable, Interventional, and Diagnostic
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.
Instituto Nacional de Saúde, Mozambique is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection
Time frame: 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.
Time frame: 3 months after treatment initiation
The median age at time of results received by patient
Time frame: Up to 6 months
The median number of days between specimen collection and results received by patient
Time frame: Up to 6 months
The median age at time of antiretroviral treatment initiation
Time frame: Up to 6 months
The median number of days between specimen collection and initiation of antiretroviral treatment.
Time frame: Up to 6 months
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Saúde, Mozambique