Status:
COMPLETED
Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation frame...
Detailed Description
Testing HIV-exposed infants by polymerase chain reaction (PCR) testing at 6 weeks is often not early enough to mitigate the substantial mortality peak that occurs around 2-3 months of age. Initial tes...
Eligibility Criteria
Inclusion
- HIV-positive pregnant women enrolled in PMTCT services or who deliver at the study hospitals and/or mothers with exposed infants presenting for EID prior to 24 weeks
- Provide informed consent
Exclusion
- HIV-positive pregnant women less than 18 years of age
- HIV-positive pregnant women unable to provide informed consent
- HIV-exposed infants presenting for HIV testing at \> 24 weeks
Key Trial Info
Start Date :
December 2 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
1999 Patients enrolled
Trial Details
Trial ID
NCT03435887
Start Date
December 2 2016
End Date
April 30 2020
Last Update
July 14 2020
Active Locations (5)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Kisumu County Hospital
Kisumu, Kenya
3
Kombewa District Hospital
Kombewa, Kenya
4
Tudor Sub-County Hospital
Mombasa, Kenya