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Table 1.—Home Collection Users, by Test Result, May 1996 Through September 1997*
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Table 2.—Characteristics of Persons Using Home Sample Collection HIV Tests*
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Table 3.—Testing History and HIV Test Result*
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1.
Bayer R, Stryker J, Smith MD. Testing for HIV infection at home.  N Engl J Med.1995;332:1296-1299.
2.
Skelley M. Not Available Testimony on behalf of the Association of State and Territorial Health Officials, Council of State and Territorial Epidemiologists, National Alliance of State and Territorial AIDS Directors, Association of State and Territorial Public Health Laboratory Directors, FDA Blood Products Advisory Committee; June 22, 1994; Washington, DC.
3.
Karon JM, Rosenberg PS, McQuillan G.  et al.  Prevalence of HIV infection in the United States, 1984 to 1992.  JAMA.1996; 276:126-131.
4.
Centers for Disease Control and Prevention.  HIV Counseling and Testing in Publicly Funded Sites: 1995 Summary Report. Atlanta, Ga: US Dept of Health and Human Services; 1997.
5.
Schopper D, Vercauteren G. Testing for HIV at home: what are the issues?  AIDS.1996;10:1255-1265.
6.
Colfax GJ, Lehman J, Hecht FM.  et al.  Likelihood of at-risk individuals using home HIV test collection kits. Paper presented at: Society of General Internal Medicine, 20th Annual Meeting; May 2, 1997; Washington, DC.
7.
Hoxie NJ, Vergeront JM, Pfister JR.  et al.  Improving estimates of HIV-1 seroprevalence among childbearing women: use of smaller blood spots.  Am J Public Health.1992;82:1370-1373.
8.
Malor CJ, Read SE, Coates RA.  et al.  Comparison of saliva and blood for human immunodeficiency virus prevalence testing.  J Infect Dis.1991;163:699-702.
9.
Schultz WB. Advisory OpinionWashington, DC: US Food and Drug Administration; 1996.
10.
Kassler WJ. Advances in HIV testing technology and their potential impact on prevention.  AIDS Educ Prev.1997;9(suppl B):27-40.
Toward Optimal Laboratory Use
November 18, 1998

Home Sample Collection Tests for HIV Infection

Author Affiliations

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.

JAMA. 1998;280(19):1699-1701. doi:10.1001/jama.280.19.1699
Context.—

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 instructions.

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 officials.

This article describes users during the first year of HSC test availability and compares them with clients of publicly funded testing programs.

METHODS

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 log.

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.

RESULTS

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 DAD users.

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 health support.

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.

COMMENT

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.

References
1.
Bayer R, Stryker J, Smith MD. Testing for HIV infection at home.  N Engl J Med.1995;332:1296-1299.
2.
Skelley M. Not Available Testimony on behalf of the Association of State and Territorial Health Officials, Council of State and Territorial Epidemiologists, National Alliance of State and Territorial AIDS Directors, Association of State and Territorial Public Health Laboratory Directors, FDA Blood Products Advisory Committee; June 22, 1994; Washington, DC.
3.
Karon JM, Rosenberg PS, McQuillan G.  et al.  Prevalence of HIV infection in the United States, 1984 to 1992.  JAMA.1996; 276:126-131.
4.
Centers for Disease Control and Prevention.  HIV Counseling and Testing in Publicly Funded Sites: 1995 Summary Report. Atlanta, Ga: US Dept of Health and Human Services; 1997.
5.
Schopper D, Vercauteren G. Testing for HIV at home: what are the issues?  AIDS.1996;10:1255-1265.
6.
Colfax GJ, Lehman J, Hecht FM.  et al.  Likelihood of at-risk individuals using home HIV test collection kits. Paper presented at: Society of General Internal Medicine, 20th Annual Meeting; May 2, 1997; Washington, DC.
7.
Hoxie NJ, Vergeront JM, Pfister JR.  et al.  Improving estimates of HIV-1 seroprevalence among childbearing women: use of smaller blood spots.  Am J Public Health.1992;82:1370-1373.
8.
Malor CJ, Read SE, Coates RA.  et al.  Comparison of saliva and blood for human immunodeficiency virus prevalence testing.  J Infect Dis.1991;163:699-702.
9.
Schultz WB. Advisory OpinionWashington, DC: US Food and Drug Administration; 1996.
10.
Kassler WJ. Advances in HIV testing technology and their potential impact on prevention.  AIDS Educ Prev.1997;9(suppl B):27-40.
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