Trial and data monitoring
ABUSE
In accordance with the National Institutes of Health (NIH) and the primary funding agency, the National Institute on Drug Abuse (NIDA), we have developed a Data and Safety Monitoring (DSM) plan, and the principal investigators and core, Denver-based, research team will maintain appropriate oversight and monitoring of the trial’s conduct in its entirety. As this trial is not a phase 3 trial and it was determined to be minimal risk to participants, no Data Safety Monitoring Board (DSMB) was required for this trial. The DSM plan was approved by the Colorado Multiple Institutional Review Board (COMIRB) and NIDA prior to initiating enrollment.The core Linkage team, consisting of one of the study principal investigators, the Linkage-to-Care Trial project coordinator, and the linkage navigators, will meet quarterly to review cases, ensure fidelity to the linkage protocols, and troubleshoot challenging linkage situations. Data monitoring will be performed from the inception of participant enrollment through follow-up as captured in REDCap. The data manager will organize all data to understand total screening and enrollment, inclusion and exclusion criteria, consent, and study procedures associated with the interventions. Weekly study team meetings will occur to review screening and enrollment. Outcomes will be collected after each interim sample has been enrolled in an effort to complete interim analyses, performed by the study’s biostatistician.