Claudia Pena, shown in 2005, told her children that she was HIV positive… (Los Angeles Times )
At any one time, hundreds of clinical trials are underway in the U.S. to test simpler and more effective ways to treat and prevent HIV infection, which afflicts more than 1 million people in this country. Most of those in the U.S. with HIV — and with AIDs in its full-blown stage — are men. So, understandably, men make up the majority of the participants in the trials.
However, women, who account for 25% of those living with HIV in the U.S., are significantly underrepresented in clinical trials, according to infectious disease researchers and health professionals who have studied this issue. For instance, a recent report on the promising "Quad" pill — a single daily tablet that combines several medications — noted that one trial had 700 participants. Just 10% were women.
Why the imbalance? Researchers say it's due to a combination of factors. The majority of HIV-positive women in the country — more than 60% — are black; 17% are Latina. That means they're often poorer, with less access to medical treatment at universities doing research, and are therefore less likely to be found when researchers are recruiting. It takes more effort to reach out to public clinics and community case workers to find women of color with HIV or AIDS; that effort can slow the start of a study. There also is a lingering mistrust of medical researchers in the black community, experts say, partly the legacy of exploitative experimentation on minorities. As a result, women and people of color have traditionally been underrepresented in clinical trials on numerous diseases and conditions.
Does it matter if women are included in HIV studies? Yes, because women metabolize or tolerate some drugs differently than men. Side effects, too, can vary depending on gender.
Some researchers are making a greater effort to seek out women and explain their studies carefully. The AIDS Clinical Trials Group has set a floor of 10% participation by women in studies, and it tries for 20%. In addition, it used grant money to hire community health "promoters" at 10 research sites across the country whose job is to make people in minority communities aware of research projects.
UCLA operates two AIDS Clinical Trials Group units. Last year, according to a university spokesperson, 16% of participants in studies there were women — actually a higher percentage than the 12% of HIV-infected Los Angeles County residents who are women. Of the women participating in the UCLA studies last year, 31% were black and 44% were Latina.
Community health providers need to be equally aggressive about staying in touch with research institutions and keeping abreast of studies enrolling new participants. Women should be encouraged to
consider joining those studies. The information on clinical trials is out there. Let's get it into the hands of women with HIV and sign them up.