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US COVID-19 Prevention Network Outlines Goals, Shows Moderna Trial Impact
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HIVR4P Virtual, January 27-28 and February 3-4, 2021
Mark Mascolini
Researchers from CoVPN, the US COVID-19 Prevention Network, outlined their goals and strategies, then detailed early results of their work in recruiting a diverse population for a phase 3 trial of the Moderna COVID-19 vaccine [1]. The network emphasizes the importance of community engagement through education, recruitment, and prevention.
The US National Institute of Allergy and Infectious Diseases (NIAID) formed CoVPN to respond to the global COVID-19 pandemic [2]. Taking advantage of their infectious disease expertise, much of it gained in controlling the HIV epidemic, CoVPN focuses on the critical need to develop vaccines and monoclonal antibodies against SARS-CoV-2, the virus that causes COVID-19. Partners include the HIV Vaccine Trials Network, the HIV Prevention Trials Network, the Infectious Disease Clinical Research Consortium, and the AIDS Clinical Trials Group.
CoVPN relies on a three-part community engagement model developed for HIV: (1) Community education promotes COVID-19 awareness, literacy, and support of HIV prevention and clinical research locally. (2) Recruitment builds on community education to draw community members into clinical trials. (3) Retention supports continued community engagement through positive trial experiences. Using Good Participatory Practice (GPP) and behavioral theories as a foundation, community engagement aims to promote (1) shared responsibility with investigators, clinical trial staff, community stakeholders, and network staff, and (2) development of locally responsive plans to reach diverse populations.
The CoVPN campaign began work on the Moderna mRNA vaccine in July 2020, with AstraZeneca's ChimpAd5 vaccine in August 2020, with Johnson & Johnson's Ad26 vaccine in September 2020, with Novavax in December 2020, and with Sanofi baculovirus prefusion protein in early 2021.
CoVPN stresses the persistence of racial disparity in COVID-19 case rates and outcomes in the United States. Through December 31, 2020, whites made up 60.2% of the US population but accounted for 54.8% of COVID-19 cases. Proportions of cases were higher than proportions of populations for non-Hispanic blacks, Hispanics, American Indians/Alaska Natives, and Native Hawaiians/Pacific Islanders [3]. Racial and ethnic minorities also account for disproportionately high numbers of COVID-19 deaths. Experts attribute these disparities to (1) a high proportion of low-wage jobs in minority groups, (2) residential segregation, and (3) increased levels of chronic stress. These factors can affect health insurance, access to health care, paid sick leave, options to work from home, poor access to healthy foods, high housing density, and multigenerational households with limited space.
The CoVPN community engagement strategy focuses on priority populations, namely, native and indigenous people, African Americans, Latinx, other communities with health disparities, people with preexisting health conditions, and older adults including those cared for in nursing homes, assisted-living facilities, and Veterans Administration facilities.
The group outlined its community engagement strategy in 5 goals:
1. Community-based participatory research approaches to develop material
2. Communications creatives and community influencers
3. Priority population expert panels
4. Community working groups familiar with research
5. Stakeholder engagement and building trust
The first part of this strategy includes a volunteer prescreening tool accessible at the CoVPN public website: https://www.PreventCOVID.org/. A call center helps older adults and those without web access to complete the survey. The volunteer recruitment effort is creating a database to support enrollment of 30,000 people for each of five or more studies. COVID- and trial-related materials in English, Spanish, and Portuguese are online at TinyURL.com/CoVPN-Assets (password CoVPNTria!$). These materials include slide sets, educational videos, infographics, social media posts, and special materials for older adults.
The CoVPN team offered some results of these efforts related to the phase 3 Moderna vaccine COVE trial [4]. Representation of minority communities in the trial population was close to general population proportions, with 20% Hispanics, 10% blacks, 4% Asians, 3% other minorities, and 63% whites. Racial/ethnic diversity improved as enrollment continued. For example, on July 27, 2020, 85% of enrollees were white. That proportion fell to 74% on August 17, 58% on September 7, and only 7% on September 21. On those same dates, Hispanic enrollment rose from 5% to 16% to 23% to 43%. Black enrollment climbed from 5% on July 27 to 29% on September 21.
References
1. Andrasik M, Rentas F, Oseso L, Wallace S, Broder G. Utilizing a robust HIV prevention community engagement framework to engage communities in COVID-19 prevention efforts. HIVR4P (HIV Research for Prevention) Virtual, January 27-28 and February 3-4, 2021. Abstract OA13.05LB.
2. COVID-19 Prevention Network (CoVPN). https://coronaviruspreventionnetwork.org/
3. Centers for Disease Control and Prevention. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#demographics
4. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. December 30, 2020. DOI: 10.1056/NEJMoa2035389.
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