Racial and Ethnic Variations in Access to Research Trials and Experimental Treatments in HIV Care

Gifford AL, Cunningham WE, Heslin KC, Andersen RM, Nakasono T, Lieu DK, Shapiro MF, Bozzette SA. Racial and Ethnic Variations in Access to Research Trials and Experimental Treatments in HIV Care. Paper presented at: VA HSR&D National Meeting; 2002 Feb 1; Washington, DC.

Objectives: To help assure that trial results are generalizable and clinically useful, populations that enroll in trials and receive investigational drugs should reflect the racial and ethnic heterogeneity of all patients in care. We therefore assessed and compared research participation across patients in care for HIV. Methods: Design: Prospective cohort study. Setting and Participants: A population-based multi-stage probability sample (N = 2864) representing all HIV-infected adults in clinical care in the contiguous United States during the first 2 months of 1996. Veterans and non-veterans were represented. Measurements: Sociodemographic, clinical, attitude, and health service use interview data were collected during three sequential interviews. Patients were asked whether they had ever tried to get, or received experimental HIV medications at baseline interview, and whether they were in a medication trial or study at baseline and at each followup interview. Results: Of HIV-infected adults in care, 10% were in a medication study at baseline, 32% had tried to get experimental medication at some time, and 24% had received experimental medication. In multiple regression models, African-Americans and Hispanics were less likely to be in a medication trial or study (odds ratio [OR] 0.51 [95% CI, 0.29 to 0.91]; OR 0.58 [CI, 0.35 to 0.95] respectively) or to have ever received experimental medication (OR 0.41 [CI, 0.32 to 0.54]; OR 0.56 [CI, 0.41 to 0.78]). Private health maintenance organization patients were less likely than private fee-for-service to be in a medication research study (OR 0.42, [CI, 0.20 to 0.86]). Patients with less education (OR 0.42 [CI, 0.28 to 0.64]) and patients located 8 or more miles from an HIV clinical trial center (OR 0.41 [CI, 0.26 to 0.64]) received experimental medications less often. Among those who sought experimental treatment, non-Hispanic whites were more likely than African-Americans or Hispanics to get it. Conclusions: Many HIV patients nationally are in trials, but significant race/ethnicity and socioeconomic barriers to study enrollment exist. Patients do not receive innovative experimental treatments equally through trials or early distribution programs, and minority patients are underrepresented. Impact statement: Patient and provider reasons for race/ethnicity disparities in research enrollment require further study. Programs to address imbalances are justified.