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

Objectives: Racial/ethnic minority communities in the United States are overrepresented among new HIV diagnoses, yet their inclusion in preventive HIV vaccine clinical trials is inadequate. An analysis of enrollment demographic characteristics from US preventive HIV vaccine clinical trials from 1988 through 2002 showed that enrollment of racial/ethnic minority groups increased. We analyzed enrollment in preventive HIV vaccine clinical trials from 2002 through 2016 and compared our data with data from the previous study, described demographic characteristics of trial participants, and assessed how well this distribution reflected the racial/ethnic distribution of new HIV diagnoses in the United States. Methods: We examined data on demographic characteristics from 43 Phase 1 and Phase 2A preventive HIV vaccine clinical trials conducted in the United States and compared the results with those of the previous study. We also compared racial/ethnic distributions from 2011 through 2015 with Centers for Disease Control and Prevention data on the number of new HIV diagnoses during the same period. Results: Of 3469 participants, 1134 (32.7%) identified as a racial/ethnic minority, a 94% increase from the previous period (634/3731; 17.0%). Percentage annual enrollment of all racial/ethnic minority participants fluctuated from 17% to 53% from mid-2002 to 2016. Percentages of new HIV diagnoses among the general population were 1.9 to 2.9 times the percentage enrollment of black participants and 1.3 to 6.6 times the percentage enrollment of Hispanic/Latino participants in clinical trials for the same period. Conclusions: Although enrollment of racial/ethnic minority groups into HIV vaccine clinical trials has increased, it is not proportional to the number of new HIV diagnoses among these groups. To enhance recruitment of racial/ethnic minority groups, the HIV Vaccine Trials Network has prioritized community partnerships and invested resources into staff training.

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

Public Health Reports ◽

10.1177/003335490512000509 ◽

2005 ◽

Vol 120 (5) ◽

pp. 543-548 ◽

Cited By ~ 27

Author(s):

Gaston Djomand ◽

Joanna Katzman ◽

Dante diTommaso ◽

Michael G. Hudgens ◽

George W. Counts ◽

...

Keyword(s):

Phase I ◽

Ethnic Minority ◽

Phase Ii ◽

Hiv Vaccine ◽

Phase I Trials ◽

Hiv Vaccine Trials ◽

Vaccine Trials ◽

Minority Participants ◽

Racial Ethnic ◽

The U.S

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.

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