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Underrepresentation of racial and ethnic minority populations in clinical research persists in the United States, highlighting the unmet ideals of generalizability and equity of research findings and products. Previous systematic reviews exploring various facets of this phenomenon concluded that community engagement with minority groups may effectively promote recruitment and retention, but the ways in which community-engaged approaches have been used for recruitment have not been examined. We performed a scoping review of the literature to identify studies of community-engaged recruitment processes. The search resulted in 2842 articles, of which 66 met inclusion criteria. These articles demonstrated a relatively large literature base of descriptive studies conveying details of community engagement approaches to enhance recruitment of minority research participants. We summarize key aspects of current practices across the spectrum of community engagement. A gap in the literature is the relative lack of the comparative studies among different engagement strategies.
A relatively large number of descriptive studies identified by this scoping review suggest that community engagement approaches can improve the integration of minority populations into clinical trials.
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The majority of studies engaged diverse community stakeholders in recruitment processes, often through study-specific or long-term community advisory boards.
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Studies described recruitment activities across the spectrum of community engagement: informing communities, consulting with communities, involving communities, collaborating with communities, and co-leadership with communities.
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There is a paucity of comparative studies on the effectiveness of the different levels of community engagement for research recruitment of racial and ethnic minority groups.
Underrepresentation of racial and ethnic minority populations in clinical research has received considerable attention in the United States. Representative participation in research is important to address health inequities and to address gaps in the literature on effective prevention and treatment strategies for minority populations. The 1993 National Institutes of Health Revitalization Act required reporting of racial and ethnic demographic data to the extent that meaningful differences in outcomes may be explored while establishing mechanisms to enhance minority recruitment.
National Institutes of Health Revitalization Act of 1993: Act to Amend the Public Health Service Act to Revise and Extend the Programs of the National Institutes of Health, and for Other Purposes. Pub L 103-43, 42 USC (1993).
The more things change, the more they stay the same: a study to evaluate compliance with inclusion and assessment of women and minorities in randomized controlled trials.
Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual; renewing the case for enhancing minority participation in cancer clinical trials.
These stark differences persist despite willingness to participate in research among racial and ethnic minority groups that is generally comparable to white populations,
A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders.
In response, there has been considerable research aimed at deriving optimal strategies for minority recruitment to clinical trials. Previous systematic reviews have assessed recruitment strategies for minority populations
What are successful recruitment and retention strategies for underserved populations? examining physical activity interventions in primary care and community settings.
Each of these reviews concluded that community engagement with minority groups may effectively promote recruitment and retention.
Community-engaged research (CEnR) is “a process of working collaboratively with groups of people who are affiliated by geographic proximity, special interests, or similar situations with respect to issues affecting their well-being,”
Centers for Disease Control and Prevention Principles of Community Engagement.
2nd ed. Department of Health and Human Services, National Institutes of Health, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry, Clinical and Translational Science Awards,
Washington, DC2011
The importance of CEnR was underscored by a 2013 Institute of Medicine report that recommended direct incorporation of community voice in all aspects of translational research.
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences; Board on Health Sciences Policy; Institute of Medicine The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research.
Different CEnR approaches can be conceived as occurring across a continuum from low levels of engagement (eg, informing a community about an intervention) to co-ownership (eg, all facets of an intervention are co-led by community and academic partners).
Participatory research approaches tend to involve high levels of engagement through equitable partnerships with community members throughout the research process and include the related disciplines of community-based participatory research (CBPR),
among others. A prior systematic review assessed the effectiveness of recruitment within CBPR trials and found that CBPR approaches were effective in increasing minority recruitment to research.
Although CEnR is recognized as an important series of approaches for improving minority recruitment and participation in the research process, the ways in which these approaches have been successfully engaged have not been systematically examined. Therefore, we performed a scoping review of the literature to address this knowledge gap.
Methods
This scoping review was planned, conducted, and reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).
Scoping reviews are a type of knowledge synthesis that “follow a systematic approach to map evidence on a topic and identify main concepts, theories, sources, and knowledge gaps.”
In this review, we included articles that discussed recruitment of research participants to clinical research within the United States. Eligible articles must have referred to minority groups explicitly and a community engagement framework for recruitment or retention. No limit on study design was implemented.
Information Sources and Literature Search
We developed a literature search strategy in consultation with an expert reference librarian, who conducted the electronic search in March 2018. We searched the following databases: Ovid MEDLINE In-Process and Other Non-Indexed Citations and Ovid MEDLINE 1946 to March 2018; Cochrane Central Register of Controlled Trials; and Scopus 2005 to March 2018. We used a controlled vocabulary supplemented with key words for recruitment of minority research participants to clinical research as well as key words to include the full spectrum of CEnR approaches.
Selection of Sources of Evidence
Each item of the literature identified in the database search was screened by 2 independent reviewers in 2 phases. In the first phase, titles and abstracts were examined to exclude nonrelevant studies. Any discrepancies in this first screening phase were automatically deemed as included to avoid missing any relevant articles. In the second phase, the full-text version of each study was screened, taking into account the inclusion criteria. Discrepancies in the second screening phase were resolved by consensus. The screening phases utilized an online standardized and piloted form using DistillerSR software (Evidence Partners). Consistency among reviewers was monitored throughout the process to ensure a robust screening of the identified literature.
Data Extraction
Studies that were deemed relevant and included from the screening phase went into the data abstraction phase. The following items were extracted from these studies: study design, study focus (recruitment, retention, or both), study population(s), study setting(s), number of minority research participants recruited, study description, community engagement intervention for minority recruitment, level of community engagement, and major findings from the study. Levels of community engagement (inform, consult, involve, collaborate, co-lead) were adapted from the International Association for Public Participation’s Spectrum of Public Participation,
The data extraction form was developed with consensus among the reviewers supported by methodology expertise and was adjusted in an iterative process. Although risk of bias assessment was built into the data extraction process, we do not report it in this review because nearly all of the included studies were descriptive.
Synthesis of Results
Overarching themes of the included studies were synthesized. We grouped studies and summarized them according to level of community engagement, main CEnR recruitment approaches, and key findings. Broad findings from each study were grouped under their respective theme.
Results
Search Results
The search resulted in 2842 articles. Screening of abstracts excluded 2396, and full-text screening excluded an additional 380 articles. This process resulted in 66 articles that met inclusion criteria (Figure).
FigurePreferred Reporting Items for Systematic Reviews and Meta-Analyses study flowchart.
The vast majority of studies were descriptive (n=62), ie, they documented observations or lessons learned about minority recruitment to clinical research studies. The remaining 4 studies were analytic observational studies or mixed-methods studies of recruitment processes. The studies outlined details of CEnR strategies for recruitment to randomized trials (n=24),
The AAKOMA Project Adult Advisory Board The significance of strategic community engagement in recruiting African American youth & families for clinical research.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
Lessons learned from community-led recruitment of immigrants and refugee participants for a randomized, community-based participatory research study [published correction appears in J Immigr Minor Health. 2016;18(5):1246].
Associations between culturally relevant recruitment strategies and participant interest, enrollment and generalizability in a weight-loss intervention for African American families.
Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: the POWER study.
Community recruitment process by race, gender, and SES gradient: lessons learned from the Community Health and Stress Evaluation (CHASE) Study experience.
The Communication, Awareness, Relationships and Empowerment (C.A.R.E.) model: an effective tool for engaging urban communities in community-based participatory research.
Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study.
Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.
HPTN 061 Study Group Engaging, recruiting, and retaining black men who have sex with men in research studies: don't underestimate the importance of staffing—lessons learned from HPTN 061, the BROTHERS study.
Increasing ethnic minority participation in substance abuse clinical trials: lessons learned in the National Institute on Drug Abuse's Clinical Trials Network.
Cultur Divers Ethnic Minor Psychol.2011; 17: 345-356
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
Engaging Hmong adults in genomic and pharmacogenomic research: toward reducing health disparities in genomic knowledge using a community-based participatory research approach.
Engaging Hmong adults in genomic and pharmacogenomic research: toward reducing health disparities in genomic knowledge using a community-based participatory research approach.
for future recruitment efforts. In this context, studies sometimes used qualitative and/or quantitative approaches to evaluate the recruitment strategies. Several studies noted initial difficulties with minority recruitment that improved after CEnR approaches were used.
However, only one study compared the effects of different community engagement approaches on recruitment outcomes, finding that incorporating sociocultural values into recruitment was superior to nonsociocultural strategies and that recruitment through community partnerships led to the highest recruitment of target populations.
Associations between culturally relevant recruitment strategies and participant interest, enrollment and generalizability in a weight-loss intervention for African American families.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
Lessons learned from community-led recruitment of immigrants and refugee participants for a randomized, community-based participatory research study [published correction appears in J Immigr Minor Health. 2016;18(5):1246].
Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: the POWER study.
Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study.
HPTN 061 Study Group Engaging, recruiting, and retaining black men who have sex with men in research studies: don't underestimate the importance of staffing—lessons learned from HPTN 061, the BROTHERS study.
The AAKOMA Project Adult Advisory Board The significance of strategic community engagement in recruiting African American youth & families for clinical research.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
Lessons learned from community-led recruitment of immigrants and refugee participants for a randomized, community-based participatory research study [published correction appears in J Immigr Minor Health. 2016;18(5):1246].
Associations between culturally relevant recruitment strategies and participant interest, enrollment and generalizability in a weight-loss intervention for African American families.
Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: the POWER study.
Community recruitment process by race, gender, and SES gradient: lessons learned from the Community Health and Stress Evaluation (CHASE) Study experience.
The Communication, Awareness, Relationships and Empowerment (C.A.R.E.) model: an effective tool for engaging urban communities in community-based participatory research.
Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study.
Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.
HPTN 061 Study Group Engaging, recruiting, and retaining black men who have sex with men in research studies: don't underestimate the importance of staffing—lessons learned from HPTN 061, the BROTHERS study.
Increasing ethnic minority participation in substance abuse clinical trials: lessons learned in the National Institute on Drug Abuse's Clinical Trials Network.
Cultur Divers Ethnic Minor Psychol.2011; 17: 345-356
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
Lessons learned from community-led recruitment of immigrants and refugee participants for a randomized, community-based participatory research study [published correction appears in J Immigr Minor Health. 2016;18(5):1246].
Increasing ethnic minority participation in substance abuse clinical trials: lessons learned in the National Institute on Drug Abuse's Clinical Trials Network.
Cultur Divers Ethnic Minor Psychol.2011; 17: 345-356
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
Engaging Hmong adults in genomic and pharmacogenomic research: toward reducing health disparities in genomic knowledge using a community-based participatory research approach.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
Lessons learned from community-led recruitment of immigrants and refugee participants for a randomized, community-based participatory research study [published correction appears in J Immigr Minor Health. 2016;18(5):1246].
Increasing ethnic minority participation in substance abuse clinical trials: lessons learned in the National Institute on Drug Abuse's Clinical Trials Network.
Cultur Divers Ethnic Minor Psychol.2011; 17: 345-356
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
The AAKOMA Project Adult Advisory Board The significance of strategic community engagement in recruiting African American youth & families for clinical research.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
Associations between culturally relevant recruitment strategies and participant interest, enrollment and generalizability in a weight-loss intervention for African American families.
Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study.
Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.
HPTN 061 Study Group Engaging, recruiting, and retaining black men who have sex with men in research studies: don't underestimate the importance of staffing—lessons learned from HPTN 061, the BROTHERS study.
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
Engaging Hmong adults in genomic and pharmacogenomic research: toward reducing health disparities in genomic knowledge using a community-based participatory research approach.
The Communication, Awareness, Relationships and Empowerment (C.A.R.E.) model: an effective tool for engaging urban communities in community-based participatory research.
Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
The AAKOMA Project Adult Advisory Board The significance of strategic community engagement in recruiting African American youth & families for clinical research.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: the POWER study.
Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
Engaging Hmong adults in genomic and pharmacogenomic research: toward reducing health disparities in genomic knowledge using a community-based participatory research approach.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
Engaging Hmong adults in genomic and pharmacogenomic research: toward reducing health disparities in genomic knowledge using a community-based participatory research approach.
Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.
Lessons learned from community-led recruitment of immigrants and refugee participants for a randomized, community-based participatory research study [published correction appears in J Immigr Minor Health. 2016;18(5):1246].
Community recruitment process by race, gender, and SES gradient: lessons learned from the Community Health and Stress Evaluation (CHASE) Study experience.
The AAKOMA Project Adult Advisory Board The significance of strategic community engagement in recruiting African American youth & families for clinical research.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
The Communication, Awareness, Relationships and Empowerment (C.A.R.E.) model: an effective tool for engaging urban communities in community-based participatory research.
Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.
Effective recruitment strategies and community-based participatory research: Community Networks Program Centers' recruitment in cancer prevention studies.
Cancer Epidemiol Biomarkers Prev.2014; 23: 416-423
Engaging Hmong adults in genomic and pharmacogenomic research: toward reducing health disparities in genomic knowledge using a community-based participatory research approach.
Most of the studies engaged diverse community stakeholders in recruitment processes, referred to in most studies as CABs. The role of CABs ranged from providing advice to the study team about recruitment strategies (consult) to direct participation in recruitment of participants or stakeholders (involve) to decision-making capacity (collaboration) and co-leadership of activities. In all of the included studies, CAB composition included members of the population targeted for recruitment, both in terms of racial/ethnic group and disease group, if applicable. This typically took the form of community members from the specific location targeted for recruitment, eg, clergy members or lay leaders from a place of worship. Some CABs also included representatives from CBOs representing important stakeholders. Compensation of CAB members was not typically discussed; those articles that did described hourly or project-based remuneration to individual CAB members or to the organization they represented.
Levels of Community Engagement
Levels of community engagement, their definitions, and themes for how CEnR was operationalized at each level for recruitment of minority research participants are presented in the Table. The full description of community-engaged activities for recruitment and retention of every study is summarized in Supplemental Table 2 (available online at http://www.mayoclinicproceedings.org).
TableLevels of Community Engagement for Recruitment
Level of community engagement
Definition
Recruitment approaches
Recruitment findings
Inform
Communities are provided with information about research opportunities
Study team conducts outreach activities in community locations to promote the study
Onsite activities allow members of target population to learn about the study and to establish relationships with the study team
Consult
Feedback is solicited from communities for research procedure(s)
CAB consulted about recruitment strategy, materials, and incentives CABs utilized as “gatekeepers” for access to registry of minority participants interested in research
CAB input substantially changes initial recruitment plan CAB brings community voice to the research and recruitment process CAB facilitates connection with difficult to reach stakeholders
Involve
Communities informed and participate in research procedures
CAB directly participates in recruitment through social networks and by applying sociocultural knowledge. Besides direct recruitment, this may include connection to key stakeholders
Involvement of trusted community members and leaders is essential for reaching target populations Incorporates contextual factors that may impact recruitment
Collaborate
Partnerships are formed with communities to work together on all procedures
Partnerships with CBOs and/or unaffiliated community members who work with target populations; typically take the lead on recruitment efforts, sometimes with help of research training Strategic planning with community partners around recruitment Community partners guide health- (and disease-) related education/advocacy activities that also promote research participation
Collaboration fosters trust between community and academic partners, thereby breaking down a key barrier to recruitment Recruitment is successful when CBOs are the “face” of the research project Recruitment is successful when there are specific targeted benefits to community partners, often beyond the research Partnerships often precede funding
Co-lead
Robust partnership with communities who hold decision-making power over all research procedures
Established partnership norms and principles guide co-ownership of processes and resources by community and academic partners Community partners lead recruitment through integration of local knowledge Development of a long-term community-based research and recruitment infrastructure
Community partners and participants become advocates for the study Participatory partnerships that extend beyond individual studies can lead to sustainable recruitment efforts Recruitment strategies emerge from communities Reliance on community strengths and resources Often mutual benefits beyond research Partnership often precedes project conception
CAB = community advisory board; CBO = community-based organization.
The study teams conducted outreach activities in community locations to promote the study. Findings were that on-site activities allowed members of the target population to learn about the study and to establish relationships with the study team.
Consult
Consultation was classified as the CEnR strategy for recruitment of minority participants in 13 studies.
GRACE Study Group Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the Gender, Race And Clinical Experience study.
Community recruitment process by race, gender, and SES gradient: lessons learned from the Community Health and Stress Evaluation (CHASE) Study experience.
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