In the national discussion about how best to perform routine HIV screening in accordance with CDC Recommendations, state law is often identified as a barrier to implementation. In this systematic review and analysis, we found that 35 states (including DC) have statutory frameworks that are consistent with or neutral to the CDC Recommendations. From a state statutory perspective, implementation of the Recommendations is permissible in these states. Sixteen states have statutory frameworks that are inconsistent with the Recommendations and would require legislative amendment to fully implement them. The movement of 9 states from the inconsistent to consistent category indicates a trend toward enabling HIV screening in the spirit of the CDC Recommendations.
By performing a comprehensive state-specific survey of statutes pertaining to HIV testing and by analyzing the consistency of each law with new and corresponding provisions of the CDC Recommendations, to our knowledge, our findings are the first to provide policymakers and providers with information about their own legal context and to clarify the degree to which state law enables or obstructs routine HIV screening. The only other published literature on HIV testing statutes provides a general overview of how certain types of laws may impede routine HIV screening (15
) or an appraisal limited to whether states require written informed consent (16
). Public health students maintain a compendium of state HIV testing laws online (73
) which, while useful, does not provide a consistency assessment of each state’s statutory framework in relation to CDC Recommendations.
State implementation strategies for the CDC Recommendations might vary depending on the degree of statutory consistency. States with some inconsistent statutes may consider implementation of those provisions that do not have statutory barriers. State law in Alabama, for instance, requires written informed consent, but does not require counseling. Providers in Alabama may consider a routine opt-in HIV screening process that utilizes written consent but does not require counseling at the time of testing. Partial implementation of the Recommendations might still increase testing (74
) and perhaps build support for amending obstructive statutes.
Apart from statutory consistency, a number of other issues must be considered before proceeding with implementation of the CDC Recommendations. State regulations, which are rules adopted by state agencies to interpret, implement, and enforce state laws (75
), may also govern the HIV testing process by, for example, requiring written consent even when not called for by law. An analysis of state regulations is beyond the scope of our research, but public health officials and providers will also need to review state regulations prior to implementing the Recommendations. Similarly, judicial decisions about HIV testing should be examined.
Any opt-out screening process must adhere to the highest standards of medical ethics and human rights protections (17
). Citing concerns about patient autonomy during opt-out screening and the impact of stigma and discrimination on patients diagnosed in the absence of adequate counseling, some human rights scholars and civil rights groups have expressed reservations about the new CDC Recommendations (11
). They argue that, due to HIV-related stigma, the use of ‘general consent’, in which a patient authorizes a medical intervention without an explicit discussion about the risks and benefits of the intervention, is problematic (14
). Moreover, those who test positive must be offered effective linkage to care, requiring that care programs be adequately funded (17
The CDC Recommendations, however, do in fact address many of the important concerns raised by critics, in some cases requiring even more protection for patients than state laws currently require. For example, the CDC does not endorse a typically understood opt-out and general consent process, as is done with other routine screening tests. Instead the Recommendations, while still using the term “opt-out screening,” actually calls on providers to offer pretest information and ask patients whether they have questions and to inform them that they may decline the test. In this regard, the Recommendations may be more protective of patient autonomy than critics realize. In addition, for patients who test positive, the Recommendations specifically require that the result be communicated confidentially through personal contact by a clinician or other skilled staff. The Recommendations also call for efforts to ensure that HIV infected patients are linked to clinical care and counseling at another provider, if not available at the screening site.
Meeting the standards for HIV screening under the CDC Recommendations first requires that providers understand the consistency of their state’s HIV testing laws and regulations with these Recommendations. If implementation is permissible, providers should receive adequate information about the HIV opt-out screening and consent process, and about the importance of establishing referral mechanisms with HIV prevention and care providers. Each of these requirements is difficult to achieve and will require coordinated efforts of public health departments, provider groups, and other stakeholders.
Illustrating the challenge, the first published data on an opt-out HIV screening program based in an emergency department revealed that half of patients who tested positive did not establish care and were lost to follow-up (76
). This screening program has since introduced a policy of having an infectious diseases physician see patients briefly while in the ER and arrange a clinic appointment within 24 hours. For settings without immediate access to infectious disease specialists, establishing formal collaborations with community-based HIV/AIDS organizations and clinical HIV/AIDS-care providers may be necessary to ensure linkage to care.
It is important not to lose sight of patient perspectives on and satisfaction with an opt-out HIV screening process. This is particularly important for vulnerable populations who may have limited access to healthcare services and are disproportionately at risk for HIV stigma and discrimination (77
). To date, patient acceptability of opt-out HIV screening has only been examined by presentation of hypothetical scenarios through convenience sample surveying of emergency room patients (78
). Further research on patient perspectives is needed to tailor the screening process for different populations and to identify unintended consequences.
Finally, we note that the completeness of our review of statutory law depends on the efficacy of our search methodology as well as the accuracy of the legal search engines we used. It is possible that a few legislative developments were not captured. We sought to mitigate this by utilizing 2 different legal search engines and performing the systematic survey of laws at 3 different time points.
With more than a quarter million Americans unaware of their HIV positive status and 56,000 new HIV infections per year (79
), it is incumbent on our health system to improve HIV screening rates. In addition to unknowingly transmitting the virus, individuals unaware of their positive status often already meet the criteria for AIDS by the time they test positive (80
), which compromises long-term immune recovery even with appropriate antiretroviral therapy (82
). In a national survey, 65% of respondents supported treating HIV testing like routine screening for any other disease (84
). Multiple analyses indicate that HIV screening according to the CDC Recommendations are cost-effective (85
). Misreading of the CDC Recommendations and inaccurate generalizations about state statutes should not derail implementation. Although many have voiced concern about potential statutory barriers, state statutes that govern HIV testing are in fact increasingly compatible with implementation of the CDC Recommendations.