Recruitment of MinoritiesRECRUITNCT01911208
A Randomized Recruitment Intervention Trial
A study testing RECRUIT intervention in people with Recruitment of Minorities, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Recruitment of Minorities
- What is being tested?
- RECRUIT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 6 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- site does not agree to be randomized;
- investigator or coordinator is under 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center School of Public Health
Houston, Texas, 77030
About this study
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
Read the 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.
- Conditions
- Recruitment of Minorities
- Being tested
- RECRUIT intervention, Control
- Keywords
- Minority, Recruitment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECRUIT interventionBehavioural
Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.
ControlBehavioural
Non-intervention control.
| Study group | Role | What they receive |
|---|---|---|
| RECRUIT intervention | Experimental | Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods. Receives: Behavioral: RECRUIT intervention |
| Control | Experimental | Clinical sites can use which ever recruitment methods they prefer. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of racially/ethnically diverse participants (minorities) enrolled
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.
Measured: Up to 2 years
Secondary outcomes (6)
Number of participant referrals
Differences between intervention and control sites in number of participant referrals.
Measured: up to 2 years
Recruitment Activities
Numbers and types of activities reported on recruitment logs by all sites.
Measured: up to 2 years
Investigator and Coordinator Outcome expectations
Change from baseline in physician investigator and coordinator outcome expectations (intervention sites only).
Measured: up to 2 years
Qualitative Key Informant Interviews
Qualitative key informant phone interviews of the physician investigators and coordinators (intervention and control sites).
Measured: up to 2 years
Participant Satisfaction
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.
Measured: up to 2 years
Investigator and Coordinator Self-Efficacy
Change from baseline in physician investigator and coordinator self-efficacy(intervention sites only).
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startNov 2011
- Primary completion6 Oct 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recruitment of MinoritiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Barbara Tilley, The University of Texas Health Science Center, Houston
- Investigators
- Barbara C. Tilley, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911208
- Sponsor's protocol ID
- NIMHD006941
- Other IDs
- U24MD006941
- Acronym
- RECRUIT
- Status last verified
- Jun 2018
- First submitted
- 24 Jan 2013
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tilley BC, Mainous AG 3rd, Amorrortu RP, McKee MD, Smith DW, Li R, DeSantis SM, Vernon SW, Koch G, Ford ME, Diaz V, Alvidrez J; additional RECRUIT Trial Center and Parent Trials' investigators. Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial. Contemp Clin Trials. 2021 Oct;109:106519. doi: 10.1016/j.cct.2021.106519. Epub 2021 Jul 30.
PubMed 34333138DeSantis SM, Li R, Zhang Y, Wang X, Vernon SW, Tilley BC, Koch G. Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions. Clin Trials. 2020 Dec;17(6):627-636. doi: 10.1177/1740774520936668. Epub 2020 Aug 24.
PubMed 32838555
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Recruitment Intervention Trial
- ClinicalTrials.gov ID
- NCT01911208
- Acronym / sponsor ID
- RECRUIT / NIMHD006941
- Conditions
- Recruitment of Minorities
- Keywords
- Minority, Recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Nov 2011
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RECRUIT intervention | Experimental | Behavioral: RECRUIT interventionClinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods. |
| Control | Experimental | Behavioral: ControlClinical sites can use which ever recruitment methods they prefer. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- site does not agree to be randomized;
- investigator or coordinator is under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECRUIT interventionSites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation. | Behavioural | RECRUIT intervention |
| ControlNon-intervention control. | Behavioural | Control |
Primary outcome
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.
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Derived from this study: PubMed 34333138Tilley BC, Mainous AG 3rd, Amorrortu RP, McKee MD, Smith DW, Li R, DeSantis SM, Vernon SW, Koch G, Ford ME, Diaz V, Alvidrez J; additional RECRUIT Trial Center and Parent Trials' investigators. Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial. Contemp Clin Trials. 2021 Oct;109:106519. doi: 10.1016/j.cct.2021.106519. Epub 2021 Jul 30.
- Derived from this study: PubMed 32838555DeSantis SM, Li R, Zhang Y, Wang X, Vernon SW, Tilley BC, Koch G. Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions. Clin Trials. 2020 Dec;17(6):627-636. doi: 10.1177/1740774520936668. Epub 2020 Aug 24.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara C. Tilley, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECRUIT intervention in people with Recruitment of Minorities, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of racially/ethnically diverse participants (minorities) enrolled (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911208, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.