NCT02634450

Early Infant Diagnosis Point of Care Pilot

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Instituto Nacional de Saúde, Mozambique · Other Government
• Sex: All
• Age: 4 Weeks – 18 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• HIV

Interventions

Type	Name	Description
DEVICE	Alere q

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2015-12-18
• Last updated: 2017-07-26

Locations

8 sites across 1 country: Mozambique