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

Table of Contents

• The Need for Studies in HIV-Positive Women
• Why Is It Difficult for Women to Participate in Trials?
• Enter GRACE
• Successful Recruitment, but Other Challenges
• Results

The Need for Studies in HIV-Positive Women

The number of women diagnosed with HIV in the U.S. is increasing. Today, women make up almost 30 percent of new HIV cases. Rates of HIV are especially high among women of color -- almost 80 percent of HIV-positive women are African American or Latina.

Despite growing numbers of HIV-positive women, HIV treatment studies (clinical trials) have traditionally included very small numbers of women. In many HIV studies, only about 10 percent of the people being studied are women. As a result, most information on the effectiveness and safety of HIV drugs comes from research done in white men.

There is a strong need to conduct studies that are specifically designed to answer questions for women. HIV and some of the HIV drugs may act differently in women's bodies. 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 HIV-positive women, and what side effects are likely to affect women. The only way to find out this information is for more HIV-positive women to participate in trials.

Why Is It Difficult for Women to Participate in Trials?

For many years, community advocates, including Dawn Averitt Bridge, 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 is so 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, 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 clinical trials remained low.

There are many reasons women have not participated in clinical trials. Some people are concerned that a trial may be unsafe or that they won't be allowed to drop out if it isn't right for them. In some African-American and Latino communities, there may be lingering distrust of clinical research because of trials that were conducted before the 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.

Enter GRACE

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, the company that makes the protease inhibitor Prezista.

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 efficacy, safety, and side effects between men and women who took Prezista for 48 weeks.

GRACE was conceived in 2006. It was the largest treatment trial to focus on HIV-positive women in the U.S. and the first to focus on women who had taken HIV drugs before. GRACE was specifically designed to enroll women and people of color.

Successful Recruitment, but Other Challenges

GRACE created a lot of excitement in the HIV community. Advocates watched closely to see if the trial would be able to overcome barriers to enrollment. GRACE was successful.

GRACE was able to reach its goals for enrollment on schedule. GRACE enrolled 67 percent women and 84 percent people of color, showing that it is possible to recruit large numbers of women, African Americans, and Latinos into clinical trials.

Some of the new strategies were selecting study sites (such as clinics and medical centers) that were accessible to women and people of color, raising awareness among the people they hoped to enroll, and providing support for the participants and the study sites. Specific strategies included:

Site Selection

• Finding sites where HIV-positive women received care, including sites that had not participated in clinical trials before
• Selecting sites in areas where there were high numbers of HIV cases among women and communities of color
• Requiring sites to enroll three women before enrolling the first male

Outreach

• Awareness campaigns in the minority media
• Community advisors and advocates working on getting the word out
• GRACE logo and materials that study sites and patients both liked
• Community events and articles in HIV community newsletters

Participant and Site Support

• Providing other HIV drugs free of charge to study participants (in addition to Prezista)
• Increased flexibility and availability of health care providers at study sites
• Funds for child care and travel for participants
• Patient and site study kits with materials to support study participation
• Continuous involvement, including regular site visits and support meetings, through all phases of the study

According to Dawn Averitt Bridge, "A whole lot of what worked in GRACE was just about the sense of being a part of something bigger than yourself, being really valued, appreciated, and respected in an environment where, frankly, a lot of people are dealing with shame and stigma."

Despite the fact that GRACE successfully enrolled women, nearly 25 percent of the women dropped out of the study by week 24. In comparison, only nine percent of male study participants dropped out. Most of the women did not drop out because the drugs did not work or because of side effects. One of the main reasons was "loss to follow up." This can mean many things such as patient moved, patient decided to go off the study (this is the right of any participant), or patient did not come back. More research is being done to better understand what caused women to drop out of the study.

The drop-out rate may be a sign of the difficulties in treating disadvantaged populations. The study reflects the obstacles HIV-positive minority women in the U.S. face in remaining in care. The higher drop-out rate among women shows the need for more strategies to keep participants from minority groups in future trials.

Results

GRACE compared efficacy, safety, and side effects between men and women taking Prezista. At 48 weeks, there were no major differences in response to treatment between women and men taking Prezista. In addition, there were no major differences in safety or side effects.

This information is very valuable. It gives women peace of mind that a drug they are taking has been studied in bodies similar to their own.

It is important for more women to get involved in HIV clinical trials. Women's health issues need to be thoroughly researched in HIV-positive women. You can help by getting involved and participating. If you are interested in learning about or enrolling in clinical trials, see The Well Project fact sheets on clinical trials.