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New Project Calls for More HIV Research That Includes Pregnant Women

A UNC bioethicist is leading the PHASES Project, funded by a grant of over $3 million from the National Institutes of Health, in an effort to address the need for effective HIV prevention and treatment options for pregnant women worldwide.

Anne Lyerly, MD, MA, associate director of the University of North Carolina (UNC) Center for Bioethics and associate professor of social medicine at the UNC School of Medicine, is leading the PHASES Project, funded by a grant of over $3 million from the National Institutes of Health, in an effort to address the need for effective HIV prevention and treatment options for pregnant women worldwide, according to a press release.

Despite scientific advancements, HIV remains a global problem; around 1.2 million people are infected with HIV in the United States alone, and of those people, about 13% are unaware that they are even infected, according to the Centers of Disease Control and Prevention (CDC). However, most of the research that is currently being done on HIV is neglecting a key population: pregnant women. Approximately 16.1 million women worldwide are estimated to be HIV-positive and millions more are at risk of infection, according to the PHASES press release posted on the UNC Center for Bioethics website.

Dr. Lyerly addressed the lack of HIV research regarding pregnant women in her study recently published in the Journal of the International AIDS Society’s August issue. She said that this lack of essential information has “led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy.”

According to the press release, most of the research that has been done regarding pregnant women who are HIV-positive, focuses mainly on the health and wellbeing of the fetus. Most HIV studies have excluded pregnant women, even the studies that discuss possible prevention strategies.

Dr. Lyerly said that the lack of available research has resulted in “major gaps in understanding how best to address the health needs of pregnant women living with or at risk for HIV.”

According to the study, 62 HIV clinicians and researchers, mostly based in the US, were interviewed to discuss what they considered might be potential barriers when it comes to conducting studies that include pregnant women. Around half of the researchers conducted international studies. Through this research, study authors found that the biggest barriers consisted of ethical (benefits/risks), legal (minimal understanding of legal regulations/liability issues), and financial concerns.

When speaking of the findings yielded by the one-on-one consultations, Lyerly said, “Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require guidance regarding ethical and legal uncertainties, incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.”

Due to the fact that there is not an adequate amount of data available regarding the safety of pregnant women and the effects of HIV drugs, researchers are apprehensive when it comes to the “unknown potential maternal-fetal exposure risks," Dr. Lyerly said. The fear of the unknown makes researchers disinclined to use pregnant women in their studies, thus, creating a cycle that continually leaves pregnant women out of the loop.

In addition to ethical barriers, there are legal concerns that researchers keep in mind. According to the press release, researchers oftentimes were unable to fully understand existing federal rules that pertain to using pregnant women in research studies. Additionally, some researchers noted that these kinds of studies were harder to conduct due to the fact that they are costly in terms of potential associated care as well as research.

Although there seems to be a number of challenges, Dr. Lyerly remains positive. She said, “Our consultations suggest that evidence gaps for the HIV response in pregnancy are due neither to lack of will among investigators nor their failure to recognize the research and clinical needs of pregnant women. Rather, these gaps are largely a function of questions, disincentives and barriers in the wider research environment, many of which we can and need to navigate in order to fairly address the health needs of pregnant women living with or at risk for HIV and their children.”

The PHASES Project aims to address and resolve these issues. According to the PHASES press release, the project will focus on three key areas of HIV research: prevention, treatment of co-infection (“HIV-infected pregnant women have active Tuberculosis at about 10 times the rate of HIV-uninfected pregnant women), and management of HIV. In order to effectively address the ethical and legal concerns raised regarding including pregnant women in HIV studies, the PHASES team of interdisciplinary researchers will engage leading HIV investigators at the Centers for AIDS Research (CFAR), bioethicists, and legal and regulatory in meetings in order to create a plan of action that will provide a “conceptual framework for ethically permissible HIV research with pregnant women and women who may become pregnant” as well as recommendations that will provide researchers with ways to over the aforementioned ethical and legal barriers.