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October 23, 2020

Recruitment of Research Participants During the Height of the COVID-19 Pandemic
By Rhonda G. Kost, MD

The Recruitment Core of the Clinical Research Support Office (CRSO) provided the strategy, services, and operations to support recruitment for COVID-19 studies at the Rockefeller University Hospital. In March, the first study was from the Laboratory of Molecular Immunology, led by Dr. Michel Nussenzweig, which required blood donations from individuals who recovered from COVID-19. An initial challenge in planning recruitment was the need for flexible eligibility criteria as the team sought to identify which clinical course (severe? moderate? asymptomatic?) might predict a strong immune response.

Recruitment specialist Kadija Fofana, MPH, drafted advertisements for social media, the internet, Rockefeller platforms, and hard copy distribution in communities that were affected early by the virus. Dr. Nussenzweig appeared on CNN, triggering inquiries from all over the country.

The research team hosted a Zoom Town Hall meeting to engage the index community of New Rochelle and many inquiries followed. Word of mouth was a powerful recruitment tool across com­munities and the study unearthed an enormous surge of altruism from people hoping to help find a treatment or cure for COVID-19. The geographic distribu­tion of the more than 900 volunteers who responded and were pre-screened by the Recruitment core before referral to the Nussenzweig team for further screening spanned Westchester, the Bronx, Man­hattan, Queens, Brooklyn, Long Island, New Jersey, and Connecticut. Volunteers were aged 18-80, with most in their 40-60s, and roughly balanced between the sexes. The Recruitment team creatively and rapidly built surge capacity to handle the call volume by training staff from oth­er cores as pre-screeners. This required training in Human Subjects Protections and the scripts of recruitment and the Research Volunteer Repository, provid­ing secure Zoom phone lines with Rock­efeller caller id for remote workers, and creating REDCap intake forms and work­flow to integrate with other applications. The surge capacity staff included: Lisa Sacerio, Sharon Adams, Maritza Sanchez, Robert Hanson, Andrea Ronning, Glenis George-Alexander, Dacia Vasquez, Kim­berly Vasquez, Anthoneth Jeffrey, and Marlyn Appleton.

Driven by the CRSO leadership and the Hospital Information Technology (IT) group, with support from Univer­sity IT, Office of General Counsel, and the IRB, new infrastructure was vetted and rapidly put into place to allow volun­teers to self-prescreen through an online weblink hosted on a HIPAA-compliant, secure Amazon web Services/REDCap platform. This is one of multiple exam­ples of the COVID-19 crisis accelerating the adoption of new processes. Hundreds of volunteers calling the 800RUCARES line and RUCARES elected to use the we­blink and were able to quickly determine whether they were eligible, thus supple­menting the hundreds of calls and con­versations provided by the recruitment team. This platform opened the door for hosting other on-line activities requiring a HIPAA-compliant and secure platform.

In addition to the logistical challenges, pre-screening under COVID identified a number of additional issues: some individuals called seeking research enrollment as a means to obtain scarce COVID testing, some volunteers were eager to donate convalescent plasma for therapeutic purposes as well as participate in research and were concerned about the timing of contributing to multiple medical efforts, many callers were eager to recount their experience with COVID-19 infection in case the clinical history would help scientists, and some recounted a dramatic clinical course consistent with COVID but because of the lack of testing could not enroll. Ultimately, there were many more eligible responders than could be studied, a tribute to the desire of so many New Yorkers to come to the aid of others . Between March 17th and April 30th, approximately 1000 volunteers contacted the recruitment team through the RUCARES voicemail or email; more than 650 met initial prescreen eligibility, and about 160 were enrolled into the study.

The recruitment core also helped Clinical Scholar Dr. Ohad Bentur successfully accrue the 10 healthy volunteers needed for his Phase I study of inhaled aerosolized hydroxychloroquine. Recruitment for this study was readily achieved using campus advertising and the Research Volunteer Repository.