Purpose
Enrollment for research studies has been challenging since March of 2020 when mandatory COVID-19 stay-at-home orders and institutional research restrictions halted recruitment and follow-up of clinical research patients. This period was particularly challenging for clinical trials for sexually transmitted infections (STI) that surged during this time. While clinical research has resumed, it is an open question whether research participation has returned to pre-pandemic levels. This study aims to examine the longitudinal impact of COVID-19 on the recruitment of adolescents and young adults (AYA) into large federally funded STI-focused randomized controlled trials (RCT) using pre-pandemic and pandemic/current recruitment data.
Methods
For this analysis, we utilize data from the TECH-PN (NCT# NCT03828994) study, a large, human-subjects-approved, single-center RCT enrolling 13-25-year-old AYA with mild-moderate pelvic inflammatory disease (PID) cared for in ambulatory settings. This study enrolled continuously from January 2019 through February 2022 with an interruption due to the COVID-19 pandemic. We examined the enrollment patterns by demographics, pre-pandemic (before public health stay-at-home order), and during/post-pandemic status among those screened for eligibility. We specifically focused on the relationship between the length of stay (LOS) (time from registration to discharge or inpatient admission) and the monthly enrollment rate by pandemic status. We also evaluated differential use of inpatient admission by period. Descriptive and bivariate analyses were performed in STATA, including a Student’s t test to compare enrollment rates in different time periods, and a Chi-square test to compare the proportion refusing enrollment.
Results
176 participants were screened for enrollment in TECH-PN, 96 (55%) pre-pandemic. 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, the age, race, and insurance type of eligible participants 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 6.5 hours (p=0.652), and the rate of refusal to participate among those eligible was marginally higher (23% versus 27%, p=0.362). There were a similar number of ineligible patients due to inpatient admissions during both periods. A review of the qualitative data recorded by research staff indicates similar patient illness severity across groups.
Conclusions
COVID-19 pandemic restrictions negatively impacted recruitment into this RCT. While there was a trend towards longer LOS for PID care during COVID-19, eligible patients were as likely to enroll in our trial if presented the opportunity. Given the recent public health STI data during COVID-19, enrollment differences may reflect ongoing perceptions of restrictions in care access or a hesitancy to use health services, which may be driven by public warnings about safety, wait times, or patient experiences in care settings. More research is needed to stabilize access to ambulatory, acute STI/PID care and access to clinical trials for youth facing sexual health disparities.
Sources of Support
This research was generously supported by the National Institutes of Health (NINR, R01NR013507).