Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya

The current EID system is hampered by significant structural barriers that contribute to late
and sporadic testing of HIV-exposed infants, lost or delayed test results from the
laboratory, and the absence of a reliable system to notify mothers of test results or the
need to return to the hospital.

Consequently, in Kenya only about one-third of HIV-exposed infants receive complete EID care
through 18 months of age, and less than 20% of diagnosed HIV+ infants are initiated on life
saving ART.

To maximize both the benefits and efficiencies of EID efforts, the investigators have
developed a system strengthening intervention called the HIV Infant Tracking System
(HITSystem©). The HITSystem intervention is an online, automated intervention designed to
overcome current EID barriers by providing efficient prospective tracking of HIV- exposed
infants and triggering electronic action 'alerts' for both EID providers and lab technicians
when time sensitive interventions are overdue for specific infants. A built-in text messaging
system sends text messages to mothers' cell phones when test results are ready or follow up
visits are needed. The ultimate goals of the HITSystem are to maximize (a) EID service
utilization for HIV-exposed infants (retention until 18 months) and (b) early ART initiation
for infants diagnosed HIV+, by facilitating collaboration and accountability between key
stakeholders (hospitals, laboratories and mothers) to improve EID outcomes.

Our pilot data from two hospitals in Kenya (one urban, one peri-urban) demonstrate the
acceptability and feasibility of implementing this intervention. Using a pre-post
intervention design the investigators compared EID outcomes from n=330 mother-infant pairs
assessed by retrospective chart review during the 12 months prior to the initiation of the
intervention to n=460 mother-infant pairs enrolled in the HITSystem intervention over the
course of several months (9 and 6 months, respectively). Pilot data indicate a 3 fold
increase in EID retention (31% vs. 97%, p<0.001), and more than doubled infant ART initiation
rates (44% vs. 95%, p<0.001).14 These data have resulted in great interest and support from
the Kenya Ministry of Health for this study, the findings of which will influence national
EID dissemination decisions.

To more rigorously evaluate the impact of the HITSystem intervention on EID care in a
low-resource country and implications for the feasibility of scaling up this intervention,
the investigators will use a cluster randomized control trial among 6 Kenyan government
hospitals (3 intervention and 3 standard of care; matched). Three specific aims guide the
proposed study:

Aim 1. Conduct a randomized controlled trial to evaluate the efficacy of the HITSystem in
improving the timely provision of 8 critical intervention benchmarks for optimal Early Infant
Diagnosis of HIV and management.

Aim 2. To identify among HIV-exposed infants predictors of (1) incomplete EID care and (2)
time periods most vulnerable to loss of contact at both intervention and control sites.

Aim 3. To estimate the incremental cost-effectiveness of the HITSystem in improving complete
EID care across study arms, and to assess user satisfaction among key stakeholders.

This study will scientifically evaluate the public health impact of the HITSystem to improve
critical EID outcomes in low-resource settings. Cost-effectiveness analyses will inform the
feasibility of scaling up the HITSystem in other settings, and opportunities to adapt the
technology to address other health outcomes.

Inclusion Criteria:

- HIV+ mother whose infant is <18 months of age

- Ability to provide consent

Exclusion Criteria: