Background: African Americans (AAs) and Latinos in United States bear a disproportionate burden of HIV infection, yet remain underrepresented in HIV vaccine trials. The success in engaging and enrolling AAs and Latinos in phase 1 and phase 2 vaccine trials at 2 research sites in New York City is described.
Methods: A retrospective analysis of 1683 HIV-uninfected individuals who completed > or = 1 stage of the screening process from 2002 to 2006. Data on sociodemographic, behavioral characteristics, medical eligibility, and enrollment in National Institutes of Health-sponsored vaccine trials were collected.
Results: 7.5% of screening participants completed enrollment; 33% were AAs, 24% Latinos. The proportion of enrollees did not differ significantly by race/ethnicity. Low-risk vs. high-risk AAs (49% vs. 23%, P = 0.006) and high-risk vs. low-risk Latinos (31% vs. 13%, P = 0.006) were more likely to enroll. Among them, loss to follow-up was the most common reason for not completing screening. In multivariate analysis, older participants, high-risk men, and high-risk women were more likely to complete enrollment.
Conclusions: Once potential minority participants are identified and engaged in the screening process, it is possible to enroll them at rates comparable to white participants. Experience at these sites suggests that the challenge in achieving high rates of minority participation is in increasing the initial pool of candidates prescreening for HIV vaccine studies.