“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”
HIV Testing During Pregnancy: The Value of Optimizing Consent
David W. Webber*
*David W. Webber, JD, is is Editor in Chief of APPJ and currently is of counsel to the AIDS Law Project of Pennsylvania, a nonprofit, public interest law firm he founded in 1988. This article was accepted for publication on 3 July 2004.
The following article is reprinted with permission from the AIDS & Public Policy Journal, Vol. 18, No. 3/4, pp. 77-82, Special Section on Prenatal Testing and Informed Consent. Copyright © 2004, University Publishing Group. All rights reserved.
The two other APPJ articles discussed in this article are available from the AIDS & Public Policy Journal.
The issues of patient autonomy and informed decision making are at the center of the debate over appropriate standards for HIV testing during pregnancy. State law standards on this issue vary significantly from state to state. Federal policy pronouncements on this issue also lack consistency. Against this legal and policy background, the two articles in this Special Section of AIDS & Public Policy Journal present a significant lesson for policy makers: patients value their decision making autonomy very highly in regard to HIV testing, and that value can be respected while at the same time achieving high rates of testing. Optimizing consent enhances the provider-patient relationship, a critically important relationship for a pregnant woman with HIV infection. Laws and policies that disfavor patients' consent, such as mandatory newborn testing laws, have little justification and should be rejected by policy makers.
HIV Testing During Pregnancy: The Value of Optimizing Consent
This special section in AIDS & Public Policy Journal presents two contributions to the already extensive body of literature pertaining to HIV testing of pregnant women. Both articles examine critical aspects of patients' consent for HIV testing during pregnancy. Sohini Sengupta and Bernard Lo evaluate the attitudes of largely low-income African-American and Hispanic prenatal clinic patients toward the Institute of Medicine's (IOM's) 1999 recommendation of "universal, voluntary" HIV testing during pregnancy. In contrast, Kristin Kelly's study is not limited to a specific racial or demographic population, but instead assesses attitudes toward HIV testing among women in a diverse range of prenatal clinics in Connecticut. The selection of Connecticut as the setting for this study is significant, in that Connecticut is one of only two states that impose mandatory HIV newborn testing.
Everyone can agree on the goal of reducing perinatal HIV transmission, and identification of HIV infection during pregnancy is obviously one means of accomplishing this goal. But at the core of the testing-during-pregnancy debate, however, is the question of whether—or to what extent—we value patients' autonomy and informed decision making. That determination may turn largely on the extent that we view HIV testing as potentially stigmatizing, and whether we believe maintaining the confidentiality of HIV test results and prohibiting HIV-related discrimination are current, ongoing problems. The Centers for Disease Control and Prevention (CDC),1 for example, has cited the U.S. Supreme Court’s 1998 decision in Bragdon v. Abbott 2 as "ensuring that persons with asymptomatic HIV disease are included under [the Americans with Disabilities Act 3] and have access to nondiscriminatory and effective health care." This is certainly a naïvely expansive reading of that case and reflects little understanding of the everyday reality of discrimination against individuals with HIV.
In addition to—some would say paramount to—the linked problems of confidentiality and discrimination is the question of whether antiretroviral treatment is medically reasonable for all HIV-infected women during pregnancy. The CDC has conceded that decisions regarding the use and choice of antiretrovirals are "increasingly complicated," even for persons who are not pregnant.4 The decision to use antiretrovirals during pregnancy is further complicated because the "long-term consequences for the infant who has been exposed to antiretroviral drugs in utero are unknown."5 Thus, testing for HIV in the perinatal care setting for the purpose of preventing transmission to the child may not make sense for all women, depending on what their choices regarding prevention of infection might be.
This debate has ranged against separate and somewhat fluid medical and legal backgrounds. On the one hand, on-going medical advances during the past decade can significantly reduce the risk of perinatal transmission, assuming that HIV infection is identified during pregnancy. Indeed, among HIV-infected women who begin antiretroviral treatment during pregnancy, the rate of HIV transmission has been as low as less than 2 percent.6 This rate is significantly below the rate of 12 to 13 percent for women who begin preventive treatment at labor and delivery or after birth, or the rate of 25 percent among women who receive no treatment.
On the other hand, many states have imposed legal restrictions on HIV testing, and many of these restrictions were adopted more than a decade ago, before preventive treatments were identified. According to one recent survey, at least 31 states by law prohibit HIV testing without the patient’s informed consent—the so-called "opt-in" approach.7 Some of these states explicitly require pre-test counseling and even describe the contents of such counseling, and some states do not. Whether state law mandates counseling, however, may be irrelevant in many cases. Informed consent can only be obtained after a healthcare professional makes a determination about the patient’s decisional capacity and knowledge level, and, typically, that determination can only be made after a face-to-face verbal exchange. Only six states require that HIV testing be done during pregnancy, unless the patient, after being notified regarding the testing, refuses it—the so-called "opt-out" approach. Eleven states require careproviders to offer HIV testing to all patients during pregnancy, but preserve the "opt-in" approach. Testing must be offered, but can only be done if the patient consents. No state imposes mandatory testing during pregnancy, and only two states, Connecticut and New York, impose mandatory testing on newborns.8
Federal policy recommendations in this area display a bewildering series of fluctuations. The CDC first recommended in 1995 that testing during pregnancy be done only on an informed consent basis.9 But four years later, the Institute of Medicine, in a report issued at the behest of the U.S. Congress, recommended that HIV testing be undertaken on a voluntary, routine basis.10 In the IOM's view, careproviders may dispense with pre-test counseling and test patients without obtaining their explicit consent. The IOM opt-out approach allowed patients the right to refuse testing, but deprived them of the right to be tested only after they give consent. Then, in 2001, in response to the IOM recommendation, the CDC replaced its 1995 guidelines with a recommendation that all pregnant women be screened for HIV, but stated that informed consent is "essential" and that patients' consent be documented "in writing, preferably with the client’s signature.11 In a nod toward the IOM’s recommendation, the CDC did allow for the streamlining of pre-test counseling, but concluded, "No evidence exists to indicate that any legal approach is more successful than others in preventing perinatal transmission." Nevertheless, a year later, the CDC compared HIV testing rates between "opt-in" and "opt-out" jurisdictions and editorialized that "jurisdictions that use an opt-in approach and that have low prenatal HIV-testing rates should reevaluate their approach."12
It is against this background that Sengupta and Lo report on patients' perceptions of the IOM "universal, routine" testing recommendation, although, it should be noted, arguably only one of the four prenatal clinics in the study had implemented that recommendation. Overall, Sengupta and Lo document two strands of opinion among the women who were interviewed. First, an overwhelming majority of the women (78 percent for, 22 percent against) believed HIV testing is important enough to be a routine part of prenatal care. Nevertheless, however, a majority of patients (61 percent for, 38 percent against) believed that HIV testing should be done only with explicit notice or with written consent. Sengupta and Lo do not speculate whether patients’ disapproval of the IOM policy would result in avoidance of prenatal care or a refusal to be tested, but that clearly is one risk of the policy, although the degree of that risk is not known.
While it was not the primary focus of their study, Sengupta and Lo compare the experiences of women in clinics that used the opt-out approach with those that used the opt-in approach, although the patient samples from each clinic are admittedly small. Clinics 1 and 2, in California, are in an opt-in jurisdiction that requires informed consent for an HIV test and requires that testing be offered to prenatal patients, but does not have a requirement regarding pre-test counseling. Clinic 3 is in North Carolina, another opt-in jurisdiction that requires informed consent, but does not require that the consent be documented in writing, does not require pre-test counseling, and does not require that HIV testing be offered to all patients. Clinic 4 is located in Washington, D.C., which does not regulate HIV testing and thus does not have an informed consent requirement, and does not mandate that HIV testing be offered. Significantly, the survey patients reported an overall high rate of HIV testing (93 percent), with most reporting testing during the first or second trimester (89 percent), despite the differences in legal standards for testing.
The data from the clinic in Washington, D.C., indicates a troubling failure in providing basic information relating to HIV testing. As described by the authors, that clinic's practice was precisely what patient advocates feared might result from attempts to implement the IOM’s recommendations: clinic staff point to a chart on the wall that lists the HIV test among a battery of prenatal tests. Not only is there no pre-test counseling, but patients are not given explicit notice of HIV testing, nor are they informed that they may refuse testing. Thus, this clinic’s practice falls below even the "voluntary" testing norm set by the IOM. As a result, one-quarter of the patients in this clinic apparently did not know they were being tested for HIV. Of the remaining patients, a majority stated that they were not "offered" an HIV test (63 percent), but were "told" that an HIV test "would be done" (67 percent). Most did not receive HIV pre-test counseling (58 percent), and 92 percent reported that they were not given information about why HIV testing is important during pregnancy.
In the second article, Kelly reports on the meaning of consent in testing of pregnant women in Connecticut. Connecticut, like New York, adopted a mandatory newborn testing law that requires all newborns to be tested for HIV unless their mothers have already been tested. Connecticut also requires that careproviders offer HIV testing to all pregnant women, and that informed consent is a prerequisite for testing. Kelly's results indicate a very high rate of testing, and indicate also that patients were not tested without their knowledge. Perhaps not surprisingly, Kelly found that, despite Connecticut's legal requirement that all HIV testing must be consensual, more than half of the surveyed patients gave their "consent" for testing as a result of their belief that testing was required, not optional. Nevertheless, nearly one-fifth of those surveyed believed that they had not received enough information about the test, although they "somewhat understood" they were taking the test, a result that suggests that, for many patients, the ease with which consent was obtained gave careproviders no incentive for pre-test counseling.
At this point, it is fair to say that the reduction in perinatally transmitted HIV has been among the few success stories in HIV prevention in the United States. The CDC’s latest reports indicate that the rate of HIV transmission has dropped significantly in recent years. HIV transmission from mother to child in the United States is now a relatively rare occurrence. The few reported cases of HIV transmission are more likely the result, not of opt-in legal requirements for HIV testing, but of lack of access to prenatal care during pregnancy. Policy makers have been wrong to focus too exclusively on testing as a means of preventing HIV transmission. There are alternatives, such as enhanced access to early prenatal care, particularly for women who use illicit drugs, that would be effective. And, obviously, reducing the rate of HIV transmission to women would also decrease the rate of perinatal HIV transmission. But, as these articles demonstrate, it is wrong to believe the problem is that pregnant women resist testing or that careproviders are unable to attain high rates of testing if they must obtain a specific consent from each patient.
Although the articles in this issue provide important insights, they do not answer all the questions presented in this area. Further research is needed, for example, to assess careproviders’ compliance with legally mandated testing protocols. When it is reported that 15 percent of patients at California clinics said that they were tested for HIV but were not required to provide consent in writing, it is unknown whether this is the result of the patients’ poor recall or whether the careproviders failed to comply with state’s written informed consent requirement. Similarly, when patients in Connecticut perceived that their HIV test was "required," it is not clear to what extent careproviders’ noncompliance with the state’s consensual testing law contributed to that perception.
A decade ago, Ruth R. Faden and her colleagues published their findings in this journal on the nature of informed consent for HIV testing in a Baltimore prenatal clinic.13 That article presents important lessons that remain highly relevant to policy makers today. That report found a high (91 percent) HIV testing rate and concluded that "a policy of voluntary HIV-antibody testing is both compatible with the public health goal of encouraging testing and feasible in a prenatal clinic." That feasibility was achieved not as a result of staff merely pointing to a chart on the wall, or even informing patients they had a right to refuse testing, and then testing them. Instead, the Baltimore clinic employed a full-time HIV counselor whose sole responsibility was to monitor and execute the clinic’s HIV-antibody testing protocol. As a result, Faden concluded, "It is possible to achieve at least a minimal threshold of voluntariness in an institutional context, provided clinic staff are sufficiently committed to communicating to patients their respect for patient choice."
For a pregnant woman unaware of her HIV infection, the decision to be tested is the first decision in a potential series of decisions. These are by no means easy decisions, and cannot be undertaken without counseling and support from healthcare professionals who have patients' implicit trust and confidence. After all, the decision whether to commence antiretroviral treatment must be made without knowing the long-term effects of in utero drug exposure on the infant. But an effective provider-patient relationship is not established by imposing HIV testing in a manner that displays little, if any, respect for a patient’s decision making, and, moreover, is disapproved of by patients, as described by Sengupta and Lo. Nor is such a relationship established when, as described by Kelly, an HIV testing protocol turns prenatal careproviders into enforcers of a legislative policy that is, for many women, a de facto mandatory testing requirement. Other states should refrain from imitating New York's and Connecticut's unfortunate experiment in mandatory newborn testing, and those states' laws should be immediately repealed.
We should not forget that so many state legislatures adopted informed consent for testing requirements for a very good reason—to give patients, not their physicians, control over testing. As the studies in this issue demonstrate, there are good reasons not to abandon that standard. Once policies are adopted that require prenatal careproviders to do nothing more than inform a patient that she will be HIV tested and can refuse, it is too easy for that policy to be translated into the mere pointing to a chart. Instead, as the CDC recommended in 2001, requiring that HIV testing be offered to every pregnant woman, and requiring documentation of that consent in her chart, ideally with her signature as evidence, is the best way to ensure respect for patients’ choices. Such practices are consistent with high rates of HIV testing, and, as these studies demonstrate, that is also what patients desire in their relationship with their prenatal careproviders.
1. CDC, "Revised Recommendations for HIV Screening of Pregnant Women," Morbidity and Mortality Weekly Report 50, no. RR-19 (2001): 63-85, p. 72.
2. 524 U.S. 624 (1998).
3. Americans with Disabilities Act, 42 U.S.C. §§ 12101-12213 (1994).
4. CDC, "U.S. Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States," Morbidity and Mortality Weekly Report 51, no. RR-18 (2002): 1-38, p. 12.
6. CDC, "Revised Recommendations for HIV Screening of Pregnant Women," Morbidity and Mortality Weekly Report 50, no. RR-19 (2001): 63-85.
7. Z. Lazzarini and L. Rosales, "Legal Issues Concerning Public Health Efforts to Reduce Perinatal HIV Transmission," Yale Journal of Health Policy, Law, and Ethics 1 (Winter 2002): 67-98.
9. CDC, "U.S. Public Health Service Recommendations for Human Immunodeficiency Virus Counseling and Voluntary Testing for Pregnant Women," Morbidity and Mortality Weekly Report 44, no. RR-7 (1995): 1-15.
10. IOM, Reducing the Odds: Preventing Perinatal Transmission of HIV in the United States (Washington, D.C.: National Academy Press, 1999).
11. CDC, "Revised Recommendations for HIV Screening of Pregnant Women," Morbidity and Mortality Weekly Report 50, no. RR-19 (2001): 63-85.
12. CDC, "HIV Testing Among Pregnant Women—United States and Canada, 1998-2001," Morbidity and Mortality Weekly Report 51, no. 45 (2002): 1013-16.
13. R.R. Faden et al., "Prenatal HIV-Antibody Testing and the Meaning of Consent," AIDS & Public Policy Journal 9, no.3 (Fall 1994): 151-9.
Reprinted with permission from the AIDS & Public Policy Journal, Vol. 18, No. 3/4, pp. 77-82, Special Section on Prenatal Testing and Informed Consent. Copyright © 2004, University Publishing Group. All rights reserved.