A Demographic Analysis of Minority Enrollment into HVTN Preventive HIV Vaccine Clinical Trials in the United States, 2002-2016
Foy Huamani, Katherine
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Background: The inclusion of participants in HIV preventive vaccine trials who identify as a member of a racial, ethnic, sexual, and/or gender minority group continues to be lacking, even though rates of HIV infection are often higher among these groups in the United States. An analysis of enrollment demographics of US HIV preventive vaccine trials from 1988 to 2002 showed that enrollment of minority group members increased over time. To determine more recent trends in minority enrollment, a similar analysis of enrollment in HIV preventive vaccine trials from 2002 to 2016 was undertaken to compare to the former study as well as compare to the current demographic distribution of trial participants to the number of new HIV diagnoses in the US annually. Methods: Participant demographic data of 43 Phase 1 and Phase 2A trials conducted in the United States were examined. Distributions of participants by racial, ethnic, sexual, and gender identity were calculated. The racial/ethnic distribution of participants was compared to that of the former study and over time by US geographic region. Racial and ethnic distributions from 2011 to 2015 were compared to CDC data on the number of new HIV diagnoses in the same time period. Recruitment strategies used by trial sites were reviewed to account for differences in minority enrollment by region. Results: A total of 3,469 participants were included in the analysis. Thirty three percent of all participants identified as a racial/ethnic minority, a significant increase from the previous time period. The proportions of enrollment of Black and Hispanic/Latinx participants were substantially less than their respective proportions of new HIV diagnoses in all regions. No conclusions were able to be made on data regarding sexual orientation and gender identity due to inconsistencies in collection and reporting. Conclusions: Although the proportion of all racial and ethnic minority group members enrolled in HVTN preventive vaccine clinical trials in the US has increased from the previous time period, comparison to data on new HIV diagnoses in the country reflects a need to continue to enhance diversity among the trial participant pools. More standardized data collection for sexual orientation and gender identity is required for any meaningful future analysis of these populations.
- Global health