A Randomized Recruitment Intervention Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recruitment of Minorities
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Percentage of racially/ethnically diverse participants (minorities) enrolled
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to test a recruitment intervention to increase racial and ethnic diversity in clinical trials. The trial will be conducted in specialty care clinics. In RECRUIT minorities are those underrepresented in clinical trials and include:
- African Americans/ Blacks
- Asians
- Native Hawaiians/Other Pacific Islanders
- Hispanic/Latinos
- Native Americans/Alaskan Natives
Detailed Description
Low minority participation in clinical trials limits our ability to assess and address potential differences in therapeutic responses. To address the problem of low minority recruitment we are initiating a randomized trial of a recruitment intervention (RECRUIT) funded by the National Institute on Minority Health and Health disparities (NIMHD) to increase racial/ethnic diversity in clinical trials. Our specific approach is directed toward multi-site trials conducted at specialty clinics within academic centers with recruiting venues that include community practices or practices of colleagues in other areas of the academic center. The intervention will focus on approximately 60 specialty clinics. Clinical sites will be randomized to the intervention or control group. The target of the intervention will be the site investigators and clinical trial coordinators.
Investigators
Barbara Tilley
SPH Faculty - Biostatistics
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •site does not agree to be randomized;
- •investigator or coordinator is under 18 years of age.
Outcomes
Primary Outcomes
Percentage of racially/ethnically diverse participants (minorities) enrolled
Time Frame: Up to 2 years
Minorities as defined in this trial include those underrepresented in clinical trials and considered underrepresented by NIH criteria with the addition of those of Asian descent.
Secondary Outcomes
- Participant Satisfaction(up to 2 years)
- Number of participant referrals(up to 2 years)
- Investigator and Coordinator Self-Efficacy(up to 2 years)
- Investigator and Coordinator Outcome expectations(up to 2 years)
- Recruitment Activities(up to 2 years)
- Qualitative Key Informant Interviews(up to 2 years)