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March 14, 2024

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2023 CTSA Fall Program Annual Meeting Poster Spotlight: Carly Herbert, B.A.

The CCOS Communications Team interviewed researchers at the 2023 CTSA Fall Program Annual Meeting poster session in November as part of a series to feature ongoing projects across the CTSA hubs. In this article, we’re featuring Carly Herbert, TL1 Fellow at the University of Massachusetts Chan Medical School who presented her work on the design and implementation of a digital-only (site-less) clinical study regarding serial rapid antigen testing for SARS-CoV-2 infections

 

Research Question 

Digital, site-less studies are underutilized in clinical research leaving their impact on recruitment of diverse and underrepresented populations unknown. In this study, Carly Herbert and her colleagues aimed to describe a digital study design that was used to evaluate longitudinal performance of SARS-CoV-2 rapid antigen testing and explore how digital technologies were leveraged to improve representation from diverse populations.

 

Research Plan 

The prospective cohort study used a digital approach to assess longitudinal performance of rapid antigen testing. Individuals over two years of age were eligible to enroll from October 2021 to February 2022, and those selected underwent screening and prioritization prior to enrollment based on SARS-CoV-2 community prevalence, vaccination status, and sociodemographic characteristics. In November of 2021, a study waitlist was implemented to give investigators the ability to enroll a balanced population. Based on the waitlist, in December of 2021, researchers began curating a geographically and socio-demographically diverse cohort by ensuring inclusion of those underrepresented in research (URR). 

 

A total of 7,316 participants were enrolled, with 492 testing positive for SARS-CoV-2 during the study. Those enrolled were from 44 different states and their geographic distribution mirrored changes in COVID-19 prevalence. Before the waitlist was implemented, only 40.7% of participants were from URR populations. Afterwards, the percentage of URR increased by 8.1% weekly with a final percentage of 86.1% in week 15.  

 

Next Steps 

The digital, site-less approach was efficient and allowed for rapid and rigorous evaluation of diagnostics for COVID-19, while promoting equitable participation from URR populations. The researchers found that to facilitate successful site-less studies in the future, it is important to engage underserved communities through local stakeholders, use a waitlist to enroll participants with desired demographics, and adequately incentivize the participants’ time invested in the study to encourage research participation.  

 

Reflection with the Researcher: What do you want the CTSA community to know about the work you presented? 

Carly said one of the major challenges was “how quickly things changed from day to day”. The researchers “would start with a strong study idea and then knowledge and research questions would shift as the pandemic progressed. They “had to pivot and remain flexible” because “everything moved very quickly.” 

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