US state laws obstruct CDC recommendations for routine HIV testing

A comprehensive analysis published in the October edition of PLoS One has found that routine HIV testing would contravene many US state laws requiring pre-test counselling, disclosure of information, and patient informed consent. Since the US Centers for Disease Control issued their recommendations for routine testing in 2006, there has been almost no move toward amending state laws to allow such testing, and many states have in fact strengthened their position on the need for consent and counselling.

Many HIV-positive people are unaware of their status. It is estimated that approximately a quarter of the one million HIV-positive people in the US are unaware of their infection, and that this lack of awareness results in 20,000 new infections every year. Current generally accepted policies on HIV testing call for explicit, informed patient consent, pre- and post-test counselling.

In September 2006, the US Centers for Disease Control and Prevention (CDC) recommended routine HIV testing for all Americans between 13 and 64 years.

According to the CDC recommendations, patients would have to be notified that they were being tested and would be able to decline, but would no longer have to explicitly consent; neither would they receive pre-test counselling.

The implications of routine testing have been extensively debated: on the one hand, the hope is that routine testing would increase the number of HIV-positive people aware of their status, increasing their own likelihood of receiving adequate care as well as hopefully reducing transmission rates by affecting risk behaviour. On the other hand, there are concerns about the removal of explicit consent and pre-test counselling.

In the United States, legal issues pertaining to health and public health are predominantly under state jurisdiction; states hold the legal authority over HIV testing policy. The CDC, while influential, does not have the authority to impose any changes on state statutes or regulations.

This research team, with expertise in medical ethics, law, and HIV prevention, has therefore investigated how the CDC recommendations related to current HIV testing statutes and regulations in the 50 US states plus the District of Columbia. Specifically, they analysed whether and to what extent individual state laws require, and/or specify the content of, pre-test counselling and informed consent relating to HIV testing, and whether any such laws have actually been amended since the CDC recommendations were published.

What do existing state laws require?

Many states have laws that require specific consent for HIV testing: 19 states require specific oral consent (of which five require that such consent be documented), 14 states require written informed consent, and eleven require pre-test counselling. Twenty-four states require that specific information be disclosed to the patient during the pre-test counselling and/or consent process, although the amount and content of this information varies widely (as follows):

• The nature of the HIV test (required by 20 states).
• HIV risk behaviours and prevention measures (required by twelve).
• Patient confidentiality and cases where exceptions may be required (twelve).
• Voluntary nature of the test (eleven).
• Fact that anonymous testing is also available (ten).
• The nature of HIV/AIDS (eight).
• Right to withdraw consent to be tested (eight).
• The risks and benefits of testing (seven).
• Referrals for further information on HIV and treatment (four).
• How HIV test results may be used (three).
• How testing may affect ability to obtain services (one).

How have these laws changed?

Since 2004, only a single state has amended its statutes to facilitate routine HIV testing, and in that case, only for pre-natal testing, where recommendations have been strongest.

In fact, the opposite has generally occurred: several states have recently amended their statutes so as to strengthen their position on consent and pre-test counselling. Two states have changed their laws to require more information to be conveyed during the consent process. One state has amended its statute to explicitly reject components of the CDC recommendations, stating that the CDC guidelines "shall in no event be interpreted or implemented in a manner inconsistent with the minimum informed consent standards [of this statute]". (The report does not name the specific states.)

Implications for change

The analysis contained in this report found "significant legal barriers to implementing the CDC's recommendations for routine HIV testing." The majority of states would need to amend their laws to remove specific requirements for consent and pre-test counselling; nearly none have done so yet, and in fact, "the trend… has been to reaffirm [such] requirements."

Implications of a move toward routine testing have been extensively discussed elsewhere (see this aidsmap report); the authors of this paper reassert that "the very limited disclosures that the CDC recommends are insufficient for making informed decisions about testing", that eliminating pre-test disclosure and counselling may "remove an important mechanism for educating individuals about HIV and reducing risk", and that the recommendations may in fact "weaken [patient] protections, without substantially increasing testing among those who are unaware that they are HIV-infected", as literature suggests that access to health insurance and a regular health care provider are among the strongest predictors of seeking testing.

In summary, they note that "understanding these legal barriers and the apparent resistance to changing state HIV testing policies is essential to effecting any policy change that might increase HIV testing."