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 ...

Minorities Remain Underrepresented in HIV/AIDS Research Despite Access to Clinical Trials

“…Hispanics and AAs have historically been reported to have less knowledge about the clinical trials for which they may be eligible. 8,13 In some instances, these limitations can be overcome by building multidisciplinary teams and strategies aimed at fulfilling the needs of specific communities, but their general applicability has yet to be evaluated. 3,5,10,12 …”

Predictors of Screening for AIDS Clinical Trials Among African-Americans and Latino/Hispanics Enrolled in an Efficacious Peer-Driven Intervention: Uncovering Socio-Demographic, Health, and Substance Use-Related Factors That Promote or Impede Screening

“…Those with current injection drug use were very unlikely to be screened, perhaps reflecting patients’ own realistic assessments that ACTs might not be appropriate for them, or that they would not be found eligible as a function of their substance use patterns. Some individuals who inject drugs, even at a high frequency, do successfully participate in ACTs, but it is not common for injection drug users to be enrolled in ACTs [18]. …”

“…African American PLHA are greatly underrepresented, and Latino/Hispanic PLHA tend to be modestly under-represented in ACTs [1,2,18,19]. The relationship between under-representation and race is complex, but the literature on barriers to clinical trials other than for HIV/AIDS indicates that racial discrimination is a primary factor associated with poor access to trials [20], and this may also be the case in ACTs [21].…”

“…While earlier studies found that women were less likely to participate in trials than men [18], more recent research suggests that female gender is not a major barrier to trials [2,7,19]. Among men, men who have sex with men (MSM) have been found to enroll in ACTs at higher rates than heterosexuals [2,7,19].…”

“…Substance use, including injection and non-injection drug use and alcohol use, is another important set of barriers to ACTs [2,18]. Substance users are less likely to be included in ACTs than their non-using peers largely because of exclusion criteria that may reflect adherence and drug interaction concerns on the part of study sponsors, providers, and clinical trials sites [22].…”