Comments on CDC Draft "Guidelines for National HIV Case Surveillance, Including Monitoring for HIV Infection and Acquired Immunodeficiency Syndrome (AIDS)," 63 Fed. Reg. 237, 68289 (Dec. 10, 1998)
Technical Information and Communications Branch
Mail Stop E-49
Division of HIV/AIDS Prevention
National Center for HIV, STD, and TB Prevention
Centers for Disease Control and Prevention
Atlanta, GA 30333
To Whom It May Concern:
The American Civil Liberties Union provides the following comments on the federal Centers for Disease Control and Prevention's draft "Guidelines for National HIV Case Surveillance, Including Monitoring for HIV Infection and Acquired Immunodeficiency Syndrome (AIDS)."
A. SUMMARY
The CDC's draft guidelines are fundamentally misguided in at least five respects: (1) they understate the deterrent effect of names-based HIV reporting on testing and ignore the body of evidence documenting this serious problem; (2) they provide incomplete and inaccurate data regarding the performance of non names-based surveillance systems and fail to acknowledge the CDC's refusal to fund or support these programs and what role said refusal may have played in any performance problems to date; (3) they fail to recognize the documented link between the adoption of names-based HIV reporting and the elimination of anonymous testing by States; (4) they do not sufficiently link federal surveillance funding to State adoption of appropriate confidentiality guarantees; and (5) they articulate arbitrary performance standards for State surveillance systems, with no explanation as to how these standards were chosen and/or why they are justified.
1. Names-Based HIV Reporting And Testing Deterrence
The draft Guidelines understate the potential negative effect on HIV testing of names-based case reporting and fail to accurately report the significant body of data documenting testing deterrence. For example, one study found that over 60% of individuals tested anonymously would not have tested if their names were reported to public health officials.1 This deterrent effect is especially pronounced among those populations with the greatest need for preventive intervention: men who have sex with men, people of color, intravenous drug users, and sex workers. Research indicates that gay men are more likely to be aware of name reporting requirements and, as a result, to avoid testing. For example, in South Carolina, after anonymous testing was eliminated the number of men who have sex with men who were tested for HIV dropped by 51%.
Name reporting is also likely to deter HIV testing among other groups at high risk for HIV. Researchers from the New York City Department of Health found that 22% of African-American and Hispanic participants would not be tested for HIV if their names were reported to public health officials. A CDC-sponsored study comparing numbers of tests before and after implementation of names reporting demonstrated that testing declined among African-Americans and injection drug users (IDU's) in Louisiana, Michigan and New Jersey.2 And names-based reporting led to a 31% decline in the number of women agreeing to an HIV test as they sought OB/GYN care.
A study cited by the draft Guidlines demonstrates that at risk individuals are more likely to test if case reporting is conducted by unique identifier rather than name. In this study, respondents were asked the likelihood they would seek testing in the next 12 months. 72% of respondents indicated they would be tested under a unique identifier-based case reporting system; 61% of respondents indicated they would seek testing under a names-based system. And CDC-supported research indicates that high risk individuals in name reporting states who do test often test later, thus reducing the possibility of successful medical intervention. The AIDS Patient Survey (UCSF/UC Berkeley, 1998) reports that individuals who test positive for HIV in name reporting states have an average CD4 count of 225, while those who test positive in non-reporting states have an average CD4 count of 304.
The ACLU notes that the data contained in the studies cited above and in others contained in Part B of these Comments are inconsistent in some respects with testing behavior data obtained from six name-reporting states and recently published in a CDC-funded report in the Journal of the American Medical Association (October 28, 1998 at p. 1421). The ACLU also notes that the report analyzing this new data contains a critique of the numerous studies relied on by the ACLU. This critique, and the data accompanying it, merit analysis and further investigation. But the new data and critique do not provide justification for the CDC's stated preference for name reporting. First, the six state report contains troubling, if inconclusive, evidence of testing deterrence among some high risk populations. Second, the report relies primarily on data from States which have maintained anonymous testing; as discussed below, anonymous testing frequently is eliminated as a corellary to adoption of name reporting. Third, the report from the six name reporting states is not compared with testing data from non name reporting states. Fourth, new data suggesting that the testing deterrent of name reporting is in question does not justify a preference for name reporting in the face of a unique identifier alternative which does not carry the potential risks associated with a names-based case reporting system.
Moreover, the little data on testing deterrence provided in the draft Guidelines undermines rather than supports the CDC's stated preference for name reporting. For example, the CDC acknowledges that testing rates were adversely affected among "racial/ethnic subgroups and HIV-risk exposure categories" according to the CDC's own six state study of the impact of name reporting. The CDC also acknowledges that its data indicates that as many as 20% of "high-risk persons" may have delayed seeking HIV testing because of "reporting to the government."
In order to provide a more accurate discussion of the data available on testing deterrence caused by names-based case reporting, the ACLU provides a detailed presentation of the data excluded from the draft Guidelines in Part B of these Comments.
Recommendations: The CDC should amend the Guidelines to accurately aprise the States of the existing data concerning risks of testing deterrence associated with names-based case reporting. In response to the clear weight of the empirical studies, the CDC should withdraw its stated preference for name reporting and should instead make federal support for State surveillance systems contingent solely on the ability to meet reasonable and justified performance standards.
2. Case Reporting By Alpha-Numeric Code Or Unique Identifier
The ACLU is concerned that the draft Guidelines do not provide an accurate report of the performance of alternative surveillance systems, but instead rely on outdated information which has been presented selectively in order to support the CDC's stated preference for name reporting. The draft Guidelines disregard more recent data made available to the CDC which demonstrate dramatic improvement in the performance of the unique identifier-based system in the State of Maryland. This data indicates reporting completeness of 85%. The more recent data provided by the Maryland AIDS Administration, along with the data contained in the recent MMWR and ACLU reports3 on Maryland's HIV surveillance system paint a picture in sharp contrast with that provided by the draft Guidelines.
The draft Guidelines also fail to acknowledge the CDC's refusal to fund or support development of unique identifier-based surveillance systems in Maryland and Texas, while at the same time providing funding for development of names-based systems. The CDC's inconsistent stance with regard to funding for alternative surveillance systems calls into question the impartiality and validity of the draft Guidelines' analysis of system performance. It is impossible to know how well the unique identifier-based systems would have performed if they had been provided the support that the CDC provided to names-based systems. Indeed, it is remarkable that the Maryland system has achieved such high levels of performance despite the complete absence of federal support.
Recommendations: The CDC should amend the draft Guidelines to provide up-to-date and accurate data concerning the performance of unique identifier-based surveillance systems. The CDC should acknowledge that its refusal to support and fund such alternative surveillance systems makes it impossible to validly compare the performance of names-based and unique identifier-based systems. The draft Guidelines must clearly state that States which opt for a unique identifier-based system will receive funding and support from the CDC similar to that provided to States with names-based systems. In light of CDC's track record to date on this issue, an independent body should be designated to review CDC funding decisions in this area and to conduct impartial analyses of system performance.
3. Continued Availability Of Anonymous Testing
The ACLU applauds the CDC's strong endorsement of anonymous testing, but the draft Guidelines must go further. Data consistently demonstrate that availability of anonymous testing is a critical component of the public health response to the HIV/AIDS epidemic. Anonymous testing reduces the period of time that individuals delay testing. Research indicates that the availability of anonymous testing reduces the average delay between deciding to get tested and actually going for the test by more than one half, from a mean of 12 months to a mean of 5 months. The data also indicates that individuals who test anonymously are far more likely to return for their results than those who test confidentially.
A recent probability sample of 835 new AIDS cases reported in the Journal of the American Medical Association (October 28, 1998 at p. 1416) found that persons tested anonymously sought testing and medical care far earlier in the course of HIV disease than persons tested confidentially. Persons tested anonymously experienced an average of 918 days in HIV-related medical care before an AIDS diagnosis vs. 531 days for persons tested confidentially. The mean time from learning they were HIV positive to the diagnosis of AIDS was 1246 days for persons tested anonymously vs. 718 days for persons tested confidentially.
The CDC draft Guidelines fail to acknowledge that States that have adopted name reporting have frequently eliminated anonymous testing, despite the CDC's long-held position that anonymous testing should be available. The CDC's opposition to the elimination of anonymous testing has been ineffectual because it has not neutralized politically motivated AIDS policies at the State level and because it has not been tied to a credible threat of loss of federal funding. As a result, eleven states have both adopted name reporting and eliminated anonymous testing.4 Assuming the data on anonymous testing hold steady in these states, this means that implementation of name reporting has led or will: (1) cause people with HIV to delay accessing medical care, and (2) cause people with HIV to progress more quickly an HIV diagnosis to an AIDS diagnosis.
Recommendations: The draft Guidelines should be amended to acknowledge that there has been a correlation between adoption of name reporting and elimination of anonymous testing and that the CDC's opposition has been ineffectual to date. The draft Guidelines must be further amended to make the availability of anonymous testing a necessary condition to receipt of federal funding for HIV surveillance. The CDC's present position, which provides that anonymous testing is a requirement for federal funding unless prohibited by law is toothless, as demonstrated by the fact that eleven states have eliminated anonymous testing.
4. Ensuring Confidentiality Protections
The ACLU shares the CDC's concern over the confidentiality of HIV-related medical information and welcomes the draft Guidelines' provision that "[t]he receipt of Federal surveillance funding is dependent on the recipient's ability to ensure the physical security and the confidentiality of case reports." But administrative security provisions address only one area of concern. Appropriate confidentiality legislation is necessary at the State level to ensure that the legitimate privacy concerns of persons with HIV are protected. Without such protective legislation, adoption of case reporting, whether by name or unique identifier, is dangerous and irresponsible.
The ACLU appreciates CDC's commitment to working in conjunction with CSTE, ASTHO, NCSL, the Georgetown/Johns Hopkins Public Health Law Project, and community organizations to develop a model state public health privacy act. However, as of the date of these comments, the draft model act falls far short of the goal of focusing solely on how a state may collect and track - but otherwise hold secure - identifiable public health information, and avoid disclosing such information to anyone except under the most narrow and clearly defined circumstances. The ACLU urges CDC to continue to work with all participants in the drafting process to develop a model act that will be a meaningful guarantee of privacy, thereby reducing the harmful effect that name reporting could have in discouraging testing or in subjecting additional persons to discrimination.
Moreover, the CDC must go further, and must do all within its power to ensure that appropriate State legislative and administrative protections for confidentiality are in place before HIV surveillance systems are adopted by States.
Recommendations: The draft Guidelines should be amended to provide that CDC funding for HIV surveillance will be provided only to States that develop and implement standards of confidentiality at least as protective as those contained in the model confidentiality act developed by CDC. That model law must be a meaningful guarantee of privacy. States should be strongly discouraged from adopting HIV case reporting until said confidentiality standards are in place.
5. Performance Standards Should Be Justifiable And Explained
As discussed above, the ACLU believes that the draft Guidelines should be amended so that States are instructed to adopt an HIV surveillance system which meets specified performance standards, without stating a preference for a names-based reporting system. The ACLU therefore does not object to the CDC's attempt to articulate performance standards for surveillance systems. However, the performance standards contained in the draft Guidelines are offered with no explanation as to how the threshold percentages were arrived at. The absence of any explanation for the performance standards suggests that the standards may have been chosen arbitrarily, or may be based on the CDC's stated preference for name reporting, rather than on reasonable epidemiological needs.
Performance standards must take into account the inherently limited value of data generated by even the most accurate HIV case reporting. The draft Guidelines in fact recognize some of the limitations. HIV case reporting will not provide an accurate picture of who has HIV, but instead of who has HIV among those who are tested. The draft Guidelines frankly concede: "Not all persons infected with HIV are tested, and of those who are, testing occurs at different stages of their infection. ... [Surveillance data] are most representative of persons who have been diagnosed with HIV infection in medical clinics and other confidential diagnostic settings. The data represent the characteristics of persons who recognize their risk and seek confidential testing, who are offered HIV testing (e.g. pregnant women, clients at sexually transmitted disease clinics), who are required to be tested (e.g. blood donors, military recruits), and who are tested because they present with HIV-related illnesses." The data indicates that individuals who test positive for HIV have an average CD4 count ranging between 225 (name reporting states) and 304 (non-name reporting states).5 This strongly suggests that HIV case reporting does not present an accurate picture of the current HIV epidemic. Case reporting data is further distorted by the fact that significant numbers of individuals test anonymously, and thereby avoid reporting of positive results.
This does not mean that HIV surveillance data is of no value, but only that it is already skewed in significant respects. In light of the admittedly skewed nature of the data, no rationale for high degrees of statistical accuracy in HIV case reporting is apparent. Such statistical accuracy would be justified only if there was reason to believe that the case reporting data would reveal an accurate picture of the HIV epidemic if properly reported. But this is not the case.
Recommendations: The draft Guidelines should be amended to provide a justification and explanation for all performance standards provided. Performance standards should be reviewed to determine if they are appropriate in light of the unavoidably skewed and inaccurate nature of HIV case reporting. States should be given a reasonable and specified period of time to attain the performance standards contained within the Guidelines. The experience of States who have adopted both names-based and unique identifier-based systems, and the presence or absence of federal funding for these systems, should be taken into consideration in determining the time necessary to attain reasonable performance standards.
B. DATA ON HIV NAME REPORTING NOT CONTAINED IN DRAFT GUIDELINES The available evidence strongly suggests that name reporting is a counterproductive public health measure that will cause individuals to avoid HIV testing. Numerous studies indicate that individuals avoid HIV testing that is not anonymous because they do not have faith that test results will remain confidential and because they fear the stigma and discrimination that is often associated with HIV and AIDS. One study found that over 60% of individuals tested anonymously would not have tested if their names were reported to public health officials.6 By contrast, anonymous testing encourages individuals to seek testing in the belief that they will be able to control the dissemination of information about their HIV status. People are more likely to be voluntarily tested for HIV if the testing is anonymous.7
Anonymous testing also reduces the period of time that individuals delay testing. Research indicates that the availability of anonymous testing reduces the average delay between deciding to get tested and actually going for the test by more than one half, from a mean of 12 months to a mean of 5 months.8 Testing associated with name reporting (confidential testing) deters people from discovering their HIV status.
Of course, HIV testing is of little use if the person tested does not return for his or her results. The available data indicates that individuals who test at locations with name reporting are much less likely to return for their results than individuals who are anonymously tested. An analysis of HIV testing in North Carolina found that 30.3% of testees undergoing confidential testing did not return, while only 8.2% of anonymous testers did not retrieve their results.9 In Colorado, a testing survey showed that 95% of anonymous testers retrieved their results, but only 85% of confidential testees returned.10
The deterrent effect of name reporting is most pronounced in the very populations with the greatest need for preventive intervention: gay and bisexual men, people of color, intravenous drug users, and sex workers. Research indicates that gay men are more likely to be aware of name reporting requirements and, as a result, to avoid testing altogether.11 One study found that half of the men who were tested anonymously would not have been tested at all if only confidential testing were offered.12 In South Carolina, after anonymous testing was eliminated the number of men who have sex with men who were tested for HIV dropped by 51%.13 The converse is also true: once anonymous testing is offered, more gay and bisexual men will be tested. Oregon, for example, reported a 125% increase in the demand for HIV testing once the option of anonymous testing was provided.14 Fear of discrimination and stigmatization is so strong among gay and bisexual men, they will travel to other states if necessary to preserve their anonymity. One South Carolina AIDS service agency reported that 40% of the people it serves were tested out of state.15 If gay and bisexual men do test confidentially, as opposed to anonymously, they often will wait longer to do so.16 Given the high seroprevalence rate among gay and bisexual men, delays in testing are counterproductive to the public health goal of HIV prevention.17
Name reporting is also likely to deter HIV testing by African-Americans and Latinos.18 The rate of HIV infection is increasing rapidly among people of color.19 Given this country's history of race discrimination in the guise of public health initiatives, minority communities often distrust coercive public health programs. Mandatory names reporting would only exacerbate this distrust. Researchers from the New York City Department of Health found that 22% of African-American and Hispanic participants would not be tested for HIV if their names were reported to public health officials.20 One clinician commented that mandatory name reporting "will be the final blow" alienating minority women from clinicians and the health care system, causing them to go "underground fast." 21
Other groups are also deterred from HIV testing by name reporting. Intravenous drug users and sex workers, many of whose primary contact with government has been through the criminal justice system, are more likely to test anonymously. One study found a 56% increase in HIV testing among female sex workers and a 17% increase among intravenous drug users when anonymous testing was an option.22 Women, in general, are often wary of name reporting schemes. One study found that name reporting led to a 31% decline in the number of women agreeing to an HIV test as they sought Ob/Gyn care.23
The ACLU recognizes that the draft Guidelines call for maintenance of anonymous testing while at the same time stating a preference for names-based HIV case reporting. However, as discussed above, anonymous testing frequently is eliminated once name reporting is adopted. Moreover, maintenance of anonymous testing does not entirely eliminate the deterrent created by name reporting. Instead, deterrence shifts from the testing to the treatment stage. In a recent survey of individuals testing for HIV in Los Angeles County, 22.6% of survey participants said they would delay treatment until they were actually sick if their doctor were required to report their name to public health authorities.24
In sum, the available evidence indicates that name reporting is likely to lead to decreased testing by those who most need it.
C. ABSTRACTS OF STUDIES EXCLUDED FROM DRAFT GUIDELINES
Andrew B. Bindman et al., Multistate Evaluation of Anonymous HIV Testing and Access to Medical Care, 280 JAMA 1416 (1997)
Irva Hertz-Picciotto et al., HIV Test-Seeking Before and After the Restriction of Anonymous Testing in North Carolina, 86 AM. J. PUB. HEALTH 1446 (1996)
Geoffrey Reed, et al., The Impact of Mandatory Name Reporting on HIV Testing and Treatment, Poster Presentation for the XI International Conference on AIDS (July 1996)
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