Early Detection of HIV: Assessing the Legislative Context

Summary: Early detection of HIV has important implications for both prevention and treatment. Promoting HIV testing, and thereby early detection, however, is a complicated task that must balance the interests of public health, personal privacy, and legislative efforts to curb transmission. This article assesses the legislative context within which public health officials must operate to promote early HIV identification. Specifically, the article reviews United States laws regarding HIV testing passed over the course of 3 years, 1997 to 1999, at the state-not the federal-level. The new laws demonstrate such major themes as limiting confidentiality of HIV test results, mandating name-based HIV reporting, partner notification and newborn testing, and criminalizing nondisclosure of HIV status in sexual and needle-sharing situations. The article evaluates these new laws and their potentially negative impact on early detection, and assesses implications for practices such as informed consent for HIV testing. Outcome evaluations of newly implemented state laws are recommended. Policy makers must be aware that these policy changes can either encourage or discourage HIV testing. Key Words: HIV testing-Confidentiality of HIV test results-Name-based HIV reporting-Partner notification-Criminal penalties for nondisclosure-HIV legislation.

Throughout its history, the AIDS epidemic has sparked intense political debate about the role the government should play in addressing public health challenges (1). Lawmakers at every level have found it difficult to strike a balance between invoking the extensive powers given to health officials to protect the public health and protecting the privacy and dignity of people living with HIV and AIDS. Legislative controversies have often involved policies regarding HIV testing: who should be tested, when people should be tested, where testing should be made available, and who should have access to test results. Today, however, medical advances have altered the landscape and vastly increased the potential importance of early HIV detection, returning the focus with new intensity to HIV testing policies.

This paper describes the legislative environment that has emerged over the last several years in the United States, particularly in state legislatures. Research presented here identified a significant trend toward more mandatory testing for broader classes of people and away from protecting the confidentiality of HIV test results. New laws make it apparent that in many instances legislators may not have considered that their actions may discourage early detection of HIV infection. Thus, recent legislative trends may raise new barriers to the generally acknowledged goal of getting more HIV-infected Americans identified and into treatment as early as possible.

In the United States, state and local health departments have historically handled local implementation of public health policies, whereas the federal government has provided resources, technical assistance, program guidance, and information on national trends. In assessing the current legislative environment, this analysis focuses primarily on legislative action by states. The National Conference of State Legislatures maintains a web-based summary of state legislation specifically addressing HIV testing from 1997 through 1999. In this article, only legislation that was passed by state legislatures and signed into law is considered. The general themes and purpose of HIV testing legislation are reviewed and analyzed.

The analysis identifies several major themes: limiting confidentiality of HIV test results, mandating name-based HIV reporting, partner notification and the testing of newborns, and criminalizing nondisclosure in sexual and needle-sharing situations. Proposals currently before the United States Congress reflect many of these same themes. This article assesses these public policies within the context of new HIV treatment options and the emerging public health priority of promoting early HIV detection.

BACKGROUND

State and federal governments promote the public health in a number of ways. One approach targets individuals and is designed to shape behaviors for the benefit of public health. Examples include laws prohibiting drunk driving and outlawing the sale of cigarettes to minors, as well as speed limit and seat belt laws designed to reduce automobile-related injuries. Regarding HIV, all 50 states have laws against its intentional transmission.

Another approach entails government-funded programs that directly promote public health. Examples include social marketing campaigns to reduce drunk driving or to reduce demand for tobacco products. Similar marketing campaigns may be used to promote knowing one's HIV status, to reduce HIV-related stigma, and to promote abstinence or condom use. Other government programs may promote public health by increasing availability of safety devices such as child safety seats to prevent injury. Programs to make condoms or clean needles available are HIV-related examples. These approaches attempt to use the resources of government to change the behavior of groups or communities, with the goal of advancing public health.

Public health policies may also directly affect the physical environment in which these behaviors occur. For example, water is fluoridated to improve dental health. The automobile industry is regulated to require certain safety standards, e.g., air bags and seat belts. Similar health and safety regulations are imposed on the airline industry, e.g., carry-on luggage requirements and nonsmoking policies. In addition, there are many examples of workplace health and safety standards, many of which, such as ergonomic standards, are the subject of controversy and public debate. Screening the blood supply for HIV and other blood-borne pathogens is an HIV-related example of an environmental intervention that has proven to be highly effective, In short, legislatures routinely debate how best to promote the public health, and employ several different methods of intervention.

Substantial investment in AIDS research over two decades has brought about expanded HIV treatment options
that not only have brought new hope to people living with HIV but also have required new government policies and altered the impact of old laws and policies. Pessimism, which for many years characterized scientific discussions on HIV disease, has now given way to restrained optimism about controlling viral replication.

Under new guidelines for the treatment of HIV-infected individuals (2,3), decisions such as when to begin therapy or to change drug combinations are made based on monitoring viral load, T-cell counts, and physical symptoms. In general, these recommendations argue for earlier and more aggressive treatment. The long-term benefit of treatment for healthier individuals with T-cell counts >500 has yet to be documented. Thus, decisions about early intervention for these asymptornatic individuals must balance a number of factors that influence risk and benefit. But for asymptomatic individuals with T-cells counts <500, or anyone with a high viral load, the guidelines recommend treatment be offered. Therefore, where symptoms appear before HIV testing takes place, an opportunity to consider the full range of treatment options has been missed. In light of such HIV treatment advances, policy makers must reassess how best to promote the public health goal of early HIV detection. Social marketing campaigns and other educational approaches are needed (4), as well as laws and policies that enhance the potential personal benefits of being tested.

The new optimism over early intervention with combination therapies has placed an increased emphasis on the role of testing in both treatment and prevention. Often, HIV testing serves as the necessary gateway to treatment. However, most of the legislation regarding HIV testing dates to the middle to late 1980s, when the HIV antibody test was new and effective medical treatments had not yet been developed. At that time antibody testing was similar to genetic testing in that the results could be psychologically distressing but it was not clear what useful medical options might be available. Thus, early laws placed emphasis on pretest counseling and informed consent.

Publicly supported testing and counseling programs began at the time the HIV antibody test was licensed in 1985, primarily to divert people from donating blood as a means of finding out their HIV status. This practice was dangerous because of the so-called window period between infection and the development of measurable antibodies (5). Later, testing, in combination with counseling, became a vital part of the public health strategy to prevent new infections. Even in the absence of effective medical treatments, health departments believed that knowledge of serostatus could bolster resolve to practice safe behaviors, encourage HIV-positive individuals to protect their loved ones, and encourage HIV-negative individuals to stay uninfected. Research studies have confirmed the importance of counseling and testing as a prevention intervention (6).

The Centers for Disease Control and Prevention (CDC) estimates that 650,000 Americans are HIV-infected and know their status and are therefore able to seek treatment (7). One study in the United States found that 36% of individuals diagnosed with AIDS were first tested for HIV within 2 months of their AIDS diagnosis, and 51 % within a year of AIDS diagnosis (8). Although these data were gathered from 1990-1992, it remains true that many individuals lose the documented benefits of early intervention because they are tested so late in the course of their infection.

New treatment options are also changing the content and importance of test-related counseling. For those who test positive, greater emphasis needs to be placed on scheduling additional testing to determine the length of time the individual has been infected, the damage done to the immune system, and the amount of virus in the blood. Thus, in addition to preventing further transmission, counseling services now seek to reduce the time between HIV testing and initiating primary care for HIV disease.

Increasingly, scientists, public health officials, and advocates have come to consensus about the importance of early HIV detection for both access to treatment and prevention (9). However, these same players, as well as legislators, must understand concerns about HIV-related stigma and the confidentiality of HIV test results before they can effectively promote HIV testing to at-risk populations.

CONFIDENTIALITY

State legislatures are clearly moving toward limiting rather than expanding HIV-related confidentiality statutes. This trend may work at cross-purposes to the goal of promoting early HIV detection. Confidentiality protections for HIV test results are an important public policy for establishing "risk-free" environments in which individuals will be more inclined to learn their HIV status and seek medical care.

After the HIV antibody test was first licensed, state legislatures and the CDC developed an alternative system of publicly funded testing sites where individuals could be tested either anonymously or with strict confidentiality protections. Strong protections for more traditional sites also were adopted in most instances. To further promote confidence among potentially infected individuals that HIV testing would remain voluntary and would not result in harmful legal or personal consequences, state laws were adopted that required specific informed consent for HIV testing (10) and provided penalties for wrongful disclosure of HIV status. These public policies were established to preempt potential negative consequences to testing that might discourage it.

An analysis of recent state legislation addressing HIV confidentiality is presented in Figure 1. A clear trend exists in bills signed into law from 1997 through 1999 toward amending confidentiality statutes to permit exceptions, rather than expanding confidentiality protections, e.g., increasing the penalty for unlawful disclosure (Information obtained from the StateServ web site; address: http://stateserv.hpts.org/pubtic/pubhome.nsf). Most of these limitations involve laws designed to protect so-called Good Samaritans, such as police, corrections officers, and emergency medical technicians (14 of 28), or to test criminal offenders or those accused of criminal offenses (9 of 28). The remaining laws are on newborn testing (2 of 28) and name-based HIV reporting (3 of 28), both of which will be discussed later.

Recent State Legislation on HIV Confidentiality

"Good Samaritan" laws are primarily a response to the concerns of emergency medical personnel and law enforcement officers who are distressed by the potential for HIV infection from exposure to blood or other bodily fluids. In general, these laws allow testing so that the exposed person can know the HIV status of the person who is the source of the exposure, even without his or her consent. These laws differ from CDC guidelines for postexposure prophylaxis in occupational settings (11), which do not require involuntary testing of the individual who is the source of the exposure. Instead, guidance is given to assist the clinician in assessing the severity of the potential risk and in offering or recommending postexposure treatment.

Testing of criminal offenders involves mandatory testing of prison inmates or, in some cases, laws permitting testing of individuals accused of specific acts of sexual assault and disclosure of serostatus to victims. Legislative debates on the emotional issue of sexual assault involve many of the same arguments as with emergency medical personnel. At present, the CDC has not developed specific guidelines for postexposure treatment after sexual assault, and developing such guidance is complicated by the criminal justice context of these cases.

NAME-BASED REPORTING

Another legislative and administrative trend is toward name-based HIV case reporting, a policy that has the potential to discourage early HIV testing. Although AIDS cases have always been required to be reported, cases of HIV infection have been considered differently because patients are not yet seriously ill. Proponents of HIV name-based reporting argue that HIV should be treated like any other sexually transmitted disease (STD) for which names are reported. They also argue that having the name assists with referral to medical care, risk reduction counseling, and partner notification. Opponents argue that the public health benefit of name-based reporting is outweighed by the deterrent effect it has on HIV testing and early identification. They also contend that name-based reporting is not necessary to achieve referral to medical care, risk reduction counseling, and/or partner notification. Whether the benefits to individual and public health outweigh the risks is still the subject of heated debate (12).

The name-based reporting issue has re-emerged largely because the new treatments have changed AIDS surveillance. With the development of more effective therapies, which significantly delay the onset of AIDS for many people, experts believe the number of AIDS cases and deaths are no longer reliable measures for monitoring the epidemic (13). Recently, the CDC recommended that all states implement HIV case surveillance as an extension of AIDS case surveillance, which is a name-based reporting system (7). Recognizing that name-based reporting is not acceptable in some states, the CDC is providing technical assistance to those states implementing unique coded systems (14). By the end of 1999, 37 states had adopted or were implementing name-based HIV case surveillance, 6 states had adopted or were implementing unique coded systems and the issue remained unresolved in the remaining 7 states (15).

As the controversial issues surrounding surveillance are debated in legislatures, policy makers would be wise to consider the implications of such policies for early HIV detection. Although proponents argue that names assist with referral to medical care, a recent study found that in name-based reporting states follow-up contacts were not associated with moving people into care earlier (16). The question becomes, then, is name-based reporting the deterrent to HIV testing that its opponents argue it to be?

The answer to this question appears to depend on the target groups that may be priorities for promoting early identification. A study of six states that adopted name-based HIV reporting looked at the 12 months before and after implementation of the new policy and found the overall level of testing went up in three states, was level in two states, and declined in one state (17). However, several studies have found that the potential deterrent effect of name-based reporting is the greatest in groups at highest risk of HIV infection. Though knowledge of state policies was low among all individuals never before tested, the deterrent effect was minimal on heterosexuals at STD clinics, moderate among injection drug users, and highest among men who have sex with men (18). A number of other studies have found a potential deterrent effect among men who have sex with men (19-23) and for Latinos and African Americans (24).

A recent San Francisco study found that HIV name-based reporting might have a particular deterrent effect on those at very high risk (25). The study examined gay men who were repeat anonymous testers and also reported at least one episode of unprotected anal sex with a partner who was HIV-infected or of unknown serostatus in the last year. It found that 68% would not be tested if names were to be reported. Even after explaining the public health benefits of name reporting, only 58% said they would be tested. This suggests that among those at greatest risk a change in attitude toward testing, and toward the public health system as a whole, must precede the change to a name-based reporting system. Otherwise, behavior may undermine the benefits of testing and HIV surveillance. As critics have noted, moving to a system of name-based HIV surveillance may drive the epidemic underground (10).

PARTNER NOTIFICATION

Another trend identified in state legislation is a move toward mandating health department-mediated partner notification. Currently, all states receiving CDC funding for HIV prevention activities are required to establish procedures for the confidential, voluntary notification of sexual and needle-sharing partners (26). These partner notification services, which are perhaps better termed "partner counseling" services, are considered part of primary prevention efforts (27).

The new treatment opportunities have been used by some to argue for a return to a narrow "find-and-treat" STD model for responding to the HIV epidemic. Some members of Congress, who argue that AIDS should be treated like other STDs, are advocating legislation that would require states to adopt name-based reporting policies and shift prevention resources to contact tracing and health department-mediated partner notification programs. Other members of Congress believe that, although they are an important part of HIV prevention, partner-counseling services must be assessed in terms of their relative priority. The CDC has established a process for HIV prevention community planning where these kinds of decisions about resource allocation for maximum prevention effectiveness are made.

Two states have recently moved to mandate name-based HIV reporting and couple it with health department-mediated partner notification. Advocates for this policy argue that having the name of the infected person allows the health department to notify sexual and needle-sharing partners and urge these people to get tested themselves. However, recent research (16) found that individuals who had been tested anonymously reported notifying as many sexual and needle-sharing partners as those whose names had been reported to health departments. Mandatory approaches to contacting partners and connecting them to HIV services are potentially problematic because voluntary cooperation is needed for these services to be effective. Partner notification can be done only as a voluntary activity. These laws may be viewed as barriers to early detection if they are perceived as "mandatory" by people living with HIV; they may be accepted as a valued service if perceived as voluntary, with a goal of assisting people in preventing further transmission (28).

CRIMINALIZATION OF NONDISCLOSURE

As of 1999, 31 states had enacted legislation making nondisclosure of HIV status in certain situations a crimi-nal offense (29). An analysis of state legislation enacted between 1996 and 1999 reveals a distinct trend toward more (from 26 to 31 states) and tougher "willful exposure" laws. The interest in criminal statutes has been fueled by highly publicized cases of multiple HIV transmission by a single person in Missouri and in New York State (30,3 1). These laws differ from state to state; some are broad in scope, whereas others are narrowly focused on specific sexual acts. Some states wrote laws with specific provisions regarding donating blood or organs, sharing needles, practicing prostitution, soliciting prostitutes, and potentially transmitting HIV to corrections or emergency health workers by persons with knowledge of an HIV/AIDS diagnosis. An analysis of these state statutes indicates that the specific sexual behaviors prohibited without disclosure are often poorly defined (32,33).

Research has not yet gauged the extent of knowledge of these statutes among those HIV-infected, nor has it tried to assess the statutes' deterrent impact. One state, which has maintained confidential HIV surveillance records for many years, recently enacted a law that requires public health officials to reveal previous HIV testing information about people charged with a sexual offense when requested by the criminal justice system. Under this law, an individual convicted of a sexual offense can be sentenced to three times the maximum penalty for that offense if public health records show the individual had been notified of his or her HIV infection prior to the crime (34). Because the legislation applies regardless of when the previous HIV test took place, it contradicts the informed consent for the initial HIV testing, which was intended for public health purposes only. While the legislature is acting to punish particularly deplorable criminal conduct, the unintended consequences also need to be assessed.

This trend toward criminalization of nondisclosure or "willful exposure" has not been studied in terms of its effect on early detection of HIV. However, it seems logical to argue that increasing an individual's risk of enhanced criminal penalty could deter HIV testing and early detection. In addition, retroactively invalidating the conditions of informed consent for testing has the potential to undermine trust in the public health system.

NEWBORN TESTING AND REDUCING PERINATAL TRANSMISSION

Three states now require the HIV-testing of newborns, hoping this practice will allow for early access to treatment for infected infants and provide an opportunity to caution mothers about potential transmission to uninfected infants through breast feeding. Testing of new-borns is actually testing the antibody status of the mothers. Thus, opponents note that requiring antibody testing of newborns is actually mandatory testing of the mothers. They argue for voluntary approaches they believe are more likely to encourage the cooperation of pregnant women. These newborn testing laws have been controversial. Congress has also adopted targeted goals for reduction of perinatal transmission, which if not achieved would trigger mandatory testing of newborns as a condition of receiving HIV-related federal funding (Ryan White CARE Act Reauthorization, 42 USC Sec. 300ff34).

Advances in treatments have also resulted in medical options to reduce the risk of transmission from an infected mother to her newborn through administering antiretroviral treatment to the mother (35). Since these advances, the number of perinatal cases of AIDS has dropped by 75%, from a high of between 1,000 and 2,000 in the early 1990s, to between 250 and 500 in 1998 (36). This progress has led to discussion of the possibility of eliminating perinatal cases of HIV in the United States. These advances have also led to legislation in several states.

A recent Institute of Medicine Committee on Perinatal Transmission of HIV report (35) also addressed the possibilities for reducing perinatal HIV transmission. The committee recommended a national policy of "universal" HIV testing for pregnant woman as a "routine" procedure, including posttest notification for women who test positive. These recommendations have several implications for state legislation. In order to implement such guidelines fully, many states would need to amend HIV testing statutes to remove a pretest and posttest counseling requirement. The implications for informed consent are even more important.

Currently, 33 states require specific informed consent for HIV testing, often in writing. The implication of routine testing is that it has raised the debate about moving from "informed consent" to "informed right of refusal." A study found that most people would accept HIV testing if they need to "opt out" of the test while fewer would be tested if they needed to "opt in" to taking a test by request (37). The goal of moving people who are infected into early care is in part motivating the policy discussions toward removing the barriers to testing. Thus, pretest counseling and specific informed consent are now viewed by some as barriers to HIV testing.

The Institute of Medicine panel's conclusion that specific informed consent may be viewed as a harmful barrier to testing is a source of concern to those who have advocated specific informed consent and civil penalties for wrongful disclosure as deterrents to rogue testing (38). At this point it is not clear how these issues will play out in a legislative context over the next several years. And, it is not clear how these policy trends will effect voluntary early HIV identification.

IMPLICATIONS AND CONCLUSION

It is now widely recognized that new treatment opportunities offer hope to those who are infected with HIV. That hope can only be realized if systems are in place that encourage individuals at risk to seek HIV testing, as well as to make maximum use of health care services as early as possible in the course of the infection. This article outlines some of the legislative trends that have emerged in the last several years in state legislatures, and suggests that some recently passed laws could be barriers to, rather than facilitators of, early HIV testing. If these laws discourage testing, the question becomes what price does public and personal health pay for the stricter legal environment.

In order to consent fully to HIV testing, individuals must understand the benefits that may result from medical treatment and the potential to prevent further HIV transmission. Potential risks of HIV testing include possible psychological distress associated with a positive test result, as well as potential limitations in employment and insurance coverage. State legislatures have added to these risks the requirements that one's name be reported to the health department, and that one may be required to disclose the names of sexual or needle-sharing partners. In addition, once an individual is aware of infection, the potential exists for criminal penalties for nondisclosure of HIV status in certain situations. These added risks and requirements create an atmosphere in which at-risk individuals and communities often draw the conclusionrightly or wrongly-that HIV testing is not in their best interest.

Much of the state legislation on HIV testing from 1997 through 1999 expresses the goal of helping HIV-infected people obtain care. The effect of many of these policies, however, is not well known or evaluated. At the federal level, states are often referred to as laboratories for new ideas and policies. Thus, it seems important to direct greater attention to the careful evaluation of these statelevel policy interventions. Scientists and public health officials must help determine whether legislated policies increase or decrease early identification of HIV as an important outcome measure in assessing such initiatives.

Developing effective policies to promote early identification of HIV will require consultation, discussion, and compromise by public health officials at all levels of government and by affected individuals, communities, and other stakeholders. Legislative policy makers also need to be part of the collective discussions on ways to promote early HIV detection.

Acknowledgments: This analysis was in part supported by the UCSF Center for AIDS Prevention Studies, a grant from the National Institute of Mental Health (MH42459) and in part by a grant on "Understanding the Impact of New Treatments on HIV Counseling and Testing" from the Henry J. Kaiser Family Foundation. An earlier version of this paper was presented at the Early Detection of HIV Conference sponsored by the Office of AIDS Research at the National Institute of Mental Health and the Center for HIV Identification, Prevention and Treatment Services at UCLA, July 29-30,1999. The author thanks Chris Collins, Mark Trautwein, and Charles Everett for their assistance with preparation of this paper.

Correspondence to Stephen F. Morin, Ph.D.
Director, AIDS Policy Research Center
University of California, San Francisco
74 New Montgomery St, Suite 600
San Francisco, CA 94105, U.S.A.
e-mail: smorin@psg.ucsf.edu

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