Document is current

Article History

Received: 13 August 2025

Accepted: 18 March 2026

First Online: 31 March 2026

Declarations

:

: This study was approved by the Johns Hopkins University School of Medicine Institutional Review Board (IRB00303116) which serves as the single IRB for this multi-institutional collaboration. Collaborating institutions include the University of California, San Diego, University of Washington, Seattle, University of North Carolina, Chapel Hill and Fenway Community Health Center, Boston. All collaborating institutions have acknowledged and approved the study protocol through their respective reliance agreements with the Johns Hopkins University School of Medicine IRB. The IRB granted waivers of informed consent and HIPAA authorization to access secondary electronic health record data used to identify patients eligible for recruitment. Written informed consent is obtained from patients enrolled in the clinical trial, and verbal or written informed consent is obtained from interview participants, per approval from the IRB. All procedures adhere to the ethical standards outlined in the Declaration of Helsinki and relevant local regulatory requirements. The trial is registered with Clinicaltrials.gov, identifier: NCT05241990, date of submission 2/16/2022.

: Not applicable.

: Practice facilitation will begin at each of the three clinics in spring 2022, 2023, and 2024, respectively, followed by 3–6 months of preparation before enrollment commences. The preparation phase may differ between the clinics due to variation in preparedness and support needed to launch enrollment. Clinics will be given one year to enroll participants in the ARCH program, followed by 3–6 months of sustainment where LIT staff will continue to approach enrolled patients for follow-up visits. Recruitment for this study began on February 15, 2023. Key enrollment milestones include March–December 2023: Recruitment of participants from Site 1, target 100–150 participants; January–June 2024: Recruitment of participants from Site 2,target 100–150 participants; July 2024–December 2025: Recruitment of participants from Site 3, target 100–150 participants. Recruitment for this study was completed 1/12/2026.

: The authors declare no competing interests.