Status:
COMPLETED
A Randomized Recruitment Intervention Trial
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Recruitment of Minorities
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
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 initiat...
Eligibility Criteria
Inclusion
- Inclusion:
- A parent trial must :
- have a coordinating Center willing to allow their Clinical Sites to participate;
- be studying be studying a condition that requires community or health system physician referral
- be studying an intervention where the recruitment approach cannot be made directly to minority community members
- need to increase recruitment of racially/ethnically diverse participants\* to the trial as demonstrated by current trial progress or historical data from other trials in the same disease;
- be a Phase II or Phase III trial
- be conducted in at least six multiple sites;
- expect each Clinical Site to recruit at least 10 participants;
- be funded by a sponsor (NIH or pharmaceutical company or other) that has a strong commitment to recruiting racially/ethnically diverse subjects;
- be willing to have investigators and coordinators attend a special training meeting (at RECRUIT expense);
- require randomization to intervention or control (could be best medical care or active control or placebo or other type of control);
- provide transportation costs for trial participants who need assistance in getting to trial sites or use some RECRUIT reimbursement for this purpose.
- The clinical site must
- be a funded Clinical Site in the parent trial;
- be located in an area where at least 20% of the population within 30 miles in the age group under study in the parent trial are from diverse populations.
- Exclusion Criteria:
- site does not agree to be randomized;
- investigator or coordinator is under 18 years of age.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01911208
Start Date
November 1 2011
End Date
October 6 2017
Last Update
June 29 2018
Active Locations (1)
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1
University of Texas Health Science Center School of Public Health
Houston, Texas, United States, 77030