Piloting At-birth Point of Care HIV Testing Strategies in Kenya

NACompletedINTERVENTIONAL
Enrollment

1,999

Participants

Timeline

Start Date

December 2, 2016

Primary Completion Date

July 1, 2019

Study Completion Date

April 30, 2020

Conditions
HIV Infections
Interventions
BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Trial Locations (5)

66160

University of Kansas Medical Center, Kansas City

Unknown

Kisumu County Hospital, Kisumu

Kombewa District Hospital, Kombewa

Tudor Sub-County Hospital, Mombasa

Rift Valley Provincial General Hospital, Nakuru

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Kansas Medical Center

OTHER

NCT03435887 - Piloting At-birth Point of Care HIV Testing Strategies in Kenya | Biotech Hunter | Biotech Hunter