Both HVTN and CoVPN are funded by NIAID, part of the National Institutes of Health.
The overarching goal of the campaign and registry is to raise awareness of the urgent need for HIV clinical trial volunteers and encourage more people – especially young people – to participate. Because COVID-19 was so widespread and so devastating, clinical trials testing experimental COVID-19 vaccines and treatments drew unprecedented numbers of volunteers in a very short period of time. In contrast, volunteer enrollment in early stages of clinical trials for HIV and other diseases has typically lagged. The “Help End HIV” campaign and the Red Ribbon Registry aim to change that.
“HIV continues its silent spread throughout both the United States and the world, and the need for an effective vaccine continues,” said Corey, who has served as principal investigator at HVTN since its inception. “Our goal is to connect with a younger generation that is largely unaware of HIV as a worldwide health crisis and the urgent need for effective vaccines.”
As the world’s largest publicly funded preventive HIV vaccine trials network, HVTN is uniquely positioned to tackle this. Since 2000, when HVTN initiated its first trial, the network has conducted over 85 clinical trials, of which approximately 80% were phase I studies. Thirteen of those trials are still active, six are enrolling participants, and over 15 studies are in the pipeline for the next year.
“HIV and SARS-CoV-2 are very different viruses, with HIV developing a tremendous number of variants, which makes it a constantly moving target. One thing we learned from the COVID-19 trials is that investments in rapid iteration of trials reap early benefits – and this is even more important as we refocus attention on an HIV vaccine,” said Dr. Stephaun Wallace, director of external relations, CoVPN/HVTN at Fred Hutch. “To be able to quickly determine which study products to move forward, we must design and implement trials quickly, and that includes recruiting and enrolling participants more efficiently. We see the Red Ribbon Registry campaign playing a critical role in this approach.”
Outreach efforts for the campaign and registry are targeting geographic areas containing a large pool of potential volunteers where HIV vaccine trials are occurring. Presently, about 41 sites across the U.S. are conducting clinical trials for HIV treatment and prevention and are actively recruiting volunteers. Volunteers will sign up via the registry so they can be matched to an appropriate trial. Potential study participants are generally healthy people ages 18 to 55 who are HIV-negative and want to help find a safe and effective vaccine to end the HIV pandemic.
Similar to the COVID-19 vaccine trials, which relied heavily on community engagement to promote participation, HVTN plans to enlist the support of faith-based and other community leaders to help spread the word about the urgent need for study volunteers – especially in communities where mistrust exists because of historical biomedical research abuses and current racial disparities in healthcare.
“We’ve seen from the COVID-19 vaccine trials that faith-based and community leaders, advocates and healthcare professionals can play an instrumental role in overcoming distrust, especially in communities of color,” Wallace said. “Effective community engagement and diversity in trial participation are critical for ensuring that a vaccine that proves efficacious in a trial actually is effective for a diverse, real-world population, as well as the eventual acceptance of vaccines or therapeutics after they become licensed. We must partner again with community leaders and advocates to ensure greater diversity in HIV clinical trials, especially among key communities that typically are underrepresented, including women, transgender people, and Black, Indigenous and People of Color.”
In conjunction with the educational campaign, HVTN has developed a redesigned and comprehensive website that interested people can visit to learn more about HIV, and access the Red Ribbon Registry via the website.
For more information, go to HelpEndHIV.org.