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

Abstract

OBJECTIVES: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: HIV infection and AIDS 1 are having an increasing impact on mortality and quality of life for women and persons of color in the United States. [2][3][4] In 1995, the AIDS incidence rate among blacks and Latinos was more than six times and two times, respectively, the rate among whites in the United States. 4 The incidence of AIDS is also increasing more rapidly among women than men; AIDS is now the third leading cause of death for all U.S. women aged 25 to 44 years. 2,5 This disease is increasingly afflicting women from all U.S. communities, but there has been a disproportionate increase in the prevalence of AIDS among minority women, particularly African Americans, Latinas, and Caribbean blacks. Women from communities of color together have accounted for nearly 76% of all reported cases of AIDS in women, while these groups represent only 21% of the general population of U.S. women. 2,5 And notably, the most common route of HIV acquisition among both women and persons of color diagnosed with AIDS to date has been injection drug use. 5 Despite their growing representation among AIDS cases, women, racial or ethnic minorities, and injection drug users have generally been underrepresented in clinical trials of drugs for the treatment of AIDS and early HIV disease. 6-10 To date, most clinical trials of treatment for HIV and HIV-related complications have been composed primarily of homosexual white men, with low participation of women, persons of color, and injection drug users. [6][7][8][9][10] Failure to include adequate numbers of women and persons of color may limit the generalizability and usefulness of study results for clinical practice. Furthermore, these subpopulations of HIV-infected individuals-women, persons of color, and injection drug users-have not had the benefit of early access to new treatments and prophylaxis for HIV and its complications that clinical trials have provided for participants. [6][7][8][9][10][11][12] It has been hypothesized that the lower participation of women, persons of color, and drug users primarily reflects impaired access to trials, due to several factors. Most initial AIDS Clinical Trials Units (ACTUs) were in centers that cared for few minorities, women, or drug users with HIV 8-10 ; and until recently, AIDS clinical trials have had restrictive eligibility criteria for women and injection drug users. 11,[13][14][15] Finally, minority patients, especially African Americans, may avoid participation in clinical trials because of suspicions about medical research resulting from a legacy of past studies that misused subjects. 8,10,16,17 Currently, there is little information about the relative rates of participation ...

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