Public Health Magazine: Winter 1995, Vol.5, No.1
Articles
Patient eduacation materials result in marked increase in AIDS knowledge

Pregnant women and AZT: Initial Results on Pregnant Women and AZT Show That Educating and Respecting Patients Can Work

Triggered by the AIDS trial 076, which studied zidovudine's (AZT) possible prevention of maternal/infant HIV transmission, newly developed patient education materials showed early indications of effectively helping HIV-positive pregnant women make well informed decisions about their health care. This pilot study has also illuminated the need to train health providers on how to inform and enable patients to make their own health care decisions.

In the CSPH study, 102 women, who were either HIV-positive or at risk for HIV infection, were asked questions about AZT and the trial 076. They then had the opportunity to read the educational brochure and were asked the questions again. The overall mean knowledge score for the pilot study participants increased from 1.5 before the brochure to 5.7 afterward. Moreover, the number of women who said they would "definitely" or "most likely" take AZT during a future pregnancy increased from 43% before reading the brochure, to 71% after.

"This is a woman's rights issue," said the project director, CSPH graduate student Stephanie Taylor. "If you educate the woman she can--and has the right to--make her own decision."

The patient education materials, which are being developed under the auspices of Associate Dean Cheryl Healton, Dr.P.H., and CSPH's Center for Applied Public Health, was one of the first responses in the country to the discontinuation of the controversial 076. The 076 study administered AZT to HIV-positive pregnant women and then to their newborn infants to see if such treatment could reduce the rate of HIV transmission from mother to child. The trial was stopped when preliminary results indicated that women who received AZT had a transmission rate of 8.3 percent, as compared with 25.5 percent among those who received placebo treatment. 076 researchers quickly released the findings and federal officials soon recommended ante partum and intra partum AZT therapy for mothers and post partum for infants to prevent unnecessary HIV-infection.

In spite of these impressive results, the mother's decision to take AZT is not as simple as it might seem. "The challenge is to effectively communicate the 076 results because the issue is complicated," Taylor explained. "076 left many vital questions unanswered." For example, because AZT can cause severe adverse reactions, what are its effects on the 75 percent of infants who are not HIV-positive in the first place? Also, the long-term side- effects for both women and children are currently being studied, but are still unknown. Finally, no one yet clearly knows when AZT is most effective: during pregnancy, at birth, in the newborn phase or all three?

The patient education brochure teaches women to consider such questions while explaining what is known and unknown about AZT therapy for women and children. It attempts to present the information evenly, and not to persuade women one way or the other regarding AZT use.

Next Step: National Study "While many were uncertain about how to communicate 076 information to patients, Dr. Healton and a team of researchers and clinicians stepped forward to develop patient education materials and test their efficacy," Taylor noted. After funding from the federal Health Resources Service Administration (HRSA) was secured, Healton and Taylor formed the New York/New Jersey Consumer and Provider Education Consortium with 23 members, representing hospitals, government, academia and AIDS research organizations.

Now, the patient education brochure is being tested on a national level. Although this second phase was originally planned for 15 sites in the New York/New Jersey area, another five to 10 sites across the country have been added. The study's sponsor, HRSA, recently approved this expansion based on the success of the pilot study.

As another part of the investigation, CSPH and its collaborators are developing an educational package for health care providers of HIV-positive women. "There's a view among providers that everyone will take the drug," said Healton, who is project investigator. "In fact, many women conclude that they do not want to take AZT, but when women decide not to take it they're treated badly."

Some clinicians believe so strongly in the benefits of AZT that there have been reports of providers refusing to treat women who decline to take the drug, said Elizabeth Ann Kovacs, M.A.T., the Center's deputy director. "A lot of doctors believe there is no decision to be made. We're trying to give women the most information to make an informed decision."

076 Reignites Civil Liberties Battle Ironically, the 076 trial gave renewed impetus not only to the study on informed patient consent, but also to just the opposite: proposals for testing and treatment mandates. Currently, some 45 states anonymously screen newborns for HIV in order to measure prevalence and to plan pediatric AIDS services. Because AZT was administered ante partum, intra partum and to newborns in 076, the success of the trial has spurred politicians in almost all of these states to propose revealing individual test results for HIV-positive babies.

Such proposals have created strong debate and pitted the proponents of informed consent against the supporters of mandates. Because HIV tests are based on antibodies, their results reflect the HIV status of the mother more than that of the baby. All children born to HIV- positive women acquire the HIV antibody, even though most (75% or more) are not actually infected. Nevertheless, while all parties agree that testing is an intrusion of the mother's right to privacy, the proponents of "unblinding," as it is called, say the baby's right to health care overrides the mother's right to privacy. The proponents of unblinding would use the test results for administration to the infant of AZT therapy and prophylaxis against certain opportunistic infections.

Vehemently fighting such legislation, Healton has reminded legislators that no evidence exists that the administration of AZT to newborns is the key to reducing HIV transmission. Many suspect that the pre partum administration may be more critical. More importantly, Healton insisted, "Mandatory testing would markedly undermine the essential atmosphere of trust and potentially drive women, and therefore their children, away from the health care system."

Other 076 related proposals go even further. Legislation is currently under consideration in several states for the mandatory testing of all pregnant women. "These proposals are not only based on a simplistic view of 076," Taylor argued, "but they carry a lack of respect for the kind of women perceived to be in this situation based on race, culture, and economics."

In a recent New England Journal of Medicine editorial, CSPH Professor Ronald Bayer, Ph.D., raised practical concerns about such proposals, in addition to the ethical concerns. Like many opponents of the mandatory testing of pregnant women, Bayer assumes that some mandatory AZT treatment for those who test positive would logically follow. "Would anything short of incarceration make such treatment possible?" Bayer wrote. "Ethics and practicality dictate the rejection of compulsory treatment of pregnant women. What is needed are strong efforts to persuade women to be tested for HIV and to encourage those who are infected to undergo [AZT] treatment after being fully informed" of the benefits and possible negative consequences of such treatment.