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NCT03435887 · ClinicalTrials.gov registry record · NA

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

A NA study of HIV Infections, sponsored by University of Kansas Medical Center.

Completed
Registry status
NA
Development phase
1,999
Enrollment target
5
Study locations

NCT03435887: Completed NA study of HIV Infections, sponsored by University of Kansas Medical Center.

NCT03435887 is a NA study of HIV Infections that has completed, run by University of Kansas Medical Center. The registered enrollment target is 1,999 participants, above the 442-participant average among 542 other HIV Infections trials with a reported enrollment target (352% higher). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03435887, a NA study of HIV Infections, has completed, sponsored by University of Kansas Medical Center.

COMPLETED
Registry status
NA
Development phase
1,999 participants
Enrollment target
5
Study locations

Study 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 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.

Primary Outcome

The proportion of infants receiving HIV testing (POC and/or PCR) during the birth testing window

Conditions Studied

Interventions

  • BEHAVIORAL Alere q HIV-1/2 Detect for point of care infant testing
  • BEHAVIORAL GeneXpert HIV-1 Qual for point of care infant testing
  • BEHAVIORAL HIV DNA PCR testing (Standard of Care)

Study Locations (5)

Other

  • Kisumu County Hospital - Kisumu
  • Kombewa District Hospital - Kombewa
  • Tudor Sub-County Hospital - Mombasa
  • Rift Valley Provincial General Hospital - Nakuru

Kansas

  • University of Kansas Medical Center - Kansas City

Trial Details

FieldValue
Enrollment Target 1,999 participants
Start Date 2016-12-02
Est. Completion 2020-04-30
Phase NA
University of Kansas Medical Center

408 total trials

What the finished NCT03435887 record still lists

NCT03435887 is an interventional study that assigns participants to a tested intervention. Its 1,999 participants enrollment target places it among the larger protocols in the corpus, above the 442-participant average among 542 other HIV Infections trials with a reported enrollment target (352% higher).

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Alere q HIV-1/2 Detect for point of care infant testing is the first listed.

NCT03435887 lists 5 locations in 2 states (Other, Kansas).

Frequently Asked Questions

What is clinical trial NCT03435887 about?

NCT03435887 is a clinical study titled "Piloting At-birth Point of Care HIV Testing Strategies in Kenya". 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 com...

What is the current status of trial NCT03435887?

This trial is currently completed. It is a NA study. The enrollment target is 1,999 participants. The study started on 2016-12-02. Estimated completion is 2020-04-30.

What conditions does trial NCT03435887 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT03435887?

The interventions under investigation include: Alere q HIV-1/2 Detect for point of care infant testing (BEHAVIORAL), GeneXpert HIV-1 Qual for point of care infant testing (BEHAVIORAL), HIV DNA PCR testing (Standard of Care) (BEHAVIORAL).

Who is sponsoring clinical trial NCT03435887?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03435887 being conducted?

This trial has 5 study locations across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03435887's enrollment target sits among peer trials

1,999 13th of 542 higher than 530 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03435887, the US trial registry maintained by the National Library of Medicine. NCT03435887 (large enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.