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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Page 1 of 2 (5 locations)

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