STD Quarterly
Simplifying consent eases testing stigma
What is your clinic's policy when it comes to getting a signed informed consent for HIV testing? By eliminating required written consent for HIV testing at the San Francisco Department of Public Health Medical Center, the average monthly rate of HIV tests has increased by 4.38 per 1,000 patient-visits, with a 67% increase (from 8.9 to 14.9) in the monthly average number of new positive HIV tests.1
Before May 15, 2006, clinicians had to complete a separate HIV test laboratory requisition form and have the patient sign an informed consent document to order an HIV test. If documentation was incomplete, the laboratory rejected the sample. The study collected HIV testing data of all adult patients seen at the San Francisco Department of Public Health medical care system from January 2003 to June 2007. Researchers compared HIV testing data before and after the medical center eliminated required written consent for HIV testing in 2006.
"The increase in routine HIV testing in medical settings and the identification of new cases has been critical to HIV prevention efforts in San Francisco," says Jeffrey Klausner, MD, MPH, deputy health officer and director of the STD Prevention and Control Services at the San Francisco Department of Public Health and associate clinical professor of medicine at the University of California, San Francisco. "New cases have been linked to partner services enabling the further discovery of previously undiagnosed persons with HIV infection."
While many urban areas throughout the United States have seen continued increases in new cases in gay men and other men who have sex with men, the number of new cases in San Francisco is very high, but stable, observes Klausner, a co-author of the current research article. "As other medical settings adopt similar procedures throughout the states, we hope to observe similar leveling off or perhaps declines in new HIV infections," states Klausner.
Streamlining the consent process follows the 2006 revision of HIV screening guidelines by the Centers for Disease Control and Prevention (CDC).2
Review the guidance on consent included in the guidelines:
- Patients should be informed orally or in writing that HIV testing will be performed unless they decline (opt-out screening). Oral or written information should include an explanation of HIV infection, and the patient should be offered an opportunity to ask questions and to decline testing. With such notification, consent for HIV screening should be incorporated into the patient's general informed consent for medical care on the same basis as are other screening or diagnostic tests. A separate consent form for HIV testing is not recommended.
- Easily understood informational materials should be made available in the languages of the commonly encountered populations within the service area. The competence of interpreters and bilingual staff to provide language assistance to patients with limited English proficiency must be ensured.3 (Editor's note: For an overview of the revised guidelines, visit the CDC HIV/AIDS web site, www.cdc.gov/hiv. Click on "Testing" and then "Healthcare Settings." Under "HIV Testing in Healthcare Settings," click on "Fact Sheets" to access a fact sheet, "CDC/HIV Science Facts: CDC Releases Revised HIV Testing Recommendations in Healthcare Settings.")
Reducing barriers to testing by removing written informed consent protocol will help increase HIV testing, particularly among some hard-to-reach, higher-risk populations, said Joey Terrill, acting public affairs director for AIDS Healthcare Foundation, the nation's largest nonprofit HIV/ AIDS health care, research, prevention, and education provider, in a statement issued in response to the research paper.
As of February 2007, 34 states had some form of state statute or regulation requiring written consent for HIV testing.4 States now are taking a look at restructuring their consent laws to make HIV screening routinely accessible. In 2007, California passed AB 682, California's Routine HIV Screening Bill, legislation which allows a patient to give simple consent, rather than informed consent, before an HIV test can be administered. The bill also has provisions to maintain and safeguard patient confidentiality, as well as an individual's right to chose whether to undergo testing.
New York has been the focus of recent legislative activity regarding HIV testing consent laws. A HIV testing consent bill introduced by assembly member Nettie Mayersohn died in committee in July 2008. Another bill introduced by assembly member Richard Gottfried moved from committee to introduction in the state senate. However, both houses decided to adjourn for the summer break before considering the bill. The Gottfried bill might be reconsidered when the legislature reconvenes in October 2008.
Under the Gottfried bill, a separate HIV consent form would no longer be required in New York State. Instead, patients would consent to the test on the general consent form for medical treatment and procedures that is issued during routine visits to the doctor.5
References
- Zetola NM, Grijalva CG, Gertler S, et al. Simplifying consent for HIV testing is associated with an increase in HIV testing and case detection in highest risk groups, San Francisco, January 2003-June 2007. PloS One 2008; 3:e2591.
- Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006; 55(RR-14):1-17.
- Centers for Disease Control and Prevention. CDC Releases Revised HIV Testing Recommendations in Health-care Settings. Fact sheet. Accessed at www.cdc.gov/hiv.
- Kaiser Family Foundation. State Statute or Regulation Requires Written Consent for HIV Testing, as of February, 2007. Fact sheet. Accessed at www.statehealthfacts.org.
- Foss S. 2 bills to expand HIV testing set off debate. The Daily Gazette; June 15, 2008. Accessed at www.dailygazette.com/news/2008/jun/15/0615_aidstest.
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