Recruitment planning for clinical trials with a vulnerable perinatal adolescent population using the Clinical Trials Transformative Initiative framework and principles of partner and community engagement

Contemp Clin Trials. 2021 May:104:106363. doi: 10.1016/j.cct.2021.106363. Epub 2021 Mar 15.


Recruitment planning is needed to establish a foundation for obesity prevention research with high risk, disadvantaged perinatal adolescent populations. In the context of developing clinical trial protocols, investigators partnered with Mississippi's Nutrition Program for Women, Infants and Children (WIC) and adopted the Clinical Trials Transformative Initiative (CTTI) framework for recruitment planning to identify and mitigate challenges to recruitment early in the clinical trial development process. The recruitment protocol consisted of 20 passive strategies grounded in principles of partner and community engagement and was flexible, accommodating, altruistic, community-focused, and minimally burdensome to partners and participants. The recruitment goal included 150 adolescent-coparticipant dyads and 145 dyads (96.7%) were successfully recruited. Investigators demonstrated the feasibility of recruiting a disadvantaged and vulnerable perinatal adolescent population that is underrepresented in health research, in one of the most persistently impoverished and poor health regions in the U.S. Four important aspects of recruitment planning using the CTTI framework are discussed including: (1) establishing partnerships with trusted community resources is a paramount investment; (2) dedicating time and resources to know and go to your community is invaluable; (3) fostering trust by offering convenient, continuous and clear communication; and (4) encouraging collaboration and participation through limiting partner and participant burden. Establishing organizational and community partnership requires a substantial amount of invaluable time and fosters recruitment success. Following the CTTI recommendations for recruitment planning led to a robust recruitment protocol that will be used in future intervention trials with an understudied perinatal adolescent population with high risk for poor maternal and fetal health outcomes.

Keywords: Minority groups; Pregnancy in adolescence; Research subject recruitment; Rural population; Vulnerable populations.

Publication types

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

MeSH terms

  • Adolescent
  • Child
  • Clinical Trials as Topic
  • Female
  • Humans
  • Obesity
  • Patient Selection
  • Pregnancy
  • Research Design*
  • Research Personnel
  • Vulnerable Populations*