Women's Participation in AIDS Clinical Trials Group (ACTG) Trials in the USA: Enough or Still Too Few?

This study evaluates women's enrollment in AIDS Clinical Trials Group (ACTG) protocols. Accrual trends of newly enrolled, adult females were summarized for ACTG studies using the Statistical and Data Analysis Center database. The yearly accrual rate of adult females in ACTG clinical trials has increased since its inception. Accrual rates of women in ACTG trials now compare favorably with the rate of female U.S. AIDS cases reported to the CDC: 14% vs 12% in 1991, 21% vs 13% in 1992, and 16% vs 16% in 1993. The percentage of white, African American, and Hispanic newly enrolled women has been fairly constant during 1991, 1992, and 1993, averaging 34%, 41%, and 24%, respectively. Conversely, the percentage of newly enrolled women with a history of injection drug use has diminished during this period: from 34% in 1991 to 26% 1992 and 20% in 1993. Two studies were responsible for 82% of the women enrolled in 1992. However, women identified through clinical trials and surveillance mechanisms differ in several aspects, including disease stage. Despite progressively inclusive enrollment criteria, women with a history of injection drug use are participating in clinical trials in a proportion lower than that of U.S. AIDS cases in women. Efforts to recruit nonwhite women and women with a history of injection drug use are being increased. Enrollment of women in ACTG trials is currently directed toward answering specific research questions.