Sunday, August 08, 2010


In September 2006, the Centers for Disease Control and Prevention (CDC) recommended routine opt-out HIV testing in health care settings without written consent (see ).  After all this time, the laws of several states still conflict with these recommendations or make them difficult to apply.  A summary current and pending state-by-state legislation on testing can be found at  Beyond AIDS has been working to achieve the CDC standards for simpler HIV testing in New York, Massachusetts, and California.

Beyond AIDS backed a successful New York State bill (A. 11487, Gottfried), that will eliminate the requirement in that state for written consent, but only for rapid testing where results are available within an hour of specimen collection (see article at  That will facilitate the testing process at special HIV testing sites and at laboratories that offer the rapid test, but will not help physicians' offices or clinics that draw blood and send it to outside labs. In the circumstances where written consent is not required, specific oral consent is needed, as opposed to "opt-out" routine testing as recommended by the Centers for Disease Control and Prevention (CDC).  A limited amount of pre-test informing of the patient must be provided.

The bill was passed by both houses and signed by Governor Paterson in July 2010, toward the end of the legislative session.  The new law also mandates the offering of HIV testing in health care settings.  Passage of this bill is the first success in a four-year effort spearheaded by bill co-sponsor Nettie Mayersohn, a state Assembly Member who is also Vice-President of Beyond AIDS. An evaluation process on the success of the bill in increasing testing is part of the bill. Beyond AIDS will be watching for the results, and will be prepared to ask for a follow-up bill to correct the deficiencies we expect will be revealed in the evaluation.

Assembly Members Nettie Mayersohn (left) and Barbara Clark (right), with Ron Hattis and Monica Sweeney in New York

Beyond AIDS also worked with former national AIDS policy director Scott Evertz and others, in an attempt to keep a similar bill for HIV testing without the need for written consent, SB 2416, alive in the Massachusetts State Senate. Unfortunately, the bill failed to pass by the end of the legislative session on July 31, 2010. It will be necessary to start over in the new legislative session.

Obtaining a blood specimen for HIV testing
In California, a bill backed by Beyond AIDS (AB 682, Berg), that permits opt-out testing without prior counseling or written consent, became law in 2008. However, this law includes complex informing and documentation requirements, that have limited its utilization and consequently its ability to increase testing.

Beyond AIDS has been invited by the state's Office of AIDS (a part of the state Department of Public Health) to provide some assistance in making it easier for physicians and other healthcare providers to follow the law's requirements. The organization's Beyond AIDS Foundation has proposed a simple checklist to assist providers in following the requirements and in documenting compliance, and is asking that this be posted on the Web site of the Department of Public Health.

A resolution that will be pending before the California Medical Association (CMA) House of Delegates in October 2010, calls for increased availability of patient information sheets that can fulfill the informing requirements of the law. The resolution, which was authored by Beyond AIDS President Ronald Hattis, MD and will be introduced by the California Academy of Preventive Medicine, also calls for CMA to work with the Department of Public Health to assist physicians (e.g., by means of checklists) to comply with the legal requirements of California's testing law.

For most of the first 20 years after the HIV antibody test became available in 1985, the official philosophy of most AIDS organizations and public health authorities was that testing should be preceded by counseling to explain the nature of HIV and of the test. Unique written consent requirements were written into laws or regulations in a number of states, due to concerns by activists that people might be pressured into testing, with the potential of discrimination against persons testing positive if the information leaked out.  But by the turn of the century, it was gradually becoming apparent that special consent and pre-test counseling were barriers to more routine testing.

The September CDC recommendations noted the vast scope of HIV testing nationwide. By 2002, at least 38% of all adults in the United States were estimated to have been tested for HIV, and 16–22 million persons aged 18–64 years were being tested annually for HIV.

Nevertheless, at the end of 2003, an estimated 250-300,000 Americans who were HIV positive were unaware of being infected. This amounted to about a quarter of the approximately 1.0–1.2 million persons estimated to be living with HIV in the United States. People who know they have HIV are more likely to avoid high-risk behavior that could pass on the virus, and can receive medical care for the disease to avoid deterioration of the immune system and life-threatening opportunistic infections.

CDC began looking for ways to encourage the people with undiagnosed infection to be tested. In 2003, CDC introduced an initiative to make HIV testing a routine part of medical care on the same voluntary basis as other diagnostic and screening tests. There was particular emphasis on making testing of pregnant women a universal practice, since the infection of newborns can be prevented by treating the mother and the baby.  Rapid testing was recommended during delivery if the woman had not been tested prenatally.
Self-collecting an oral specimen for rapid testing

CDC by 2003 acknowledged that pre-test counseling might not be appropriate or feasible in all settings, and that some providers perceived requirements for such counseling and for written
informed consent as a barrier to routine counseling. The initiative advocated "streamlined approaches" to counseling and testing, which had substantially increased acceptance of routine prenatal testing. Finally, in the 2006 guidelines, CDC spelled out these approaches more clearly, including elimination of requirements for written consent; making HIV testing an "opt-out" rather than "opt-in" process (i.e., patients should be told of the intent to test and may refuse, rather than requiring them to actively request testing); and doing the counseling post-test, in the course of explaining results.

As of 2010, according to the compendium (, Massachusetts, Michigan, Nebraska, and Pennsylvania still required written consent for HIV testing; and as noted above, written consent will still be required in New York under its new law, except when a rapid testing method is employed. Pre-test counseling or specific pre-test informing were required by California (in latest law described above), Georgia, Illinois, Maryland, Michigan, Missouri, Montana, New York (in the latest law described above), Pennsylvania, Rhode Island, and Wisconsin.  Many other states required specific informed consent for HIV testing that may be done orally, but but not on an "opt-out" basis. In addition, many states required post-test counseling, which at least should not serve as a hurdle before testing can be performed, unless it discourages some providers from ordering the test. Beyond AIDS will be looking for opportunities to simplify testing requirements wherever these impede routine testing.

Safe handling of a blood specimen for HIV testing

1 comment:

Carol William said...

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