Results of double randomizations
EVENTS
Overall, despite a few errors, the randomization strategy was very successful, saving the staff substantial time and minimizing randomization and data entry errors. In total, 675 participants met all the inclusion criteria and none of the exclusion criteria. All 675 participants have been successfully randomized to their first randomization assignment. Figure Participants who were initially randomized to “Navigation Services” underwent second randomization as follows: among those who completed COVID-19 testing, 6% (Participants who were initially randomized to “Brochure” underwent second randomization as follows: among those who completed COVID-19 testing, 5% (The second randomization failed for nine participants (equivalent to 1.3% error): three participants were missing second randomization assignments, these participants dropped out before the second round of randomization occurred; four participants had no COVID-19 test information inputted, and therefore they were never assigned a second intervention; and two participants were inadvertently and manually assigned to a different intervention by a study staff member. The combination of these unexpected events led to slight difference in participant allocation ratio between the two intervention treatment arms. The first randomization sequence allocated and assigned interventions for 675 participants. The second randomization sequence allocated and assigned interventions for 666 participants, which is a difference of 9.
Summary of sequential multiple randomizations resultsBecause the randomization process occurred daily, in some instances the automatically assigned interventions were delivered two to three days after they were due to be delivered. These delays occurred when the randomization assignments were generated on weekends when study staff were not available to check the system and deliver the intervention within the required 24-hour window post-randomization. To mitigate this issue, we limited the REDCap entry of the two key variables (i.e., 