Publication
Research Article
Background: Exercise is effective for managing symptoms and improving quality of life among people with multiple sclerosis (MS). However, African Americans are underrepresented in MS exercise trials, partly due to limited recruitment resources and avenues tailored to this demographic. This paper describes participant outreach and recruitment strategies for an ongoing, remotely delivered, culturally tailored exercise training program for African American individuals with MS.
Methods: Initially, a passive, indirect approach in the form of virtual outreach was employed, distributing study information through MS organizations, local experts, community leaders, patient representatives, and others in the southern United States. The effectiveness of these outreach and recruitment strategies in screening and enrolling was assessed using study coordinator and participant data.
Results: Over 15 months, the outreach methods successfully recruited 80 African Americans with MS into the clinical trial. Following a delayed start and slower initial recruitment, active outreach strategies were incorporated (eg, in-person engagements at local MS events, recreation and community centers, health care facilities, and schools). Additional tactics included study website enhancements, an informational video, email templates, and updates to the study flyer. Most participants (64.9%) were recruited through MS organizations, with virtual platforms (ie, websites, social media; 14.3%) and support groups (9.1%) also contributing to recruitment success.
Conclusions: This study demonstrates the effectiveness of a multipronged, experience-informed approach for successfully enrolling African Americans with MS into clinical trials. While MS organizations proved pivotal for recruiting and enrolling African Americans with MS, leveraging diverse recruitment outlets highlighted the importance of multifaceted strategies for engaging participants from minority backgrounds in research.
From the Department of Health Behavior, The University of Alabama at Birmingham, Birmingham, AL (WNN DP); Department of Kinesiology and Nutrition, The University of Illinois at Chicago, Chicago, IL (DG, VF, RWM); NORC at the University of Chicago, Chicago, IL (EF); Joi Life Wellness Group Multiple Sclerosis Center, Atlanta, GA (MJW); and the School of Kinesiology, University of Michigan, Ann Arbor, MI (DK-H). Correspondence: Whitney N. Neal, Department of Medicine, The University of Alabama at Birmingham, 1717 11th Ave S, Birmingham, AL, 35205; email: wneal@uabmc.edu. Robert W. Motl, PhD, Department of Kinesiology and Nutrition, The University of Illinois at Chicago, 1919 West Taylor St, Chicago, IL, 60612; email: robmotl@uic.edu.
Exercise training is highly effective for managing symptoms and improving health-related quality of life among persons with multiple sclerosis (MS),1 yet African American (AA) individuals with MS report lower levels of physical activity participation than White individuals.2,3 This may, in part, be associated with the observation that the majority of exercise training randomized controlled trials (RCTs) involving people with MS lack information on the race or ethnicity of participants (n = 44, 81%), and in the 9 studies that did collect those data, only 1.7% of participants self-identified as AA.4 There is an absence of evidence of the benefits of exercise training, and rehabilitation broadly, in AA individuals with MS, thereby undermining efforts for behavior change and health promotion.
One potential reason for the limited recruitment and inclusion of diverse samples of people with MS in exercise training RCTs may be that recruitment has often been achieved through a single avenue, typically an MS specialty clinic (84.7%) or an MS organization (13.2%).5 These avenues increase confidence that the people recruited will meet necessary diagnostic criteria for MS, but they may result in limited minority representation based on inequitable health care access across racial and ethnic groups. One review reported that AA and Hispanic people with neurological illnesses, including MS, were less likely to access outpatient neurological care and more likely to seek care in the emergency department compared with their White counterparts.6 Another study observed that AA participants were more likely to cite newspapers or magazines and others with MS as trustworthy sources of research information and less likely to trust universities compared with White participants.7 This suggests that relying on recruitment through MS clinics and organizations alone may impact the diversity of resulting samples.
Effective recruitment of AA participants with MS may require multipronged, nontraditional avenues such as collaboration with nonspecialist community providers and local agencies.5 We are aware of 2 papers involving exercise interventions for people with MS that provide detailed data on multipronged recruitment strategies.8,9 The papers highlight the use of consultant mail-outs, engagement of clinical partners, and trial awareness strategies; however, neither study described specific strategies for the inclusion of participants from underrepresented groups or included data on the race or ethnicity of the enrolled participants.8,9
To facilitate recruitment of AA individuals with MS into exercise training RCTs, and perhaps rehabilitation more broadly, the field requires greater awareness of the unique needs and preferences of the target population. This paper describes our experiences and lessons learned with outreach and recruitment strategies implemented in an ongoing RCT of a remotely delivered, culturally tailored exercise training program for AA persons with MS.10 We also report on the strategies that were most effective in screening and enrolling participants. These strategies may help future researchers recruit participants with MS from underrepresented populations into RCTs of exercise training and, perhaps, other rehabilitation research.
Trial Overview
The Targeted Exercise for African-Americans with MS (TEAAMS) study examines the effects of a 16-week, remotely delivered, culturally tailored aerobic and resistance exercise training program compared with an active control condition (stretching and flexibility) for immediate and sustained improvements in walking and other outcomes among AA persons with MS located in the southern portion of the US. The primary outcomes are walking dysfunction, as measured by the Multiple Sclerosis Walking Scale (MSWS-12), and mobility disability based on the Patient-Determined Disease Steps (PDDS). Outcomes are assessed remotely via Qualtrics at baseline, immediately post intervention (4 months), and 4 months post intervention (8 months). The University of Illinois at Chicago (UIC) Institutional Review Board approved this study, and all participants provided informed consent before enrollment. The TEAAMS study protocol has been described fully elsewhere.10
Eligibility Criteria
(E.F. and D.G.) before entering the trial. The primary criteria for inclusion and exclusion are included in Table S1. Participants who satisfy the initial eligibility assessment complete a second screening on walking dysfunction (MSWS-12 score of 25-75 on a 100-point scale) and mobility disability (PDDS score of 2-6 on an 8-point scale).
Table S1. TEAAMS Study Primary Inclusion and Exclusion Criteria
Recruitment Methods
The power analysis indicated enrollment of 80 participants (40 per group) to yield appropriate power for testing the time × condition interaction on the main trial outcome of walking impairment. The final enrollment goal is 100 participants (50 per group) based on an anticipated dropout rate of approximately 20%. The project is funded for 4 years, and the initial enrollment target was 5 participants per month over 20 months, with recruitment beginning in November 2022.
Recruitment Preparation Process
The sociocultural and historical factors surrounding the recruitment of underrepresented groups mentioned in the introduction influenced decisions about staffing, collaborators for recruitment efforts, and recruitment strategies. We began planning recruitment activities in July 2022 during a team meeting. The meeting included the study principal investigator (White male, Illinois resident) and co-investigator (White female, Alabama resident), project coordinator (Hispanic/Latino male, Illinois resident), outreach coordinator (Black female, Alabama resident), consultant (Black female, Michigan resident), and behavioral coach (Filipino female, Illinois resident). The principal investigator (PI; R.W.M.) described the purpose of the study, its eligibility requirements, and preliminary plans for recruitment (eg, development of a study name and logo). The group then brainstormed potential recruitment strategies and sources and discussed the rationale of our recruitment strategy (ie, existing health inequities among AA individuals with MS living in the southeast) and the logistics of virtual recruitment and outreach. We decided that study outreach activities to support participant recruitment would be performed by the University of Alabama at Birmingham (UAB) outreach coordinator (W.N.N.), under the supervision of the UAB-site PI (D.P.). The UIC would play a passive role in outreach and oversee participant screening, consenting, data collection, participant monitoring, intervention delivery, and data analysis and interpretation.
The initial and subsequent team meetings allowed for the development of an explicit marketing plan, discussion of logistics for participant screening and enrollment, and identification of additional recruitment sources, strategies, and methods. Participants would be recruited in groups or waves staggered at 4-month intervals, with the first wave of participants beginning the intervention in December 2022 and assessments for the final wave planned for November 2024. We aimed to screen 30 to 40 participants per wave and enroll 20 participants per wave for our sample size goal of 100 participants in 20 months.
Description of Our Original Outreach and Recruitment Strategy
Our outreach and recruitment strategy considered participant-level barriers for diverse populations, including lack of access to competent care, lack of awareness of clinical trial opportunities, mistrust, and systemic racism and discrimination. Because previous research suggests that AA individuals with MS are less likely to trust universities as sources of research information,7 the lead outreach coordinator did not share study information directly with AA individuals with MS. Instead, the original plan focused on a passive, indirect approach to recruitment in the form of virtual outreach to MS organizations, local experts in the disease area, trusted community leaders, and patient advocates. We anticipated initiating outreach and recruitment efforts one state at a time, starting with Alabama. See Table for an overview of the original recruitment strategy.
Table. TEAAMS Original Outreach and Recruitment Plan
To ensure recognition of the TEAAMS study, a logo (Figure S1) was developed to be included on all study materials for project branding and recognition. We created a study website to provide a brief overview of the study, eligibility information, and contact details for the study team (https://projectteaams.ahs .uic.edu/). Program materials were modified to include culturally appropriate content based on formative feedback from a national sample of AA individuals with MS.11 The modifications included (1) images of AAs in the program manual, newsletters, and videos; (2) resources and tips that address culturally relevant barriers to exercise; and (3) inspirational quotes rooted in faith and/or well-known quotes.
Figure S1. TEAAMS Study Logo
Modifications of the Original Recruitment Strategy
We anticipated that most individuals would be recruited through the methods described in Table 1, yet regular engagement among the research team, feedback from trusted community leaders and patient advocates, and trial-and-error provided opportunities to improve the scope and effectiveness of outreach efforts through modifications to the original recruitment strategy. The recruitment and enrollment period was extended from 20 to 22 months (November 2022 to September 2024) due to a delayed intervention start by 1 month and the initial recruitment rate being slower than expected. After the first wave of participants, we modified our recruitment and enrollment timeline (ie, enrollment staggered at 4-month intervals with 20 participants per wave) so that subsequent waves began at 2-month intervals with 6 to 10 participants per wave. Outreach and recruitment efforts were expanded to include all states per wave and targeted Southern states (ie, Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, and Texas). After the initial months of recruitment, we shifted our focus from contacting churches and health ministries to partnering with other community organizations, such as public libraries; local and AA-owned newspapers; and AA civil, social, or fraternal organizations. Virtual, primarily passive, outreach efforts were broadened to include active strategies (eg, face-to-face engagement at local recreation or community centers, senior centers, health care facilities, schools, and community or health fairs).
Modifications to outreach and recruitment materials included: (1) creating a short video describing the study, which was provided to champions and change agents (eg, faith-based organizations, social media influencers, community organizations) for online sharing (see supplementary content); (2) updating email templates used to contact champions and change agents to increase response rates (eg, using lay language for support group leaders, defining MS for non–disease-specific organizations, personalizing to location, adding headshot to signature); (3) adding a prescreening form to the study website that allows interested individuals to be contacted by the study coordinator; and (4) revising the language on the study flyer to highlight the benefits of participating in the study and including a QR code to direct participants to the website and prescreening form (Figure S2).
Figure S2. Iterations of the TEAAMS Study Recruitment Flyer
Outreach and Response Rates
As of February 2024, the outreach coordinators contacted 453 entities, including MS organizations, health care providers, community organizations, patient representatives, universities, and professional organizations. The response rates from the entities differed by category, with MS organizations (ie, National Multiple Sclerosis Society [NMSS], Multiple Sclerosis Association of America [MSAA], North American Research Committee on Multiple Sclerosis [NARCOMS], National African Americans with Multiple Sclerosis Registry [NAAMSR], Accelerated Cure Project [ACP], Multiple Sclerosis Views and News [MSV&N], and Multiple Sclerosis Foundation [MSF]) yielding the highest response rates. Those organizations supported our outreach efforts by sharing study information through emails, newsletters, and social media with registry members who met our basic eligibility criteria (ie, self-identify as Black or AA, live in 1 of the included states), or by providing direct access to self-help group leaders for further community outreach (MSF). Of the 24 directly contacted MSF self-help groups, 4 agreed to distribute study flyers, and 2 requested an information session. Both sessions were conducted via Zoom and included an introduction to general and MS-specific benefits of physical activity, recommendations for becoming and staying physically active, and an overview of the TEAAMS study, followed by a question-and-answer session. Additionally, the NMSS and MSV&N facilitated recruitment opportunities by inviting the lead outreach coordinator to local events (eg, fundraising walks, luncheons, and information sessions) to distribute TEAAMS study information. The NMSS also featured a blog post on their Momentum Magazine website describing how the TEAAMS study contributed to the need for more culturally competent research (https://www.nationalmssociety.org/news-and-magazine/momentum-magazine/research-and-science/breaking-the-cycle-of-exclusion). While few individually owned physical therapy clinics responded to our request to share study information with their clients, a partnership was established with a large physical therapy provider to distribute information to clinicians and patients at over 500 clinics throughout the South.
Of the 42 AA-owned newspapers contacted, one (Tennessee Tribune) published an article regarding the importance of exercise for AAs with MS and the TEAAMS study (https://tntribune.com/teaams-project-shines-light-on-ms-and-the-black -community/). Surprisingly, focusing on predominantly AA churches and health ministries was one of the less effective outreach strategies. Only 3 of the 51 African Methodist Episcopal and Missionary Baptist churches contacted responded to our email and/or phone calls. The pastors agreed to share the study flyer with congregation members, though it was unclear if any members were diagnosed with MS. Other community-based professional organizations, including Black in Neuro, the National Black Nurses Association, and the Council on Black Health, played a supportive role by disseminating study information within their professional networks.
Although quantifying the exact impact of distributing letters and study flyers to over 164 public libraries and medical facilities within our target area is difficult, we know that at least 4 neurology clinics shared study information with patients, as evidenced by participants mentioning how they learned about TEAAMS. Other less frequent approaches include sharing study information via universities with established community networks and distributing flyers via community health workers. We explored using paid traditional advertisements (ie, television, radio, newspaper) but ultimately found these options to exceed our study’s budget constraints. Nevertheless, we allocated a small portion of the budget to collaborate with an ethnic disease-specific organization (We Are ILL) to distribute the study flyer to their existing member registry that contained over 1300 individuals.
Screening and Enrollment Flow
As of February 2024, approximately 393 persons with MS have expressed interest in the study, and 354 (90.1%) were contacted by the project coordinator. Of the contacted individuals, 205 (57.9%) were scheduled for phone screenings, and 192 (54.2%) underwent eligibility assessments. Among those assessed, 88 were eligible for participation, and 8 declined to participate, resulting in the enrollment of 80 (41.7%) participants (Figure S3). Of the 104 individuals deemed ineligible for the study, the majority (71.2%) were excluded due to protocol-defined criteria associated with disease status and physical activity levels: 19 individuals (18.3%) did not meet the walking dysfunction criterion, 37 (35.6%) failed to meet both the ambulatory disability and walking dysfunction criteria, and 18 (17.3%) did not meet the physical activity, ambulatory disability, or walking dysfunction criteria. Two (1.9%) individuals were excluded based on not self-identifying as Black or African American, and 12 individuals (11.5%) were excluded as they did not self-identify as residing in the southern US.
Figure S3. Projected Number of Participants vs Cumulative Number of Participants
Recruitment Rate and Yield
Of the 393 interested participants, 268 (68.2%) completed the website prescreening form, and 111 (28.2%) contacted the project coordinator via email. Other initial contact methods included phone calls (n = 28, 7.1%) and referrals from neurologists (n = 6, 1.5%), with some potential participants utilizing multiple contact methods.
Recruitment methods for 40.1% (n = 77) of the 192 participants assessed for eligibility were identified (Figure). The yield varied by recruitment method, with referrals from disease-specific organizations (eg, NMSS, NAAMSR, ACP, MSAA, We Are ILL, and MSF newsletters) being the most effective (n = 50, 64.9%). Other effective recruitment methods included referrals from MS organization–affiliated support groups (n = 7, 9.1%) and virtual platforms, such as websites, Facebook, and disease-specific podcasts (n = 11, 14.3%).
Figure. Recruitment Strategy Effectiveness
This paper describes participant recruitment strategies implemented for a remotely delivered, culturally tailored exercise training program for AA individuals with MS and provides a resource for future researchers conducting inclusive rehabilitation research with underrepresented populations. Although the trial is ongoing, the TEAAMS study implemented a multipronged approach to recruitment that involved primarily passive outreach strategies to achieve 88.9% of our recruitment goal after 15 months (80 enrolled participants divided by 90 expected eligible and enrolled by February 2024).
Most participants (64.9%) were recruited via MS organizations, in line with a previous exercise training intervention for persons with MS.8 Although recruitment data were not available for most screened participants (60%), noticeable increases in interest were observed following the inclusion of study information in MS organization newsletters. A recent study indicated that MS organizations and MS websites/blogs were the top 2 sources for research information reported by people with MS, with no differences between racial and ethnic groups.7 Awareness of MS in AAs has prompted disease-specific organizations to provide more resources and programs catered to this segment of the MS population, likely contributing to increased response rates. Moreover, the variety in how participants learned of the study highlights the necessity for variable recruitment strategies. For instance, 7 individuals assessed for eligibility learned about the study from 1 of the 6 support groups that agreed to distribute our flyers.
Initial recruitment progressed more slowly than expected, but we ultimately achieved an average monthly enrollment rate of 5.3 participants. While seldom detailed in existing literature, this metric surpasses the enrollment rate of a comparable large-scale MS exercise trial, which reported 3.5 participants enrolled per month8; however, this study required regular in-person attendance, unlike our home-based training program. Physical activity and exercise training interventions involving other populations, such as AA women living in Alabama and older AA breast cancer survivors, have reported similar enrollment rates at 7.0 per month12 and 5.8 per month,13 respectively, suggesting that our recruitment rate is a realistic target for future remote exercise training interventions for AA adults with MS.
Lessons Learned
Intentionally Diverse Research Staff
Matching the race of the research staff with the desired participants is beneficial to study recruitment and retention14; other factors such as class, education, personality, and shared values may also influence the recruitment of AA individuals into clinical trials.15 Our study team was intentionally diverse across these dimensions to foster recruitment of a more diverse study sample. The lead outreach coordinator (W.N.N.), a lifelong resident of the AA community in Alabama, leveraged personal experiences and local knowledge to effectively support TEAAMS study recruitment. Team members, including consultants and coordinators, came from other underrepresented backgrounds, sharing similar knowledge and values. We strongly suggest that future research teams mirror the diversity, values, and experiences of the underrepresented communities they seek to engage in their recruitment efforts.
Multipronged, Nontraditional Recruitment Strategies
The development of our comprehensive, multifaceted recruitment and engagement plan aligns with recommendations to diversify clinical trials for people with MS.16 Our approach combined 7 passive strategies, from traditional partnerships with MS organizations to engaging local libraries and ethnic organizations, which is more than the reported 5 strategies utilized in previous MS research studies.5 Multiple passive, nontraditional approaches, such as engaging with nonspecialist community providers, local community agencies, and patient partners, were effective for identifying AAs with MS living in the South.
The study’s unique structure, with the lead site (UIC) in a supportive role and UAB directing outreach, enhanced recruitment efforts. This is similar to other studies using institutional support to reach underrepresented groups.17 The lead study site’s management of enrollment activities allowed the lead outreach coordinator to develop innovative recruitment materials and quickly pivot to integrate active outreach strategies. Although direct impact is challenging to quantify, this focused approach to outreach and engagement facilitated the identification of nearly 500 potential collaborators.
Weekly Videoconferences
Weekly videoconferences with the research team identified recruitment challenges and devised timely solutions. This adaptability led to the development of improved strategies for identifying potential participants. For instance, to counter recruitment slowdowns, we broadened our outreach to include local event attendance, which enhanced connections with disease-specific organizations, maintained study visibility, and uncovered new opportunities for support and recruitment.
Study Website and Online Prescreening Form
A prescreening form on the study website (https://projectteaams.ahs.uic.edu/) emerged as the top method for potential participant contact, with 68.2% using this method to indicate their interest. All recruitment materials, such as flyers and information in organizational newsletters, directed individuals to the study website, which explained the TEAAMS study in lay language, alongside details about the research team and online interest form (hosted via Qualtrics). Given the extensive online presence of MS resources,18 the large number of potential participants recruited via the website prescreening form suggests that this may be an effective strategy for increasing research engagement among AAs with MS.
Ineffective Recruitment Strategies
Despite previous research suggesting that faith-based settings could effectively recruit AAs into clinical research trials,19 our outreach attempts had limited success. Fewer than 6% of the African Methodist Episcopal and Missionary Baptist churches we contacted responded to our emails and/or phone calls, leading us to refocus our outreach efforts toward other community organizations, such as public libraries and local and AA-owned newspapers. The lack of success with churches might stem from relying on passive outreach methods without first establishing rapport with church leaders and members. In contrast, previous research suggests that a prior working relationship with churches may play a role in recruitment success,20 highlighting the importance of fostering relationships with the churches before requesting recruitment assistance.
Limitations
This study is not without limitations. Notably, we could only trace the enrollment source for 40.1% of participants. This gap stems from the omission of a referral question in the screening form; the coordinator collected such details post screening. Future research should include referral tracking in initial questionnaires to gauge recruitment strategy effectiveness. In addition, fewer than half of the participants assessed for eligibility were enrolled in the study, with reasons for ineligibility primarily related to not meeting inclusion criteria for walking dysfunction. Eligibility of interested participants may have been further limited by our requirement for internet access. Lastly, the focus on AA individuals with MS in the southern US likely limits the applicability of these results to other regions.
This paper highlights the importance of a flexible, comprehensive, multifaceted plan for recruitment and engagement of AAs with MS in exercise training RCTs. Despite the effectiveness of referrals from MS organizations, the diversity of how participants learned about the study showcases the success of integrating multiple traditional and nontraditional approaches. To our knowledge, this is the first paper to report recruitment strategies in an exercise RCT specifically for AAs with MS, offering a framework for future research to incorporate underrepresented groups in exercise RCTs and perhaps broader rehabilitation studies.
Financial Disclosures: The authors declare no conflicts of interest.
Funding/Support: This research is funded through a grant from the Bristol Myers Squibb Foundation (BMSF). All statements in this paper reflect those of the authors and do not necessarily reflect the views of the BMSF.
Prior Presentation: The study design and preliminary data from the clinical trial were presented as an oral presentation at the Consortium of Multiple Sclerosis Centers Annual Meeting; May 29-June 1, 2024; Nashville, Tennessee.
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