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

Testing HIV-exposed infants by polymerase chain reaction (PCR) testing at 6 weeks is often
not early enough to mitigate the substantial mortality peak that occurs around 2-3 months of
age. Initial testing at birth would foster more rapid identification of infants with
intrauterine (IU) infection and speed up the initiation of antiretroviral therapy (ART) for
HIV-positive infants. Consequently, Kenya introduced new early infant diagnosis guidelines
recommending at-birth (0-2 weeks) virologic testing in addition to the SOC tests at 6 weeks
(6 - <24 weeks), 6 months and 12 months. POC testing performed in the clinic setting can
potentially further reduce the time to diagnosis. Investigators will pilot test the
implementation, performance, and cost-effectiveness of two POC test systems (Xpert HIV-1
Qual, Alere q HIV-1/2 Detect) in samples from neonates (at-birth test) and older infants
(6-week test) in four government hospitals in Kenya.

In the formative phase of the study, interviews will be conducted with parents, providers and
community members regarding benefits and concerns about the implementation of at-birth and
POC testing. Interviews with parents (pregnant women living with HIV and their partners if
available) will focus on the impact for the child and family. Interviews with providers who
would carry out POC testing at each site (maternity nurses, mentor mothers, hospital
laboratory staff) will highlight issues of training, logistics and implementation. Interviews
with community members (parents of HIV-exposed infants, community health workers, community
leaders) in surrounding communities will elicit attitudes and suggestions regarding the
potential for POC HIV testing in hard to access communities. Investigators will develop a
codebook with typical exemplars for each theme, calculating the frequency and distribution of
themes within the larger topic areas. The study team will rapidly review themes to inform the
POC pilot.

In the intervention phase the investigators will pilot at-birth and POC infant testing
strategies in four hospitals over a continuous 12-month enrollment period. Sites will be
randomized to pilot Xpert HIV-1 Qual (n=2) or Alere q HIV-1/2 Detect (n=2), both targeting
the at-birth and 6-week testing points. A second blood sample will be collected at each time
point to be tested by SOC laboratory-based HIV DNA PCR, which will correspond with the Kenya
government's 2016 guidelines that recommend adding an at-birth test to the EID schedule.
At-birth samples will ideally be collected within 24 hours of delivery and results
communicated to the mother with counseling prior to discharge from maternity. The expected
due dates of exposed infant will be tracked to encourage mothers who deliver outside the
hospital to return for infant testing within two weeks postnatal. Infants enrolled in this
pilot will be tracked until HIV results at birth and 6 weeks postnatal have been provided by
POC and standard PCR, or until ART is initiated for HIV-positive infants. Investigators will
assess user uptake, age at notification of HIV test results, age of ART initiation among HIV+
infants, POC machine performance, costs, and user experiences (providers will participate in
a monthly focus group to discuss challenges and solutions) to inform the feasibility and
optimal implementation of Kenya's 2016 at-birth test recommendation and of the mobile POC
test systems for the improvement of EID outcomes.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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