1,999
Participants
Start Date
December 2, 2016
Primary Completion Date
July 1, 2019
Study Completion Date
April 30, 2020
Alere q HIV-1/2 Detect for point of care infant testing
The investigators will pilot the Alere q HIV-1/2 Detect mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4-8 weeks postnatal) for analysis with Alere q HIV-1/2 Detect, with results available within 1-2 hours to enable mother notification at the same clinic visit.
GeneXpert HIV-1 Qual for point of care infant testing
The investigators will pilot the GeneXpert HIV-1 Qual mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4 to \<24 weeks postnatal) for analysis with GeneXpert HIV-1 Qual, with results available within 1-2 hours to enable mother notification at the same clinic visit.
HIV DNA PCR testing (Standard of Care)
This is the standard of care for infant HIV testing. A dried blood spot sample will be collected from the infant and shipped to a central laboratory for HIV DNA PCR testing. Results will then be returned to the hospital.
University of Kansas Medical Center, Kansas City
Kisumu County Hospital, Kisumu
Kombewa District Hospital, Kombewa
Tudor Sub-County Hospital, Mombasa
Rift Valley Provincial General Hospital, Nakuru
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Kansas Medical Center
OTHER