HomeAccess Post-Marketing HIV Surveillance Study

Purpose
To verify the safety and efficacy of the Home Access® HIV-1 test system under conditions of routine use (as observed in Phase III clinical trials and as published in the American Medical Association’s Archives of Internal Medicine, 2/10/97, Volume 157) and to examine the impact of Home Access testing for use in a public health setting.

Methodology
There are three groups being examined in the study: people who purchase the Home Access® system commercially; people who are utilizing current HIV testing and counseling services at public test sites; and people who randomly will receive a Home Access test kit as part of the study. [Kits are distributed at public health outreach (street) sites or public health specialty clinics, such family planning clinics, HIV testing clinics, STD clinics, or needle exchange.]

Results

1. Comparison of HIV Home Test Systems to Public Health HIV Test Services

The objective of this study was to examine the utility of home HIV test services in public health settings. We compared utilization and receipt of results of commercially available home HIV test services (Home Access® HIV-1 Test System, Home Access Health Corporation, Hoffman Estates, Illinois) to public health HIV test services.

2. HIV Testing: Public Health vs. Home Test Services

The objective of this study was to compare a commercially available home HIV test system (Home Access® HIV-1 Test System, Home Access Health Corporation, Hoffman Estates, Illinois) to public health HIV test services. The responses of self-reported medical problems experienced by clients during testing for HIV at public health test sites or using home test systems provided the basis of comparison.

HIV and AIDS Surveillance Information

Surveillance Findings from The Kaiser Foundation Report on HIV/AIDS:

Women
New cases on the rise.

Minorities
The epidemic shifts to minorities.

Injection Drug Users & Heterosexuals
Most rapid increase in new cases.

Men & Youth
White men on decline. Youth face new challenges.

Projected Progress of Disease
From the CDC HIV/AIDS Prevention web page:

Women:
The proportion of new cases continues to rise among women. During the period 1981-87, women comprised 8% of AIDS cases; this figure rose to 18% during 1993-95. In 1994, 41% of women with AIDS reported injecting drug use as the contributing risk factor and 38% reported heterosexual contact with a partner at risk of, or known to be infected with, HIV.

Another 2% reported exposure to contaminated blood or blood products and 19% were unsure of the source of exposure. AIDS cases among women are more likely than among men to be reported initially without a risk factor for HIV, as many women and their care providers may not recognize or report the risk behaviors of the women or their partners.

The increasing death rate among women will also affect the care their children. The CDC predicts that what some have called the "orphan burden" will be profound. The estimated 80,000 women who were living with HIV disease in 1992 will leave behind 125,000 to 150,000 children when they die during the 1990s and early years of the next century.

Minorities:
The epidemic continues to shift into minority populations. Contrasting the time periods 1981-87 and 1993-95 the proportion of AIDS cases among whites decreased from 60% to 43%. At the same time, cases increased among blacks from 25% to 38% and for Hispanics from 14 to 18%. The per capita rate of AIDS cases is 101 per 100,000 for blacks compared to 17 per 100,000 for whites.

In other words, the prevalence of AIDS is six times higher among blacks and three times higher among Hispanics than among whites.

Race and ethnicity are not by themselves risk factor for transmitting HIV. Nevertheless less, racial, ethnic, social, and economic factors that influence risk behavior must be addressed as part of any prevention efforts.

Injection Drug Users & Heterosexuals:
Newly reported AIDS cases are increasing most rapidly among people infected due to injection drug use and heterosexual contact. The proportion of AIDS cases among injection drug users has increased from 17% during 1981 to 1987 to 27% during 1993 to 1995.

During the same time periods the proportion of cases attributed to heterosexual transmission increased from 3 to 10%, while cases among men who have sex with men declined from 64 to 45%.

Men & Youth:
One of the most important concerns for HIV prevention is the number of young adults who continue to become infected. There has been a marked decline in the rate of infection among white men in their late twenties and thirties-who have accounted for 44 percent of all AIDS cases to date. The decline among white men has contributed significantly to the stabilization in infection rates overall. Infection rates have not declined for other groups, however, and young gay and bisexual men of all races remain at high risk.

As each generation of young people they must face the AIDS epidemic anew. In every group, by race and gender, there is substantial increase in the rate of infection as individuals enter their late teens and early twenties, with rates peaking in the mid-to late twenties.

Worldwide Trends

According to the World Health Organization or WHO, the following trends of the worldwide epidemic (or pandemic) of HIV are evident:

WHO estimates that 18 million adults and adolescents, and about 1.5 million children have been infected with HIV.

Today over 4.5 million individuals have developed AIDS.

Sub-Saharan Africa has 11 million people living with HIV. But HIV is spreading fastest in South and Southeast Asia with 3 million infected adults.

Women are becoming increasingly affected by HIV. Worldwide, the cumulative number of infected women is expected to reach 15 million by the year 2000. By this same year, as many as 5 to 10 million children are expected to lose their mother or both parents to AIDS.

Also by the year 2000, between 30 and 40 million men, women, and children will have been infected with HIV; over 90% of all people with HIV infection will be from developing countries.

In 1981 AIDS was first reported in the United States. Today, HIV is present in virtually all countries and has infected around 18 million adults and adolescents and 1.5 million children. Now in its second decade, the epidemic continues to grow, invisibly, at an estimated rate of 6000 new infections in the world each day.

The importance of the HIV/AIDS pandemic cannot be measured solely by the number of infected of ill individuals. Because HIV is transmitted sexually, it mainly strikes adolescents, young adults, and people in early middle age. These are the very people on whom society relies for production and reproduction. These are the men and women who raise the young and care for the old. Yet as they die of AIDS, their elderly relatives are left without support and their children become orphans. They are the ones who grow the crops, work in the mines and factories, run the schools and the hospitals, and even govern the country. Largely because of the lost productivity of this key demographic group, Thailand, for example, has estimated that the HIV pandemic will cost its economy close to 11 billion U.S. dollars by the year 2000. Thus, for every person with AIDS, countless more people are affected by the impact of HIV and AIDS. Hard-won gains in child survival are being erased. In countries that are not yet industrialized, or are in the process of industrializing, AIDS threatens development itself.

For current statistics on the number of diagnosed AIDS cases in the world, please contact the Pan American Health Organization which is the regional office for the Americas of the World Health Organization at 525 23rd Street, N.W., Washington, D.C. 20037, telephone: 202-861-4346.

National Survey on Attitudes Toward HIV Testing

Between April 24-26, 1998, Market Facts, Inc. of Arlington Heights, IL through its TeleNation methodology, randomly interviewed people for Home Access Health Corporation in an attempt to discover attitudes toward HIV testing in general and in terms of of current or future relationships.

The TeleNation survey consists of a minimum of 1,000 interviews with adults 18 years of age or older; 500 male and 500 female. TeleNation uses a single-stage, random digit-dial (RDD) sample technique to select each sample from all available residential telephone numbers in the contiguous United States. This non-clustered approach insures true random selection among all telephone numbers and provides a truly independent sample. TeleNation interviews are conducted over a three day period via Market Facts' CATI network in its National Telephone Centers. TeleNation employs AUTOQUEST®, Market Facts' computer assisted telephone interviewing system, to conduct telephone interviews.

Survey Highlights

FOR INFORMATIONAL PURPOSES ONLY. Home Access Health makes no scientific claims regarding the data generated by this survey.

The following represents responses from 533 people who had first indicated they have never been tested for HIV or have never actively sought to get tested for HIV.

1. How likely would you be to consider a potential partner’s HIV status before beginning a physical relationship with that partner?

Very Likely	54.6%
Somewhat Likely	10.4%
Somewhat Unlikely	4.0%
Very Unlikely	26.7%
Don’t Know/No Answer	4.3%

2. How likely do you think a potential partner would support a request to get tested for HIV before entering into a physical relationship?

Very Likely	36.3%
Somewhat Likely	21.8%
Somewhat Unlikely	11.4%
Very Unlikely	12.0%
Don’t Know/No Answer	18.5%

3. What’s the likelihood of you being supportive if a potential partner requested you to get tested for HIV before beginning a physical relationship?

Very Likely	70.1%
Somewhat Likely	12.3%
Somewhat Unlikely	3.1%
Very Unlikely	8.2%
Don’t Know/No Answer	3.3%

4. Would your feelings about someone change if they required an HIV test from you before entering into a physical relationship?

More Favorable	40.7%
Feelings Wouldn’t Change	40.5%
Less Favorable	11.3%
Don’t Know/No Answer	7.5%

5. How likely would you be to delay or deny an initial physical encounter with someone until they got tested for HIV?

Very Likely	52.3%
Somewhat Likely	14.6%
Somewhat Unlikely	7.1%
Very Unlikely	17.8%
Don’t Know/No Answer	8.2%

6. How likely would you be to take someone’s word that they have been tested for HIV and are currently HIV negative?

Very Likely	13.0%
Somewhat Likely	24.8%
Somewhat Unlikely	15.3%
Very Unlikely	38.3%
Don’t Know/No Answer	8.6%

7. Who should be responsible for bringing up the subject of HIV testing in a relationship?

My Own Responsibility	48.7%
Both Equally	38.2%
Partner’s Responsibility	4.8%
Don’t Know/No Answer	8.3%

8. How likely would you be to initiate a discussion about HIV testing if the partner doesn’t bring up the subject?

Very Likely	56.4%
Somewhat Likely	24.3%
Somewhat Unlikely	5.1%
Very Unlikely	8.0%
Don’t Know/No Answer	6.1%

9. Thinking back over the last ten years, what best describes the number of relationships you’ve had in which HIV testing was discussed?

Every Relationship	2.5%
Most of Them	4.2%
Some of Them	4.7%
Very Few of Them	3.1%
None of Them	18.5%
Only One Relationship/Discussed	14.3%
Only One Relationship/Not Discussed	36.6%
No Relationships	10.6%
Don’t Know/No Answer	5.5%

10. What is your level of agreement with the following statement? The only way anybody can know with 100% certainty about a partner’s HIV status is to have him or her tested for HIV.

Strongly Agree	67.2%
Somewhat Agree	19.1%
Neither Agree or Disagree	2.7%
Somewhat Disagree	3.0%
Strongly Disagree	3.7%
Don’t Know	2.6%

Katarzyna E. Kruzel, MPH
Allan P. Frank, MD
Bernard M. Branson, MD
Denise K. Boyd, MS, MPH
Michael G. Wandell, PharmD

Introduction
Home HIV Test Services became available in 1996. The objective of this study was to examine the utility of home HIV test services in public health settings. We compared utilization and receipt of results of commercially available home HIV test services (Home Access® HIV-1 Test System, Home Access Health Corporation, Hoffman Estates, Illinois) to public health HIV test services.

Methods
Five health departments undertook a randomized controlled trial from January 1 through December 31, 1997, in three public health settings:

1.	In clinic participants received either traditional Clinic Counseling and Testing (Clinic CT) or a Home Access® HIV-1 Test System. The clinic sites included anonymous testing sites in Arizona (Coconino, Maricopa, Mohave and Pima Counties) and the Snohomish Health District (Everett, Washington).
2.	Outreach testing program participants received either Counseling and Testing in the Field (Field CT) or a Home Access® HIV-1 Test System. The on-site outreach testing programs included various anonymous testing sites sponsored by Seattle-King County AIDS Prevention Project (Seattle, Washington) and various outreach sites matched for demographics and exposure categories through Lake County Health Department (Lake County, Illinois).
3.	Outreach referral program participants received either a referral card to a public health clinic providing HIV counseling and testing services (Outreach Referral) or a Home Access® HIV-1 Test System. The outreach referral programs included needle exchange sites in Seattle, Washington and various health education outreach sites sponsored by Champaign-Urbana Public Health District in the mid section of Illinois.

Results
The total number of participants was 4133.

Overall, of the 528 participants who received traditional testing, test results were available for 421. 297 (70.5%) returned to receive results. 5 (1.2%) were positive, and 2 (40.0%) returned for results and were offered referrals. Of the 416 HIV negative participants 295 (70.9%) returned for results. 107 participants were excluded from analysis because anonymous test results could not be linked to the individual participant.

There were 2666 participants who received a Home Access® HIV-1 Test System. Of the 1162 (43.6%) samples submitted to the laboratory for testing, 1049 (90.3%) samples were tested, and 153 (9.7%) of the samples were unsuitable for testing. The reasons samples are unsuitable include samples: insufficient in volume, contaminated, clotted, or expired; or because an error occurred during the packaging of the sample for shipment to the laboratory for testing. Of the 1049 tested samples, 984 (93.8%) participants called to receive results. There were 12 (1.1%) participants testing HIV positive, and all 12 (100.0%) called to receive results and were offered referrals. There were 1037 participants testing HIV negative and 972 (93.7%) of them called to receive results.

Home HIV Test Service Utilization

	Clinic CT		Field CT		Outreach Referral		Total
	N	(%)	N	(%)	N	(%)	N	(%)
Received Test	616		406		1644		2666
Submitted Sample	508	(82.5)	172	(42.4)	482	(29.3)	1162	(43.6)
Tested Sample	467	(75.8)	153	(37.7)	429	(26.1)	1049	(39.3)

Despite the attempts at randomization, many persons who enrolled in the study insisted on receiving a home test service from the public health sites. Therefore, more participants received a home test service compared to traditional counseling and testing.

In the three public health settings:

1.	200 clinic participants received traditional counseling and testing services, for whom 124 test results were accessible, 114 (91.9%) returned for results. 616 clinic participants received a Home Access® HIV-1 Test System, 508 submitted samples for testing, and 467 were tested. 456 (97.6%) participants received results.
2.	328 participants received Field CT, for whom 297 test results were accessible, 179 (60.3%) returned for results. 406 field outreach participants received a Home Access® HIV-1 Test System, 172 submitted samples for testing, and 153 samples were tested. 139 (90.8%) participants received results.
3.	>939 outreach participants received a referral card to an HIV counseling and testing site, 1 (0.1%) participant tested and returned for results. 1644 outreach participants received a Home Access HIV-1 Test System, 482 submitted samples for testing, and 429 samples were tested. 389 (90.7%) participants received results

Results From Clinic Participants

	Number of clients receiving	Submitted Sample	Samples Tested	Received Results
Referral Card	939	1 (0.2%)	1	1 (100.0%)
Home HIV Test Service	1644	482 (29.3%)	429	389(90.7%)

	Total Samples Tested	Total Results Given	Positive Samples	Positive Results Given	Negative Samples	Negative Results Given
PH HIV Test Services	124	114	1	0	123	114
Home HIV Test Services	467	456	7	7	460	449

Conclusions
Compared with traditional HIV testing a greater percentage of persons who used the home test service received their test results.

In outreach settings many more persons test when they are given a home test service than when they are referred to a counseling and testing site.

The randomization of the trial was unsuccessful because many of the participants insisted on receiving a home test service. In outreach settings many of the persons who accepted a home test service did not pursue HIV testing.

This analysis suggests that an HIV home test service is most useful in outreach settings because a larger proportion of persons learn their HIV status when they use a home test service. It may also be useful in anonymous settings where many people fail to return for results.

Medical Problems Associated with HIV Testing: Public Health vs. Home Test Services

Poster # 33291
Presented at the XI International Conference on AIDS
Geneva, Switzerland
July 1, 1998

Allan P. Frank, MD
Katarzyna E. Kruzel, MPH
Denise K. Boyd, MS, MPH
Michael G. Wandell, PharmD

Study Investigators and Coordinators

Denise Boyd, MS, MPH Principal Investigator HIV/AIDS Surveillance Program Manager Arizona Department of Health Services Phoenix, Arizona	Bernard M. Branson, M.D. Technical Advisor Medical Epidemiologist Division of HIV/AIDS Prevention, CDC Atlanta, Georgia
Frank Busicio, MA, MPH Site Coordinator Program Supervisor Snohomish Health District Everett, Washington	Allan P. Frank, M.D. Principal Investigator Medical Director/ Vice-President Clinical Affairs Home Access Health Corporation Hoffman Estates, Illinois
Gary Goldbaum, MD, MPH Site Investigator Medical Director, AIDS Prevention Project Seattle-King County Health Department Seattle, Washington	Anne Jensen, RN, BS, MBA Site Investigator Coordinator STD/HIV Program Lake County Health Department Waukegan, Illinois
Katarzyna E. Kruzel, MPH Study Coordinator Clinical Research Associate Home Access Health Corporation Hoffman Estates, Illinois	Robert Marks, M.Ed. Site Coordinator Disease Intervention Specialist Seattle-King County Health Department Seattle, Washington
Michael McKee, M.Ed. Site Coordinator HIV Counselor/ Health Educator Snohomish Health District Everett, Washington	Julie Pryde, MSW Site Investigator Program Consultant Champain-Urbana Public Health District Champaign, Illinois
Cheri Speelman Site Coordinator Community Health Outreach Worker Pacific Treatment Alternatives Everett, Washington	Christopher Spitters, MD, MPH Site Investigator Deputy Health Officer & TB Control Officer Snohomish Health District Everett, Washington

Introduction
The use of home HIV test services in public health settings has been controversial. The objective of this study was to compare a commercially available home HIV test system (Home Access® HIV-1 Test System, Home Access Health Corporation, Hoffman Estates, Illinois) to public health HIV test services. The responses of self- reported medical problems experienced by clients during testing for HIV at public health test sites or using home test systems will be discussed in this presentation.

Methods
Five health departments and Home Access Health Corporation conducted a randomized controlled trial of home HIV test services from January 1, 1997 through March 5, 1998. Participants through the public health departments received counseling and testing in one of the following venues:

1.	Traditional- Clinic Counseling and Testing. The clinic sites consisted of anonymous testing sites in Arizona Department of Health Services at the following sites Coconino, Maricopa, Mohave and Pima Counties, Champaign-Urbana Public Health District (Champaign, Illinois), and Snohomish Health District (Everett, Washington). Outreach On-site Counseling and Testing. The on-site outreach testing programs included various anonymous testing sites sponsored by Seattle-King County AIDS Prevention Project in Seattle, Washington and various outreach sites matched for demographics and exposure categories through Lake County Health Department, Lake County, Illinois.
2.	PH Distributed Home Access® HIV-1 Test System, Hoffman Estates, Illinois, distributed by one of the above mentioned health departments in either the clinic setting or outreach programs.
3.	Purchasers -Home Access® HIV-1 Test System, Hoffman Estates, Illinois, purchased over the counter, or placing an order through direct response (toll free number).

After receiving HIV test results, participants were asked or reminded to participate in the survey, to evaluate their testing experience. This information presented here specifically discusses the medical problems that occurred during the testing process.

Results
From the three treatment groups 2405 clients were invited to participate in the study survey, a total of 1530 (63.6 %) responded to the testing experience questionnaire. Among 554 Traditional participants, 217 (39.2 %) responded to the survey. Of the 1049 using home test services (PH Distributed) 771 (73.5%) responded, and 542 (61.7%) of 879home test service Purchasers responded to the survey.

There were 879 Purchasers, receiving a test result and invited to participate in the survey, 559 were HIV negative clients of which 519 (92.8%) responded, and 320 were HIV positive of which 23(7.2%) responded.

The number agreeing to be surveyed and reporting any medical problem included 21 (9.7%) Traditional participants, 65 (8.4%) PH Distributed and 39 (7.2%) Purchasers. Overall, a total of 125 (8.2%) participants experienced some type of medical problem, while the majority of those participating 1405 (91.8%) did not.

In each of the three groups those reporting any medical problem most commonly reported an unspecified medical problem: Traditional testers 76.2%, home test services (PH Distributed) 52.3%, and Purchasers 59.0%. The next most commonly reported problems were "bruising" 21.5% of home test services (PH Distributed) and 17.9% of Purchasers, and "bruising and dizziness" 9.5% of Traditional testers.

Although these reports were of a minor nature and did not require medical intervention, one MDR (medical device report) was submitted outside the survey. In the MDR a health worker who helping a friend obtain a blood spot sample accidentally punctured their own skin after penetrating the users skin. This problem did not require medical intervention.

Clients Responding	Experienced Any Medical Problems
	Traditional Testing Public Health	Home HIV Test Public Health	Home HIV Test Purchasers
No Medical Problems	196	706	503
Yes Medical Problems	21	65	39

Clients Responding	Percent of Medical Problems Experienced
	Traditional N = 21	PH Distributed N = 65	Purchasers N = 39
Bruising Only	4.8%	21.5%	17.9%
Bleeding Only	0.0%	1.5%	2.6%
Dizziness Only	4.8%	6.2%	5.1%
Bruising and Bleeding	0.0%	7.7%	10.3%
Bruising and Dizziness	9.5%	6.2%	0.0%
Bleeding and Dizziness	0.0%	0.0%	2.6%
Bruising, Bleeding, and Dizziness	4.8%	4.6%	2.6%
None Specified By Client	76.2%	52.3%	59.0%

Conclusions
While the response rate to the testing experience survey was higher among home testers regardless of how they received their test, not surprisingly those testing negative were much more likely to respond verses those testing positive. The incidences of reports (104, 7.9%) of "any medical problem" were less than those noted in the Phase III clinical study for the home test system. Even though traditional public health users had no reliable denominator data, a higher percentage of users (9.7%) reported a medical problem compared to home test users (7.9%).

Moreover, though home test users were unlikely to participate in the post-test experience survey after being informed that they were HIV-1 infected, overall respondents registered a small number of medical problems associated with home test use.

A low number of reported medical problems associated with home test system use validates the experience of the Home Access HIV-1 Phase III trial. This new test system offers access, anonymity and safe testing to those who otherwise may not elect to determine their HIV-1 serostatus.

Anonymous HIV Testing Using Home Collection and Tel emedicine Counseling: A Multicenter Evaluation

Allan P. Frank, M.D., Attending Physician, Dept. of Medicine, Illinois Masonic Medical Center, Chicago, IL, previously Clinical Instructor, Cook County Hospital Dept. of Medicine, Chicago, IL.
Michael G. Wandell, Pharm.D., Vice-President of Scientific Affairs, Home Access Health Corp., Hoffman Estates, IL
Milton D. Headings, M.A., Director of Counseling Services, Home Access Health Corporation, Hoffman Estates, IL
Marcus A. Conant, M.D., Clinical Professor, University of California Medical Center, San Francisco, CA
George E. Woody, M.D., Clinical Professor, University of Pennsylvania, Dept. of Psychiatry, Philadelphia, PA and Philadelphia Veteran Affairs Medical Center, Philadelphia PA
Catherine Michel, Ph.D., Research Project Director, Corning Besselaar, Princeton, NJ.

Abstract

Summary

Conclusion
The Home Access® HIV Test System is a safe and accurate alternative to venous blood testing. The dried blood spot testing demonstrated the same results as the venous blood tests, proving to be 100% accurate. Counseling services were found to have positive implications on the participants. Participants were able to successfully collect their own blood spots to be analyzed.

Summary of Results
The blood spot tests were in 100% agreement with the venous results. Participants answered 96.1% of the HIV prevention comprehension questions correctly. A total of 166 (13%) of the subjects were found to be HIV-positive-- 38 subjects were diagnosed as positive for the first time.

All positive or indeterminate results and numerous randomly selected negative results were delivered by counselors. All participants had access to 24-hour counseling seven days a week via the toll-free number. A total of 270 (21.5%) participants spoke with a counselor in post-test counseling and 417 (33%) subjects chose to speak with a counselor during the study. Counselors offered healthcare referrals to all participants with positive or indeterminate results.

Objective
To measure the accuracy of self-collected blood spot HIV testing compared to venous blood sample tests, to evaluate the benefits of pre- and post-test counseling services and to determine participants, ability to collect their own blood spot samples.

Study Population
1,255 ethnically diverse participants at nine outpatient U.S. clinics were enrolled in the clinical study. Of the subjects, a total of 471 (37.5%) were female, 767 (61.1%) were male and 17 (1.4%) did not specify. 886 (70.6%) of participants were Caucasian, 238 (19%) were African-American, 57 (4.5%) were Hispanic and 74 (5.9%) were from other various ethnic backgrounds.

Collection of Data
Participants were given a Home Access Express® (results in 3 days) kit to collect a blood sample. After completion of the self-collected blood specimens, professionals drew finger-stick and venous blood samples for basis of comparison. Participants received pre-test counseling and HIV risk reduction information by phone and afterward were asked a series of comprehension questions. The participants were able to choose either a live counselor or automated interactive voice response system (IVR). All services were offered in both English and Spanish.

Introduction
Over 1 million Americans are infected with the human immunodeficiency virus type 1 (HIV-1)^{1, 2}. Despite more than a decade of public health efforts directed toward HIV risk education and HIV-1 antibody testing, the HIV-1 epidemic continues to grow. Since neither an effective vaccine nor a pharmacological cure is likely in the near future, the only viable initiative for curtailing the HIV-1 epidemic is preventing exposure through HIV risk reduction education.

Most persons infected remain unaware of their infection and continue to pass the infection to their sexual and needle-sharing partners ^{3, 4, 5}. Initially, the HIV epidemic incidence in the United States was centered in both the gay and the intravenous drug user communities ⁶. At present, however, the rate of infection is increasing most rapidly among young and middle-aged heterosexuals ^{7, 8 ,9 ,10}, particularly black ¹¹ and Hispanic women ^{12, 13, 14} and has become a leading cause of death for 25 to 44 year-olds ^{15, 16}. If HIV-1 spread can be slowed through improved access to education and prevention efforts aimed at reducing high HIV-risk behaviors¹⁷, then the components of HIV/AIDS prevention are testing for evidence of HIV infection, access to client-centered counseling ^{18, 19, 20} focused on risk reduction, and early medical intervention ^{21, 22}.

Although population surveys indicate that millions of people would like to be tested for HIV 23, 24, most have not been tested ²⁵. Some potential barriers to HIV testing are lack of anonymity²⁶ particularly when combined with state regulations requiring named reporting27 and inconvenience ^28,29,30. These and other barriers to HIV testing, whether real or perceived, reduce the potential for testing most people ^31,32.

Technological advances in HIV-1 antibody testing have eliminated the need for a venous blood draw by using lancet-drawn blood spots collected on filter paper, dried, and shipped to a laboratory for analysis ^{33, 34, 35}. Millions of people, particularly neonates 36, have been screened for HIV using this method ³⁷. This study was based upon the assumption that if adequate instructions and materials were provided, medically untrained individuals could draw, collect, and ship their own blood sample on filter paper, eliminating the clinic visit for specimen collection and counseling. Home sample collection and centralized laboratory testing combined with telemedicine (interactive telephone counseling), enable subjects to receive HIV test results, pre- and post-test counseling, and medical referrals anonymously at home³⁸. However, this modality has been controversial³⁹ due to concerns of suicide ^40,41,42, blood sample stability ⁴³, ^{44, 45} and the opposition of some public health officials ^46,47,48.

To address many of these concerns, we tested an anonymous system in which a person collects his/her blood as a dried blood spot, ships the blood to the laboratory for testing, and receives interactive prevention and risk reduction counseling and test results by telephone.

Methods

Subjects
1255 subjects were enrolled and recruited from five US sites believed to have low HIV seroprevalence and four US sites believed to be high HIV seroprevalence based upon the sites historical HIV seroprevalence data. Subject were included in the study if they were able to follow verbal and written instructions in English or Spanish and did not meet exclusion criteria. Subjects were excluded from the study if they were less than 18 years of age, had hemophilia, or were being treated with anticoagulants. Recruitment was performed using radio and newspaper advertisements offering a free HIV test and payment for participation.

Materials
Each Investigator Master Kit contained three boxes per subject: a Home Collection Kit (subject finger-stick materials), a phlebotomist venous sample kit, and a phlebotomist finger-stick kit. Master Kits and their boxes were numbered, linked, and tracked by the packaging and distribution company (Fitzco, Inc. Maple Plain, MN).

Each Home Collection Kit (HCK) consisted of a cardboard box containing a HIV/AIDS information booklet, instruction booklet, specimen collection paper containing a tear-off page listing the Home Access® Code Number, toll free telephone number, and blood collection materials (lancet, lancet disposal container, alcohol wipe, adhesive bandage, and sterile gauze). Enclosed shipping materials included an air-impermeable envelope containing desiccant and a pre-addressed prepaid fedex® return envelope. To ensure anonymity, each Home Access® Code Number was unique and designed to be the only link between subjects and their test results.

Each phlebotomist finger-stick kit consisted of a cardboard box with blood collection contents identical to the Home Collection Kit, except for the HIV/AIDS information booklet and instructional manual. Each phlebotomist venous sample kit consisted of a cardboard box containing a sterile 21 G needle, Vacutainer, tourniquet, alcohol wipe, sterile gauze, adhesive bandage, red-top blood specimen tube, protective transport tube, water-impermeable bag, and a pre-addressed prepaid FedEx® envelope.

All kits and blood specimen components were numbered and linked. Each of three specimens for each subject was identified with unique bar-codes which blindly linked the samples with the subject's Home Access® Code Number. Central laboratory personnel were blinded to the link between the three specimens for any given subject or the subject identity.

Procedures
After receiving the HCK, subjects were provided with a private room with a telephone and only directed to follow the test kit instructions. Subjects were to follow package insert instructions by calling the toll-free telephone number to anonymously register their unique code number with Home Access® Health Corp., provide demographic information (age, gender, race, zip code), risk factors (male and/or female sex partner(s), non-prescription injectable drug use, blood transfusions, or HIV-positive sex partners), and previous HIV testing history. Registration created an electronic file labeled with the subject's anonymous and unique code number. At the subject's choice, registration and pre-test counseling was accomplished by either a counselor or an automated interactive voice response system (IVR). During the automated registration process, subjects were again offered human counseling. All facets of the service were offered in both English and Spanish.

HIV Education and Prevention Counseling
Following registration, subjects were given educational information about HIV risk reduction, AIDS, and HIV antibody testing by telephone. All counselors had been recently trained by a board-certified internist and a CDC-certified trainer in HIV prevention and risk reduction counseling. Subjects were offered a choice of either a counselor or an automated (IVR) session for the educational messages. Afterward, subjects' comprehension of the information was assessed with the following series (correct answers in parentheses):

1.	HIV can be spread by having unprotected sex. (T)
2.	HIV can be spread by using public toilets. (F)
3.	HIV can be spread by sharing needles. (T)
4.	After being infected with HIV, it can take up to six months for an antibody test to become positive. (T)
5.	I can reduce my chances of becoming infected with HIV by correctly using a latex condom during sexual intercourse. (T)
6.	I can reduce my chances of becoming infected with HIV by abstaining from sexual intercourse.(T)
7.	I can reduce my chances of becoming infected with HIV by using birth control pills. (F)
8.	If I am HIV positive, I can give the infection to my sex partners. (T)

Sample Collection
The subjects were to follow kit instructions to draw blood from a fingertip using a safety lancet (Becton Dickinson and Co.), fill a 5/8 inch circle imprinted on the specimen collection paper (Schleicher & Schuell), allow blood spot to air-dry for 30 minutes, sign the informed consent with their code number, and insert the filter paper specimen collection card in a foil-lined, air-impermeable bag prepackaged with desiccant and mail the sample to the prepaid laboratory address. Subjects were instructed to call the toll-free number three days later to obtain test results and appropriate counseling.

After subjects completed the blood spot kit self-collection, phlebotomists drew a finger-stick blood spot and a venous blood sample as controls. The three samples (subject-collected blood spot and phlebotomist-collected controls) were blinded and shipped to the laboratory using standard Fedex® service.

Sample Analysis
A CLIA-certified clinical laboratory performed sample analyses (Corning Clinical Labs, Wood Dale, IL). Incoming blood spot specimens were assessed for sample adequacy, gross sample contamination, desiccant presence and color, lancet return, and signed informed consent. Each venous serum sample and the two 0.05 inch' blood samples were screened according to package insert instructions of the enzyme-linked immunosorbent assay (EIA) manufacturer. Samples repeatedly reactive on EIA were confirmed with HIV-1 Immunofluorescent Antibody (IFA), (Fluorognost® Waldheim Pharmazeutica, Vienna, Austria) for the absence or presence of HIV-1 antibody. IFA results were reported as positive, negative, or indeterminate depending upon the fluorescence appearance.

Subjects were directed to call the Home Access® system for results three business days after shipping their sample. Subjects were counseled based upon their venous sample result. HIV counselors and board-certified internists were available to subjects 24 hours a day via toll-free telephone number. All non-negative results and some randomly selected negative results were answered by a counselor; the remaining results were given the IVR with the option to speak with a counselor. Counselors maintained subject anonymity while documenting conversation content, referrals, and emotional status of subjects.

Test Performance
The test results from subject-collected blood spots were compared to phlebotomist collected venous samples as the standard criterion. The laboratory was blinded to the sample origin and subject identity. Possible test outcomes for HIV antibody analysis were: positive, negative, indeterminate, and insufficient sample.

Safety Analysis
Safety of the collection kit was assessed by questioning each participant regarding adverse experiences immediately following the blood spot collection and/or at the follow-up clinic visit when subjects called to obtain their test results. Any additional complaints reaching the counseling service were documented; subject satisfaction and product inquiries were not routinely assessed. Adverse experiences were considered serious if they resulted in death, were life-threatening, permanently disabling, or required hospitalization.

Subject Disposition
Subjects were considered to have completed the study if they called to register their anonymous code number with Home Access Health Corporation, called to obtain test results, and kept their follow-up clinic visit during the clinical trial. Data was analyzed according to "intent to treat" design; all subjects receiving a sample collection kit were included for analysis.

Results

1255 subjects were recruited, 471 (37.5%) were female, 767 (61.1%) were male, and 17 (1.4%) did not specify. Demographic data, summarized in Table 1, indicated a diverse racial and HIV-risk factor population. 166 (13%) of 1255 subjects were HIV antibody positive, 38 of whom were diagnosed HIV positive for the first time using the home collection system. Of the 1255 subjects enrolled in the study, 151 subjects (12%) did not call for results, did not return for their follow-up visit, or did not complete the study for an reason.

Test Performance
The results obtained from subject-collected blood spots are compared with phlebotomist-collected venous samples in Table 2. Of the 1255 subjects enrolled in the clinical trial, 1147 submitted a testable amount of blood for both the subject-collected blood spot and the phlebotomist-collected venous sample. The remaining samples are found in the "insufficient" row and column of the cross tabulation in Table 2.

Using the FDA-approved HIV-1 serum test methodologies as a criterion standard, there were no false negatives or false positives for the dried blood spots submitted by subjects. All samples were correctly identified, demonstrating 100% sensitivity and 100% specificity of subject-collected dried blood spots compared to phlebotomist-collected venous blood.

The time from registration of Home Access® Code Number to availability of laboratory results to the subjects was 3.1 + 2.5 days (95% C.I.). 270 (21.5%) of enrolled subjects spoke with a counselor for post-test counseling. Healthcare referrals were offered to all subjects with non-negative results. Subjects with negative results were provided referrals if requested.

Test Adequacy
Blood sample adequacy was defined as a minimum of two 0.05 inch 2 punches, the minimum necessary to complete the test algorithm requiring both an EIA screening assay and an IFA confirmatory assay. 98% of subjects were able to collect an adequate blood sample compared with professional finger-stick collection by phlebotomists. 62 (4.9%) subjects requested counselor verbal assistance in collection and/or shipping their blood sample.

Test Safety
There were 14 (1.1%) reported adverse events in the clinical trial; 7 were probably or possibly related to use of the home collection kit and 7 were probably or possibly related to phlebotomist-drawn samples (Table 3). Ten subjects complained of dizziness, the most frequent adverse event noted. No serious adverse effects were reported.

Concurrent medical conditions, such as diabetes, connective tissue disease, easy bruisability and malignancy were reported in 174 subjects and did not affect the safety or efficacy of the system. 93 (7.4%) chronic non-steroidal anti-inflammatory drug users and 20 (1.6%) chronic prednisone users participated in the study. No skin infections were reported.

When asked, 120 (9.6%) subjects reported difficulty collecting their blood specimen; however, 92 of the 120 were able to collect an adequate blood specimen. The most frequent difficulty encountered was needing more than two finger-sticks to obtain an adequate blood sample. Other difficulties encountered were inability to puncture finger, maintain blood flow, comprehend test kit instructions, and access test results due to misplaced anonymous code numbers.

Comprehension of HIV Information
All counseling was performed by live telephone counselors and/or interactive automated information recordings depending upon the subject's choice. Pre-test counseling was effective, with 96.1% of comprehension questions answered correctly (Table 4). The question answered correctly by most (99%) subjects regarded HIV transmission by sharing needles. The question answered correctly least frequently (86%) regarded the seroconversion window between HIV infection and a positive HIV antibody test. A total of 417 (33%) subjects chose to speak with a telephone counselor for any reason during the study, including pre-test, post-test, referral information, product information, and additional follow-up counseling. 1070 (85.3%) of enrolled subjects chose the automated pre-recorded education session for pre-test and post-test counseling. 119 (9.5%) of subjects chose a telephone counselor during pre-test counseling rather than using an automated system.

Table 1

Table 2. Venous blood (x axis) vs. Dried Blood Spots

Table 3. Summary of All Adverse Events

Table 4. Pre-test Education Results

Discussion

Human Immunodeficiency Virus-type 1 (HIV-1) remains a growing threat despite public health attempts at prevention, including health testing, counseling, and education. Paralleling the rates occurring in the gay community during the early HIV epidemic, HIV spread among the heterosexual communities in alarming, particularly in the communities of color where public health initiatives have failed to slow infection rates.

Clearly, innovative new strategies are needed to help curb the epidemic. Although vaccine, anti-retrovirals, and anti-opportunistic infection research must continue, prudence dictates utilization of methods currently available.

This study evaluates the safety and efficacy of one such method in a diverse US population, the intended users, by utilizing telemedicine combined with a Home Collection Kit (HCK) to obtain blood spot for HIV-1 antibody testing. The controversy surrounding HCK has been two-fold: can an untrained person safely and adequately collect their own blood, and can that person also safely and effectively receive test results and counseling by telephone.

This study demonstrates that both concerns can be adequately and effectively addressed. It also demonstrates that patient-collected dried blood samples yield results as accurate as phlebotomist-collected venous samples. Test performance using the self-collected blood spots yielded 100% sensitivity and 100% specificity, or 100% concordance between professionally-collected venous blood and subject-collected blood spot samples. Interestingly, untrained individuals given proper instructions demonstrated a rate of successful collection comparable (98%) to phlebotomist rates for dried blood spots.

Study completion rates were reasonable. 151 of the 1255 subjects did not complete the study, an attrition rate less than that observed in clinical practice 50 Motivational factors are important to note: of the 151 subjects not completing the study, 44% stated they had previously tested HIV antibody positive prior to entering the study. The remaining subjects not completing the study were from low seroprevalence sites and had received payment for participation for their initial clinic visit. Presumably, this motivation paucity and the related attrition would be less likely for consumers making both emotional and financial investments in Home Collection Kits.

This study demonstrates that people can receive HIV test results and referrals by telephone without adverse outcome. Although some persons had suggestions for improving their perception of counseling operating procedures or for targeting the marketing of the HCK, there were no suggestions that the system was unsafe. 14 subjects ( ~ 1%) reported adverse reactions to self-collected blood, most often related to light-headedness associated with blood draw or the sight of blood. The event rate was similar whether the subjects or phlebotomists drew the blood; half of the reported events occurred in possible association with the self-collection device and half occurred with phlebotomist collection of blood.

Suicidal intent was an anticipated possibility in the system design based upon a literature review confirming that emotional distress is not unique to HIV or AIDS 51, 52, but encountered in any chronic or terminal illness. In addition to preparing counselors in training, the Home Access Health system provided subjects with 24 hour a day access to counselors for interaction, emotional assessment and appropriate referrals. No subjects expressed suicidal intent, however subjects were not routinely asked about suicidal thoughts unless they expressed emotional distress upon learning their HIV test result. The literature suggests that anticipation of HIV antibody results causes more emotional distress than actually receiving results, regardless of the test result 53, 54. Despite this, health providers have not recommended that unpleasant news be given in person, nor does the literature suggest that unpleasant news is better received in person. However, concerns of suicidal thoughts with HIV diagnosis or any chronic and potentially terminal illness must be taken seriously and counselors must be prepared to address the issue, as they were in this study.

Questions of safety and efficacy aside, this does not dismiss all public health concern surrounding potential loss of epidemiological data and possible inability to provide contact notification. When designing a service in which the client's identity can not be compromised, it seems reasonable that companies marketing a HCK would collect and distribute demographic information to appropriate public health officials. At present, however, most states would be unaffected as most states collect data on persons diagnosed with AIDS but not on persons solely testing HIV positive 55. HCK's determine the serologic markers of HIV infection only, not AIDS.

Some questions about HCK's long-term sequelae remain to be addressed. How will HCK services impact public health tracking of HIV epidemiology or partner notification? Will HCK services empower people to make risk reduction behavior changes? What new legal issues will surface with the advent of HCK services? Will the projected numbers of newly-diagnosed HIV positive persons overwhelm current health care resources or will HCK systems unburden public clinics by removing the "worried well" from the public health system? Will public health officials work together with companies marketing HCK services to enhance delivery of HIV testing and counseling services? Will HCK technology be adaptable to third world and developing countries?

These questions will take time to answer, but most should become clearer when addressed appropriately in post-marketing studies by companies marketing HCK . The most important question will be HCK's overall impact on the HIV epidemic, which we expect to be an instrumental component in ending the epidemic.

Although HIV transmission can be prevented through education and testing programs, these methods have proven largely unsuccessful. Despite conventional service availability in all communities, these services cannot or will not be accessed due to numerous barriers . HCK services offer a choice in HIV testing which can help overcome these barriers by allowing people to decide which HIV testing modality is best for them.

Some barriers are emotional - people receiving HIV antibody test results may not feel capable of immediately interacting with health care workers. Some can not schedule or keep a return appointment for anxiety-producing information. They can become anxious between visits or at night and not have access to an informed HIV counselor. In addition, long waiting periods, fear of physicians, and fear of needles are emotional barriers for some.

The financial barrier of a HCK is less than that at most clinics 56. Consumers can save additional money by not incurring hidden costs for clinic visits, such as child care, leave from work, telephone calls, and transportation.

Social barriers for those using a HCK would be fewer. People would neither suffer embarrassment associated with stigmatized clinics, nor face clinic personnel. The latter stigmatization can be substantial, particularly in smaller cities where the simple request to test for HIV can result in unfavorable stigmatization of the person. Additionally, some people do not want their partner, family, or co-workers to know about their clinic visit to receive a HIV test.

These financial, emotional, and social barriers signify examples barring access to HIV testing. Undoubtedly, other barriers exist which have prevented the majority of HIV-infected individuals from testing as well.

While not all questions concerning HCK's have been answered, it seems reasonable to conclude that HCK's can provide a safe and effective alternative to traditional face-to-face HIV testing and counseling.

Conclusion

For most people, testing for HIV is a highly emotional personal choice. Home collection kits (HCK's) afford anonymity and accuracy in a safe and accessible manner. This study demonstrates that a HCK system can provide an option to currently available HIV testing modalities provided the HCK is integrated into a counseling program with appropriately trained, sensitive counselors available for pre-test and post-test counseling 57 and referrals.

We are indebted to Rogelio Cadena, Michael Martinez, and Jorge Zayasbazan for counseling support and to Brian McDonald for computer support. Special thanks to Michael Chiarella, Richard Costanzo and Amy Stern from Corning Besselaar for site monitoring and statistical support. We thank the staff of: Conant Medical Clinic, particularly Dan Cardiff and Mark Fisher; Future Health Care Clinics staff, particularly Nancy Rayburn, Jenny Heber, Judy Cunningham, Jean Giannone, Jim Lincoln, Barbara Anderson, and Drs.. James McCarty, Richard Bath, Thomas Garland, Jr., Randall Gore, Joseph Liotti, and Dennis McCluskey; Louisiana Cardiovascular Research Clinic, particularly Dr. William Smith and Eric Stevens; and Dr. David Metzger and Tamara Boney of the Philadelphia Veteran's Affairs Medical Center/ University of Pennsylvania RAP Office. We thank Drs. Ken Clinc, Terry Conway, Sharon Irons, Steven Knox, Maria Martinez, Scott McCallister, and Anthony Vaccaro for consultative support. We thank Mary Cushman and Richard Quattrocchi for editing assistance.

This study was funded by Home Access Health Corp., Hoffman Estates, IL. Authors Frank, Headings, Michel, and Wandell were consultants and/or employees of Home Access Health Corporation at the time of this study.

Reprint requests to: Allan P. Frank, Medical Director, 2401 W. Hassell Rd, Suite 1510, Hoffman Estates, IL 60195.

Footnotes

1 Center for Disease Control. Mandatory HIV reporting: characteristics of adults reported with HIV compared to AIDS in the United States. 9th International Conf. on AIDS, Berlin, June 1993. Abstract #WS-C17-2.

2 HIV prevalence estimates and AIDS case projections for the United States: report based upon a workshop. MMWR 1990; 39 (RR-16):1-31.

3 Center for Disease Control. Public Health Service Guidelines for Counseling and Antibody Testing to Prevent HIV Infection and AIDS. MMWR 1987; 36(31):509-515.

4 Jones, WK. Non-Conventional Approaches to HIV Antibody Testing. Assoc. of State Terr. Pub H. Lab.Dir. Reno, Nevada. 1994.

5 Hardy A, Dawson D. HIV antibody testing among adults in the United States: Data from 1988 NHIS. Amer J Pub H 1990;80:586-589.

6 The second 100,000 cases of acquired immunodeficiency syndrome--United States, June 1981 - Dec 1991. MMWR 1992;41:28-29.

7 Avins AL, Woods, WJ, Lindan CP, Hudes, ES, Clark, W. et al. HIV Infection and Risk Behaviors Among Heterosexuals in Alcohol Treatment Programs. JAMA 1994;271:515-518.

8 Ilegbodu AE, Frank, ML, Poindexter, AN, Johnson D. Characteristics of teens tested for HIV in a metropolitan area. J. of Adolesc. Health 1994;5:479-484.

9 Holmes KK, Karon JM, Kreiss J. The increasing frequency of heterosexually acquired AIDS in the United States 1983-88. Am J Public Health 1990;80:858-862.

10 Update: mortality attributable to HIV infection/AIDS among persons aged 25-44 years-United States, 1990 and 1991. MMWR 1993;42:481-486.

11 Update: acquired immunodeficiency syndrome--United States, 1994. MMWR, Feb 3, 1995.

12 Hopkins DR. AIDS in minority populations in the United States. Public Health Rep. 1987;102:677-681.

13 Selik RM, Castro KG, Pappaioanou M. Racial/ethnic differences in the risk of AIDS in the United States. AM J Public Health 1988;78:1539-45.

14 Gostin LO. Public Health strategies for confronting AIDS: legislative and regulatory policy in the United States. JAMA 1989:261:1621-1630.

15 National Center for Health Statistics. Advance Report of Final Mortality Statistics, 12989. 1992;40(8):suppl 2.

16 National Center for Health Statistics. Annual summary of births, marriages, divorces, and deaths: United States, 1993. Hyattsville, MD: US Dept. of Health and Human Ser. Public Health Service, Centers for Disease Control, 1994:18-20. Monthly vital statistics report, vol 42, no 13.

17 De Vincenzi I, and The European Study Group on Heterosexual Transmission of HIV. A longitudinal study of human immunodeficiency virus transmission by heterosexual partners. N Engl J Med 1994:331:341-346.

18 Davis H, Fallowfield L. (Eds.) Counseling and communication in health care. New York: John Wiley and Sons. 1991:23-25.

19 Aruffo JF, Coverdale, JH,Pavlik VN, Valbona C. AIDS knowledge in minorities: Significance of locus of control. Am J Prev Med 1993: 9:15-20.

20 Centers for Disease Control. Technical Guidance on HIV Counseling. MMWR 1993:42 (RR-2):8-17.

21 Centers for Disease Control. Additional recommendations to reduce sexual and drug abuse- related transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR 1986:35:152-155.

22 Special initiative on AIDS of the American Public Health Association. Washington, DC. 1989.

23 Phillips KA, Flatt SJ, Morrison KR, Coates TJ. Potential use of home HIV testing. N Engl J Med 1995:332:1308-10.

24 HCI Custom Research, Inc. 1992.

25 Center for Disease Control. Public Health Service Guidelines for Counseling and Antibody Testing to Prevent HIV Infection and AIDS. MMWR 1987:36(31):509-515.

26 Fehrs, LJ, Fleming, D, Foster, LR, McAlister, RO, Fox, V. et.al. Trial of anonymous versus confidential human immunodeficiency virus testing. Lancet 1988;August: 379-382.

27 Public Health Foundation for the Office of the Assistant Secretary for Health. HIV Home Collection Kits: An Analysis of State Legislative and Regulatory Restrictions. Public Health Foundation 1992. Publication No. 133.

28 Jacobson, P, Perry, S, Hirsch, DA. Behavioral and psychological responses to HIV antibody testing. J Consul Clin Psychology 1990; 58:31-37.

29 Coates, TJ, Stall, R, Hoff, C. Changes in sexual behavior among gay and bisexual men since the beginning of the AIDS epidemic. In Psychological Perspectives on AIDS. Temoshok & Baum (Eds.). Hillsdale, NJ: Erlbaum. 1990.

30 Coates, TJ, Stall, R, Kegeles, S, Lo, B, Morin, S, et.al. AIDS antibody testing: Will it stop the AIDS epidemic? Will it help people infected with HIV? Amer Psychologist 1988;43:859-864.

31 Gostin, LO. Public Health Strategies for Confronting AIDS. Legislative and Regulatory Policy in the United States. JAMA 1989;261:1621-1630.

32 Kalichman, SC, Hunter, TL. HIV-Related Risk and Antibody Testing: An Urban Community Survey. AIDS Education Prev 1993;5(3):232-243.

33 Hannon WH, Lewis S, Jones WK, Powell MK. A Quality Assurance Program for Human Immunodeficiency Virus Seropositivity Screening of Dried-Blood Spot Specimens. Infect Control Hosp Epidemiol 1989; 10(1):8-13.

34 George JR, Hannon WH, Jones WK, Hoff R, Stevens RW, et.al. Serologic Assays for Human Immunodeficiency virus antibody in dried-blood specimens collected on filter paper from neonates. 1989; U.S. Dept of Health and Human Services, Nat. Inst. of Child Health and Human Dev. Center for Disease Control. Atlanta, GA.

35 Evengard, B, Linder, E, Lundbergh P. Standardization of a filter-paper technique for blood sampling. Ann Trop. Med and Para. 1988; 82(3):295-303.

36 Gwinn M, Redus MA, Granade TC, Hannon WH, George JR. HIV-1 Serologic Test Results for One Million Newborn Dried-Blood Specimens: Assay Performance and Implications for Screening. J Acq Imm Def Syndromes. 1992; 5:505-512.

37 Granade TC, Phillips SK, Bell CJ, Pau C, Parekh B, et. al. Factors influencing HIV-1 banding patterns in miniaturized Western blot testing of dried blood spot specimens. J Immun Method 1992;154:225-233.

38 Marwick C. Home testing kits for HIV apt to get FDA approval. JAMA 1995;273(12): 908-909.

39 Bloods Products Advisory Committee. 13th mtg. Dept. of Health and Human Svc. Food and Drug Administration. July 1990. Rockville MD.

40 Marzuk PM, Perry SW. Suicide and HIV researchers and clinicians beware. AIDS Care. 1993;5(4):387-390.

41 Perry S, Jacobsberg L, Fishman B. Suicidal Ideation and HIV Testing. JAMA 1990;263: 679-682.

42 Pugh K, O'Donnell I, Catala J, Suicide and HIV disease. AIDS Care. 1993;5(4):391-397.

43 Evengard B, Ehrnst A, von Sydow M, Pehrson PO, Lundbergh P, et.al. Effect of heat on extracted HIV viral infectivity and antibody activity using the filter paper technique of blood sampling. AIDS 1989;3:591-595.

44 Frank A, Wandell M, Weiblen B. Stability of DBS samples exposed to heat and humidty in three shipping envelopes. Poster. ASPHLTD convention. Reno NV. March 1995.

45 Public Health Foundation. HIV Home Collection Kits: An analysis of State legislative and regulatory restrictions. 1992. Publication No. 133.

46 Barsdell S. Should wider HIV testing be encouraged on the ground of HIV prevention? AIDS Care 1994;6(1):5-19.

47 American College of Physicians and Infectious Disease Society of America. Position paper. Human Immunodeficiency Virus (HIV) Infection. Ann Int Med 1994;120:310-319.

48 Landis SE, Schoenbnch VJ, Wever DJ, Mittal M, et al. Results of a randomized trial of partner notification in cases of HIV infection in North Carolina. N Engl J Med 1992;326:101-106

49 One venous sample initially characterized as positive by viral lysate EIA (reactive) and IFA (positive) but was tested negative in both the subject-collected and phlebotomist-collected blood spot samples. It was recharacterized as negative after further testing: recombinant EIA (non- reactive), Western Blot (no bands), p24 antigen (negative), HIV 1/2 EIA (non-reactive). This female patient has autoimmune complaints and ruptured silicone breast implants.

50 Valdiserri RO, Moore M, Gerber AR, Campbell CH Jr, Dillon BA, West GR. A study of clients returning for counseling after HIV testing: implications for improving rates of return. Public Health Rep 1993;108:12-8.

51 Louhivuori KA, Hakama M. Risk of suicide among cancer subjects. Am J Epidemiol.1979;109:59-65.

52 Abram HS, Moore GL, Westervelt FB. Suicidal behavior in chronic dialysis subjects. Am J Psychiatry. 1971;127:119-124. 53 Woody G E, Mercer U, Metzger D S. Psychotherapy and Counseling for HlV+ Individuals. Textbook of AIDS Medicine. Chp

53. 1994. Williams & Wilkins. U.S.A.

54 Frank AP. Suicide, HIV Testing, and A1DS: a synopsis. in consideration. 1994. Cook County Hospital, Dept. of Medicine. Chicago IL.

55 Ibid 27. 8-12.

56 Personal communication. Quattrocchi R. Home Access Health Corporation. Estimated at $30 - $40 for home collection kits and $40 - $120 for community clinics.

57 Authors note: HIV Prevention and Risk Reduction counseling, as recommended by the US Centers for Disease Control, is the most appropriate state-of-the-art terminology for the program utilized in this study. For familiarity's sake, we have used the terms "pre-test" and "post-test" counseling.

Home Access HIV Counseling and Testing Report

The first published account of national HIV seroprevalence and demographic data among home test users was issued on December 1, 1997 by Home Access Health Corporation. Reviewed by the US Centers for Disease Control and Prevention (CDC), the Home Access® HIV Counseling and Testing Report is the first report to provide consistent tracking of HIV demographics, risk assessments, and test outcomes in all 50 states.

THE HOME ACCESS HIV COUNSELING AND TESTING REPORT CAN BE REPRINTED ONLY WITH PERMISSION FROM HOME ACCESS HEALTH CORPORATION.

Below is the overview section of the Home Access® HIV Counseling and Testing Report. 

Overview of At-Home HIV Test Data

From inception through June 1997, 152,044 persons used home HIV testing systems in order to obtain anonymous HIV testing, HIV counseling and referrals or both. Of those persons, 148,039 called to receive test results. The overall HIV seropositive rate was 0.9 percent.²

Demographic Data of Home Access Users
This report is based on 78,358 clients who were asked to provide anonymous demographic data during pre-test counseling. Although most clients agreed to give demographic data, response rate for questions varied. HIV seropositive individuals were more likely to give demographic data than seronegative individuals. All seropositive clients calling for results speak to a counselor; the counselor elicits additional information to aid in making appropriate referrals.

Response rates for survey questions by (Home Access Users)

Home Access Users	Sex	Race	Age	Risk Behavior	Previous HIV Test	Zip Code
All Users (78,358)	70%	65%	68%	65%	66%	51%
Positive Clients (636)	85%	69%	73%	73%	74%	74%

HIV Exposure
Approximately 65% of clients provided exposure information. The exposure most often reported by seropositive clients was a history of bisexual encounters (38%). Heterosexual (both males and females) and homosexual exposure was reported by similar proportions of those testing HIV positive.

* Injection Drug User
** Men who have sex with men

Test Outcomes
Over all 76,328 clients (97.4%) called to receive test results, and the HIV seroprevalence was 0.81%. Seroprevalence rates were higher in males (1.4%) than females (0.5%). Among clients who reported their race, seroprevalence rates were highest in African American (2.8%) and Hispanic (2.4%) clients, compared to Caucasian (0.7%) clients.

Client Previous Testing History
57% of Home Access Health clients indicated that they had not tested for HIV previously, and 41% had previously tested HIV negative. The seroprevalence of both groups was the same (0.8%).

Overview of telemedicine Counseling
In pre- and post test counseling sessions among Home Access Health clients,³the following outcomes have been identified:

1.	It is standard practice of care to deliver client-centered counseling.4
2.	It is not uncommon for Home Access Health clients to spend 30 minutes in a pre-test counseling session, and 10 to 30 minutes in a post-test counseling session regardless of result.
3.	Medical and social referrals to care are consistently given during pre- and post-test counseling sessions.

Footnotes
2 "First Looks: Uses of Home Collection Systems for HIV Testing in the U.S.," Bernard M. Branson, Allan P. Frank, Katarzyna E. Kruzel, Program and Abstracts of the International Society of Sexually Transmitted Diseases Research, abstract #P407, Seville, Spain, 1997

4 "Technical Guidance on HIV Counseling," CDC, MMWR, January 15, 1993, Vol. 42, No. RR-2

Home Access Health Corporation HIV Test Counseling Services
Summary of External Evaluation
January 1997-July 1998

Process of Evaluation
From January 1997-July 1998 TeleCare Consulting provided Home Access Health Corporation (HAHC) with external evaluation of its HIV test counseling and related product information services. HIV test calls were placed to HAHC counselors by trained TeleCare call simulators who roleplayed a variety of scenarios. Using a set of customer service questions they commented on the positive or negative impact of the call in a number of areas.

A TeleCare telephone counseling evaluator listened remotely to each call and completed a detailed evaluation instrument. Using criteria developed together with the Manager of Counseling and Client Services at HAHC, the evaluator provided a monthly report on counselor performance, customer service and access. The report covered various counseling skills including the ability to deliver information effectively, provide client-centered pre-test counseling and accurate test results, offer useful referrals, and provide tailored prevention counseling.