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

N/A
Waitlist Available
Led By Sarah Kessler, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • HIV Suppression
  • Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of infants tested at 6-weeks
Proportion of infants tested at birth
Secondary study objectives
Completeness of POC and SOC tests
Costs
Efficiency of POC and SOC tests
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Alere q HIV-1/2 Detect for point of care infant testingActive Control2 Interventions
POC testing with Alere q HIV-1/2 Detect at birth and 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing
Group II: GeneXpert HIV-1 Qual for point of care infant testingActive Control2 Interventions
POC testing with GeneXpert HIV-1 Qual at-birth and at 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
512 Previous Clinical Trials
174,728 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,062 Previous Clinical Trials
2,744,268 Total Patients Enrolled
Sarah Kessler, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
Raphael Lwembe, PhDPrincipal InvestigatorKenya Medical Research Institute
~222 spots leftby Dec 2025
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