Undermining the Translational Potential of Clinical Research with Adolescents and Young Adults: Differential Enrollment in Randomized Clinical Trials During COVID-19.

BACKGROUND

COVID-19 stay-at-home orders and research restrictions halted recruitment and follow-up of clinical research patients. While clinical research has resumed, it is an open question whether research participation has returned to levels similar to those before COVID-19.

METHODS

We utilized data from the TECH-PN (NCT# NCT03828994) study, a single-center RCT enrolling 13-25-year-olds with mild-moderate pelvic inflammatory disease (PID) receiving ambulatory care. We examined enrollment patterns before COVID-19 and during/after COVID-19 among those assessed for eligibility by estimating the average rate of recruitment visits for each period. We focused on this monthly rate by pandemic status, the length of stay (LOS) by pandemic status, as well as the relationship between the LOS and patient demographics. Descriptive analyses were conducted, including Student's t-test to compare rates between time periods and a Chi-square test to compare the proportion refusing enrollment.

RESULTS

The monthly enrollment rate during/post-pandemic was significantly lower than before COVID-19 (4.8 per month compared to 7.4 per month, p < 0.001). However, eligible participants' age, race, and insurance type were similar pre- and during/post-pandemic. Among eligible patients, LOS for receiving PID care was slightly increased, from a median of 5.4 hours to 6.4 hours (p = 0.650), and the rate of refusal to participate among those eligible was similar (23% versus 27%, p = 0.362). There was a similar number of ineligible patients due to inpatient admissions during both periods.

CONCLUSION

COVID-19 pandemic restrictions negatively impacted recruitment into this RCT. Enrollment differences may reflect ongoing perceptions of restrictions in care access or a hesitancy to use health services. More research is needed to stabilize access to ambulatory STI/PID care and access to clinical trials.

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