An Evaluation of Prescreen Recruitment Data: Enrolling Racial/Ethnic Minorities in Phase I HIV Vaccine clinical trials

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 enrollment of minorities compared to whites among healthy HIV-uninfected volunteers into phase I HIV vaccine studies in metropolitan Washington, DC.

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 then reconsented for enrollment into vaccine trials. Data are collected at prescreen, clinical screen, upon vaccination trial enrollment, and during follow-up clinical visits. Data are entered into the clinical trial management system and cross-referenced with the clinical data management and clinical research information systems.

Of n=645 individuals prescreened from January 1–December 31, 2009, for HIV-1 vaccine clinical trials, n=150 (23%) progressed to clinical screen and n=48 (7%) enrolled in a vaccination protocol. Minorities constituted 54%, 42%, and 35% at each stage. The study enrollment rate was 5%. For African-Americans specifically, it was only 3% compared to 11% for whites. Minorities were more likely to be unable to enroll due to protocol ineligibility (43%) or to discontinue screening (53%) compared to 40% and 48% respectively among whites. Among African-Americans, 47% (n=117) were ineligible based on protocol exclusions and 48% (n=119) discontinued screening. African-Americans account for 39% (n=250) of prescreens but only 3% of overall study enrollees; compared to 40% of prescreens and 65% of enrollees among whites.

Minorities comprise 54% of prescreening volunteers indicating significant interest in the community for participating in phase I HIV vaccine studies. Minority volunteers have a greater chance of enrollment ineligibility than whites and more often decide not to participate during the enrollment process. Prescreen and clinical screen ineligibilities suggest that health care disparities by race can impact clinical research opportunities. Additional research is required regarding how eligibility criteria may create barriers to participation of minorities particularly African-Americans. 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 clinical trials.