Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines

Abstract

Purpose: Inclusion of women and racial/ethnic minorities is a requirement for federally supported clinical research, but data on clinical research participation from women and racial/ethnic minorities with HIV are few. To describe participation in clinical research of HIV medicines among women and racial/ethnic minorities, and associated factors, we used data from a cross-sectional behavioral surveillance interview project conducted in 15 U.S. states.

Methods: Data were from 6,892 persons living with HIV infection, recruited in facilities in seven U.S. states and using population-based methods in eight other states, between 2000-2004. We calculated self-reported participation in a clinical research study of HIV medicines, factors associated with self-reported study participation among men and women, and reasons for not participating in a study among nonparticipants.

Main findings: Overall, 17% of respondents had ever participated in a clinical research study. For men, the odds of participation were lower for black or Hispanic men (versus white men) and were higher for men whose risk for HIV infection was male-male sex (versus men with male-female sex risk) and for men with AIDS. For men who had not participated in a study, black men were more likely than white men to report not participating in a study because they were unaware of available studies or were not offered enrollment (75% vs. 69%), and because they did not want to be a "guinea pig" (11% vs. 8%). Among women, participation was not associated with race/ethnicity or risk for HIV infection but was associated with living in an area with an NIH- or CDC- supported clinical research network. HIV-infected women were more likely than HIV-infected men with comparable modes of HIV acquisition to have participated in a study.

Conclusions: Among persons with HIV interviewed in these 15 states, self-reported participation in clinical research studies was higher among women than men, but racial/ethnic minority men were less likely to report study participation. Our data suggest that clinicians and researchers should make increased efforts to offer study participation to racial and ethnic minority men.