Early Infant Diagnosis Point of Care Pilot

Instituto Nacional de Saúde, Mozambique

Status: Completed

Conditions: HIV

Treatments: Device: Alere q

Study type: Interventional

Funder types: Other

Identifiers

NCT02634450

POC EID PILOT

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 4 weeks to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Intervention

Active Comparator group

Description:

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

Treatment:

Device: Alere q