A Randomized Recruitment Intervention Trial (RECRUIT)

The University of Texas System (UT)

Status: Completed

Conditions: Recruitment of Minorities

Treatments: Behavioral: Control; Behavioral: RECRUIT intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01911208

NIMHD006941

U24MD006941 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

RECRUIT intervention

Experimental group

Description:

Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods.

Treatment:

Behavioral: RECRUIT intervention

Control

Experimental group

Description:

Clinical sites can use which ever recruitment methods they prefer.

Treatment:

Behavioral: Control