Designing for Women—Not Just a Fashion Statement Anymore
Certain words and phrases come to mind when we think about women and HIV. Invisible. Stigma. Shame. Female-controlled prevention methods. Feminization of an epidemic. Half of the world’s infected population.
The problem is, we don’t always think about women and HIV as much as we probably should.
According to the U. S. Centers for Disease Control and Prevention’s (CDC) most recent data, HIV infection was “the leading cause of death for black women (including African American women) aged 25–34 years…[and] the 5th leading cause of death among all women aged 35–44 years. The only diseases causing more deaths of women were cancer and heart disease.”
Interestingly, according to the CDC “high-risk heterosexual contact was the source of 80% of…newly diagnosed infections.” But sadly enough, a recent study showed that women were “slightly less likely than men to receive prescriptions for the most effective treatments for HIV infection.”
This issue of Positively Aware poses a simple question to our readers: Why is this happening—and what can we do about it? Unfortunately, simple questions don’t always bring forth easy solutions.
One of the solutions, however, and one which you’ll read about more in this issue, is simple—at least in theory. Studies designed with women in mind, and in which women and people of color are adequately represented. This should be easier to do now that the vast majority of studies concerning HIV medications are not using experimental drugs, but, rather, are comparing standard-of-care treatments. It can be done by not only recruiting these populations, but also by retaining them, or keeping them, in the study. It’s also important to select the appropriate study sites for any particular study, and to then offer the sites the support they need in order to be successful.
I was recently invited to attend an investigators’ meeting for the GRACE study. GRACE, which stands for Gender, Race, and Clinical Experience, was the first study of its kind, enrolling approximately 70% women, the majority of whom were women of color. The study was conducted by Tibotec Therapeutics, using their newly approved HIV protease inhibitor, Prezista (darunavir), and newly approved HIV NNRTI, Intelence (etravirine) and was designed to observe differences in viral load and CD4 response according to gender and race. The results of the study will be published and presented at upcoming conferences and in scientific journals in the coming months, but some of the real successes of GRACE were not only in the data, but in the stories and people behind the study itself.
Halfway through the day’s meeting, the folks at Tibotec decided to mix it up between invited community representatives and clinical site investigators, and those of us from the community were able to hear firsthand some of the amazing stories behind GRACE.
We heard the story of one study participant who called a site investigator over the Christmas holidays and told her she had run out of her meds, and was confused about which medications to take, and what they were for. The investigator cancelled an appointment she had, went and got her the replacement meds, and brought them to the study participant at the housing project where she lived, and then sat down with her to explain the regimen.
Tragically, another woman’s house burned down, and her meds were destroyed in the fire. The investigator went to go find her, and called Tibotec to get her replacement meds.
One individual in the study travelled 40 miles to every visit. Her mother read her the informed consent form for the study, because she wasn’t able to read it herself. But she was able to do all this, and had the motivation to succeed, because she received support from her family and didn’t feel stigmatized.
We heard that, “Some of this is just the way women’s lives are. We are the caretakers, the wives, the mothers.”
Ultimately, it speaks to the need for studies to be more inclusive than exclusive. “Don’t not consider a patient because of their past,” said one investigator.
The common thread woven through many of these patient success stories were that patients felt valued, and that they mattered. One investigator said that they just wouldn’t let the patients fail.
Another key to the study’s successes seemed to lie in the fact that study sites were chosen where the community practitioners were, and the study also provided the background regimen of drugs to participants, free of charge. And it raises the question, “What is the role of the clinical trial beyond getting data?”
Approximately 10% of these sites had never conducted or participated in a study before. And granted, this was their only study, whereas many sites typically have a dozen or more studies going on at any given time, spreading their resources thin.
The important thing to remember is that the success of a study can be measured not only by the data that comes out of it, but also by the thought and planning that goes into it, the care that is provided during the course of the study, and the ongoing connection with patients that is made through direct contact and support. And sometimes success is achieved just by going that extra mile, which can make a world of difference to someone taking part in a study.
Take care of yourself, and each other.
Jeff Berry, Editor
publications@tpan.com
