Hecht Mindy Feldman, Minguez Mara, Aguirre Alejandra, Fajardo Melissa, Williams Olajide
Office of Community Health, Vagelos College of Physicians and Surgeons Columbia University Irving Medical Center, 51 Audubon Ave, 8th Fl, New York, NY, 10032, USA.
Department of Pediatrics, Columbia University Irving Medical Center, 60 Haven Avenue Suite B3, New York, NY, 10032, USA.
Contemp Clin Trials Commun. 2025 Jul 7;46:101521. doi: 10.1016/j.conctc.2025.101521. eCollection 2025 Aug.
Despite efforts to increase racial and ethnic representation in clinical trials (CT), inclusion of minoritized participants remains inadequate. To address the barriers of ineffective outreach and reduced opportunities, we developed a program called Community health worker Outreach and Navigation Network for Enhancing representation in Clinical Trials (CONNECT). This article describes CONNECT and its feasibility of implementation over a 3-month period.
At the core of CONNECT is a dedicated culturally and language concordant CT-trained Community Health Worker (CHW) and local community physician. The CHW was embedded in a local community physician's practice, where they educated patients about CTs during one-on-one encounters. The CHW then followed up with patients to assist with referral to a CT that fit patients' interests. Our primary outcome was patient openness and fit for CTs as demonstrated by a CHW referral to a CT.
The CHW met with 74 of ∼150 patients (49 %) one-on-one and referred 62 of the 74 participants (84 %) to CTs that fit their preferences.
Our study demonstrates the feasibility of the CONNECT model for increasing openness and fit to CT referrals for underrepresented populations. Strengthening relationships with community physicians serving wide-ranging patient populations and embedding a CHW in their practice to educate patients about CTs may be an important pathway for increasing openness to and support for CT participation. We found that CHWs can bridge the research trust gaps, facilitate openness to CT participation and create accessible opportunities to participate in CTs that fit participant preferences.
尽管为提高临床试验（CT）中的种族和民族代表性做出了努力，但纳入少数族裔参与者的情况仍然不足。为了解决外展效果不佳和机会减少的障碍，我们开发了一个名为“社区卫生工作者临床试验代表性增强外展与导航网络”（CONNECT）的项目。本文介绍了 CONNECT 及其在 3 个月期间的实施可行性。
CONNECT 的核心是一名经过专门的临床试验培训、具备文化和语言适配能力的社区卫生工作者（CHW）以及当地社区医生。CHW 融入当地社区医生的诊所，在一对一诊疗过程中向患者介绍临床试验。然后，CHW 对患者进行随访，协助他们转诊至符合其兴趣的临床试验。我们的主要结果是 CHW 将患者转诊至临床试验所体现出的患者对临床试验的接受度和适配度。
CHW 与约 150 名患者中的 74 名（49%）进行了一对一交流，并将其中 62 名参与者（84%）转诊至符合他们偏好的临床试验。
我们的研究证明了 CONNECT 模式对于提高代表性不足人群对临床试验转诊的接受度和适配度的可行性。加强与服务广泛患者群体的社区医生的关系，并在其诊所中安排一名 CHW 向患者介绍临床试验，可能是提高对参与临床试验的接受度和支持度的重要途径。我们发现，CHW 可以弥合研究信任差距，促进对参与临床试验的接受度，并创造符合参与者偏好的参与临床试验的便利机会。
