New determination and new knowledge for HIV clinical research
Building on the momentum of highly successful clinical trials of the COVID-19 vaccine, the HIV Vaccine Trials Network (HVTN) is launching a new HIV awareness campaign and unveiling a first-of-its-kind national registry that will provide up-to-date HIV information and facilitate learning about and participation in HIV clinical trials at HelpEndHIV.org.
The “Help End HIV” campaign is designed to increase awareness – especially among young people – that HIV remains a major health problem around the world and in the United States. A recent audience survey conducted by HVTN found that many Americans are unaware that HIV is still a health issue in the United States, unsure if they might be vulnerable to exposure, and unaware if there is a cure.
The awareness campaign is combined with the launch of the Red ribbon Registry, a unique, user-friendly volunteer database designed to connect people interested in supporting HIV vaccine research with HIV clinical trials in their communities.
The new Red Ribbon Registry builds on the successful community engagement work of COVID-19 vaccine trials led by the COVID-19 Prevention Network. CoVPN is a clinical trial network enabled for the COVID-19 pandemic based on the HVTN infrastructure funded by the National Institute of Allergy and Infectious Diseases. Community advocates, physicians, scientists, epidemiologists and others are learning lessons from COVID-19 vaccine research and applying effective strategies and tactics to reinvigorate HIV vaccine research.
“HIV vaccine research has now come full circle,” said Dr. Larry Corey, who directs both the HVTN and the CoVPN, and is a virologist at the Fred Hutchinson Cancer Center, where both networks are headquartered. . “The registry grew out of what we learned during the COVID-19 vaccine trials, which were themselves based on knowledge gained from previous clinical trials of the HIV vaccine.
HVTN and CoVPN are funded by NIAID, which is part of the National Institutes of Health.
The overarching goal of the campaign and registry is to raise awareness of the urgent need for volunteers for HIV clinical trials and to encourage more people – especially young people – to participate. Because COVID-19 was so widespread and so devastating, clinical trials testing vaccines and experimental treatments for COVID-19 attracted unprecedented numbers of volunteers in a very short time. In contrast, recruitment of volunteers in the early stages of clinical trials for HIV and other diseases has generally lagged. The Help End HIV campaign and the Red Ribbon Registry aim to change that.
“HIV continues its silent spread in the United States and around the world, and the need for an effective vaccine continues,” said Corey, who has been a principal investigator at the HVTN since its inception. “Our goal is to connect with a younger generation who are largely unaware that HIV is a global health crisis and the urgent need for effective vaccines.
As the world’s largest publicly funded preventive HIV vaccine trial network, the HVTN is uniquely positioned to tackle this issue. Since 2000, when HVTN launched its first trial, the network has conducted more than 85 clinical trials, approximately 80% of which were Phase I studies. Thirteen of these trials are still active, six are recruiting participants, and more than 15 studies are in preparation for next year.
“HIV and SARS-CoV-2 are very different viruses, with HIV developing a considerable number of variants, making it an ever-changing target. One thing we have learned from 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 need to design and implement trials quickly, which includes more efficient participant recruitment and enrollment. We see the Red Ribbon Registry campaign playing a vital role in this approach.
Outreach efforts for the campaign and registry target geographic areas with a large pool of potential volunteers where HIV vaccine trials are underway. Currently, approximately 41 sites across the United States are conducting clinical trials for HIV treatment and prevention and are actively recruiting volunteers. Volunteers will register through the registry so they can be matched to an appropriate trial. Potential study participants are generally healthy people between the ages of 18 and 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 solicit support from faith leaders and other community leaders to help raise awareness of the urgent need for volunteers for the study – especially in communities where distrust exists due to historical abuses of biomedical research and current racial disparities in health care.
“We’ve seen in COVID-19 vaccine trials that religious and community leaders, advocates, and medical professionals can be instrumental in overcoming mistrust, especially in communities of color,” Wallace said. “Effective community engagement and diversity in trial participation are critical to ensuring that a vaccine that proves effective in a trial is actually effective for a diverse, real-world population, as well as for eventual acceptance of vaccines or therapies after they are licensed We need to partner again with community leaders and advocates to ensure greater diversity in HIV clinical trials, especially among key communities that are typically underrepresented, including women, transgender people and black, indigenous and people of color.”
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