DETERMINANTS OF ACCRUAL OF WOMEN TO A LARGE, MULTICENTER CLINICAL-TRIALS PROGRAM OF HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

To determine factors influencing the enrollment of women in a large mu lticenter human immunodeficiency virus (HIV) clinical trials program i n the United States, we analyzed enrollment and demographic data of th e AIDS Clinical Trials Group (ACTG) during the period 1987-90. Women c omprised 6.7% of 11,909 ACTG participants enrolled in 1987-90. Women e ntering ACTG trials were significantly more likely to be white (48.5%) and less likely to have ever used i.v. drugs (22.6%) than U.S. women reported to have AIDS (26.5% were white; 51.0% had ever used i.v. drug s, p < 0.0001). In a multiple logistic regression model, specific attr ibutes of individual trials did not influence enrollment of women with the exception that trials that targeted asymptomatic persons had grea ter enrollment of women. There was wide variation among research units in the percentage of women enrolled (1.0-37.5%), and evidence of sign ificant regional variation in the ability of units to recruit availabl e women. Units with female principal or coprincipal investigators had more than twice the percentage of female enrollment as units headed by men (10.8 vs. 5.3%, p < 0.001). Enrollment of women in a large HIV cl inical trials program was low and appeared to be influenced more by de mographic and geographic factors that attributes of specific trials. A n apparent positive influence of female leadership on the enrollment o f women warrants further study.