295 Quantifying the impact of community engagement on enrollment and retention

Objectives/Goals: Substantial evidence supports the use of community engagement in CTS. Yet, there is a lack of empirical basis for recommending a particular level of community engagement over others. We aimed to identify associations between level of community involvement and study process outcomes, focusing on procedures to promote enrollment and inclusion. Methods/Study Population: Using manifest content analysis, we analyzed community engagement (CEn) strategies of studies indexed in ClinicalTrials.gov, focusing on studies 1) associated with 20 medical schools located in 8 southern states in the Black Belt, 2) conducted in 2015–2019, and 3) on 7 topics: cancer, depression, anxiety, hypertension, substance use disorder, cardiovascular disease, and HIV/AIDS. Data source was the ClinicalTrials.gov entry and publication for each study. We categorized each study on level of community involvement as described by the study protocol CTSA Consortium Community Engagement Key Function Committee Task Force on the Principles of Community Engagement continuum. Outcomes included recruitment and representativeness. Other codes included funder type, study phase, study status, and time to enrollment. Results/Anticipated Results: Of 890 studies that met inclusion criteria, only 493 had published findings. 286 studies (58%) met enrollment targets. Only 9 studies described any level of CEn (1 outreach, 3 consult, 1 involvement, 3 collaboration, and 1 shared leadership). Time to enrollment for these 9 studies (mean 28.78 mos.) was shorter than for studies without CEn (mean 37.43 months) (n.s.). CEn studies reached significantly higher enrollment (CEn mean = 2395.11, non-CEn mean = 463.93), p Discussion/Significance of Impact: Results demonstrate the substantial effect of CEn on enrollment and inclusion in clinical studies. However, the infinitesimal number of studies that reported CEn did not allow comparisons of level of engagement on the outcomes. Findings highlight ethical questions surrounding the lack of publishing incomplete studies.