Prospective cohort study of fentanyl test strip use and distribution in three states: the stay safe study protocol and implementation recommendations for researchers

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BACKGROUND: The Stay Safe Study is the first observational prospective cohort study investigating fentanyl test strip (FTS) use by people who use drugs (PWUD) and distribution by community organizations that provide harm reduction services (e.g., naloxone distribution) in three states (Kentucky, New York, and Ohio). The purpose of this paper is to describe the study design, along with implementation successes and challenges. A related goal is to provide recommendations and encourage researchers to undertake multi-state and multilevel studies of FTS use and distribution. METHODS: The Stay Safe Study has one primary, five secondary, and three exploratory objectives. From May-December 2023, we collected survey, interview, and oral fluid drug test data with the primary population of PWUD attending service locations of partner organizations that distribute FTS. We collected survey and interview data with a population of community organizations providing harm reduction services that have a distribution relationship to FTS. There was no intervention, and the study did not distribute FTS. RESULTS: A total of 1,156 PWUD participants were enrolled in the study and were invited to complete four weekly survey assessments. Of these, 732 PWUD participants (97.6% of the target) completed at least two of the four weekly surveys and reported drug use at least once during the 28-day observation period. A subset of enrolled participants completed a one-time oral fluid data collection visit (48-hour self-report survey and oral fluid specimen collection) (n = 267) and one-on-one semi-structured interviews (n = 120). From the population of 36 organizations providing harm reduction services, employees of 28 (78%) in 22 counties across 3 states completed a web-based survey and employees of 24 (66.7%) completed an interview. Study findings will be presented in subsequent publications [1, 2]. CONCLUSION: The research team successfully enrolled a large sample of PWUD participants and organizations that provide harm reduction services in three states, followed a cohort of PWUD participants, and generated rich data using three types of instruments. Factors contributing to implementation success include drawing on the community expertise of the parent HEALing Communities Study, selecting incentive amounts that acknowledged the time and expertise of PWUD participants, centralizing survey data collection, and tracking implementation challenges and solutions. Areas of implementation complexity included conducting research on site at the service locations of 14 partner organizations, facilitating timely incentive payments, overseeing research staff, and returning oral fluid results to PWUD participants.

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