The Strengthening Translational Research in Diverse Enrollment (STRIDE) study developed and tested an intervention the addresses barriers to research participation during the informed consent process.
African Americans and Latinxs are underrepresented in health-related research studies despite disparities in leading cause of death, morbidity and disability. Barriers to research participation result from many factors, often stemming from historical social injustices. These barriers exist at several levels, including the research team and patient levels. Informed consent is a multi-step process that offers an opportunity to address these barriers and potentially improve access to research by individuals from underrepresented groups.
STRIDE was a five-year study funded by the National Center for Advancing Translational Sciences (NCATS) and the Clinical and Translational Science Awards (CTSA) Program. CTSA Program Hubs at the University of Alabama at Birmingham (UAB), the University of Massachusetts Medical School (UMMS) and the Vanderbilt University Medical Center (VUMC) collaborated to refine and integrate existing tools and then test the integrated model with ongoing research studies at the three institutions.
Aim 1. Expand the previously developed intervention components at the three participating CTSA hubs using community-engaged approaches: (1) Storytelling for promotion of research literacy, (2) Simulation-based training for improving culturally appropriate recruitment and informed consent, and (3) e-Consent. Iterative pilot testing will refine the intervention and ensure compatibility with routine clinical trial work flow.
Aim 2. Test the effectiveness of the STRIDE intervention to improve participation of African Americans and Latinos in ongoing translational clinical trials at each of our three partnering CTSA hubs. Effectiveness will be assessed with a randomized interrupted time series design with contemporary controls and the primary outcome will be enrollment of African American and Latino participants.
Aim 3. Promote widespread translation/dissemination to CTSA hubs, other research institutions and community organizations. We will develop an integrated toolkit and make it publically available on the Internet, actively engage the entire CTSA network and offer a series of workshops at national venues.
Development of the integrated intervention: The STRIDE teams at UAB, UMMA, and VUMC collaborated to refine and integrate the elements, developed their separate teams into the STRIDE approach using a community-engaged process. Each study team included one or two Community Investigators, local community members or diverse racial/ethnic backgrounds who contributed to intervention development, pilot testing and dissemination. Components were first developed in parallel using community-engaged approaches, then assembled and pilot-tested.
Piloting of the integrated intervention: The University of Alabama at Birmingham piloted the integrated intervention in a two-step process. STRIDE staff reviewed the paper consent for a “live” trial with the Community Investigators and IRB staff and recommended changes. STRIDE staff then built an eConsent platform for the live trial that was reviewed with research assistants/nurses of diverse backgrounds and from diverse specialties.
Trial: The STRIDE approach was tested by partnering with two studies at each of the three institutions. One study at each institution agreed to serve as the intervention study, and one study at each institution agreed to serve as the control. Intervention studies worked with the respective STRIDE team to tailor the STRIDE approach to their needs and adapt their informed consent process to use the interactive eConsent platform and incorporate STRIDE stories. Their recruitment staff participated in STRIDE simulation training. STRIDE study design was a three-phase interrupted time series (baseline period, ramp-up period, intervention period). We collected recruitment data for intervention and control studies. We collected eConsent and story usage data for the intervention studies through the eConsent platform.