“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
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.
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
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
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
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
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
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.
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.