Culturally Tailored Messages and Trial Registry Enrollment: A Randomized Clinical Trial.

IMPORTANCE

Marginalized populations have lower levels of clinical trial representation than other populations. Tailoring recruitment materials and providing incentives may improve representation.

OBJECTIVE

To determine whether culturally tailored video improves parents' decision to enroll (DTE) Black children in a research registry.

DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial, using mixed methods and consecutive sampling, was conducted in an urban primary care pediatric clinic. A post hoc study assessed the association of a monetary incentive with DTE. Ninety-three parents were recruited before their child's scheduled clinic visit. Participants completed a survey during which they were randomly assigned to review a paragraph (control group), generic video, or tailored video and received a gift card. Video watchers completed questions about its effectiveness. All participants were invited to join the registry. In the post hoc study, consenting participants followed the control group protocol and the coordinator promised them an ink pen for participating. The study was conducted between November 15, 2022, and August 29, 2023.

INTERVENTION

A survey regarding the importance of being included in research studies was administered after participants watched a culturally tailored video.

MAIN OUTCOME AND MEASURES

The primary outcome was DTE. Covariates were message effectiveness, clinical trial knowledge, and trust. Intention-to-treat analysis was performed.

RESULTS

A total of 125 individuals were included. All groups had similar mean (SD) parent age (overall, 32.6 [7.35] years), gender (110 [88.0%] women), and race (116 [92.8%] Black or African American). There was no significant difference in the odds of DTE between the appeal video and control (odds ratio [OR], 1.19; 95% CI, 0.38-3.72) or between the generic video and control (OR, 1.91; 95% CI, 0.54-6.71). However, DTE was higher for all 3 gift card groups vs the ink pen incentive group (eg, control vs ink pen incentive: OR, 5.01; 95% CI, 1.68-14.95). After adjusting for trust, monetary incentives were associated with higher odds of DTE (adjusted OR, 5.92; 95% CI, 2.44-14.39).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, targeted messaging was not associated with a higher decision to enroll in a pediatric clinical trial registry. There may be a role for combining holistic messaging with monetary incentives to improve enrollment.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT06138145.