Consent in HIV testing divides health experts

Last week the Legislature's Joint Committee on Public Health heard testimony on House Bill 2209, a bill that would repeal the legal requirement on medical providers to get written informed consent from patients before testing them for HIV (see "State Hears Testimony On AIDS Bills," Sept. 27). The bill, which is supported by the Massachusetts Medical Society but opposed by AIDS Action Committee and Gay and Lesbian Advocates and Defenders (GLAD), would bring Massachusetts law into sync with recommendations issued last year by the Centers for Disease Control and Prevention (CDC) to increase HIV testing by making testing more routine; one of those recommendations is to repeal requirements for written consent and pre-test counseling for HIV testing. Bay Windows spoke with providers and health officials about what impact removing the written consent requirement would have on HIV testing in Massachusetts and found that there were strong differences of opinion about whether the state should take that step.

Dr. Stephen Boswell, president and CEO of Fenway Community Health, said that while the written consent and pre-test counseling requirements present no barrier to testing patients at the Fenway, he believes they may in other healthcare settings such as mainstream doctor's offices and emergency rooms. He said HIV/AIDS is such a routine part of Fenway's work that there are consent forms for HIV testing in every exam room and providers are well-versed in consent and pre-test counseling procedures.

"I think where these new regulations, if they're going to have an effect, the major opportunity to really have a significant effect resides in institutions that really don't do more HIV care than you'd expect in the general population," said Boswell. "In an institution that doesn't do as much of this they may have to go out and find the proper consent form. ... In a very busy practice that can be a big impediment."

He said the CDC's recommendations do not do away with consent for HIV testing but instead fold that consent into the general consent people give when seeking medical treatment. The recommendations say that physicians should offer patients the opportunity to opt out of testing. Boswell said the state should try eliminating the written consent requirements to see if that approach leads to an increase in people getting tested.

"I think this is a reasonable approach to take to see if by destigmatizing HIV, by regularizing the way it's looked at, it's like other conditions we'd run tests for, by doing that it becomes possible to capture many of the close to a quarter of a million people who are infected who haven't been tested," said Boswell.

Dr. Dale Magee, a gynecologist in Shrewsbury and president of the Massachusetts Medical Society, said that from his own experience he has found that the written consent process is a barrier to getting patients tested not only because of the time involved but because the consent forms make some patients uncomfortable. He said patients who readily consent to tests for syphilis and gonorrhea freeze up when he brings out the consent forms for the HIV test.

"The testing goes down, and that's because no matter what you say, if you say to them you have to sign this form to take this test, they take it as an admission that they are at higher risk. ... When you bring out that form it sends out a different message to the patient, and a lot of them retreat," said Magee.

He said even without a written consent form physicians can be trusted to make sure that their patients understand the potential consequences of getting tested and what a positive diagnosis could mean for them.

"There is information that responsible clinicians need to give their patients, and if we are to assure that the HIV test is not stigmatized then mainstreaming it is certainly the thing to do. There is responsibility for clinicians in every test that we do, and we manage that," said Magee.

Unlike Magee, Ariel Persing, coordinator of counseling and testing and support services at the Sydney Borum Health Center, said she does not see written consent forms as a barrier to getting people tested. The health center, a program of JRI Health, provides services for at-risk youth. Persing said for many of their clients coming in to get tested the consent form gives them a sense of control over the HIV testing process.

"I would almost say [it gives patients] a sense of security. There's a sense of control, that they are deciding this, they are controlling this," said Persing.

She said the process of asking for written consent takes "a matter of minutes," and the pre-test counseling takes an average of 13-20 minutes. The entire process of counseling, the consent form, the HIV rapid test and post-test counseling takes approximately 45 minutes.

Persing said the only component of the consent process that has presented a potential barrier to getting people tested is explaining the state's HIV reporting policies. Prior to the start of this year providers who had patients testing positive for HIV were required to report the cases to the state Department of Public Health, but the providers maintained patient confidentiality by replacing the patients' names with codes. Under pressure from the CDC to use name-based HIV data, DPH instituted regulations that went into effect in January mandating that providers send them the names of patients who test positive. Persing said that some patients have been hesitant about getting tested after learning about DPH's name-based reporting system, but after learning about the security procedures DPH uses to protect patient information patients have all been willing to go through with the test.

Persing said if the law removing the written consent requirement passes, she is unsure how the Borum health center will respond. She said even if the health center abandons written consent she hopes there will still be the opportunity to provide information to the patient about the test before administering it.

"I think there needs to be some discussion so there's still a sense of responsibility and control on their side," said Persing.

Vanessa Sasso, manager for HIV counseling and testing for Boston Medical Center (BMC), said her program has worked to provide HIV tests to patients in a wide variety of settings in BMC, from drop-in HIV testing clinics to primary and urgent care settings. The 12 counselors in the program test an average of 7000 people per year. Sasso said in her opinion, which she explained does not represent the official view of BMC, the written consent process is not a barrier to getting people tested. She said the counselors in her program offer testing to patients on a routine basis, going from room to room in different BMC facilities and offering testing to anyone who is willing. For those who consent, Vasso said counselors first ask a series of questions to determine if the person is mentally prepared to get tested and then go through the written consent process.

Sasso said counselors try to ensure when testing patients who are at BMC for reasons unrelated to HIV testing that they do not interfere with whatever other treatment the patient is receiving. A counselor may test patients waiting in a waiting room or exam room and then duck out of the room when doctors or nurses begin treating the patient.

"We have to be mindful that they're here, they're in urgent care because they've sprained their ankle, whatever, and we need to be mindful of what's going on and how best to insert what we're trying to do and not get in the way of the clinical setting," said Sasso.

She said she sees pre-test counseling and written consent as being particularly important in more mainstream clinical settings because while many patients coming into an HIV testing center are familiar with HIV testing, other patients may not see themselves as being at risk for HIV and may be uninformed about HIV and the importance of getting tested.

"But here we are coming in and talking to them a little bit more, and we say to them, all you know is what you're doing. You might be married for more than 20 years, but do you know your status?" said Sasso.

She said if the legislation to remove the written consent requirement passes she believes the counseling and testing program at BMC may continue using written consent forms, although she said doctors at BMC offering testing to their patients may take another approach.

"I think we could preserve [the written consent form] in some respect because it is a tool, it is an aide for us as we go through the pretest counseling to make sure the person understands what they're agreeing to. ... You really want to make sure that the person's ready and understands what it is," said Sasso.

Like Persing she said some of the clients her program sees have expressed concern about the state's HIV name reporting system, but she agreed that those concerns have not prompted anyone to decline to be tested. She said BMC offers some anonymous non-rapid HIV testing in which results are not reported to the state, but since January Sasso said there has been no increase in demand for the anonymous testing.

Dr. Bernard Branson, Associate Director for Laboratory Diagnostics for the CDC's Division of HIV/AIDS Prevention, explained that the agency issued its recommendations to remove the written consent and pre-test counseling requirements because studies found that one of the primary barriers to getting people tested was the amount of time required to carry out pre-test counseling and the written consent process. He pointed to a literature review published this year in the journal AIDS analyzing available studies on why physicians fail to test their patients for HIV, and one of the common themes in those studies was that the consent process and pre-test counseling are major hurdles to testing patients.

Branson said that while the counseling and written consent requirements were enacted in many states to provide protection to patients at a time when there were no effective treatments for AIDS and when stigma associated with the disease was high, the CDC believes that the most effective approach to get the estimated 250,000 Americans who are unaware that they are infected tested and into treatment is by making HIV testing as routine as possible.

Branson said some states have found alternatives to informing patients about HIV and consequences of HIV testing while minimizing the time burden on doctors. He pointed to a July 2006 study in the Annals of Emergency Medicine that found that when patients at Jacobi Medical Center in the Bronx watched a video on HIV, they performed just as well on a test measuring HIV knowledge as patients who received counseling from a dedicated HIV counselor. Branson argued that by eliminating the written consent requirement providers can provide crucial information to patients while increasing productivity, ensuring that more people get tested.

"There are a lot of opportunities to make information available to people that fulfill both needs," said Branson.