Successful recruitment and retention of diverse participants in a genomics clinical trial: a good invitation to a great party

Genet Med. 2019 Oct;21(10):2364-2370. doi: 10.1038/s41436-019-0498-x. Epub 2019 Apr 5.

Abstract

Purpose: African ancestry (AA) individuals are inadequately included in translational genomics research, limiting generalizability of findings and benefits of genomic discoveries for populations already facing disproportionately poor health outcomes. We aimed to determine the impact of stakeholder-engaged strategies on recruitment and retention of AA adult patients into a clinical trial testing them for renal risk variants nearly exclusive to AAs.

Methods: Our academic-clinical-community team developed ten key strategies that recognize AAs' barriers and facilitators for participation. Using electronic health records (EHRs), we identified potentially eligible patients. Recruiters reached out through letters, phone calls, and at medical visits.

Results: Of 5481 AA patients reached, 51% were ineligible, 37% enrolled, 4% declined, 7% were undecided when enrollment finished. We retained 93% at 3-month and 88% at 12-month follow-up. Those enrolled are more likely female, seen at community sites, and reached through active strategies, than those who declined. Those retained are more likely female, health-literate, and older. While many patients have low income, low clinician trust, and perceive racism in health care, none of these attributes correlate with retention.

Conclusion: With robust stakeholder engagement, recruiters from patients' communities, and active approaches, we successfully recruited and retained AA patients into a genomic clinical trial.

Keywords: African ancestry; genomics; race; recruitment; retention.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • African Americans / psychology*
  • Clinical Trials as Topic / methods*
  • Female
  • Genomics / ethics
  • Genomics / methods
  • Humans
  • Male
  • Middle Aged
  • Patient Selection / ethics*
  • Stakeholder Participation / psychology