Comparison of remote to hybrid methods on recruitment and retention rates in a smoking cessation trial.

OBJECTIVES: Due to the COVD-19 pandemic, many ongoing clinical trials had to rapidly shift to using remote trials, including our smoking cessation trial within a criminal legal population. The objective of this study was to compare recruitment rate, study adherence, retention, nicotine replacement therapy adherence, and quit attempts between participants who completed the study as planned (In-Person; N = 236), after implementation of a voucher system and additional check-in appointments (Incentivized; N = 126), and after the pandemic began (Hybrid; N = 153). METHODS: 515 participants were recruited with criminal legal involvement from Birmingham, AL, and randomized to an In Vivo nicotine replacement therapy (NRT) sampling group or a standard smoking cessation counseling group, with both groups receiving 12 weeks of NRT. RESULTS: There were no significant differences in any of the study outcomes between the methodology groups, suggesting that hybrid methods of research do not result in a slower recruitment pace, less visits attended, or a higher likelihood of drop-out. Completing the study remotely did not appear to impact study outcomes such as likelihood of making a quit attempt or using NRT. CONCLUSIONS: This study suggests that remote methods may be as effective as in-person methods in a clinical trial, although a randomized trial of these methods is needed.