HIV-diagnosed infants who do not start receiving antiretroviral therapy (ART) by 12 weeks of age are at a distinctly higher risk of dying. Most HIV+ infants are older than 12 weeks at ART initiation.

Kenya's 2016 national emerging infectious diseases (EID) guidelines endorsed the concept of introducing polymerase chain reaction (PCR) testing at birth as an alternative to waiting until infants reach 6 weeks. We are among the first teams in the country actively piloting the implementation of PCR testing for newborns, a key step toward countrywide scale-up.

Preliminary results suggest that PCR testing at birth is feasible in Kenyan government hospitals, resulting in speedier notification of results, with the majority of birth results available in time for the 6 week re-testing time point.

The study, at four Kenyan hospitals, is also piloting the implementation of newly approved point-of-care (POC) HIV testing platforms in the clinic setting. The POC test technologies are aimed at further expediting diagnosis by bypassing the time-consuming steps of PCR testing at off-site laboratories, ideally enabling mothers to be notified of their infants' results before discharge from Maternity.

This rapid testing is comparable to diagnosis strategies for HIV-exposed infants in the US but has never been a feasible option in Kenya and other low resource settings, where HIV DNA PCR testing at 6 six weeks of age is the current standard.

Ours is the first study in Kenya to pilot the use of POC machines for testing infants at birth. We designed the study to capture comprehensive information on the acceptability, feasibility, and impact of these new testing strategies in order to inform national implementation. Our team is sharing findings with members of the Kenya Ministry of Health as they emerge.

Natabhona Mabachi led the team in conducting formative research with providers, parents and community members to optimize the implementation strategy for the study. Trained clinical staff at the four study hospitals enrolled pregnant HIV+ mothers during their antenatal care and prepared them on what to expect from point-of-care testing at delivery.

Point-of-care testing will facilitate treatment initiation among HIV-positive infants within the first days and weeks of life, which will significantly improve their likelihood of survival.