The feasibility of the Community health worker Outreach and Navigation Network for Enhancing representation in Clinical Trials (CONNECT) model: A community-physician engagement approach for increasing representation in clinical trials.

Background: 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. Methods: 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. Results: 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. Conclusion: 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.