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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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 framework. The programmatic impact of these tools on early infant diagnosis (EID) will be measured in comparison with parallel standard of care (SOC) HIV DNA PCR testing initiated at 6 weeks of age.

Key facts

Study ID

NCT03435887

Run by

University of Kansas Medical Center

People needed

1999

Starts

2016-12-02

Expected to finish

2020-04-30

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kisumu County Hospital — Kisumu, Kenya
• Kombewa District Hospital — Kombewa, Kenya
• Tudor Sub-County Hospital — Mombasa, Kenya
• Rift Valley Provincial General Hospital — Nakuru, Kenya

Full record on ClinicalTrials.gov

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