HIV-Positive Minorities, HMO Enrollees Less Likely to Participate in Clinical Medication Trials, Study Says
Among HIV-positive individuals, minorities and people enrolled in HMOs are less likely to participate in HIV medication trials or studies, according to a study in the May 2 issue of the New England Journal of Medicine, the Washington Post reports (Okie, Washington Post, 5/2). The study, conducted by researchers from the Veterans Affairs San Diego Healthcare System and the University of California, states that racial, gender and socioeconomic parity in HIV-related studies is essential because the course of HIV infection is affected by both the biology of the infected person and "socially influenced health-related behavior." To evaluate different subgroups' participation in medication trials and access to experimental medicines, researchers analyzed data on 2,864 individuals that were taken from the HIV Cost and Services Utilization Study, which includes all adults ages 18 and older who were receiving care for known HIV infection in the 48 contiguous states in early 1996. The HCSUS study did not include individuals who received care for HIV in prisons, active duty military facilities or emergency departments. The researchers collected information on the sociodemographic characteristics, health insurance status and attitudes and beliefs of study participants and weighed these data with information about subjects' participation in medication trials, access to experimental medicines and attempts to access experimental medication. Several of the study findings are presented below:
- Approximately 14% of those receiving care for HIV infection had participated in a medication trial or study, 24% had received experimental medications at some point, and 8% had tried and failed to obtain experimental treatments.
- Non-Hispanic whites accounted for 49% of those receiving care for HIV and 44% of reported AIDS cases, but they represented 62% of clinical trial participants. In contrast, non-Hispanic blacks accounted for 37% of reported AIDS cases and 33% of those receiving care for HIV but only 23% of clinical trial participants.
- Hispanics were slightly more likely than blacks to have participated in medication studies.
- Non-Hispanic whites were almost three times as likely as non-Hispanic blacks, and twice as likely as Hispanics, to have received experimental medications.
- Women were "well represented" in research trials and had the same likelihood of receiving experimental treatments as men.
- Patients enrolled in fee-for-service insurance plans were nearly 60% more likely to participate in trials than those enrolled in HMOs. Patients with fee-for-service insurance received experimental medications more often than patients who were uninsured or enrolled in HMOs.
"Our findings confirm that there are disparities among racial or ethnic groups in the rate of study enrollment," the researchers write. According to the authors, the fact that black patients were significantly less likely than white patients to seek experimental HIV medicines suggests that there is "less awareness and a more widespread negative attitude about research in minority communities" (Gifford et al., New England Journal of Medicine, 5/2). Stephen Thomas, director of the University of Pittsburgh's Center for Minority Health, said that lower minority participation in clinical trials reflects a "distrust" that stems from government research experiments, such as the "notorious" Tuskegee project, in which hundreds of African-American men were left untreated for syphilis infection. James Powell, director of biomedical education and research for the National Medical Association, a black physicians' group, offered another possible reason for the racial disparity. Powell said that 1994 NIH guidelines urging the inclusion of more minorities in research did not cover privately funded research, meaning that such projects continue to lack "adequate" minority representation (Tomsho, Wall Street Journal, 5/2). As the AIDS epidemic continues to shift toward minorities and low-income individuals, the "disproportionately small number of disadvantaged patients who are enrolled in treatment trials or have early access to experimental therapies is of particular concern," the study states. "Outreach programs and efforts by providers to educate patients about research and investigational treatments could improve trust in researchers and boost enrollment. ... Innovative and culturally sensitive methods of communicating the benefits and risks of research to minority group patients could be helpful, and consideration should be given to expanding such efforts," the study concludes (NEJM, 5/2).