A $3.6 million grant from the National Institute of Health (NIH) to Georgetown and three other universities will fund a project aimed at improving the health of one of the most vulnerable patient groups in the world – pregnant women with HIV.
Pregnancy & HIV/AIDS: Seeking Equitable Study (PHASES) will work with the HIV community locally and internationally to build a roadmap for conducting research designed to meet the distinctive needs of pregnant women with the virus.
“PHASES will provide two critical products – practical consensus guidelines on ethical standards for doing research, and a portfolio of creative trial designs to show what these guidelines look like in action,” says Margaret Little, the grant’s co-principal investigator and director of Georgetown’s Kennedy Institute of Ethics. “The goal is to save lives.”
No Evidence Base
The project is an outgrowth of an initiative launched at a 2009 conference at Georgetown that highlighted the lack of research on the health of pregnant women.
“Millions of women each year face a pregnancy complicated by serious illness,” Little says, “yet we have next to no evidence base for how to safely and effectively treat illness during pregnancy, leaving pregnant women and their providers to guess about the best course of action.”
Pregnancy can act as a wildcard in how medications work, Little notes, yet concerns about the ethical complexity of research with pregnant women have kept most researchers from investigating these questions.
“While this is understandable,” Little says, “the reticence to conduct research with this cohort actually puts pregnant women and their babies in harm’s way, as providers use medications with unknown effects – or hesitate to use medications that could significantly help these women.”
Excluded from Research
The problem is especially severe for women with HIV. According to the World Health Organization, more than 16 million women are living with HIV worldwide, and millions more face the risk of infection.
“Many of these women are of reproductive age, making treatment and prevention of HIV during pregnancy an especially important issue,” Little notes. “Despite this, pregnant women continue to be excluded from most HIV research, and even when they are included, their own health outcomes are often ignored.”
Little will work with Ruth Faden of Johns Hopkins University’s Berman Center for Bioethics, Anne Drapkin Lyerly of UNC Chapel Hill’s Center for Bioethics, and Anna Mastroianni of the University of Washington’s School of Law to conduct the research funded by the grant.
The research team will spend four years engaging with researchers, regulators, ethical experts and pregnant women living with HIV to identify barriers to research and develop a concrete roadmap to overcoming them.
The research will take place in both the United States as well as select countries in Africa (to include: South Africa, Botswana, and Malawi), where HIV rates are especially high.
“Thoughtful research with pregnant women is ethically possible,” Little says. “The aim of this study is to talk with both leaders of the field, and the women they treat, to find creative solutions.”