STRIDE is a research study supported by the National Institutes of Health/National Center for Advancing Translational Sciences under award number U01TR001812. The content is solely the

responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Kenneth Saag, MD, MSc, Stride Co-PI

Lowe Professor and Vice Chair

Director, CCTS TL1 and KL2, and Center of Outcomes Research

University of Alabama at Birmingham

Stephenie Lemon, PhD (STRIDE PI)

Professor of Medicine

Director of the Umass CCTS Community Engagement Section and the

Umass Worcester Prevention Research Center

Jeroan Allison, MD, MSc (STRIDE co-PI)

Professor and Vice Chair of the Umass Department of Quantitative Health

Associate Vice Provost for Health Disparities Research

Paul Harris, PhD (STRIDE co-PI)

Professor of Biomedical Informatics and Research Professor of Biomedical

Engineering at Vanderbilt University

Director of the Vanderbilt Office of Research Informatics

The Goal of STRIDE

To improve racial and ethnic minority recruitment in clinical trials by creating culturally relevant tools and interventions

Critical Challenges in Clinical Trial Recruitment• ~30% clinical trials have issues

reaching enrollment goals1

• ~20% clinical trials do not enroll a single patient1

• >90% all clinical trials do not meet their proposed timelines because of difficulties with enrollment1

• Recruitment time is biggest contributor to trial increased costs2 0

10

20

30

40

50

60

70

80

90

Blacks Latinos Whites

% of US Pop.

% in ClinicalTrials

1Tufts Center for the Study of Drug Development, 2014. 2Hargreaves. Clinical Trials and their Patients: The Rising Costs and how to Stem the Loss. 2016. www.pharmalife.com3 Dorsett T. Diversity in clinical trials is an issue that we can no longer ignore. MedCity News MedCitizens Program. January 2017. http://medcitynews.com/2017/01/diversity-clinical-trials-issue-can-no-longer-ignore/?rf=1

Minority Representation in Clinical Trials3

Clinical Trial Recruitment in a More Diverse Nation

In 2016, African Americans made up just 7% of clinical trial participants according to FDA reports

According to the US Census, for the first time in 2014, more than 50% of children under 5 were minorities in the US

STRIDE Specific Aims

Aim 1: Expand 3 previously developed intervention components: Storytelling for promotion of research literacy; Simulation-based training for improving culturally appropriate recruitment and informed consent; eConsent

Aim 2: Test effectiveness of STRIDE multi-modal intervention to improve participation of African Americans and Latinos in ongoing clinical trials at each of 3 partnering CTSA hubs

Aim 3: Promote widespread translation/dissemination to CTSA hubs, other research institutions and community organizations

STRIDE Intervention Approach

• Comprehensive, multi-component approach

• Aims to provides clinical trial research teams with the training and tools for culturally adapted informed consent

eConsent

Research Assistant Training

Storytelling

STRIDE is a Three CTSA Collaboration

• Intervention pilot testing

• Integrating components

(storytelling, simulation,

eConsent) into existing

clinical trials

• Simulation: training

research assistants to be

culturally aware when

consenting participants

• Storytelling: participant

stories to increase

understanding of clinical

trials

• eConsent

• Community Studios to

provide feedback on

intervention components.

STRIDE Intervention - Community Input on All Components

Community Investigators Community Engagement Studios

Collaboration with Community Campus Partnerships for Health (CCPH)

Fred Jenoure, UMMS

Jackie Simms, VUMC

Clarice Davis, UAB

STRIDE Intervention Steps

Develop with community input

Evaluate in collaboration with ongoing clinical trials

Disseminatethroughout the CTSA program

and Trial Innovation Network

Aim 1 Aim 2 Aim 3

eConsent

Research Assistant Training

Storytelling

• Contains all of traditional elements of

paper consent PLUS

• Culturally relevant videos for commonly

consented research procedures (e.g. LP,

MRI, CT), Avatars, and hover-over

definitions with audio pronunciations

• Deployable in REDCap – scalable and

shareable

• Part 11 compliant

• Example video:

https://www.youtube.com/watch?v=3hldK

0aD99k&feature=youtu.be

STRIDE Intervention eConsent- What is It?

• Editing of first 4 videos – disseminated

via Recruitment Innovation Center

(RIC)

• Final development of part-11 compliant

“virtual lock box” to store signed

consent documents – deployed

nationally via the REDCap Consortium

• Refining “hover and click” feature with

audio pronunciation – deployed

nationally via REDCap Consortium

STRIDE Intervention eConsent- Progress

eConsent

Research Assistant Training

Storytelling

STRIDE Intervention Research Assistant (RA) Training- What is it?

• Simulation-based training

• Modeled after medical school experiential learning using standardized patients

• Training based on previously established core competencies• establishing rapport

• supporting understanding

• responding to emotion

• 2-day intensive training

• Delivered at UMass Medical School

STRIDE Intervention RA Training – What is it?

• Preparatory work (home site)

• Pretest, training and post-test (UMass)• Standardized checklist

• Minimum passing score

• Opportunity to retrain and reassess

• Debriefing (UMass)

• Deliberate practice (home site)

• In situ validation (home site)

STRIDE Intervention RA Training –Progress

• Training protocols-Developed with Community Investigator input

• Evaluation checklists

eConsent

Research Assistant Training

Storytelling

STRIDE Intervention Storytelling - What is it?

• Short, culturally-relevant video stories

• Real participants from past clinical trials

• Describe personal experiences with research and approaches to overcoming barriers

• Ancillary component to eConsent

• Introduce potential participants to goals of clinical trials research

• Clarify what is trial research? during the informed consent process

STRIDE Intervention Storytelling - Progress

• Completed Story Development at UAB and VUMC• 21 personal interviews filmed

• Initiated process of thematic analysis for story preparation

• Example storytelling video: https://vimeo.com/234717195

• Ongoing Interviews at UMass Medical School

STRIDE - Year 2 Plans

• Actively recruiting eligible clinical trials at each collaborating site

• Completing intervention materials• eConsent

• Storytelling videos

• Case simulations for RA training

• Piloting intervention materials at UAB

June/July, 2018STRIDE Intervention

Implementation Begins

STRIDE Intervention Evaluation: Years 3-4 Plans • Quasi-experimental study

design:• Intervention: Integration

into ongoing clinical trials at UAB, UMass and Vanderbilt (n=3 trials)

• Comparison: Usual protocol (n=3 trials)

• Interrupted time-series design

• Assess rate of recruitment of under-represented minorities before and after the STRIDE intervention is introduced

Original inclusion criteria

• RCT

• >75 weeks

• N > 60

• Chronic disease

• New therapy vs. existing

• Drug trial

Revised inclusion criteria

• RCT

• >30 weeks

• N = 30-40

• > minimal risk

• Include as independent study if multi-site trial

RA travel for training

STRIDE timeline

PI receptivity to intervention

IRB modification for STRIDE overlay

Sponsor permission

Available studies

Study Eligibility Modifications

Based on Stakeholder Input

STRIDE Intervention- Future DisseminationGoal: Make STRIDE intervention widely available to the CTSA Network and

beyond

• Planned scientific reports

• STRIDE design

• Three-phase interrupted time-series study design

• CTSA Network Community Engagement-Community of Practice model

• REDCap consortium – dissemination of plugins, data dictionaries,

customizations

• CTSA conferences

• Trial Innovation Network – RIC toolkit, eConsent

• Community Campus Partnerships for Health

STRIDE Summary• Three CTSA collaboration - focused on critical gap in clinical

research

• Utilization of community investigators in all study phases

• Innovations • Consent including e-consent and storytelling• Research assistant training using simulation• Quasi-experimental design to test multi-modal intervention in practice

• Planned dissemination of tested materials across sites in CTSA network and beyond

Potential to improve informed consent process and enhance under-represented minority participation in research

STRIDE TEAM UMASS

• Stephenie Lemon, Ph.D.-PI

• Jeroan Allison, MD, MS-PI

• Karin Valentine Goins, MPH-

Program Manager

• Fred Jenoure-Community

Investigator

• German Chiriboga, MPH-

Storytelling

• Shauna Simpson, MS-Storytelling

• Isabelle Pierre-Louis, MPH-

Storytelling

• Melissa Fischer, MD-Simulation

• Melissa Puliafico, MBA-Simulation

• Hilarie Haley-Simulation

• Carol Bova, Ph.D.-IRB Chair

• Allison Blodgett, Ph.D.-IRB Director

VANDERBILT

• Paul Harris, Ph.D.-PI

• Colleen Lawrence, Ph.D.-Program Manager

• Jackie Simms-Community Investigator

• Daniel Cruz-Community Investigator

• Leah Dunkel, MPH-Project Coordinator

• Tiffany Israel, MSSW-Community Studios

• Yvonne Boyd, MS-IRB

UAB

• Ken Saag, MD, MSc-PI

• Maio Danila, Ph.D.-Co-I

• Liz Rahn-Ph.D.-Program Manager

• Clarice Davis-Community Investigator

• Amancia Alvarado Carrera-Community Investigator

• Josh Melnick-Project Coordinator

• Vanessa Champigny-IRB

CCPH

• Al Richmond, MSW-Consultant