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Lessons From GRACE: A U.S. Study Focused on Women Living With HIV

September 8, 2015

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Lessons From GRACE: A U.S. Study Focused on Women Living With HIV

Table of Contents

The Need for Studies of Women Living With HIV (HIV+)

The proportion of HIV and AIDS cases among women in the US more than tripled from seven percent in 1985 to an alarming 23 percent in 2011. That means that about one in four Americans living with HIV is a woman. Rates of HIV are especially high among women of color -- almost eight out of ten women living with HIV in the US are African American or Latina.

Globally, the World Health Organization reported that women made up about half of all people living with HIV in 2013. In some areas, particularly in sub-Saharan Africa, almost six out of ten people living with HIV are women.

Despite growing numbers of women living with HIV, studies of HIV prevention and treatment (clinical trials) have traditionally included very small numbers of women. In many HIV studies, only one in ten of the people being studied is a woman. As a result, most information on the effectiveness and safety of HIV drugs is based on research done in men.

Because HIV and some HIV drugs may act differently in women's bodies, there is a strong need to conduct studies that are specifically designed to answer questions for women. More information is needed on specific drug doses for women, possible differences in lab tests (such as CD4 cells and viral load), how infections and gynecological conditions affect women living with HIV, and what side effects are likely to affect women. The only way to find out this information is for more women living with HIV to participate in clinical trials.

Why Have There Been so Few Women Participating in Trials?

For many years, community advocates, including Dawn Averitt, the founder of The Well Project, have been calling for trials to include more women and people of color. There are many reasons why this has been hard to do.

Historically, women were kept out of many types of clinical trials (not just HIV studies). This was out of concern that they might become pregnant while on a trial of an experimental drug that could turn out to harm the baby. In 1993, US regulations were changed and women were encouraged to participate in clinical trials, but progress has been very slow and the number of women in HIV studies has remained low.

There are many reasons women have not participated in clinical trials. Some are concerned that a trial may be unsafe or that they will not be allowed to drop out if it is not right for them. In some African-American and Latino communities, there may be distrust of the medical establishment in general and/or clinical researchers in particular because of trials that were conducted before the US government established strong guidelines to protect people who participate in clinical trials.

In addition, stigma, lack of support, lack of child care, lack of information about the studies, and lack of transportation often prevent women and people of color from participating in HIV trials.


An HIV clinical trial needed to be designed in a way that could overcome some of the barriers for women and people of color. In order to do this, health care providers and community advocates worked with Tibotec (now Janssen), the company that makes the protease inhibitor Prezista (darunavir).

The result was the GRACE study. GRACE stands for Gender, Race, And Clinical Experience. The study was designed to see if there were differences in drug effectiveness, safety, and side effects between men and women who took Prezista for 48 weeks.

GRACE began in 2006. It was the largest treatment trial to focus on women living with HIV in the US and the first to focus on women who had experience taking HIV drugs. GRACE was specifically designed to enroll women and people of color.

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This article was provided by The Well Project. Visit The Well Project's Web site to learn more about their resources and initiatives for women living with HIV. The Well Project shares its content with to ensure all people have access to the highest quality treatment information available. The Well Project receives no advertising revenue from or the advertisers on this site. No advertiser on this site has any editorial input into The Well Project's content.

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