Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 10:21 PM
Study NCT ID:
NCT02634450
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2015-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Infant Diagnosis Point of Care Pilot
Sponsor:
Instituto Nacional de Saúde, Mozambique
Organization:
Study Overview
Official Title:
Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: