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.

The Future of Sexually Transmitted Infection Research: Understanding Adolescent Perspectives for Implementation of a Chlamydia Vaccine.

PURPOSE: Despite advancements in developing a vaccine for Chlamydia trachomatis (CT), vaccine hesitancy has historically limited the adoption of sexually transmitted infection immunization. This report investigates adolescent perspectives toward a potential CT vaccine and vaccine research. METHODS: As part of the Technology Enhanced Community Health Nursing (TECH-N) study, conducted from 2012-2017, we surveyed 112 adolescents and young adults aged 13-25 years who presented with pelvic inflammatory disease regarding their perspectives on a CT vaccine and willingness to participate in vaccine research. Descriptive statistical analyses were conducted. RESULTS: Most participants were African American (95%), on Medicaid (89%), and sexually experienced (100%). Most respondents would accept a vaccine (95%) and preferred a provider's recommendation (86%) over parents, partners, or friends. A majority (70%) would not be embarrassed to participate in research. DISCUSSION: Respondents showed favorable attitudes toward CT vaccination and research in this high-risk study population.