P15-30 LB. An evaluation of prescreen recruitment data: enrolling racial/ethnic minorities in Phase I HIV vaccine clinical trials

Background

Published literature indicates racial/ethnic minorities are underrepresented in clinical trials when compared to white/non-Hispanics. Enrollment of diverse populations is important because minorities have disproportionately higher rates of HIV infection. This analysis evaluates the enrollment process for minorities compared to whites at the Vaccine Research Center (VRC) Clinical Trials Core (CTC) among healthy HIV-uninfected volunteer into HIV vaccine studies in metropolitan Washington, DC.

Methods

Demographic and medical data were collected to determine volunteer eligibility for in-person clinical screen. Consented volunteers underwent laboratory evaluation and physical exam. Eligible subjects were consented again for enrollment into vaccine trials.

Results

Of n = 304 individuals prescreened in 2009 for HIV-1 vaccine clinical trials, n = 66 (22%) progressed to clinical screen; and n = 17 (6%) enrolled in a vaccination protocol; at each stage, 61%, 41%, and 29% were minorities, respectively. Minorities were more likely to be unable to enroll due to protocol ineligibility (65%) or discontinued screening (70%) compared to their white counterparts; 35% and 30% respectively.

Conclusion

Minorities comprise 68% of prescreening volunteers indicating significant interest in the minority community for participating in phase I HIV vaccine studies. However, minority volunteers have a greater chance of enrollment ineligibility than their white counterparts, and more often decide not to participate during the enrollment process. This suggests health care disparities based on race impact access to clinical research opportunities, and that greater efforts are needed in community outreach and education, access to health care, and trust-building to assure participation and enrollment of diverse populations in HIV vaccine trials.