Using a point-of-care test to diagnose HIV in infants
significantly improved retention in care, speeded up antiretroviral therapy (ART) initiation and
increased the proportion of infants who started treatment, a large randomised
study in Mozambique has found. The results were presented at the 2017 Conference
on Retroviruses and Opportunistic Infections (CROI) in Seattle on Tuesday.
Improving HIV diagnosis in infants is critical for
increasing the proportion of infants who receive antiretroviral treatment and
for prevention of early death. HIV diagnosis in infants requires testing for
HIV DNA; HIV antibodies inherited from the mother may linger for up to 18
months, leading to a false positive result, and HIV DNA may not be detectable
for several weeks after birth if infection occurred during delivery or through
Although the World Health Organization recommends that all
infants exposed to HIV during pregnancy or delivery should receive a nucleic
acid test for HIV DNA within six weeks of birth to rule out infection, there
are numerous logistical barriers to achieving this target.
In order for an early diagnostic test to be carried out
successfully, the infant needs to return to a health facility within two months
of delivery, blood must be drawn, sent to a laboratory for testing, the result
must be returned to the health facility, and the mother must then return to the
health facility and be informed of the result. If the result is positive, the
child ought to be offered ART. If the result is negative,
the infant should be tested again at the end of the breastfeeding period to
ensure that she is still HIV negative.
Many of these barriers could be overcome if the test were to
be carried out at the health facility while the mother and infant wait, so that
treatment could be offered immediately after the result was known. Use of point-of-care
testing might also reduce loss to follow-up. Two point-of-care tests for early
infant diagnosis have been approved recently by the World Health Organization.
To study whether the use of one of these point-of-care tests, the Alere HIV-1/2
Detect system, would improve retention in care and treatment uptake, UNITAID
and UNICEF supported a cluster-randomised study in Mozambique, conducted by
Mozambique’s National Institute of Health.
The study randomised 16 health facilities to provide
standard-of-care testing or to implement point-of-care testing. At the eight facilities in the standard-of-care
arm 1876 infants were included in the study, and 2034 at the point-of-care
The study found a substantial difference in the number of
test results that were available at the health facility; whereas all of the
results for infants tested by point-of-care diagnostic were available at the
health facility, 19% of the results of tests carried out by the standard method
failed to be returned to the facility.
A total of 8.6% of infants in the point-of-care arm and 6.7% in the
standard-of-care arm tested positive for HIV. Infants in the standard-of-care
arm were significantly more likely to be tested before the age of 2 months
(79.2% vs 59.3%, p = 0.001), but not at any other time point.
Of the point-of-care results, 99.5% were provided to the
infant’s caregiver, compared to 65% of the standard-of-care test results. Only
7.2% of the results of standard-of-care tests reached the caregiver within two
months of testing, and only 47.2% within six months of testing. Results took a
median of 125 days to reach caregivers after the sample was collected in the
ART initiation was similarly impeded by slow return of test
results. Infants in the point-of care facilities were seven times more likely
to start treatment within two months than those in the standard-of-care
facilities. Whereas 89.7% of infants who tested positive on a point-of-care
test had started treatment within two months of diagnosis, only 12.8% of those
tested by the standard method had started treatment (p < 0.001). (The
difference between the proportion who started treatment and the proportion with
test results at two months in the standard-of-care group is explained by
presumptive initiation of ART in symptomatic children.)
It took a median of 127 days after a sample was taken for a
child with HIV to start treatment in the standard-of-care facilities, and one
year after testing, 53 children in standard-of-care facilities still hadn’t
Six months after testing, infants in the point-of-care arm
were still around two-and-a-half times more likely to be on treatment (90.3% vs
40.2%, p < 0.001).
Even when results came back, infants in the standard-of-care
arm were still less likely to have started treatment within one month of the
result being disclosed (92.7% vs 77.6%, p = 0.004), and less likely to be
retained on ART three months after starting treatment (61.6% vs 42.9%, p = 0.027).
UNITAID, the international drug and diagnostics purchase
fund, is investing $63 million in point-of-care early infant diagnosis and HIV
viral load testing in nine countries in sub-Saharan Africa, with the aim of
increasing the proportion of infants who are tested, retained in care and
initiated on ART. UNITAID is working with the Elisabeth Glaser Pediatric AIDS
Foundation to test at least 215,000 infants.