Branson BM. Home Sample Collection Tests for HIV Infection. JAMA. 1998;280(19):1699-1701. doi:10.1001/jama.280.19.1699
From the National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Ga.
Toward Optimal Laboratory Use section editor: George D. Lundberg,
MD, Editor, JAMA.
Context.— Home sample collection (HSC) tests allow persons to test themselves
for human immunodeficiency virus (HIV) infection at home without medical supervision.
Characterizing the use of such tests can help assess their potential effect
on public health efforts to prevent and control HIV.
Objective.— To describe use of HIV HSC tests.
Design.— Retrospective descriptive analysis from data collected by test manufacturers
during 1996 and 1997.
Setting.— United States.
Participants.— Volunteer sample of consumers who used either of 2 HSC tests.
Main Outcome Measures.— Demographic and behavioral aspects of users.
Results.— During the first year of availability, 174,316 HIV HSC tests were submitted
to the manufacturers for analysis; 0.9% of the results were positive for HIV,
and 97% of all users called to learn test results. Survey responses from 70,620
HIV-negative and 865 HIV-positive users revealed that most were men, white,
and aged 25 to 34 years; HIV prevalence was highest among nonwhites, aged
35 to 44 years, men who have sex with men, and injection drug users. Bisexual
men accounted for a large proportion of HIV-positive users. Nearly 60% of
all users and 49% of those who tested HIV positive had never been tested before.
Telephone counselors found that 23% of HIV-positive users already had a source
of follow-up care, 65% accepted referrals, and 12% had tested themselves to
evaluate the effects of antiretroviral therapy.
Conclusions.— Home sample collection tests for HIV were used by persons who were at
risk for HIV and by persons who did not use other testing. Most HIV-positive
users either had a source of medical care or received referrals.
IN 1996, the Food and Drug Administration (FDA) approved 2 products
for home sample collection (HSC) for human immunodeficiency virus (HIV) testing.
The HSC kits are marketed directly to consumers. Users perform a finger-stick
to obtain a dried-blood spot specimen on filter paper. The specimen is identified
by an anonymous code number and mailed directly to a laboratory for HIV antibody
testing by enzyme immunoassay. Reactive specimens are confirmed by Western
blot or immunofluorescence assay. The user calls a toll-free telephone number
to obtain test results, counseling, and referrals. Persons with negative results
may choose to speak with a counselor, but most receive a prerecorded message
with their result and counseling information. All users who test positive
or indeterminate and those whose specimen was unsuitable for testing are connected
to a counselor who provides test results, counseling, and referrals or follow-up
Considerable debate preceded approval of HSC HIV testing. Proponents
maintained that its availability would increase testing,1
but opponents raised concerns about negative consequences after people received
results by telephone and the possible negative effect on public health surveillance
and control.2 Under regulations that permit
the postmarketing evaluation of products that are brought to market before
all outstanding questions are resolved, the FDA required HSC product manufacturers
to collect data on users and to share this information with public health
This article describes users during the first year of HSC test availability
and compares them with clients of publicly funded testing programs.
Data from both HSC kit manufacturers were included in this analysis.
Demographic questions asked by the 2 manufacturers were comparable, but the
methods used to elicit information differed.
Home Access Health Corporation (HAHC, Hoffman Estates, Ill) requires
users to register their test kit before submitting a specimen. During this
telephone registration, users are asked to provide demographic and behavioral
information via Touch-Tone telephone. During a second call to obtain test
results, users with negative results receive them and counseling via prerecorded
message unless they elect to speak with a counselor. Users whose specimens
are positive, indeterminate, or unsuitable for testing are connected to a
counselor who may elicit additional demographic and risk information and who
also enters a summary of the telephone interaction in a call log. Home Access
Health Corporation provided line-listed data for July 1996 through September
1997 for this analysis, including both the demographic survey and the call
Direct Access Diagnostics (DAD, Bridgewater, NJ) used a pamphlet included
with the HSC test kit to provide pretest counseling information. The users'
first contact with the company took place when they called for results. Users
were asked for demographic and behavioral information after they received
their test results. Direct Access Diagnostics surveyed only HIV-positive users
from May 1996 through mid February 1997 and began to survey all users in February
1997. On June 26, 1997, the company announced the withdrawal of its product
due to lack of demand, but continued to provide test results and administer
the survey until August 19, 1997. Information on the total number of tests,
test results, and sample adequacy was available for May 1996 to August 1997,
but demographic and behavioral information comprises only those users who
called from February 10 through August 29, 1997. Direct Access Diagnostics
provided summary information aggregated by quarter and did not provide access
to the call log.
Data in this analysis reflect the number of tests, not individual users,
because HSC tests are anonymous, and it is impossible to ascertain if some
users are repeat testers. No tests of statistical significance were performed
for comparisons, because although all data available from HSC test users were
included, there is little assurance that users who responded to the survey
constitute a representative sample.
Data were available for 174,316 tests, of which 95,955 (55%) were performed
by DAD and 78,361 (45%) by HAHC (Table 1). Overall, 97% of users called for their results. A total of 165,194
specimens (95%) were suitable for testing; 9073 (5%) were not tested because
they were contaminated, contained an insufficient amount of blood, or were
submitted too long after they were obtained. The HIV prevalence among HSC
test users was 0.9%.
Demographic and behavioral data were available from 76,373 persons (59%)
who responded to at least 1 survey question: 70,620 HIV-negative, 865 HIV-positive,
and 4888 persons who submitted samples unsuitable for testing. Response rates
differed for the 2 HSC products and also for specific questions. Response
rates averaged 67% among 78,361 HAHC users surveyed during pretest counseling.
More users provided information on sex (70%) and age (68%) than ZIP code (51%).
Response rates for all questions were higher (average, 75%) among HIV-positive
HAHC users because counselors asked for further demographic information when
giving test results and making referrals. Response rates for 49,712 DAD users,
surveyed when they called for test results, averaged 43%. Like HAHC users,
fewer DAD users provided ZIP code information, but response rates for HIV-positive
and HIV-negative DAD users were similar. Because of higher response rates
and the longer survey period, HAHC users account for approximately 72% of
demographic and behavioral information. However, there were no significant
differences in demographic or behavioral characteristics between HAHC and
Tests were submitted from all 50 states, Washington, DC, Puerto Rico,
and the US Virgin Islands. Most users were heterosexual; the largest percentages
were men, white, and aged 25 to 34 years (Table 2). The HIV prevalence was highest among African Americans
and Hispanics, those aged 35 to 44 years, men who have sex with men, and injection
drug users. Although only 5% of users were African American and 5% Hispanic,
they accounted for 16% and 12%, respectively, of positive results. Bisexual
men constituted 8% of all users tested and 27% of positive results; this percentage
may be even higher because the DAD survey did not distinguish bisexual men
from other men who have sex with men. Considering data from only HAHC users,
bisexual men accounted for 38% of the positive results.
Home Access Health Corporation asked users whether they had been tested
previously for HIV and what they expected the test results to be. Overall,
58% of users reported they were testing for the first time (Table 3). The HIV prevalence was slightly higher (0.8%) among first-time
testers than among users who had previously tested negative (0.7%). Of HIV-positive
users, nearly half had never been tested before. Only 17% of those who tested
positive for HIV had anticipated that their results would be positive, 46%
expected their results to be negative, and 37% were uncertain. Among HAHC
users found to be HIV negative, 2% had expected a positive test result.
Content analysis of the HAHC call log revealed that 65% of HIV-positive
users who called to receive results accepted referrals for medical care and
psychosocial services, 23% refused referrals because they had a source of
follow-up care, and 12% were receiving antiretroviral therapy but had tested
to see whether their HIV status had changed. During the telephone sessions,
counselors noted that 21% of persons discussed notifying their partners, 8%
asked the counselor to discuss the test result with their partner, and 5%
disclosed that they already knew their partner was HIV positive. However,
such information was not actively elicited from all callers.
The HAHC call log was also used to assess the psychological distress
of HIV-positive users when they received their results. Information about
coping was not systematically elicited from each user, but counselors recorded
that 7% of the HIV-positive users expressed shock and dismay at an unexpected
positive test result; 5% hung up immediately on receiving a positive test
result, without counseling; and 3% asked someone else to call for their results
(the counselor accommodated only after obtaining permission from the user).
One of the 610 HIV-positive users expressed suicidal ideation; the counselor
noted that this person was with a friend, who agreed to facilitate mental
Of the 71,263 HIV-negative HAHC users who called for test results, 82%
received the recorded message only, 29% called more than once to hear their
test results and counseling, and 12% elected to speak with a counselor.
Comparison of HSC test users with those tested at publicly funded HIV
sites suggests that HSC is used by persons who are at risk for HIV and those
who do not seek other testing. The 0.9% HIV prevalence among HSC test users
is nearly 3 times the estimated prevalence in the general population3 and similar to that observed in 1996 at publicly funded
clinics among persons tested for the first time (1.1%) and those whose previous
result was negative (0.9%) (Centers for Disease Control and Prevention Client
Record Database, unpublished data, 1997). Although 58% of HSC test users and
44% of those tested at publicly funded sites were being tested for the first
time, the proportion of HIV-positive HSC test users who had never been tested
before (49%) is considerably higher than that (29%) at publicly funded sites.
The high proportion (97%) of users who called for results compares favorably
with publicly funded clinics, where the return rate in 1996 averaged 67%,
ranging from 51% at sexually transmitted disease clinics to 83% at voluntary
HIV counseling and testing sites.4
It is important to recognize the limitations of the data on user characteristics,
as only 59% of users responded to questions about demographics and behavior.
Because HSC testing is anonymous, no information is available about nonrespondents.
This inability to characterize persons who may have used HSC testing hampers
our understanding of the ultimate role of HSC in HIV testing strategies.
Two reviews1,5 posed questions
about home testing for which data now suggest some answers. The following
5 questions relate specifically to HSC and also to more general issues about
consumer influence in the context of HIV testing.
1.Do HSC tests expand access
to testing? Proponents argue that HSC tests encourage persons to be
tested who might not otherwise. Evidence from this analysis supports this
view: more than half of the users had not been tested previously. The data
also show that HIV-infected bisexual males, African Americans, and Hispanics
are using HSC tests, suggesting that it is an acceptable option for persons
who may have less access to testing or who may be particularly concerned about
confidentiality. Although relatively few African Americans and Hispanics used
HSC tests, the risk for HIV seemed to be high among those who did. African
Americans and Hispanics each accounted for 5% of HSC test users (compared
with 30% and 18%, respectively, at publicly funded sites), but their HIV prevalence
(2.7% and 2.6%, respectively) was similar to that for publicly funded test
site users (2.6% and 2.0%).4
The overall effect of HSC tests on access to testing may be small. Excluding
blood donors, an estimated 16.6 million HIV tests are performed annually in
the United States.4 Publicly funded clinics
account for approximately 2.5 million (15%) of these tests and HSC accounts
for approximately 200,000 (1%). Cost of the test ($30-$40) may present a barrier
to the use of HSC. In a survey of 2370 HIV-negative persons in 9 states, 76%
of respondents said they might use a free HSC test within the next year, but
only 40% said they might use one if it cost $40.6
2.Can consumers correctly
use the HSC test? Of specimens submitted by consumers, 5% were unsuitable
for HIV testing, compared with 4.8% of dried-blood spot samples obtained by
health professionals.7 This suggests that consumers
can obtain an adequate sample for testing. However, many persons are unwilling
to provide finger-stick specimens,8 which may
limit the acceptability of HSC tests.
3.Do HSC test users suffer
because they receive no face-to-face counseling? Opponents of HSC tests
feared that telephone counseling would lead to emotional distress for persons
who tested HIV positive and that many might commit suicide or fail to obtain
follow-up medical care and psychological support. The evidence to date, based
on small numbers of HIV-positive users, is mixed. In the first year of use,
only 1 caller expressed suicidal ideation. More worrisome, 5% of callers who
tested HIV positive hung up without counseling, and no follow-up information
is available for them.
The data indicate that many HIV-positive HSC test users have a source
of care and that those who do not are willing to accept referrals. Information
is insufficient to determine whether HSC test users actually seek medical
care or whether telephone counseling is effective for encouraging users to
change their risk behaviors.
4.How do HSC tests affect
public health practices?Concern about the effect of anonymous HSC testing
on name reporting and partner notification led to attempts by several states
to block the sale of HSC HIV tests, citing state laws that mandated the reporting
of names of HIV-infected persons. However, under the federal Food, Drug, and
Cosmetic Act, FDA approval of HSC tests preempted these more restrictive state
laws.9 No data yet exist on whether the availability
of HSC tests hinders effective and timely surveillance or partner notification,
but such information is also meager about other anonymous and private-sector
testing. However, given the high proportion of users with sources of care
or accepting referrals and the fact that health care professionals are required
to report new cases, HSC tests are likely to improve these efforts: a high
percentage of HIV-positive persons are learning of their HIV infection from
HSC as their first test.
5.What have we learned about
evaluating consumer-use testing? The course negotiated by the FDA during
considerations of HSC testing offers some insight about whether the process
for evaluating the safety and effectiveness of HSC tests will be useful for
the introduction of other new technologies. The HSC tests were approved 10
years after the first product was submitted, during which the FDA grappled
with its mandate to ensure the safety and effectiveness of home diagnostic
products for HIV. For HSC tests, it seems to have been possible to collect
sufficient data to evaluate safety and effectiveness of the device itself
as well as the consequences of its approved use, such as the psychological
responses of users. More detailed information also exists about the cost and
feasibility of the data collection and postmarketing studies that were imposed
on HSC product sponsors as conditions of approval. The approval of HSC tests
for HIV may pave the way for the approval of other technologies, such as 1-step
rapid HIV tests, which can provide results in 10 to 15 minutes without the
need for a laboratory, and even true home tests,10
which consumers could perform and interpret at home. These could dramatically
change HIV testing, and HIV prevention strategies based on immediate access
to test results could greatly affect the AIDS epidemic.