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Acceptability of HIV self-testing: A systematic
literature review
ARTICLE in BMC PUBLIC HEALTH · AUGUST 2013
Impact Factor: 2.26 · DOI: 10.1186/1471-2458-13-735 · Source: PubMed
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RESEARCH ARTICLE Open Access
Acceptability of HIV self-testing:
a systematic literature review
Janne Krause1*
, Friederike Subklew-Sehume2
, Chris Kenyon3,4
and Robert Colebunders3,5
Abstract
Background: The uptake of HIV testing and counselling services remains low in risk groups around the world. Fear
of stigmatisation, discrimination and breach of confidentiality results in low service usage among risk groups. HIV
self-testing (HST) is a confidential HIV testing option that enables people to find out their status in the privacy of
their homes. We evaluated the acceptability of HST and the benefits and challenges linked to the introduction of
HST.
Methods: A literature review was conducted on the acceptability of HST in projects in which HST was offered to
study participants. Besides acceptability rates of HST, accuracy rates of self-testing, referral rates of HIV-positive
individuals into medical care, disclosure rates and rates of first-time testers were assessed. In addition, the utilisation
rate of a telephone hotline for counselling issues and clients` attitudes towards HST were extracted.
Results: Eleven studies met the inclusion criteria (HST had been offered effectively to study participants and had
been administered by participants themselves) and demonstrated universally high acceptability of HST among
study populations. Studies included populations from resource poor settings (Kenya and Malawi) and from
high-income countries (USA, Spain and Singapore). The majority of study participants were able to perform HST
accurately with no or little support from trained staff. Participants appreciated the confidentiality and privacy but
felt that the provision of adequate counselling services was inadequate.
Conclusions: The review demonstrates that HST is an acceptable testing alternative for risk groups and can be
performed accurately by the majority of self-testers. Clients especially value the privacy and confidentiality of HST.
Linkage to counselling as well as to treatment and care services remain major challenges.
Keywords: HIV, Testing, Alternative, Counselling, Self-test, Home test
Background
Globally, only about one third of young people know
their HIV status, which is far below the United Nations
General Assembly Special Session target of 95% [1]. In-
creasing access to and uptake of HIV testing is critical to
reduce the incidence of HIV and to improve access to
treatment and support for seropositive people. People
who are aware of being HIV-positive are less likely to
engage in sexual risk behaviour [2] and people who re-
ceive antiretroviral treatment (ART) and adhere to it are
less likely to be infective to others [3]. Both will decrease
transmission of the virus and impact on the epidemic.
Moreover, stigma is likely to decline the more people
know their serostatus as this could enhance a ´normalisa-
tion` of the diagnosis [4,5]. In order to increase global test-
ing rates and to ensure early access to treatment, a further
exploration of new HIV testing options should be a re-
search priority. HIV self-testing (HST), which refers to the
performance of a simple saliva or blood-based self-test
similar to a pregnancy test in the privacy of clients` homes
or any other place that suits clients, could have the poten-
tial to bypass some barriers currently deterring people
from testing. HST can either be performed using home
sample collection kits or home self-testing. With real do-it-
yourself tests, the client collects a sample, usually saliva or
a blood spot from a finger prick, runs the rapid test and
reads the test results. Pre-test information is provided in
written form or online on websites of manufacturers and
post-test counselling is provided via telephone hotlines.
* Correspondence: jannekrause22@googlemail.com
1
Institute of Tropical Medicine and International Health,
Charité-Universitätsmedizin, Berlin, Germany
Full list of author information is available at the end of the article
© 2013 Krause et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Krause et al. BMC Public Health 2013, 13:735
http://www.biomedcentral.com/1471-2458/13/735
With home sample collection kits, the client takes a sam-
ple, saliva or a dried blood spot (DBS), which is then mailed
to a laboratory. Afterwards, the client receives the result by
phone or mail, which is linked to post-test counselling and,
in case of a reactive test, is referred to follow-up services.
Community outreach HIV counselling and testing
(HCT) programs like mobile clinics and door-to-door test-
ing are among the tested alternative strategies and have
already significantly improved testing uptake and reached
higher rates of first-time testers than facility-based testing
services in Sub-Saharan Africa [6-11]. International ex-
perts believe that HST could be the next step [12,13].
Highly accurate self-test kits exist. The OraQuick® In-
home HIV test (OraSure Technologies, Inc.) has a sensi-
tivity of 92% and a specificity of 99.9% and was recently
approved by the U.S. Food and Drug Administration for
over-the-counter sale [14]. It is now available at major
American pharmacies [15]. A commonly raised concern
as regards HST is that testing without counselling may re-
sult in adverse psychological outcomes [16]. In addition,
linkage to care constitutes a particular challenge [17]. Fur-
ther research is needed to answer critical questions on ac-
ceptability, feasibility, safety and cost-effectiveness of HST.
As a first step, we performed a systematic literature review
with the main objective to assess the acceptability of HST
by key populations. Secondary objectives were to review
the accuracy of HST, linkage to care of clients with a re-
active HIV self-test, disclosure rates of self-testers, utilisa-
tion rates of telephone hotlines for counselling and
qualitative attributes of HST.
Methods
Study design
We performed a systematic literature review using the
guidelines for Preferred Reporting Items for Systematic Re-
views and Meta-Analyses [18]. We included all studies in
which HST was offered to and performed by study partici-
pants. Utilised HIV test devices included home sample col-
lection tests with performance of standard Western blot
and real self-tests based on blood or saliva rapid tests. We
included the two HST methods, as our main interest was
acceptability of HIV testing in privacy, which is central to
both testing strategies. In the absence of international rec-
ommendations about HST, no standardised procedure for
HST was required.
Search strategy and restrictions
Pubmed, Embase, ScienceDirect, The Cochrane Library
and the Global Health Database were systematically
searched for matching manuscripts and a comprehensive
Google search was performed for grey literature. Search
terms included ´HIV` AND ´self-test` OR ´self-test` OR
´self-testing` or ´home test` OR ´home sample collec-
tion test`. Preferably peer-reviewed studies published in
English between 1998 and October 2012 were included.
Conference abstracts were eligible but no comments, ed-
itorials and unpublished reports. Because of the limited
number of published studies, the search was not re-
stricted to a specific study type. The different phases of
the study selection process are presented in a flow dia-
gram (Figure 1).
Data analysis
The study focussed on the outcome ´acceptability of
HST`. The acceptability rate was defined as the propor-
tion of all people approached to participate in a study,
who eventually performed HST. Insights around the fol-
lowing topics were also extracted whenever possible: ac-
curacy of HST, here defined as the proportion of self-
test results in agreement with confirmatory test results
performed and interpreted by trained health staff (in-
valid test results have been included as discordant test
results), referral rate of those who tested seropositive
into medical care, disclosure rate of self-test results, rate
of first-time self-testers and utilisation rate of a tele-
phone counselling hotline. Besides extraction of these
rates, each study was reviewed for various qualitative as-
pects of HST. Because of the heterogeneity of included
studies regarding study design and study populations, no
meta-analysis has been performed. Study characteristics
as well as outcomes are presented in tabular form
(Tables 1 and 2, Table 3 respectively).
Results
Eleven studies met our inclusion criteria [19-29] Tables 1
and 2. The home sample collection method was
performed in two studies [28,29], the remaining studies
used either blood-based [21,22,25,27] or saliva-based
[19,20,23] rapid tests. A very recent study from Singapore
[30] on accuracy and acceptability of HST was not eligible
for the review, as the study does not mention the propor-
tion of all people approached who accepted HST and thus
does not provide an acceptability rate. Yet, the study in-
corporated a survey on user acceptability after perform-
ance of HST to which we refer in the discussion section.
Two studies were performed in Sub-Saharan Africa
[24,26], six in the USA [19,20,23,25,28,29], two in Spain
[21,22], and one in Singapore [27]. Study populations
consisted of risk groups like health care workers (HCW)
[26], men who have sex with men (MSM), injecting drug
users (IDU), clients of sexually transmitted infection (STI)
clinics, women with multiple sexual partners or HIV-
seropositive sexual partners [19,20,23,27-29] and the gen-
eral population [21,22,24,25]. Most included studies were
observational and lacked a comparison group. Typically, a
cross-sectional survey was performed. Only two studies
consisted of a randomized controlled trial [23,28]. Out-
comes are summarised in Table 3.
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Acceptability of HST
Acceptability of HST was high in most studies. Seventy
per cent of all clients who were included in the reviewed
studies performed HST. The acceptability rate ranged
from 22% to 87% and was highest in Malawi where HST
was offered at home with minimal supervision [24]. In the
Malawian study, HST uptake was similar for both genders
despite a significantly lower testing history among men. In
Baltimore, overall acceptability of HST was high among
hospital emergency department clients, but far more
people (91% vs. 9%) opted for saliva-based HST compared
to blood-based HST [25]. Spielberg et al. [28] demon-
strated high initial interest to self-test (81%) but greater
adherence in the oral fluid bi-monthly specimen collection
arm compared to the DBS arm. In Spain, 78% [22] and
83% [21] of clients of mobile testing units agreed to HST.
HST in these mobile testing units was especially attractive
to gay people, young people, singles and people who had
never tested before for HIV. At least two-thirds of an
American high-risk MSM population reported use of HST
with an average use of 1.6 times/per person [23]. 73% of
MSM with frequent unprotected anal intercourse and
changing sexual partners agreed to HST [19], as did 82%
of their sexual partners [20]. As early as 2000 [29], accept-
ability of HST among MSM participating in the Urban
Men´s Health study had been high (67%). Uptake among
Kenyan HCW was substantially lower [26]. Only slightly
more than a fifth (22%) of all approached HCW eventually
performed HST, and only about one third (31%) of those
HCW who participated in the post-intervention survey
had performed HST. Among HCW who attended pre-test
information sessions, acceptability of HST was as high as
in other studies (75%). In a separate intervention session
arm, in which the intervention team had actively formed
groups to attend pre-test information sessions, 97% of
HCW took a test kit, but there was no further investiga-
tion around how many of them subsequently performed
the test. HCW were additionally offered to take test kits
for their partners, which resulted in 55% of partners
performing HST.
508 records
identified
123 duplicates
excluded
IDENTIFICATION
SCREENING
385 records screened
(322 study abstracts,30 full
text studies, 11 comments/
editorials, 3 book chapters,
10 press releases, 3
conference schedules, 1
guideline, 5 records
published before 1998
21 full text studies excluded
(acceptability rate missing
or no HST performed, 1
analysis of a commercial
test manufacturer)
ELIGIBILITY
32 full text studies assessed
for eligibility
353 records
excluded
INCLUDED
11 studies
included in
review
Figure 1 Selection process of HIV self-testing studies following the PRISMA methodology [18].
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Table 1 Studies evaluating HIV self-testing (HST) in high-income countries
Study Carballo-Diéguez
et al., [19]
Carballo-Diéguez
et al., [20]
De la Fuente
et al., [21]
Belza
et al., [22]
Katz
et al., [23]
Gaydos
et al., [25]
Lee
et al., [27]
Spielberg
et al., [28]
Osmond
et al., [29]
Objective Acceptability of oral
fluid HST and
willingness to use
prior to sexual
intercourse among
high-risk MSM
Acceptability of oral
fluid HST prior to
sexual intercourse
among sexual
partners of MSM
Feasibility of
blood-based
HST and
interpretation
of results by
laypersons
Feasibility
of blood-based
HST by
laypersons
Acceptability
and ease of
use of oral
fluid HST
compared to
clinic-based
HCT among
MSM
Feasibility and
accuracy of oral
fluid and blood-
based HST by
laypersons
compared to
trained staff
Acceptability and
feasibility of blood-
based HST among
high-risk
populations
Feasibility and
acceptability of
bimonthly oral
fluid and DBS
HSC among
high-risk
populations
Acceptability and
feasibility of oral
fluid HSC for HIV
testing among
MSM
Location New York City, USA New York City, USA Gay districts
and university
sites, Madrid,
Spain
see De la
Fuente et al., [21]
USA Baltimore, USA Singapore USA San Francisco,
Los Angeles, New
York City, Chicago,
USA
Population 57 high-risk MSM 140 sexual partners
of high-risk MSM
313 HCT clients
of mobile
testing units
267 HCT clients
of mobile
testing units
68 HIV-
negative high-
risk MSM
565 patients
of emergency
departments
420 HIV-positive-
and at-risk clients
of communicable
disease and
STI centres
297 participants
of HIV Network
for Prevention
Trials
615 participants
of Urban men´s
health study
Sex 100% male 100% male 69% female,
29% male
41% female,
51% male
100% male 59% female,
41% male
9% female,
75% male
20% female,
80% male
100% male
Median age 34 years n.s. n.s. n.s. 39 years 38,4 years 33 years 36 years n.s.
Ethnicity 39% Latino, 32%
Black, 21% White,
7% Asian
n.s. 83% White,
16% Latino
83% White,
16% Latino,
1% n.s.
73% White,
13% Latino,
9% Black,
4% Asian
69% Black,
29% White
98% Asian 64% White,
18% Black,
12% Latino,
2% Asian
69% White,
12% Hispanic,
8% Black
MSM 100% 100% 35% 38% 100% n.s. 9% 58% 100%
IDU - - n.s. n.s. - > 15% n.s. 30% -
WAHR - - n.s. n.s. - n.s. n.s. 12% -
Acceptability of HST 73,7% 81,5% 83% 77.9% 63.2% 84.6% 83.3% 81.1% 67%
Incentives No Yes No No No Yes No Yes Yes
n.s. not specified, MSM Men who have sex with men, IDU Injecting drug users, WAHR Women at heterosexual risk.
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Accuracy of HST
Overall, agreement between test results performed by
laypersons and health staff was high with 86% of self-
tests and 98% of home samples collected adequately.
Disagreement between health staff and study partici-
pants` results was mainly caused by invalid test results
due to performance errors. Overall, no false positive test
results occurred and the few false negative or inconclu-
sive test results were mainly related to misinterpretation
of very faint lines. In Spain, self-testers performed tests
as accurately as health staff with 99% of tests being valid
results [22]. However, the proportion of valid HST re-
sults decreased to 92%, when demonstration of the test-
ing procedure through trained health staff was omitted
[21]. Accurate performance was associated with the level
of education. Misinterpretation of photo results was gen-
erally rare (4,9%) and associated with older age, Latin
American origin and lower educational levels. Although
self-administered tests were performed very accurately
in Malawi, overall sensitivity (97.9%) remained slightly
below sensitivity claimed by the manufacturers and was
even lower (96.4%) among those who were previously
not known to be HIV-positive [24]. Test results of par-
ticipants in Baltimore concurred in 99,6% with the re-
sults of the tests performed by health staff [25]. The
study from Singapore [27] was the only one with high
rates (54,4%) of invalid test results largely because most
users failed to correctly transfer a blood sample with a
capillary tube. Known HIV-positive participants were
more likely to perform and interpret HST accurately.
Utilisation of a counselling telephone hotline
Few studies provided information on this topic, two
from Sub-Saharan Africa [24,26] and three from the
USA [23,28,29]. Utilisation of a counselling telephone
hotline differed markedly between studies and countries
and was substantially lower in Sub-Saharan Africa than
in the USA. African participants clearly expressed a need
for face to face counselling and comprehensive post-test
counselling services [24,26]. American high-risk individ-
uals on the other hand strongly preferred post-test coun-
selling by phone (95%) and the majority suggested that,
in the case of repeated testing, pre-test information
would only need to be given every 6–12 months [28].
Despite these findings, only 40% of MSM included in
the Urban Men´s Health Study called for their results
and 7% of those who declined to participate in the study
expressed concerns on being given the result by phone
[29]. American high-risk MSM used the 24-hours
Table 2 Studies evaluating HIV self-testing (HST) in
low-income countries
Study Choko et al., [24] Kalibala et al., [26]
Objective Use and accuracy
of oral fluid HST
in the general
population
Acceptability and
feasibility of free oral
fluid HST among HCW
Location High residential
suburbs of
Blantyre, Malawi
District and provincial
hospitals in Kenya with
variable degrees of
pre-existing HIV related
services
Population 298 of adult
population and
community peer
group members
1081 HCW
Sex 52% female,
48% male
33% female,
67% male
Median age 26.5 years n.s.
Ethnicity n.s. n.s.
MSM n.s. n.s.
IDU n.s. n.s.
WAHR n.s. n.s.
Acceptability of HST 87.2% 21.9%
Incentives No No
n.s. not specified, MSM Men who have sex with men, IDU Injecting drug users,
WAHR Women at heterosexual risk.
Table 3 Outcomes of HIV self-testing (HST) studies
Study Carballo-
Diéguez
et al., [19]
Carballo-
Diéguez
et al., [20]
De la
Fuente
et al., [21]
Belza
et al., [22]
Katz
et al., [23]
Choko
et al., [24]
Gaydos
et al., [25]
Kalibala
et al., [26]
Lee
et al., [27]
Spielberg
et al., [28]
Osmond
et al., [29]
Sample size 57 140 377 267 68 298 565 1081 420 297 615
Outcome N % N % N % N % N % N % N % N % N % N % N %
Acceptability rate 42 73,7 101 72,1 313 83 208 77,9 43 63,2 260 87,2 478 84,6 237 21,9 350 83,3 241 81,1 412 67
Accuracy rate - - 288* 92 206** 99 - 256 98,4 476 99,6 - 158*** 45,6 658 99 402 97,1
Proportion of
1st-testers
- - 142 45,4 111 56,9 - 94 36,2 - - - - 71 17,2
Disclosure rate – - - - - - - 192 81 - -
Telephone hotline
utilisation rate
- - - - - - - 1 0,4 - 228 94,6 172 41,7
*25 invalid test results.
**2 invalid test results.
***192 invalid test results.
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contact line only to request new test devices and called
the study office for counselling issues [23].
Disclosure of test results
The reviewed studies give little information on disclosure
of test results among self-testers. Most HCW (81%) and
partners (85%) discussed their test result with another per-
son, mainly with their sexual partner [26]. Other persons
of trust were colleagues and friends, but only 10%
discussed their result with another HCW. Couple testing
showed increased disclosure rates. Women in Malawi felt
HST could make involvement of their husbands in testing
easier and remove some of the burden of testing from
their shoulders [24]. Disclosure of test results did not
seem to be an issue for American high-risk MSM, as the
vast majority agreed to partner testing and accordingly
disclosed their status [20].
Proportion of first-time testers
In the four studies [21,22,24,29] that investigated the
proportions of first-time testers, the proportions of
people who had never tested before were equal among
those who finally performed HST and those who were
eligible to participate in studies. This suggests a high up-
take of HST among first-time testers. In both Spanish
studies half of participants were testing for the first time
[21,22]. In Malawi, 50% of seropositive cases were newly
detected through HST [24]. Among American high-risk
MSM who tested seropositive, 60% had previously been
unaware of their HIV-status [20].
Attitudes and opinions on HST
Despite very different individual, socio-economic and
cultural backgrounds, emerging qualitative assessments
of HST were similar among study populations. HST was
perceived as highly confidential and private [24,26,28]
and participants believed HST could give people more
control over their health [25]. High-risk MSM thought
HST would increase testing frequency [23] and HCW
regarded HST to be a testing strategy that they could
easily access and that would facilitate their decision to
get tested including testing for the purpose of post ex-
posure prophylaxis [26]. People generally thought HST
was easy to perform especially when a saliva-based test
was used [21,23-29]. Indeed, Spanish participants rated
collection of blood drops as the most difficult step of
HST and those with invalid test results were more likely
to believe that instructions were complicated [21]. Rapid
oral fluid testing was generally preferred to blood-based
testing [25-28]. Participants who self-tested were likely
to use HST for their next HIV test and stated they would
recommend HST to family and friends [19-21,24-28].
Trust in HST was high [25], but there was also some
scepticism on accuracy [26,27,29] and the limitation of
adequate post-test counselling services [24,26-29]. Fur-
ther, acceptance of HST was influenced by its costs al-
though most participants were willing to pay a small to
medium amount [21,23,26-29]. Whereas Kenyan health
care workers opted for a small fee ´comparable to a
pregnancy test` [26], European and American clients
would accept higher costs: 20 Euros [21] and 10 to 40
USD [23], respectively. Moreover, the way in which HST
kits are distributed impacts on their acceptability. Partic-
ipants from the USA and Singapore opted for public sale
of HST kits [20,27], such as at pharmacies, whereas par-
ticipants from Malawi [24] preferred home-based distri-
bution of self-testing kits. Kenyan HCW believed self-
test kits should be universally available at health facilities
or even distributed on a routine base [26].
Discussion
Our reviewed studies demonstrated consistently high ac-
ceptability of HST, particularly with saliva based rapid
tests, in all populations where so far the testing was evalu-
ated. Acceptability was also high in the two home sample
collection studies (81% [28] and 67% [29]). HST encour-
aged testing equally among both genders [24]. Moreover,
it encouraged repeated testing and first-time testing in
hard-to-reach groups [20,22,23]. Even in African countries
with existing successful testing programmes HST in-
creased the reach of HIV testing services: 41% of partici-
pants in Malawi had never tested before and 78% had
tested longer than a year ago [24]. Further, HST seems to
be an acceptable screening tool prior to sexual intercourse
for MSM with high-risk sexual behaviour [19,20] despite
its limitations related to the window period. Uptake of
HST among MSM and their partners was high, HST was
predominantly well appraised and a significant number of
unknown seropositive cases were detected [20]. As such
HST could detect and prevent HIV transmission in this
population at least partly. In a recent study from
Singapore [30], overall, 87.4% of participants would pur-
chase an over-the-counter rapid test kit, with the highest
proportion being among private clinic at-risk participants
(92.4%).
With regard to Sub-Saharan African countries, accept-
ability rates of HST seem to be comparable to those of
home-based HCT or provider-initiated HCT approaches
[31-33]. However, high testing uptake of home-based
HCT is often impaired through low rates of clients who
finally learn their results [34,35]. The majority of
reviewed studies do not report how many clients who
tested reactive on HST consulted for obtaining a con-
firmatory test, thus we do not know how many self-
testers really learn their result. Only 42% of MSM, who
used the home sample collection method in the Urban
Men´s Health Study [29] called the help line for their
testing result and participants of the HIV Early
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Detection Study [28] were more willing to test for HIV
with rapid tests than with the home sample collection
method in order to avoid an unpleasant waiting period.
The acceptability of HST was lowest for Kenyan HCW
[26]. The reason for this may be related to the low at-
tendance rates of pre-test information sessions where
HCW could receive HST kits. Acceptability was compar-
ably high to other studies, once HCW attended pre-test
information sessions. In some studies, willingness to test
for HIV was a precondition for inclusion in the study
[21,22,25,28]. Therefore, acceptability rates did not truly
reflect participants` decision to get tested, but rather
whether someone wanted to experience HST. In other
studies, participants received incentives, which might also
have impacted on their decision to self-test [20,25,28,29].
It is possible, that the Kenyan study gives a more realistic
picture of the degree to which HST, if available in a coun-
try, could add to HCT uptake through existing testing
strategies. In this case, an increase of 20% of HCW know-
ing their HIV status through HST could be regarded as a
considerable achievement. Part of this benefit would be re-
lated to the high partner-testing rate and disclosure rate,
that the study of Kalibala et al. [26] found.
Critics often question the feasibility of HST among lay-
persons. However, most participants performed HST ac-
curately with little or no help of trained personnel
[21,22,24,25]. There were no false positive results, which
is remarkable as false positive results have been reported
consistently in the context of rapid HIV tests especially
in low-prevalence settings, highlighting the need for
follow-up of clients for confirmatory testing [36-40]. The
exact accuracy of HST in real-life settings remains to be
determined. In several studies, clients were trained by pro-
fessional staff prior to HST [22,23,26,28], performed the
self-test under supervision [20-22,24] or had just received
an oral fluid rapid test performed by trained personnel
[25]. In Spain [21], the proportion of valid test results
dropped from 99% to 92%, when the demonstration of the
test through trained staff was omitted. In Malawi [24],
10% of self-testers, especially illiterate, less educated par-
ticipants and women, requested the help of supervisors.
Hence, accuracy is likely to be reduced, when clients de-
pend only on themselves. User-friendliness of self-test de-
vices is crucial to accurate performance. Studies by De la
Fuente et al. [21] and Ng et al. [30] have demonstrated
that depositing blood drops directly onto the test reactive
strip (bypassing the use of a capillary tube for blood col-
lection) improved the validity of HST. The now FDA-
approved OraQuick® ADVANCE Rapid HIV-1/2 test
seems to fulfil pegged requirements and reaches high ac-
curacy in the hand of laypersons [41].
Our results support the theory that HST holds the po-
tential to increase testing uptake. Nevertheless, some is-
sues remain unanswered. Future research will also need
to concentrate on other target groups that so far have
been neglected in the context of HST like youth, women
and couples. Furthermore, the organisation of counsel-
ling services and linkage to treatment and care has to
date not been sufficiently investigated. Research from
The Netherlands suggests that self-testers feel even more
responsible for their health and show higher levels of
self-efficacy than people who do not use self-tests [16].
Most studies included confirmatory testing of HST
[20-22,24,25,27,28], none of the reviewed studies have,
however, examined whether self-testers reliably seek
medical care in case of a positive result and what effect
HST could have on HIV transmission. In any case, it will
be essential to link HST to adequate counselling and
support services. However, various degrees of counsel-
ling and various counselling models are conceivable.
Today it is considered that pre-test counselling can be
minimal, merely providing the client with sufficient
knowledge to give informed consent [42]. In fact, Ameri-
can high-risk individuals preferred optional counselling,
telephone hotlines or written pre-test information to
mandatory in-person counselling [43-45]. Further, in-
person counselling is no guarantee for good quality: an
evaluation of calls at the South African National AIDS
helpline indicated that a substantial proportion of clients
who received in-person counselling at VCT services did
not understand the meaning of their result, or only re-
ceived a written test result without any counselling [46].
HST is so far only linked to counselling telephone
hotlines, but, especially in developing countries, tele-
phone hotlines do often not seem to cover clients` needs
when it comes to notification of results and adequate
post-test counselling. In rural areas with limited tele-
phone, group information sessions and close links to on-
site social organisations could be a possible counselling
and support strategy for self-testers [12,13]. A recent
study from Malawi demonstrated that linking HST to
home assessment and the initiation of HIV care can sig-
nificantly increase both the disclosure of HIV status and
the initiation of ART at a population level [47]. Two of
the self-testing studies took place in mobile units in
Spain [21,22]. Staff offered HST to clients asking for
VCT and reached a significant number of people. Clients
received counselling and performed HST under supervi-
sion of trained personnel at the mobile unit.
At the moment, HST is still of disputed legality in
many countries, such as South Africa, and happening
only informally [48]. Although international policies
stress a public health approach to HTC and a move
away from obligatory in-depth pre-test counselling, the
World Health Organization has not as yet given any spe-
cific advice for the implementation of HST services [49].
Legal and policy frameworks would need to be devel-
oped to ensure that HST reaches those most in need, is
Krause et al. BMC Public Health 2013, 13:735 Page 7 of 9
http://www.biomedcentral.com/1471-2458/13/735
conducted in a safe and supported fashion and yields ac-
curate results. Clinical trials may be useful to explore
the optimal strategies of introducing HST and to assess
its place in a comprehensive HIV prevention package.
We acknowledge that our review has several limitations.
First, we used voluntary participation rate as an indicator
for the acceptability of the testing strategy. We did not use
other indicators such as satisfaction with the testing
method, perceived ease of use, difficulties in understand-
ing the testing instructions, satisfaction with pre- and
post-test counselling and intention/willingness to use HST
[30,43,50-53] because information about these indicators
were not available in several of the studies included in the
review. We only included studies where participants ac-
tively performed HST. Further, only studies published in
English were considered. Selection bias is likely as most
study populations have been carefully selected and testing
experience was generally high. In some studies wanting to
perform an HIV test was a precondition for inclusion into
the study. Acceptance of HST may be considerably lower
among people with less testing experience or for people
who did not consider testing for HIV. Overall the quality
of the studies included was rather low, included only a
small sample of selected participants, and most studies did
not compare HST with more traditional testing strategies.
Finally, study designs and populations were very heteroge-
neous and results valid for one country may not be trans-
ferrable to another country.
Conclusions
HST is an acceptable HIV testing strategy for key popu-
lations as well as the general population and can be
performed accurately by the majority of persons. Linkage
to treatment and care services remains a major challenge
and different models of HST provision should be ex-
plored further. More research is needed to assess feasible
and acceptable components of an HST service in order
to ensure its safe and reliable use.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
JK and RC designed the study. JK collected the data, analysed and
interpreted the data and drafted and reviewed the manuscript. RC helped to
analyse and interpret the data and to draft the manuscript and reviewed all
drafts of the manuscript. FSS and CK participated in the interpretation of the
data and reviewed drafts of the manuscript. All authors read and approved
the final manuscript.
Acknowledgements
We thank Dr. Matthias Borchert for his support and for critically reviewing
the final manuscript.
Author details
1
Institute of Tropical Medicine and International Health,
Charité-Universitätsmedizin, Berlin, Germany. 2
loveLife, HIV prevention and
youth development NGO, Johannesburg, South Africa. 3
Institute of Tropical
Medicine, Antwerp, Belgium. 4
University of Cape Town, Cape Town, South
Africa. 5
University of Antwerp, Antwerp, Belgium.
Received: 6 April 2013 Accepted: 2 August 2013
Published: 8 August 2013
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doi:10.1186/1471-2458-13-735
Cite this article as: Krause et al.: Acceptability of HIV self-testing:
a systematic literature review. BMC Public Health 2013 13:735.
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Acceptability of HIV self-testing a systematic literature review.pdf

  • 1. See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/255705728 Acceptability of HIV self-testing: A systematic literature review ARTICLE in BMC PUBLIC HEALTH · AUGUST 2013 Impact Factor: 2.26 · DOI: 10.1186/1471-2458-13-735 · Source: PubMed CITATIONS 24 READS 64 4 AUTHORS, INCLUDING: Chris Kenyon Institute Of Tropical Medicine 91 PUBLICATIONS 406 CITATIONS SEE PROFILE Robert Colebunders Institute of Tropical Medicine 636 PUBLICATIONS 10,738 CITATIONS SEE PROFILE Available from: Robert Colebunders Retrieved on: 10 February 2016
  • 2. RESEARCH ARTICLE Open Access Acceptability of HIV self-testing: a systematic literature review Janne Krause1* , Friederike Subklew-Sehume2 , Chris Kenyon3,4 and Robert Colebunders3,5 Abstract Background: The uptake of HIV testing and counselling services remains low in risk groups around the world. Fear of stigmatisation, discrimination and breach of confidentiality results in low service usage among risk groups. HIV self-testing (HST) is a confidential HIV testing option that enables people to find out their status in the privacy of their homes. We evaluated the acceptability of HST and the benefits and challenges linked to the introduction of HST. Methods: A literature review was conducted on the acceptability of HST in projects in which HST was offered to study participants. Besides acceptability rates of HST, accuracy rates of self-testing, referral rates of HIV-positive individuals into medical care, disclosure rates and rates of first-time testers were assessed. In addition, the utilisation rate of a telephone hotline for counselling issues and clients` attitudes towards HST were extracted. Results: Eleven studies met the inclusion criteria (HST had been offered effectively to study participants and had been administered by participants themselves) and demonstrated universally high acceptability of HST among study populations. Studies included populations from resource poor settings (Kenya and Malawi) and from high-income countries (USA, Spain and Singapore). The majority of study participants were able to perform HST accurately with no or little support from trained staff. Participants appreciated the confidentiality and privacy but felt that the provision of adequate counselling services was inadequate. Conclusions: The review demonstrates that HST is an acceptable testing alternative for risk groups and can be performed accurately by the majority of self-testers. Clients especially value the privacy and confidentiality of HST. Linkage to counselling as well as to treatment and care services remain major challenges. Keywords: HIV, Testing, Alternative, Counselling, Self-test, Home test Background Globally, only about one third of young people know their HIV status, which is far below the United Nations General Assembly Special Session target of 95% [1]. In- creasing access to and uptake of HIV testing is critical to reduce the incidence of HIV and to improve access to treatment and support for seropositive people. People who are aware of being HIV-positive are less likely to engage in sexual risk behaviour [2] and people who re- ceive antiretroviral treatment (ART) and adhere to it are less likely to be infective to others [3]. Both will decrease transmission of the virus and impact on the epidemic. Moreover, stigma is likely to decline the more people know their serostatus as this could enhance a ´normalisa- tion` of the diagnosis [4,5]. In order to increase global test- ing rates and to ensure early access to treatment, a further exploration of new HIV testing options should be a re- search priority. HIV self-testing (HST), which refers to the performance of a simple saliva or blood-based self-test similar to a pregnancy test in the privacy of clients` homes or any other place that suits clients, could have the poten- tial to bypass some barriers currently deterring people from testing. HST can either be performed using home sample collection kits or home self-testing. With real do-it- yourself tests, the client collects a sample, usually saliva or a blood spot from a finger prick, runs the rapid test and reads the test results. Pre-test information is provided in written form or online on websites of manufacturers and post-test counselling is provided via telephone hotlines. * Correspondence: jannekrause22@googlemail.com 1 Institute of Tropical Medicine and International Health, Charité-Universitätsmedizin, Berlin, Germany Full list of author information is available at the end of the article © 2013 Krause et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Krause et al. BMC Public Health 2013, 13:735 http://www.biomedcentral.com/1471-2458/13/735
  • 3. With home sample collection kits, the client takes a sam- ple, saliva or a dried blood spot (DBS), which is then mailed to a laboratory. Afterwards, the client receives the result by phone or mail, which is linked to post-test counselling and, in case of a reactive test, is referred to follow-up services. Community outreach HIV counselling and testing (HCT) programs like mobile clinics and door-to-door test- ing are among the tested alternative strategies and have already significantly improved testing uptake and reached higher rates of first-time testers than facility-based testing services in Sub-Saharan Africa [6-11]. International ex- perts believe that HST could be the next step [12,13]. Highly accurate self-test kits exist. The OraQuick® In- home HIV test (OraSure Technologies, Inc.) has a sensi- tivity of 92% and a specificity of 99.9% and was recently approved by the U.S. Food and Drug Administration for over-the-counter sale [14]. It is now available at major American pharmacies [15]. A commonly raised concern as regards HST is that testing without counselling may re- sult in adverse psychological outcomes [16]. In addition, linkage to care constitutes a particular challenge [17]. Fur- ther research is needed to answer critical questions on ac- ceptability, feasibility, safety and cost-effectiveness of HST. As a first step, we performed a systematic literature review with the main objective to assess the acceptability of HST by key populations. Secondary objectives were to review the accuracy of HST, linkage to care of clients with a re- active HIV self-test, disclosure rates of self-testers, utilisa- tion rates of telephone hotlines for counselling and qualitative attributes of HST. Methods Study design We performed a systematic literature review using the guidelines for Preferred Reporting Items for Systematic Re- views and Meta-Analyses [18]. We included all studies in which HST was offered to and performed by study partici- pants. Utilised HIV test devices included home sample col- lection tests with performance of standard Western blot and real self-tests based on blood or saliva rapid tests. We included the two HST methods, as our main interest was acceptability of HIV testing in privacy, which is central to both testing strategies. In the absence of international rec- ommendations about HST, no standardised procedure for HST was required. Search strategy and restrictions Pubmed, Embase, ScienceDirect, The Cochrane Library and the Global Health Database were systematically searched for matching manuscripts and a comprehensive Google search was performed for grey literature. Search terms included ´HIV` AND ´self-test` OR ´self-test` OR ´self-testing` or ´home test` OR ´home sample collec- tion test`. Preferably peer-reviewed studies published in English between 1998 and October 2012 were included. Conference abstracts were eligible but no comments, ed- itorials and unpublished reports. Because of the limited number of published studies, the search was not re- stricted to a specific study type. The different phases of the study selection process are presented in a flow dia- gram (Figure 1). Data analysis The study focussed on the outcome ´acceptability of HST`. The acceptability rate was defined as the propor- tion of all people approached to participate in a study, who eventually performed HST. Insights around the fol- lowing topics were also extracted whenever possible: ac- curacy of HST, here defined as the proportion of self- test results in agreement with confirmatory test results performed and interpreted by trained health staff (in- valid test results have been included as discordant test results), referral rate of those who tested seropositive into medical care, disclosure rate of self-test results, rate of first-time self-testers and utilisation rate of a tele- phone counselling hotline. Besides extraction of these rates, each study was reviewed for various qualitative as- pects of HST. Because of the heterogeneity of included studies regarding study design and study populations, no meta-analysis has been performed. Study characteristics as well as outcomes are presented in tabular form (Tables 1 and 2, Table 3 respectively). Results Eleven studies met our inclusion criteria [19-29] Tables 1 and 2. The home sample collection method was performed in two studies [28,29], the remaining studies used either blood-based [21,22,25,27] or saliva-based [19,20,23] rapid tests. A very recent study from Singapore [30] on accuracy and acceptability of HST was not eligible for the review, as the study does not mention the propor- tion of all people approached who accepted HST and thus does not provide an acceptability rate. Yet, the study in- corporated a survey on user acceptability after perform- ance of HST to which we refer in the discussion section. Two studies were performed in Sub-Saharan Africa [24,26], six in the USA [19,20,23,25,28,29], two in Spain [21,22], and one in Singapore [27]. Study populations consisted of risk groups like health care workers (HCW) [26], men who have sex with men (MSM), injecting drug users (IDU), clients of sexually transmitted infection (STI) clinics, women with multiple sexual partners or HIV- seropositive sexual partners [19,20,23,27-29] and the gen- eral population [21,22,24,25]. Most included studies were observational and lacked a comparison group. Typically, a cross-sectional survey was performed. Only two studies consisted of a randomized controlled trial [23,28]. Out- comes are summarised in Table 3. Krause et al. BMC Public Health 2013, 13:735 Page 2 of 9 http://www.biomedcentral.com/1471-2458/13/735
  • 4. Acceptability of HST Acceptability of HST was high in most studies. Seventy per cent of all clients who were included in the reviewed studies performed HST. The acceptability rate ranged from 22% to 87% and was highest in Malawi where HST was offered at home with minimal supervision [24]. In the Malawian study, HST uptake was similar for both genders despite a significantly lower testing history among men. In Baltimore, overall acceptability of HST was high among hospital emergency department clients, but far more people (91% vs. 9%) opted for saliva-based HST compared to blood-based HST [25]. Spielberg et al. [28] demon- strated high initial interest to self-test (81%) but greater adherence in the oral fluid bi-monthly specimen collection arm compared to the DBS arm. In Spain, 78% [22] and 83% [21] of clients of mobile testing units agreed to HST. HST in these mobile testing units was especially attractive to gay people, young people, singles and people who had never tested before for HIV. At least two-thirds of an American high-risk MSM population reported use of HST with an average use of 1.6 times/per person [23]. 73% of MSM with frequent unprotected anal intercourse and changing sexual partners agreed to HST [19], as did 82% of their sexual partners [20]. As early as 2000 [29], accept- ability of HST among MSM participating in the Urban Men´s Health study had been high (67%). Uptake among Kenyan HCW was substantially lower [26]. Only slightly more than a fifth (22%) of all approached HCW eventually performed HST, and only about one third (31%) of those HCW who participated in the post-intervention survey had performed HST. Among HCW who attended pre-test information sessions, acceptability of HST was as high as in other studies (75%). In a separate intervention session arm, in which the intervention team had actively formed groups to attend pre-test information sessions, 97% of HCW took a test kit, but there was no further investiga- tion around how many of them subsequently performed the test. HCW were additionally offered to take test kits for their partners, which resulted in 55% of partners performing HST. 508 records identified 123 duplicates excluded IDENTIFICATION SCREENING 385 records screened (322 study abstracts,30 full text studies, 11 comments/ editorials, 3 book chapters, 10 press releases, 3 conference schedules, 1 guideline, 5 records published before 1998 21 full text studies excluded (acceptability rate missing or no HST performed, 1 analysis of a commercial test manufacturer) ELIGIBILITY 32 full text studies assessed for eligibility 353 records excluded INCLUDED 11 studies included in review Figure 1 Selection process of HIV self-testing studies following the PRISMA methodology [18]. Krause et al. BMC Public Health 2013, 13:735 Page 3 of 9 http://www.biomedcentral.com/1471-2458/13/735
  • 5. Table 1 Studies evaluating HIV self-testing (HST) in high-income countries Study Carballo-Diéguez et al., [19] Carballo-Diéguez et al., [20] De la Fuente et al., [21] Belza et al., [22] Katz et al., [23] Gaydos et al., [25] Lee et al., [27] Spielberg et al., [28] Osmond et al., [29] Objective Acceptability of oral fluid HST and willingness to use prior to sexual intercourse among high-risk MSM Acceptability of oral fluid HST prior to sexual intercourse among sexual partners of MSM Feasibility of blood-based HST and interpretation of results by laypersons Feasibility of blood-based HST by laypersons Acceptability and ease of use of oral fluid HST compared to clinic-based HCT among MSM Feasibility and accuracy of oral fluid and blood- based HST by laypersons compared to trained staff Acceptability and feasibility of blood- based HST among high-risk populations Feasibility and acceptability of bimonthly oral fluid and DBS HSC among high-risk populations Acceptability and feasibility of oral fluid HSC for HIV testing among MSM Location New York City, USA New York City, USA Gay districts and university sites, Madrid, Spain see De la Fuente et al., [21] USA Baltimore, USA Singapore USA San Francisco, Los Angeles, New York City, Chicago, USA Population 57 high-risk MSM 140 sexual partners of high-risk MSM 313 HCT clients of mobile testing units 267 HCT clients of mobile testing units 68 HIV- negative high- risk MSM 565 patients of emergency departments 420 HIV-positive- and at-risk clients of communicable disease and STI centres 297 participants of HIV Network for Prevention Trials 615 participants of Urban men´s health study Sex 100% male 100% male 69% female, 29% male 41% female, 51% male 100% male 59% female, 41% male 9% female, 75% male 20% female, 80% male 100% male Median age 34 years n.s. n.s. n.s. 39 years 38,4 years 33 years 36 years n.s. Ethnicity 39% Latino, 32% Black, 21% White, 7% Asian n.s. 83% White, 16% Latino 83% White, 16% Latino, 1% n.s. 73% White, 13% Latino, 9% Black, 4% Asian 69% Black, 29% White 98% Asian 64% White, 18% Black, 12% Latino, 2% Asian 69% White, 12% Hispanic, 8% Black MSM 100% 100% 35% 38% 100% n.s. 9% 58% 100% IDU - - n.s. n.s. - > 15% n.s. 30% - WAHR - - n.s. n.s. - n.s. n.s. 12% - Acceptability of HST 73,7% 81,5% 83% 77.9% 63.2% 84.6% 83.3% 81.1% 67% Incentives No Yes No No No Yes No Yes Yes n.s. not specified, MSM Men who have sex with men, IDU Injecting drug users, WAHR Women at heterosexual risk. Krause et al. BMC Public Health 2013, 13:735 Page 4 of 9 http://www.biomedcentral.com/1471-2458/13/735
  • 6. Accuracy of HST Overall, agreement between test results performed by laypersons and health staff was high with 86% of self- tests and 98% of home samples collected adequately. Disagreement between health staff and study partici- pants` results was mainly caused by invalid test results due to performance errors. Overall, no false positive test results occurred and the few false negative or inconclu- sive test results were mainly related to misinterpretation of very faint lines. In Spain, self-testers performed tests as accurately as health staff with 99% of tests being valid results [22]. However, the proportion of valid HST re- sults decreased to 92%, when demonstration of the test- ing procedure through trained health staff was omitted [21]. Accurate performance was associated with the level of education. Misinterpretation of photo results was gen- erally rare (4,9%) and associated with older age, Latin American origin and lower educational levels. Although self-administered tests were performed very accurately in Malawi, overall sensitivity (97.9%) remained slightly below sensitivity claimed by the manufacturers and was even lower (96.4%) among those who were previously not known to be HIV-positive [24]. Test results of par- ticipants in Baltimore concurred in 99,6% with the re- sults of the tests performed by health staff [25]. The study from Singapore [27] was the only one with high rates (54,4%) of invalid test results largely because most users failed to correctly transfer a blood sample with a capillary tube. Known HIV-positive participants were more likely to perform and interpret HST accurately. Utilisation of a counselling telephone hotline Few studies provided information on this topic, two from Sub-Saharan Africa [24,26] and three from the USA [23,28,29]. Utilisation of a counselling telephone hotline differed markedly between studies and countries and was substantially lower in Sub-Saharan Africa than in the USA. African participants clearly expressed a need for face to face counselling and comprehensive post-test counselling services [24,26]. American high-risk individ- uals on the other hand strongly preferred post-test coun- selling by phone (95%) and the majority suggested that, in the case of repeated testing, pre-test information would only need to be given every 6–12 months [28]. Despite these findings, only 40% of MSM included in the Urban Men´s Health Study called for their results and 7% of those who declined to participate in the study expressed concerns on being given the result by phone [29]. American high-risk MSM used the 24-hours Table 2 Studies evaluating HIV self-testing (HST) in low-income countries Study Choko et al., [24] Kalibala et al., [26] Objective Use and accuracy of oral fluid HST in the general population Acceptability and feasibility of free oral fluid HST among HCW Location High residential suburbs of Blantyre, Malawi District and provincial hospitals in Kenya with variable degrees of pre-existing HIV related services Population 298 of adult population and community peer group members 1081 HCW Sex 52% female, 48% male 33% female, 67% male Median age 26.5 years n.s. Ethnicity n.s. n.s. MSM n.s. n.s. IDU n.s. n.s. WAHR n.s. n.s. Acceptability of HST 87.2% 21.9% Incentives No No n.s. not specified, MSM Men who have sex with men, IDU Injecting drug users, WAHR Women at heterosexual risk. Table 3 Outcomes of HIV self-testing (HST) studies Study Carballo- Diéguez et al., [19] Carballo- Diéguez et al., [20] De la Fuente et al., [21] Belza et al., [22] Katz et al., [23] Choko et al., [24] Gaydos et al., [25] Kalibala et al., [26] Lee et al., [27] Spielberg et al., [28] Osmond et al., [29] Sample size 57 140 377 267 68 298 565 1081 420 297 615 Outcome N % N % N % N % N % N % N % N % N % N % N % Acceptability rate 42 73,7 101 72,1 313 83 208 77,9 43 63,2 260 87,2 478 84,6 237 21,9 350 83,3 241 81,1 412 67 Accuracy rate - - 288* 92 206** 99 - 256 98,4 476 99,6 - 158*** 45,6 658 99 402 97,1 Proportion of 1st-testers - - 142 45,4 111 56,9 - 94 36,2 - - - - 71 17,2 Disclosure rate – - - - - - - 192 81 - - Telephone hotline utilisation rate - - - - - - - 1 0,4 - 228 94,6 172 41,7 *25 invalid test results. **2 invalid test results. ***192 invalid test results. Krause et al. BMC Public Health 2013, 13:735 Page 5 of 9 http://www.biomedcentral.com/1471-2458/13/735
  • 7. contact line only to request new test devices and called the study office for counselling issues [23]. Disclosure of test results The reviewed studies give little information on disclosure of test results among self-testers. Most HCW (81%) and partners (85%) discussed their test result with another per- son, mainly with their sexual partner [26]. Other persons of trust were colleagues and friends, but only 10% discussed their result with another HCW. Couple testing showed increased disclosure rates. Women in Malawi felt HST could make involvement of their husbands in testing easier and remove some of the burden of testing from their shoulders [24]. Disclosure of test results did not seem to be an issue for American high-risk MSM, as the vast majority agreed to partner testing and accordingly disclosed their status [20]. Proportion of first-time testers In the four studies [21,22,24,29] that investigated the proportions of first-time testers, the proportions of people who had never tested before were equal among those who finally performed HST and those who were eligible to participate in studies. This suggests a high up- take of HST among first-time testers. In both Spanish studies half of participants were testing for the first time [21,22]. In Malawi, 50% of seropositive cases were newly detected through HST [24]. Among American high-risk MSM who tested seropositive, 60% had previously been unaware of their HIV-status [20]. Attitudes and opinions on HST Despite very different individual, socio-economic and cultural backgrounds, emerging qualitative assessments of HST were similar among study populations. HST was perceived as highly confidential and private [24,26,28] and participants believed HST could give people more control over their health [25]. High-risk MSM thought HST would increase testing frequency [23] and HCW regarded HST to be a testing strategy that they could easily access and that would facilitate their decision to get tested including testing for the purpose of post ex- posure prophylaxis [26]. People generally thought HST was easy to perform especially when a saliva-based test was used [21,23-29]. Indeed, Spanish participants rated collection of blood drops as the most difficult step of HST and those with invalid test results were more likely to believe that instructions were complicated [21]. Rapid oral fluid testing was generally preferred to blood-based testing [25-28]. Participants who self-tested were likely to use HST for their next HIV test and stated they would recommend HST to family and friends [19-21,24-28]. Trust in HST was high [25], but there was also some scepticism on accuracy [26,27,29] and the limitation of adequate post-test counselling services [24,26-29]. Fur- ther, acceptance of HST was influenced by its costs al- though most participants were willing to pay a small to medium amount [21,23,26-29]. Whereas Kenyan health care workers opted for a small fee ´comparable to a pregnancy test` [26], European and American clients would accept higher costs: 20 Euros [21] and 10 to 40 USD [23], respectively. Moreover, the way in which HST kits are distributed impacts on their acceptability. Partic- ipants from the USA and Singapore opted for public sale of HST kits [20,27], such as at pharmacies, whereas par- ticipants from Malawi [24] preferred home-based distri- bution of self-testing kits. Kenyan HCW believed self- test kits should be universally available at health facilities or even distributed on a routine base [26]. Discussion Our reviewed studies demonstrated consistently high ac- ceptability of HST, particularly with saliva based rapid tests, in all populations where so far the testing was evalu- ated. Acceptability was also high in the two home sample collection studies (81% [28] and 67% [29]). HST encour- aged testing equally among both genders [24]. Moreover, it encouraged repeated testing and first-time testing in hard-to-reach groups [20,22,23]. Even in African countries with existing successful testing programmes HST in- creased the reach of HIV testing services: 41% of partici- pants in Malawi had never tested before and 78% had tested longer than a year ago [24]. Further, HST seems to be an acceptable screening tool prior to sexual intercourse for MSM with high-risk sexual behaviour [19,20] despite its limitations related to the window period. Uptake of HST among MSM and their partners was high, HST was predominantly well appraised and a significant number of unknown seropositive cases were detected [20]. As such HST could detect and prevent HIV transmission in this population at least partly. In a recent study from Singapore [30], overall, 87.4% of participants would pur- chase an over-the-counter rapid test kit, with the highest proportion being among private clinic at-risk participants (92.4%). With regard to Sub-Saharan African countries, accept- ability rates of HST seem to be comparable to those of home-based HCT or provider-initiated HCT approaches [31-33]. However, high testing uptake of home-based HCT is often impaired through low rates of clients who finally learn their results [34,35]. The majority of reviewed studies do not report how many clients who tested reactive on HST consulted for obtaining a con- firmatory test, thus we do not know how many self- testers really learn their result. Only 42% of MSM, who used the home sample collection method in the Urban Men´s Health Study [29] called the help line for their testing result and participants of the HIV Early Krause et al. 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  • 8. Detection Study [28] were more willing to test for HIV with rapid tests than with the home sample collection method in order to avoid an unpleasant waiting period. The acceptability of HST was lowest for Kenyan HCW [26]. The reason for this may be related to the low at- tendance rates of pre-test information sessions where HCW could receive HST kits. Acceptability was compar- ably high to other studies, once HCW attended pre-test information sessions. In some studies, willingness to test for HIV was a precondition for inclusion in the study [21,22,25,28]. Therefore, acceptability rates did not truly reflect participants` decision to get tested, but rather whether someone wanted to experience HST. In other studies, participants received incentives, which might also have impacted on their decision to self-test [20,25,28,29]. It is possible, that the Kenyan study gives a more realistic picture of the degree to which HST, if available in a coun- try, could add to HCT uptake through existing testing strategies. In this case, an increase of 20% of HCW know- ing their HIV status through HST could be regarded as a considerable achievement. Part of this benefit would be re- lated to the high partner-testing rate and disclosure rate, that the study of Kalibala et al. [26] found. Critics often question the feasibility of HST among lay- persons. However, most participants performed HST ac- curately with little or no help of trained personnel [21,22,24,25]. There were no false positive results, which is remarkable as false positive results have been reported consistently in the context of rapid HIV tests especially in low-prevalence settings, highlighting the need for follow-up of clients for confirmatory testing [36-40]. The exact accuracy of HST in real-life settings remains to be determined. In several studies, clients were trained by pro- fessional staff prior to HST [22,23,26,28], performed the self-test under supervision [20-22,24] or had just received an oral fluid rapid test performed by trained personnel [25]. In Spain [21], the proportion of valid test results dropped from 99% to 92%, when the demonstration of the test through trained staff was omitted. In Malawi [24], 10% of self-testers, especially illiterate, less educated par- ticipants and women, requested the help of supervisors. Hence, accuracy is likely to be reduced, when clients de- pend only on themselves. User-friendliness of self-test de- vices is crucial to accurate performance. Studies by De la Fuente et al. [21] and Ng et al. [30] have demonstrated that depositing blood drops directly onto the test reactive strip (bypassing the use of a capillary tube for blood col- lection) improved the validity of HST. The now FDA- approved OraQuick® ADVANCE Rapid HIV-1/2 test seems to fulfil pegged requirements and reaches high ac- curacy in the hand of laypersons [41]. Our results support the theory that HST holds the po- tential to increase testing uptake. Nevertheless, some is- sues remain unanswered. Future research will also need to concentrate on other target groups that so far have been neglected in the context of HST like youth, women and couples. Furthermore, the organisation of counsel- ling services and linkage to treatment and care has to date not been sufficiently investigated. Research from The Netherlands suggests that self-testers feel even more responsible for their health and show higher levels of self-efficacy than people who do not use self-tests [16]. Most studies included confirmatory testing of HST [20-22,24,25,27,28], none of the reviewed studies have, however, examined whether self-testers reliably seek medical care in case of a positive result and what effect HST could have on HIV transmission. In any case, it will be essential to link HST to adequate counselling and support services. However, various degrees of counsel- ling and various counselling models are conceivable. Today it is considered that pre-test counselling can be minimal, merely providing the client with sufficient knowledge to give informed consent [42]. In fact, Ameri- can high-risk individuals preferred optional counselling, telephone hotlines or written pre-test information to mandatory in-person counselling [43-45]. Further, in- person counselling is no guarantee for good quality: an evaluation of calls at the South African National AIDS helpline indicated that a substantial proportion of clients who received in-person counselling at VCT services did not understand the meaning of their result, or only re- ceived a written test result without any counselling [46]. HST is so far only linked to counselling telephone hotlines, but, especially in developing countries, tele- phone hotlines do often not seem to cover clients` needs when it comes to notification of results and adequate post-test counselling. In rural areas with limited tele- phone, group information sessions and close links to on- site social organisations could be a possible counselling and support strategy for self-testers [12,13]. A recent study from Malawi demonstrated that linking HST to home assessment and the initiation of HIV care can sig- nificantly increase both the disclosure of HIV status and the initiation of ART at a population level [47]. Two of the self-testing studies took place in mobile units in Spain [21,22]. Staff offered HST to clients asking for VCT and reached a significant number of people. Clients received counselling and performed HST under supervi- sion of trained personnel at the mobile unit. At the moment, HST is still of disputed legality in many countries, such as South Africa, and happening only informally [48]. Although international policies stress a public health approach to HTC and a move away from obligatory in-depth pre-test counselling, the World Health Organization has not as yet given any spe- cific advice for the implementation of HST services [49]. Legal and policy frameworks would need to be devel- oped to ensure that HST reaches those most in need, is Krause et al. 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  • 9. conducted in a safe and supported fashion and yields ac- curate results. Clinical trials may be useful to explore the optimal strategies of introducing HST and to assess its place in a comprehensive HIV prevention package. We acknowledge that our review has several limitations. First, we used voluntary participation rate as an indicator for the acceptability of the testing strategy. We did not use other indicators such as satisfaction with the testing method, perceived ease of use, difficulties in understand- ing the testing instructions, satisfaction with pre- and post-test counselling and intention/willingness to use HST [30,43,50-53] because information about these indicators were not available in several of the studies included in the review. We only included studies where participants ac- tively performed HST. Further, only studies published in English were considered. Selection bias is likely as most study populations have been carefully selected and testing experience was generally high. In some studies wanting to perform an HIV test was a precondition for inclusion into the study. Acceptance of HST may be considerably lower among people with less testing experience or for people who did not consider testing for HIV. Overall the quality of the studies included was rather low, included only a small sample of selected participants, and most studies did not compare HST with more traditional testing strategies. Finally, study designs and populations were very heteroge- neous and results valid for one country may not be trans- ferrable to another country. Conclusions HST is an acceptable HIV testing strategy for key popu- lations as well as the general population and can be performed accurately by the majority of persons. Linkage to treatment and care services remains a major challenge and different models of HST provision should be ex- plored further. More research is needed to assess feasible and acceptable components of an HST service in order to ensure its safe and reliable use. Competing interests The authors declare that they have no competing interests. Authors’ contributions JK and RC designed the study. JK collected the data, analysed and interpreted the data and drafted and reviewed the manuscript. RC helped to analyse and interpret the data and to draft the manuscript and reviewed all drafts of the manuscript. FSS and CK participated in the interpretation of the data and reviewed drafts of the manuscript. All authors read and approved the final manuscript. Acknowledgements We thank Dr. Matthias Borchert for his support and for critically reviewing the final manuscript. 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Namakhoma I, Bongolo G, Bello G, Nyirenda L, Phoya A, Phiri S, Theobald S, Obermeyer CM: Negotiating multiple barriers: health workers' access to counseling, testing and treatment in Malawi. AIDS Care 2010, 22(1):68–76. doi:10.1186/1471-2458-13-735 Cite this article as: Krause et al.: Acceptability of HIV self-testing: a systematic literature review. BMC Public Health 2013 13:735. Submit your next manuscript to BioMed Central and take full advantage of: • Convenient online submission • Thorough peer review • No space constraints or color figure charges • Immediate publication on acceptance • Inclusion in PubMed, CAS, Scopus and Google Scholar • Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit Krause et al. BMC Public Health 2013, 13:735 Page 9 of 9 http://www.biomedcentral.com/1471-2458/13/735