HIV self-testing (sometimes called ‘home testing’) should be
offered as an additional approach to HIV testing services, the World Health
Organization (WHO) recommends in new guidelines issued today.
HIV self-testing “represents another step in line with
efforts to increase patient autonomy, decentralize services and create demand
for HIV testing among those unreached by existing services,” say WHO. They hope
that it may increase testing rates in men, adolescents, men who have sex with
men and other key populations.
Evidence to support the new guidance comes from five
randomised controlled trials, including two Kenyan studies in which women
distributed tests kits to their male partners, and three studies with men who
have sex with men (MSM) in Australia, China and the United States. A number of
observational studies were also consulted.
Key findings from the randomised studies were that, when
compared with HIV testing in health facilities, self-testing increased the
uptake of testing by male partners of pregnant women, increased the uptake of
couples testing in this group, increased the uptake and frequency of testing in
MSM, did not increase risky sexual behaviour or sexually transmitted infections
(STI), did not lead to less STI testing, and did not increase intimate partner
violence or other social harms.
WHO also conducted a systematic review and meta-analysis of
test accuracy. It found that self-testers got as accurate results as trained
Self-tests using blood samples had a sensitivity (i.e.
ability to give accurate results to people who have HIV) ranging from 96.2 to
100%. Blood-based tests had a specificity (i.e. ability to give accurate
results to people who do not have HIV) ranging from 99.5 to 100%.
For tests using oral fluid samples, sensitivity ranged from
80 to 100% and specificity ranged from 95.1 to 100%. While this is a little
less accurate, WHO do not recommend one form of test over another.
However, they do clearly state that any self-test used must
be approved by the relevant regulatory authority. At present, only four tests
have a CE mark for sale in Europe (BioSure,
autotest VIH, INSTI and OraQuick) and
only one test is approved by the US Food and Drug Administration (FDA) for sale in the United States (OraQuick). No test is yet pre-qualified
by the World Health Organization (indicating that a test meets global standards
for quality, safety and efficacy) but evaluation of a number of devices has
The guidelines leave plenty of scope for countries and
programmes to identify the best ways to distribute self-tests. Self-testing
should aim to fill gaps in current coverage of HIV testing. It should reach
people at high risk of HIV who do not use existing testing services often
Distribution might be door-to-door, delivered by a person’s
sexual partner, in healthcare facilities, integrated with outreach for other
health programmes (such as male circumcision or TB screening), through
workplace health programmes, in commercial pharmacies, online, or through
Clear instructions for how to use a self-test and interpret
the result must be provided. These may be provided through written, pictorial
and video instructions and also remote support (e.g. a telephone hotline or
online support). In some low-literacy settings it may be appropriate for
self-testing to be ‘assisted’ by a healthcare or outreach worker who can demonstrate
the process and be present while a person tests.
Clear messages are needed to describe what to do if the
result is ‘reactive’ (potentially positive), WHO says. Users must understand
that a reactive test result must be confirmed through further testing and
should be given details of the services they can go to for this.
WHO acknowledge gaps in the evidence base on strategies to
promote linkage to care after self-testing. Pro-active follow-up by peer or
outreach workers may be appropriate, especially if the test was ‘assisted’.
Studies suggest that allowing people to initiate HIV treatment at home (i.e.
being visited by a counsellor at home and having medication delivered there) is
effective. Phone hotlines, video counselling, appointment cards and vouchers
(to cover transport costs) may also help linkage to care.
Clear messages are also needed so that people getting negative
results understand that the result is not definitive, especially if the
person’s last possible exposure to HIV was within the test’s window period. In
the light of this, “HIV self-test results should not be used to serosort or to
justify HIV risk behaviour such as condomless sex following a negative
self-test result”. WHO says this advice is particularly relevant in communities
where the rate of new infections is high, for example in most groups of gay men.
Information should be provided on disclosure, in particular
to help couples cope with serodiscordant self-test results. Information on
services to help with domestic abuse and intimate partner violence should be
included. Self-testing is not recommended for couples in which abuse or
violence is already a problem.
WHO says that many countries will need to adapt their
national policies and regulations, so that HIV self-tests can be legally sold
or distributed, non-healthcare workers can perform a test, and devices can be
approved by regulatory authorities. Age of consent laws may need to be modified to
allow adolescents to self-test for HIV. Laws and policies that address misuse
(such as coercive testing and violence) may need to be adapted.