without the community, science does not move forward
By: Aziel Gangerdine, HVTN Core, Seattle, WA, USA
Walking into Dr. Stephaun Wallace’s office I am greeted by the clatter of his computer’s keyboard. The air is cool and complements his personality. This all too familiar experience has become the introduction to our often-unscheduled meetings to talk about Mosaico, also known as HVTN 706/HPX3002.
Mosaico, he explains, is currently the only Phase 3 HIV vaccine efficacy clinical trial happening in the world. It will test an investigational vaccine regimen at more than 50 trial sites in the U.S., Mexico, Peru, Brazil, Argentina, Poland, Italy, and Spain. Wallace, the Social and Behavioral Sciences Junior Investigator Liaison at the HIV Vaccine Trials Network (HVTN), then delves into why the success of Mosaico pivots on steadfast community engagement. Our discussion is focused and structured by an informal question and answer dialogue.
“In the HVTN, meaningfully engaging and involving communities is not a theoretical concept, but a routine practice”, says Wallace. “We center the voices and perspectives of communities in our studies.” The HVTN, since its inception in 1999, has conducted over 80 clinical trials involving over 22,000 study participants in 13 countries. The network currently coordinates two large-scale HIV vaccine efficacy clinical trials in sub-Saharan Africa (HVTN 702 and HVTN 705/HPX2008), and the two Antibody Mediated Prevention (AMP) studies to test whether a broadly neutralizing antibody (bnAb) called VRC01 can prevent HIV infection. Mosaico, now the fifth efficacy trial, will bolster the HVTN’s relentless scientific pursuit for a safe and globally effective preventive HIV vaccine.
The epidemic has surpassed its third decade unabated, and continues to impact global communities. Despite major breakthroughs in HIV prevention and treatment, there are an estimated 5,000 new HIV transmissions around the world every day. Gay men and other men who have sex with men accounted for an estimated 17% of new HIV infections globally in 2018. The statistics are astounding, yet not nearly as sobering as the awareness that each number represents a personal story and an account of how HIV impacts individuals, their families and communities.
Our dialogue warms the cool office air when brassy-voiced Wallace describes what makes the HVTN’s community engagement program (CEP) an “elixir” to keeping global communities engaged, involved in, and committed to the scientific pursuit. The network has a global footprint evaluating investigational HIV vaccines in key populations ranging from young heterosexual women in southern Africa to transgender persons and MSM in the Americas. Through its Social and Behavioral Sciences and Community Engagement Unit (SBS/CEU), the team implements its CEP to adequately prepare each site for a trial such as Mosaico. The legacy of the HVTN’s CEP transcends nearly two decades of conducting clinical trials.
Mosaico study teams will recruit, screen and, if study participants are eligible and willing to participate, enroll 3,800 HIV-negative at-risk cisgender men and transgender people who have sex with cisgender men and/or transgender people. An awareness of the social, behavioral, economic and political drivers of HIV transmission in each local community helps study teams to understand why transgender women in the US may have up to a 49 times greater burden of HIV than the general population, for example. Being mindful of those drivers engenders robust engagement between the local study teams and potential study participants in their communities.
The Mosaico protocol team includes three Community Educator/Recruiter representatives and two Community Advisory Board members, which is a standard practice in the HVTN. “Community members serve in key roles to inform our scientific agenda, support protocol development and implementation, and are involved in dissemination of results activities,” Wallace elaborates.
The SBS/CEU conducts training with participating sites on community education and recruitment to enhance the skills and tactics study teams employ to encourage community involvement in the study. Teams at trial sites educate communities about the study, the broader HIV prevention landscape, and HIV vaccine science, paving the way for study participants and communities to be involved and meaningfully participate in Mosaico. Community engagement and outreach activities are critical, and underscore how the local study teams gain an intimate understanding of the structural and social drivers of HIV in their communities.
Throughout the day I find myself pondering the meaning and value of what Wallace shared. Mosaico will evaluate an investigational vaccine based on “mosaic” immunogens—vaccine components made from elements from multiple strains of HIV—that aim to induce immune responses against the wide variety of global HIV strains, resulting in a globally effective vaccine.
The trial is itself a mosaic, an assembly of science coupled with the heart and will of the diverse communities from around the world who will make Mosaico possible. To safeguard future generations from the transmission of HIV: therein lies the promise of such an assembly.
Mosaico is a clinical trial supported by a public-private partnership that includes the HVTN; Janssen Vaccines and Prevention BV, part of the Janssen Pharmaceutical Companies of Johnson & Johnson; the National Institutes of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health (NIH); and The US Army Medical Research and Development Command (USAMRDC).
Aziel Gangerdine is the Director of Communications for the HVTN based in Seattle, WA.