A digital health system combining
online services with text messages is highly effective in early infant
diagnosis of HIV according to findings from a cluster-randomised controlled
trial in Kenya published in The Lancet
HIV
.

The HIV Infant Tracking
System (HITSystem), a novel integrated system, links providers of early infant
diagnosis, laboratory technicians and mothers and infants to improve outcomes
for HIV-exposed infants. Infants allocated to facilities with this intervention
were significantly more likely to get complete early infant diagnosis services
(85%) than those assigned to control facilities (60%).

Early diagnosis of HIV
infection is essential for the timely initiation of life-saving antiretroviral
therapy (ART) for infants born to HIV-positive mothers so preventing death and
disease. Disease progression is rapid in the first few months of life. The Children with HIV (CHER) study showed a 76%
reduction in disease and a 75% reduction in death, with notable short-term cost
reductions, when HIV-infected infants started ART under three months of age
.

Confirmation of an HIV-exposed
infant’s HIV status begins at six weeks with a succession of steps taking up to
18 months for testing to be completed. As maternal antibodies cross the
placenta and persist in infant blood for up to 18 months, antibodies detected
in infants usually represent exposure to maternal HIV, not true infant HIV
infection. Antibody testing can only be used to exclude infant infection after
12 months of age or confirm infection after 15-18 months of age. Accurate
diagnosis before this needs detection of viral components (virological testing)
including DNA integrated into host cells. DNA can be detected by PCR-based
tests.

In Kenya, the casacade of
care includes:

  • dried blood spot sample
    collection for HIV DNA PCR testing at six weeks of age
  • shipment and processing of
    the sample at a central laboratory
  • return of the paper-based results
    to the health facility
  • notifying the mother of the
    result and
  • either starting
    antiretroviral therapy for HIV-positive infants or antibody retesting at nine
    and 18 months for HIV-negative infants.

In Kenya, as in other high
volume and remote resource-poor settings, implementation of early infant
diagnosis programmes with completion of the diagnostic steps is challenging. Barriers
include successfully identifying, offering and acceptance of testing among those
HIV-exposed as well as unknown; accurate specimen collection, transport and
laboratory processing; getting results to healthcare providers and infants’
caregivers; and difficulties in retaining mother-infant pairs in care due to
transport issues as well as social and economic factors.

While early infant diagnosis increased
from 36% in 2012 to 53% in 2016 it falls far short of the target of testing all
HIV-exposed infants by six weeks of age and starting ART for HIV-positive
infants by 12 weeks of age.

Evidence of the usefulness of
digital health services for maternal and child health is increasing, including SMS text messaging to improve early infant
diagnosis
, completion of the initial
test and turnaround time for PCR results.

The authors undertook a
cluster-randomised trial in six hospitals to determine the efficacy of the
HITSystem, a comprehensive eHealth initiative, to improve the quality and
efficiency of early infant diagnosis services in Kenya. The HITSystem tracks
infants and sends alerts to hospitals, laboratories and mothers so that interventions
are completed. Hospital staff can view test results in real time; mothers are
sent discreetly worded text messages inviting them to attend the clinic; and
delays trigger alerts.

Quality (the primary outcome)
refers to completion of all the services and efficiency (the secondary outcome)
to the turnaround time of the many time-sensitive early infant diagnosis
services.

The hospitals, matched on
geographic region, resource level and patient volume (high, medium and low),
were randomly allocated to either the HITSystem (intervention) or standard of
care (control). Mothers 18 years of age or more with an infant younger than 24
weeks presenting for their first early infant diagnosis were eligible to
participate.

There were 392 mother-infant
pairs in the intervention sites and 298 mother-infant pairs in the control
sites. There were no significant differences in education, income level, maternal
age (median 29 years) or disclosure status.

Infants diagnosed as
HIV-positive were followed up for a median of 2.1 months and HIV-negative
infants for a median of 17 months.

Infants allocated to
intervention facilities were significantly more likely to get complete early
infant diagnosis services compared with those assigned to the standard of care:
85% (334 of 392) and 60% (180 of 298), respectively; adjusted odds ratio: 3.7,
95% CI: 2.5-5.5, p0.0001.

Initial PCR test results were
received in a median of 20 days vs. 38.5 days for intervention and control
sites, respectively. Mothers were notified of their infant’s test results in a
median of 14 days vs. 23 days.

The turnaround time for ART
initiation among infants diagnosed with HIV did not improve at intervention
sites but was actually slower, due possibly to more maternal counselling sessions
before infant ART initiation. Nonetheless median infant age at the start of ART
was 7.6 weeks younger in intervention sites (17.5 vs. 25.1 weeks).

The intervention had a
significant effect on quality and efficiency at sites with medium- and
low-patient volume, but not at high-volume sites.

The authors conclude that the
HITSystem, an innovative public health intervention, is effective and feasible
in resource-poor settings. Its algorithms have been modified to reflect Kenya’s
new policies to include HIV testing at birth.

Dr. Richard T. Lester of the
University of British Columbia, in an accompanying comment article, suggests
the reason for no intervention effect in high-volume facilities is that smaller
volume facilities have more to gain and/or are able to better adapt to new
technologies.

A decentralised implementation
approach, he adds, for innovations such as the HITSystem provides an
opportunity to close the digital divide so improving access and support for
those hardest to reach.

Yet the greatest challenge,
Dr. Lester stresses, is converting these findings into a scalable service. Too
often successful pilots are not integrated into health services for decades. He
cites the examples of two innovative programmes in Kenya involving SMS to
support ART adherence in adults.

Funders appear to be reluctant
to invest in the integration of successful pilots, which likely contributes to delays
in their implementation, he concludes.