Prospective Cohort Study of Fentanyl Test Strip Use and Distribution in Three States: The Stay Safe Study Protocol and Implementation Recommendations for Researchers

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 harm reduction organizations in three states (Kentucky, New York, and Ohio). The purpose of this paper is to describe the study design, along with implementation success 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 protocol has one primary, five secondary, and three exploratory objectives. From May-December 2023, the study collected survey, interview, and oral fluid drug test (ODT) data with the primary population of PWUD attending community harm reduction organizations that distribute FTS. We collected survey and interview data with a secondary population of community harm reduction organizations that have a distribution relationship to FTS. There was no intervention and the study did not distribute FTS. Results The full study sample was 732 PWUD participants (97.6% of the target) from 1,156 enrolled PWUD participants. Enrolled PWUD participants completed a baseline assessment and at least two of four weekly survey assessments. A subset of participants completed a one-time ODT (n=269) and one-on-one semi-structured interviews (n=120). From the secondary population of 36 harm reduction organizations, employees of 28 organizations (78%) in 22 counties across 3 states completed a web-based survey and employees of 24 organizations (66.7%) completed an interview. Study findings will be presented in subsequent publications. Conclusion The study team successfully enrolled a large sample of PWUD and organizational participants 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 community harm reduction organizations, facilitating timely incentive payments, overseeing study staff, and returning ODT results to PWUD participants.