Enrollment of Racial/Ethnic Minorities in NIAID-Funded Networks of HIV Vaccine Trials in the United States, 1988 to 2002

Abstract

Objective. The purpose of this study was to analyze enrollment of racial/ethnic minorities in Phase I and Phase II HIV vaccine trials in the U.S. conducted by National Institute of Allergy and Infectious Diseases (NIAID)-funded networks from 1988 to 2002. Methods. A centralized database was searched for all NIAID-funded networks of HIV vaccine trial enrollment data in the U.S. from 1988 through 2002. The authors reviewed data from Phase I or Phase II preventive HIV vaccine trials that included HIV-1 uninfected participants at low to moderate or high risk for HIV infection based on self-reported risk behaviors. Of 66 identified trials, 55 (52 Phase I, 3 Phase II) met selection criteria and were used for analyses. Investigators extracted data on participant demographics using statistical software. Results. A total of 3,731 volunteers enrolled in U.S. NIAID-funded network HIV vaccine trials from 1988 to 2002. Racial/ethnic minority participants represented 17% of the overall enrollment. By pooling data across all NIAID-funded networks from 1988 to 2002, the proportion of racial/ethnic minority participants was significantly greater (Fisher's exact test p-value <0.001) in Phase II trials (278/1,061 or 26%) than in Phase I trials (347/2,670 or 13%). By generalized estimating equations, the proportion of minorities in Phase I trials increased over time ( p=0.017), indicating a significant increase in racial/ethnic minority participants from 1988 to 2002. Conclusions. There has been a gradual increase in racial/ethnic minority participation in NIAID-funded network HIV vaccine trials in the U.S. since 1988. In the light of recent efficacy trial results, it is essential to continue to increase the enrollment of diverse populations in HIV vaccine research.

Enrollment of women and minorities in NINDS trials

“…Unless measures are taken to increase Hispanic American enrollment, the magnitude of underrepresentation will likely increase as the Hispanic population is rapidly growing; Hispanic Americans are estimated to make up 16% of the US population in 2010 and 19% by 2020. 17 The discordance between Hispanic American underrepresentation and African American overrepresentation in our series has not been reported in disease-specific series, 11,25 but is consistent with the overall trend in NIH trial enrollment. 10 There are several potential explanations.…”

“…24 Despite this willingness to participate, underrepresentation of Hispanic Americans has been repeatedly documented. 9,11,25 Several hypotheses have been postulated to explain this phenomenon. 11,26 For example, language barriers, 27 potential concerns about documentation status, 28 and the geographic distribution of trial enrollment sites relative to the Hispanic American population 29 may be issues in this subgroup.…”

“…17 Finally, recent increased awareness of cardiovascular disparities in African Americans compared to Hispanic Americans may have contributed to this difference as our series included more recent trials than previous series. 11,25 Women have made up the majority of participants in NIH trials every year since 1995. 10 This effect appears to be driven largely by gender-specific trials.…”

Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention

“…[3][4][5] For example, the AIDSVAX B/B study, which included relatively small numbers of minority participants, suggested that vaccine efficacy rates were higher among Black and Asian participants; however, this subgroup analysis was inconclusive. 6,7 The racial/ethnic disparities in the epidemiology of HIV are also a justification for increased enrollment of minorities in HIV vaccine trials, as the US Food and Drug Administration (FDA) desires adequate representation of race/ethnicity in evaluation of new products (Dr Jared Baeten, personal communication). However, in one meta-analysis of hypothetical HIV vaccine acceptiblity in the US, being Black/African-American (in reference to White) was negatively associated with HIV vaccine acceptibility.…”

Factors Associated with Past Research Participation Among Low-Income Persons Living with HIV

“…2 While development of an effective vaccine has remained elusive, medical treatment for HIV/AIDS has burgeoned, and heightened attention is being paid to factors affecting participation in treatment-related clinical trials and behavioral research. In addition, recognition of an under-representation of minorities in clinical trials disproportionate to the disease burden of minority populations [3][4][5] has led to increasing numbers of studies to understand motivations for participating in HIV-related research across diverse populations.…”