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Do HIV Testing Rates Improve When Written Consent Is No Longer Required?
In the San Francisco healthcare system, HIV testing rates increased significantly after the requirement for written informed consent was eliminated.
In September 2006, the CDC released guidelines advocating not only routine, voluntary HIV testing of all adults in healthcare settings but also the elimination of written informed consent for HIV testing. The potential influence of such a change in consent practices is unknown, but the experience of the San Francisco Department of Public Health (SFDPH) may shed some light.
In May 2006, the SFDPH eliminated the requirement for written informed consent for HIV testing within the city’s hospitals and primary care centers, as long as clinicians documented in the medical record that verbal consent was obtained (i.e., patient signature was not required). Although physicians were electronically notified of the policy change, there were no simultaneous community campaigns to promote HIV testing. During a 15-month period prior to the policy change (January 2004 through March 2005), the number of HIV tests per 1000 patient visits increased steadily from about 8 to 11. In the 7 months after the policy was implemented, testing rates increased markedly — from 13.5 tests per 1000 visits in June 2006 to 17.9 tests per 1000 visits in December 2006. The mean number of HIV-infected individuals newly identified each month also increased significantly, from 20.6 (95% confidence interval, 17.3–23.8) before the policy change to 30.6 (95% CI, 25.7–35.5) afterward. No tests were rejected for failure to document the patients’ verbal consent in the chart.
Comment: Secular trends in implementing routine HIV testing in healthcare settings could explain some of the testing increase seen in this study. However, the rapidity with which the testing rate increased after the policy change, and the increased number of patients identified, are impressive. This report lends further evidence that written informed consent is a barrier to testing and to identifying infected individuals.
National implementation of a policy such as San Francisco’s is currently impossible. As of 2004, more than half of all states mandated that HIV testing be accompanied by written informed consent. These laws, many of which were written in the era that preceded effective therapy, are often linked to confidentiality issues or requirements for universal access to HIV care. Policymakers in HIV testing must work closely with colleagues in the legal domain to ensure that barriers to HIV testing can be overcome ethically and legally without compromising the civil rights of patients.
— Rochelle P. Walensky, MD, MPH
Dr. Walensky is Associate Director of the Program in Epidemiology and Outcomes Research at the Center for AIDS Research at Harvard Medical School and an Infectious Disease Specialist at Massachusetts General Hospital and Brigham and Women’s Hospital in Boston.
Published in AIDS Clinical Care March 26, 2007
Citation(s):
Zetola NM et al. Association between rates of HIV testing and elimination of written consents in San Francisco. JAMA 2007 Mar 14; 297:1061-2.
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