This trial is active, not recruiting.

Condition recruitment of minorities
Treatments recruit intervention, control
Sponsor The University of Texas Health Science Center, Houston
Collaborator National Institute on Minority Health and Health Disparities (NIMHD)
Start date November 2011
End date April 2017
Trial size 60 participants
Trial identifier NCT01911208, NIMHD006941, U24MD006941


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods.
recruit intervention
Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.
Clinical sites can use which ever recruitment methods they prefer.
Non-intervention control.

Primary Outcomes

Percentage of racially/ethnically diverse participants (minorities) enrolled
time frame: Up to 2 years

Secondary Outcomes

Number of participant referrals
time frame: up to 2 years
Recruitment Activities
time frame: up to 2 years
Investigator and Coordinator Outcome expectations
time frame: up to 2 years
Qualitative Key Informant Interviews
time frame: up to 2 years
Participant Satisfaction
time frame: up to 2 years
Investigator and Coordinator Self-Efficacy
time frame: up to 2 years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title A Randomized Recruitment Intervention Trial
Principal investigator Barbara C. Tilley, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston.