Race, Gender, Drug Use, and Participation in AIDS Clinical Trials: Lessons from a Municipal Hospital Cohort

OBJECTIVE: To determine whether participation rates of women, persons of color, and injection drug users in AIDS clinical trials are similar to those of other HIV/AIDS patients, and to examine whether differences in patients' knowledge of clinical trials or reasons for not participating explain differences in participation rates by gender, race, or drug use. DESIGN Cross-sectional survey of patients with HIV disease. SETTING: Ambulatory practice of a municipal teaching hospital. PATIENTS: Two hundred sixty patients receiving primary care for HIV disease. MEASUREMENTS AND MAIN RESULTS: Overall, 22.3% of patients had participated in a clinical trial. Women, patients of color, and drug users were significantly less likely to have ever participated in an AIDS clinical trial (p < .05). Multiple logistic regression confirmed being a person of color (odds ratio [OR] 2.14; 95% confidence interval [CI] 1.12-4.08) and injection drug use (OR 2.09; 95% CI 1.08-4.04) as significant predictors of nonparticipation in AIDS clinical trials (p < .05). Patients of color and women reported less knowledge of clinical trials, and were less likely to have been told about clinical trials for which they were eligible (p < .05). Patients of color were half as likely as whites to cite ineligibility as their reason for not participating (10.4% vs 22.4%), and more likely to hold unfavorable opinions of clinical research (50.7% vs. 40.5%). Reasons for nonparticipation did not differ by gender. CONCLUSIONS: Even when AIDS clinical trials are available on-site, persons of color, women, and drug users are less likely to participate. Educational efforts for patients and providers are needed to remedy continuing disparities in participation by race, gender, and risk factor group in AIDS clinical trials.