Self-testing for HIV is highly acceptable
to people in a variety of settings, investigators report in the open-access
journal PLoS Medicine. The authors
reviewed the results of 21 separate studies and found an acceptability rate of
up to 100%. Self-testing using point-of-care assays generally provided accurate
results, and there was no evidence that a positive test would lead to a major
adverse event such as suicide. However, the investigators could only identify
one study that looked at linkage to care following a positive result using
“More data from diverse settings and
preferably from randomized controlled trials must be collected before any
initiatives for global scale-up of self-testing for HIV infection are
implemented,” the journal’s editor cautions.
Many HIV infections are undiagnosed. This
is a major concern globally. Late diagnosis is associated with high mortality
rates, and there is good evidence that large numbers of onward HIV
transmissions originate in undiagnosed individuals.
Testing is therefore central to HIV
treatment and prevention initiatives. Possible obstacles to testing include the
inconvenience of visiting a healthcare facility and a fear of the stigma that
many associated with HIV services.
Self-testing could provide a way of
overcoming these barriers, and in July 2012 the Food and Drug Administration in
the US approved the oral OraQuick
point-of-care test for over-the-counter sale.
However, little is known about the
acceptability, accuracy and consequences of self-testing.
A team of investigators therefore searched
databases of published research and conference presentations to identify
studies looking at these issues. A total of 21 separate studies conducted
between 2000 and 2012 were identified. Only one was a randomised controlled
trial, the rest had an observational design.
Two-third of the studies evaluated oral
self-testing, the others finger-prick testing. Fourteen studies were concerned
with supervised self-testing, a strategy where a healthcare professional provides
support throughout the testing process, even though the actual test is
performed by the person testing. The remaining studies were unsupervised, with
counselling and linkage to care offered via a method such as a helpline.
Three-quarters of the studies were
conducted in high-income countries, the remainder in resource-limited settings.
They involved diverse populations, ranging from groups with a high HIV risk,
such as non-monogamous gay men in US cities, to lower-risk groups in the
Overall, acceptability was high.
Acceptability of supervised testing ranged
from 74% among US gay men to 100% among Canadian students. The acceptability of
unsupervised testing was documented in two studies, and ranged from 78% among
healthcare professionals in Kenya to 84% in non-monogamous US urban gay men.
The results provided by self-testing were,
on the whole, highly accurate. Both supervised and unsupervised self-testing
accurately determined when a person was HIV negative, and false-negative
results were almost unheard of. Although rare, false-positive results were
occasionally recorded, and were slightly more common with unsupervised testing,
with a rate as high as 7% in one US study.
Self-testing was shown to be feasible, with
95% of US urban gay men reporting that unsupervised testing kits were “very
easy to use”.
The frequency of operational errors varied
from 0.37% to 5%, the higher rate relating to a Spanish study evaluating
Common errors included:
Failing to place oral test
device in developer solution after swabbing.
Removing the test kit from the
developer solution too early.
Spilling the developer
Dipping the testing device in
the developer before swabbing.
A small number of individuals also reported
difficulty interpreting the testing device or were unable to read or interpret
a faint or weakly positive test line on the testing device.
Across all settings, and for both supervised and unsupervised strategies,
motivations for self-testing were:
Approximately two-thirds of people
preferred oral to finger-prick tests.
Low-income populations in all settings
tended to prefer free self-testing kits, whereas a cost of up to $20 was
generally acceptable for more affluent individuals. “This finding implies that
the price of a self-testing kit will be an important factor in determining the
uptake of self tests,” comment the authors. “This is crucial to policy
Only one study (on unsupervised testing) reported on
linkage to care after a positive result. The rate was high, with 96% of
individuals testing HIV positive stating they would seek post-test counselling.
“Linkages could be better documented in the next phase of controlled studies,”
the investigators suggest. “At all times…linking positive self-test results
within an 8-24 h window period to post-test counselling followed by CD4 count
and ART initiation should…be emphasized.”
Evidence of extreme adverse outcomes, such
as suicide following an HIV-positive result, were “entirely absent”.
The authors conclude “self-testing offers
an alternative for individuals who desire privacy and confidentiality to find
out their sero-status…it offers the potential to bring more people to
self-screen and proactively seek linkage to care and prevention, but its
potential in optimizing linkages remains unproven.”