Vaccine and Infectious Disease Division
An analysis conducted by the HIV Vaccine Trials Network (HVTN) observed an overall increase in the proportion of racial and ethnic minorities enrolled in Phase 1 and Phase 2A preventive HIV vaccine clinical trials in the United States between 2002 and 2016 compared to 1988 to 2002. The findings were published on December 5, 2018 in Public Health Reports.
Among the 3,469 study participants enrolled from 2002 to 2016, 33 percent identified as a racial and/or ethnic minority compared with 17 percent among 3,731 participants enrolled during the period 1988 to 2002, a two-fold increase overall.
“We are making significant improvements in engaging, recruiting and retaining racial and ethnic minority participants,” said Michele Andrasik, Ph.D., director of Social Behavioral Sciences and Community Engagement, HVTN and senior staff scientist in the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center, and an affiliate assistant professor at the University of Washington. “Despite the progress, we still have a long way to go, especially with our efforts in the South, which has the highest rates of new HIV infections in the United States.”
The authors also compared enrollment to new HIV diagnoses for racial and ethnic minorities as reported in the National HIV Surveillance System (NHSS) maintained by the US Centers for Disease Control and Prevention. This analysis revealed that the percentages of Black and Latinx enrollment were less than the percentages of new HIV diagnoses among these minority groups, particularly in the Southern region, where new infections occur disproportionately among Blacks. The NHSS data indicate that racial and ethnic minorities accounted for 69% to 73% of newly diagnosed HIV infections from 2002 to 2016, well above the percentage of minorities enrolled in Phase 1 and 2A HVTN preventive HIV vaccine trials during the same time period.
These Phase 1 and 2A vaccine trials enrolled individuals who were not infected with HIV and who were primarily at low risk of becoming infected. Future tests of the efficacy of an experimental HIV vaccine would be within populations at high risk of infection, as reflected in the NHSS new HIV diagnoses data. Without the participation of individuals from populations carrying the greatest burden of HIV infection, trial outcomes lack the ability to be generalizable to the diverse US population and, as such, may have limited relevance for those groups that are most affected.
According to the authors, a wide variety of factors can present challenges for recruitment and enrollment of minorities, including distrust of clinical research and the motives of researchers. The lack of representation of minorities in the health workforce, language barriers, and geographic and cultural issues all contribute to challenges in the recruitment and enrollment of racial and ethnic minorities in HIV vaccine clinical trials.
To help bridge these barriers, Clinical Research Sites (CRS), where trial recruitment takes place, develop community engagement plans specific to their local context. These plans detail specific strategies for engagement, recruitment and retention of under-represented groups disproportionately impacted by HIV/AIDS. The HVTN provides technical support and capacity building assistance to assist CRS staff in the implementation of these strategies.
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Funding for HIV vaccine trials conducted by the HVTN is primarily provided by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). The HVTN implements community engagement strategies at all of its clinical trial sites across the globe, based on the principles set out in the Good Clinical Practice and Good Participatory Practice guidelines to uphold the responsibility to educate, inform and involve communities in all aspects of HIV vaccine research.