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

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.

Conditions

• HIV Infections

Interventions

BEHAVIORAL

Alere q HIV-1/2 Detect for point of care infant testing

The investigators will pilot the Alere q HIV-1/2 Detect mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4-8 weeks postnatal) for analysis with Alere q HIV-1/2 Detect, with results available within 1-2 hours to enable mother notification at the same clinic visit.

BEHAVIORAL

GeneXpert HIV-1 Qual for point of care infant testing

The investigators will pilot the GeneXpert HIV-1 Qual mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4 to \<24 weeks postnatal) for analysis with GeneXpert HIV-1 Qual, with results available within 1-2 hours to enable mother notification at the same clinic visit.

BEHAVIORAL

HIV DNA PCR testing (Standard of Care)

This is the standard of care for infant HIV testing. A dried blood spot sample will be collected from the infant and shipped to a central laboratory for HIV DNA PCR testing. Results will then be returned to the hospital.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Kansas Medical Center

  lead OTHER

Principal Investigators

• Sarah Kessler, PhD · University of Kansas Medical Center

• Raphael Lwembe, PhD · Kenya Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-02

Primary Completion

2019-07-01

Completion

2020-04-30

Countries

• United States
• Kenya

Study Locations