A Randomized Recruitment Intervention Trial

Not Applicable

Completed

• Conditions: Recruitment of Minorities
• Interventions: Behavioral: RECRUIT intervention; Behavioral: Control

• Registration Number: NCT01911208
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Primary Completion: 2017-10-06
• Study Completion: 2017-10-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• site does not agree to be randomized;
• investigator or coordinator is under 18 years of age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RECRUIT intervention	RECRUIT intervention	Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods.
Control	Control	Clinical sites can use which ever recruitment methods they prefer.

Primary Outcome Measures

Name	Time	Method
Percentage of racially/ethnically diverse participants (minorities) enrolled	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 Outcome Measures

Name	Time	Method
Participant Satisfaction	up to 2 years	Potential/enrolled participant satisfaction with intervention and control trial site investigators and coordinators. Subjects will be given a satisfaction survey at screening and at every follow up visit.
Number of participant referrals	up to 2 years	Differences between intervention and control sites in number of participant referrals.
Investigator and Coordinator Self-Efficacy	up to 2 years	Change from baseline in physician investigator and coordinator self-efficacy(intervention sites only).
Investigator and Coordinator Outcome expectations	up to 2 years	Change from baseline in physician investigator and coordinator outcome expectations (intervention sites only).
Recruitment Activities	up to 2 years	Numbers and types of activities reported on recruitment logs by all sites.
Qualitative Key Informant Interviews	up to 2 years	Qualitative key informant phone interviews of the physician investigators and coordinators (intervention and control sites).

Trial Locations

Locations (1)

University of Texas Health Science Center School of Public Health; 🇺🇸 Houston, Texas, United States