P2368 - Enrollment Rate of African Americans in a Colon Cancer Screening Trial at a Historically Black College and University Is Similar to Other Patient Populations

Award: ACG Governors Award for Excellence in Clinical Research (Trainee)
Award: Presidential Poster Award

Award: ACG Governors Award for Excellence in Clinical Research (Trainee)

Award: Presidential Poster Award

Krystal Mills, MD¹, Benjamin D. Renelus, MD², Hope Nyina-muntu, RN¹, Signe Fransen, MSc³, Paula Adamson, MD⁴, Chuanbo Xu, PhD³, Jeffrey Gregg, MD³, Adam M. Parker, MD⁵, Sarah Glover, DO⁵, Robert Adelman, PhD⁶, Priscilla Pemu, MD, MSCR¹, Theodore Levin, MD⁷, Aasma Shaukat, MD, MPH⁸, Julia Liu, MD^1
1Morehouse School of Medicine, Atlanta, GA; ²Johns Hopkins University School of Medicine, Baltimore, MD; ³Freenome Inc, South San Francisco, CA; ⁴University of Louisville, Louisville, KY; ⁵University of Mississippi Medical Center, Jackson, MS; ⁶University of Buffalo, Buffalo, NY; ⁷Kaiser Permanente Division of Research, Oakland, CA; ⁸University of Minnesota, Minneapolis, MN

Introduction: Clinical trials often have low enrollment of minorities, particularly African-Americans (AAs), which may limit the generalizability of research findings. Previously identified barriers to AAs recruitment include historical abuses leading to mistrust, communication issues with providers, socio-economic factors, and a lack of access to clinical trials. In a Historically Black College and University (HBCU) serving a primarily AA population at a large safe-net hospital, we evaluated the enrollment of eligible AA patients for a colorectal cancer (CRC) screening clinical trial. This was compared to the enrollment rates across other study sites.

Methods: A large, prospective, multi-centered clinical trial to validate a blood-based test for early detection of CRC (PREEMPT-CRC) was initiated at a HBCU, where 84% of patients are AAs. To maximize study recruitment, culturally sensitive methods were employed including racially congruent recruitment staff as well as synchronized timing of consent/study procedures with pre-endoscopy COVID testing/clinic visits. Detailed information for all eligible subjects was recorded. Demographic and socio-economic data including census information for enrolled and not enrolled subjects were compared. The enrollment rate (defined as enrolled/eligible patients) over the first 6 weeks at the HBCU and that of the other study sites providing screening logs was analyzed.

Results: The enrollment rate at the HBCU was 55% (44 out of 80 eligible patients; 95% CI 43.5-66.2%), compared to 49.8% (258 out of 518 eligible patients; 95% CI 45.4- 54.2%) at the other 26 study sites. While age and gender of enrolled patients at the HBCU were comparable to other sites, the main difference was race: at the HBCU the study participants were 79.5% AAs and 9.1% Caucasians, while at the other sites the participants were 11.5% AAs and 82.8% Caucasians (p< 0.001). At the HBCU, the demographic characteristics and socio-demographic data including income, marital status, insurance status/type, and census tract median household income of the 44 enrolled and 36 not-enrolled subjects were similar (Table 1).

Discussion: Contrary to conventional belief that AAs do not want to be involved in clinical trials, we find their enrollment is similar to a predominant Caucasian study population when offered the opportunity in a culturally sensitive setting. Future trials should consider including HBCU sites in order to attain adequate AA enrollment to improve the generalizability of research findings.

	Not Enrolled (N=36)	Enrolled (N=44)	p-value
Female	20 (55.6%)	23 (52.3%)	0.77
Age	57.4 ± 8.3	60.73 ± 7.3	0.06
Race			0.15
African American	32 (88.9%)	35 (79.5%)
American Indian	1 (2.8%)	0 (0.0%)
Asian	0 (0.0%)	4 (9.1%)
Caucasian	2 (5.6 %)	4 (9.1%)
Hispanic	0 (0.0%)	1 (2.3 %)
Unknown	1 (2.8%)	0 (0.0%)
BMI	30.8 ± 11.3	31.0 ± 8.1	0.93
Marital Status			0.51
Divorced/Separated	11 (30.6%)	13 (29.5%)
Married	6 (16.7%)	10 (22.7%)
Single	18 (50.0%)	16 (36.4%)
Unknown	0 (0.0%)	1 (2.3%)
Widowed	1 (2.8%)	4 (9.1%)
Religion (Christian)	28 (77.8%)	34 (77.3%)	0.96
Insurance Status			0.72
Medicare	12 (33.3%)	11 (25.0%)
Medicaid	5 (13.9%)	6 (13.6%)
Private	10 (27.8%)	11 (25.0%)
None	9 (25.0%)	16 (36.4%)
Census Tract Median Household Income	$53,000	$48,000	0.29

Table: Table 1. Baseline Patient Demographic and Sociodemographic Information


Disclosures:
Krystal Mills indicated no relevant financial relationships.
Benjamin Renelus indicated no relevant financial relationships.
Hope Nyina-muntu indicated no relevant financial relationships.
Signe Fransen: Freenome Inc. – Employee.
Paula Adamson indicated no relevant financial relationships.
Chuanbo Xu: Freenome Inc. – Employee.
Jeffrey Gregg: Freenome Inc. – Employee.
Adam Parker indicated no relevant financial relationships.
Sarah Glover indicated no relevant financial relationships.
Robert Adelman indicated no relevant financial relationships.
Priscilla Pemu indicated no relevant financial relationships.
Theodore Levin indicated no relevant financial relationships.
Aasma Shaukat indicated no relevant financial relationships.
Julia Liu indicated no relevant financial relationships.


Krystal Mills, MD¹, Benjamin D. Renelus, MD², Hope Nyina-muntu, RN¹, Signe Fransen, MSc³, Paula Adamson, MD⁴, Chuanbo Xu, PhD³, Jeffrey Gregg, MD³, Adam M. Parker, MD⁵, Sarah Glover, DO⁵, Robert Adelman, PhD⁶, Priscilla Pemu, MD, MSCR¹, Theodore Levin, MD⁷, Aasma Shaukat, MD, MPH⁸, Julia Liu, MD¹. P2368 - Enrollment Rate of African Americans in a Colon Cancer Screening Trial at a Historically Black College and University Is Similar to Other Patient Populations, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.