Transitioning to the Remote Collection of Urine Specimens for Urine Drug Screening During COVID-19
Leslie, R.; Lewis, M.; Shmueli-Blumberg, D.; Jelstrom, E.
COVID-19 challenges; drug screening; urine specimens
The National Drug Abuse Treatment Clinical Trials Network (CTN) routinely conducts multi-site clinical trials involving behavioral and pharmacological interventions for the treatment of substance use disorders. This commonly involves trials that test for substance use using urine drug screening procedures. Recent substance use is assessed by measuring the concentration of the various substances or their metabolites in urine specimens obtained from study participants once they provide consent and are enrolled in the study. This is an important assessment used in CTN trials, as these results are used for study outcomes and/or clinical care. The Emmes Company, LLC, acting as the Clinical Coordinating Center (CCC) is responsible for providing and managing the urine drug screen (UDS) supplies for these trials. Traditionally, this testing would occur when a participant is on-site for a study visit. Due to the COVID-19 pandemic and the stay at home orders set forth, this has disrupted the process of performing substance use testing at research sites. The CCC has developed a process to allow the studies to continue urine drug screening by obtaining urine specimens from trial participants remotely. This process is achieved with sites sending participants a ‘urine collection kit’ which contains the necessary supplies for the collection and transportation of urine. The urine collection kits are easy to use and contain detailed instructions. Participants will collect their urine and ship it in the kit provided back to the site for screening. Once the kits are received on-site, research staff will first test the urine specimen for adulteration then substance screening. Since this is a new process within the CTN, the CCC worked closely with research staff to deliver specific training to enable consistent collection and testing of urine samples from participants. This training included the International Air Transport Association (IATA) regulations and packing requirements for exempt human specimens and instructions for the preparation, shipping and receipt of the urine collection kits. The CCC also provided additional resources for sites, such as a Remote Urine Specimen Collection and Shipping Manual which details the entire process. While this process has enabled studies to continue, one limitation is that study staff are not able to determine that the urine specimen is definitively from the study participant. When urine specimens are collected in person, research staff will do a temperature check on the specimen to determine that it is from the study participant. This reduces the likelihood of substitution. For urine samples collected remotely, the temperature check cannot be performed. Therefore, Principal Investigators must be aware of the potential for urine specimens to be from another source when considering this option for their studies. All options considered, utilizing this different approach for remote urine collection has allowed for studies to continue capturing important study data during the pandemic when participants cannot access the research site. Although this process was developed to solve a need during the COVID-19 pandemic, it can potentially be a primary method for the collection of specimens for other studies in the future.