The RIC Recruitment & Retention Materials Toolkit - a resource for developing community-informed study materials.

Clinical trials face many challenges with meeting projected enrollment and retention goals. A study's recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit.

Comparative Evaluation of 2 Work Experience Approaches for Predominantly Black Youth in a Rural Community: Implications for Public Health Workforce Development.

CONTEXT: In order to create a more diverse workforce, there is a need to involve historically excluded youth in public health-related work. Youth involvement in asset-based work experience approaches is especially relevant for rural areas with workforce shortages. OBJECTIVE: To explore the public health workforce development implications of community-based career exploration and asset mapping work experience from the perspective of Black youth. DESIGN: We used qualitative in-depth interviews with youth, aged 14 to 22 years, who participated in a work experience program anchored in several rural counties in southeastern United States. A phenomenological lens was applied for qualitative analyses with iterative, team-based data coding. Participants were also surveyed pre- and postprogram to supplement findings. PROGRAM: A rural community-based organization's work experience program consisted of 2 tracks: (1) Youth Connect-a career exploration track that included work placement within community agencies; and (2) MAPSCorps-a track that employs youth to conduct asset mapping for their community. RESULTS: We interviewed 28 of 31 total participants in the 2 tracks. We uncovered 4 emergent profiles in how youth described shifts in their perceptions of community: (1) Skill Developers; (2) Community Questioners; (3) Community Observers; and (4) Community Enthusiasts. In comparing between tracks, youth who participated in work experience that involved asset mapping uniquely described increased observation and expanded view of community resources and had greater increases in research self-efficacy than youth who participated only in career exploration. CONCLUSION: Asset mapping work experience that is directly placed in rural communities can expose Black youth to and engage them in essential public health services (assessing and mobilizing community assets) that impact their community. This type of program, directly integrated into rural communities rather than placed near academic centers, could play a role in creating a more diverse public health workforce.

"If you're in a community together, then you're basically a family": Perceptions of community among a predominantly African-American/Black youth cohort in a semi-rural region in the Southeastern United States.

Geographic racism gives rise to health inequities that impact communities in detrimental ways. Southern ethnic minority groups, particularly African American/Black semi-rural communities, are subject to especially unjust outcomes in health, education, and wealth. Asset-based community development (ABCD) is a way of engaging with communities in participatory and positive ways that center community voices as expert. Youth can participate in ABCD, are sensitive to the ways in which their communities are structured, and have insights as to how to improve the places they live. We undertook a qualitative interview study which included a cognitive mapping exercise with 28 youth to understand how African American/Black youth who had participated in an ABCD-informed summer program conceptualized community and preferences about where they lived. Using a phenomenological approach to qualitative analysis, our study revealed that many youth defined community as a combination of people and place, enjoyed engaging with unique resources in their communities as well as seeking peace and quiet, experienced hardships as "something everybody knows" when observing constraints on their communities, and were committed to their communities and interested in seeing-and participating in-their flourishing. Our study provides a nuanced and contemporary understanding of the ways in which African American/Black semi-rural youth experience community which can contribute to cyclical asset-based development strategy aimed at empowering young people and improving health outcomes in resilient communities.

A Cluster Randomized Trial of a Community-Based Intervention Among African-American Adults: Effects on Dietary and Physical Activity Outcomes.

Evidence of the effectiveness of community-based lifestyle behavior change interventions among African-American adults is mixed. We implemented a behavioral lifestyle change intervention, Heart Matters, in two rural counties in North Carolina with African-American adults. Our aim was to evaluate the effect of Heart Matters on dietary and physical activity behaviors, self-efficacy, and social support. We used a cluster randomized controlled trial to compare Heart Matters to a delayed intervention control group after 6 months. A total of 143 African-American participants were recruited and 108 completed 6-month follow-up assessments (75.5%). We used mixed regression models to evaluate changes in outcomes from baseline to 6-month follow-up. The intervention had a significant positive effect on self-reported scores of encouragement of healthy eating, resulting in an increase in social support from family of 6.11 units (95% CI [1.99, 10.22]) (p < .01). However, intervention participants also had an increase in discouragement of healthy eating compared to controls of 5.59 units (95% CI [1.46, 9.73]) among family (p < .01). There were no significant differences in changes in dietary behaviors. Intervention participants had increased odds (OR = 2.86, 95% CI [1.18, 6.93]) of increased frequency of vigorous activity for at least 20 min per week compared to control participants (p < .05). Individual and group lifestyle behavior counseling can have a role in promoting physical activity levels among rural African-American adults, but more research is needed to identify the best strategies to bolster effectiveness and influence dietary change. Trial Registration: Clinical Trials, NCT02707432. Registered 13 March 2016.

Understanding African American youth and adult perspectives on sex education in rural North Carolina.

African American youth in the US rural South are at elevated risk for poor sexual health outcomes, including sexually transmitted infections and teen pregnancy. Historically, the southeastern USA has lagged behind in providing comprehensive sexuality-based education in secondary school, which may contribute to poor reproductive and sexual health outcomes. This study aims to understand the perspectives of African American youth and adults on comprehensive sexuality-based education in rural North Carolina. Twenty-four individuals (12 youth and 12 adults) participated in both semi-structured interviews and small discussion groups. Data were analysed and coded using inductive and deductive approaches to thematic analysis. Results indicated that comprehensive sexuality-based education was highly desirable; however, current efforts were viewed as insufficient. While both young people and adults agreed that abstinence was the most desirable path for youth, participants also acknowledged young people's autonomy in engaging in sexual activity and suggested that comprehensive sexuality-based education was needed to protect against unintended consequences. The findings of this study have practical implications for addressing challenges associated with providing sexuality-based education to African American youth in rural communities and offers suggestions regarding directions for future research.

Adaptation of an Evidence-Based Cardiovascular Health Intervention for Rural African Americans in the Southeast.

BACKGROUND: African Americans (AA) living in the southeast United States have the highest prevalence of cardiovascular diseases (CVD) and rural minorities bear a significant burden of co-occurring CVD risk factors. Few evidence-based interventions (EBI) address social and physical environmental barriers in rural minority communities. We used intervention mapping together with community-based participatory research (CBPR) principles to adapt objectives of a multi-component CVD lifestyle EBI to fit the needs of a rural AA community. We sought to describe the process of using CPBR to adapt an EBI using intervention mapping to an AA rural setting and to identify and document the adaptations mapped onto the EBI and how they enhance the intervention to meet community needs. METHODS: Focus groups, dyadic interviews, and organizational web-based surveys were used to assess content interest, retention strategies, and incorporation of auxiliary components to the EBI. Using CBPR principles, community and academic stakeholders met weekly to collaboratively integrate formative research findings into the intervention mapping process. We used a framework developed by Wilstey Stirman et al. to document changes. RESULTS: Key changes were made to the content, context, and training and evaluation components of the existing EBI. A matrix including behavioral objectives from the original EBI and new objectives was developed. Categories of objectives included physical activity, nutrition, alcohol, and tobacco divided into three levels, namely, individual, interpersonal, and environmental. CONCLUSIONS: Intervention mapping integrated with principles of CBPR is an efficient and flexible process for adapting a comprehensive and culturally appropriate lifestyle EBI for a rural AA community context.

Convergence Despite Divergence: Views of Academic and Community Stakeholders about the Ethics of Community-Engaged Research.

Purpose: Stakeholder engagement and community-engaged research (CEnR) are recognized as approaches necessary to promote health equity. Few studies have examined variations in stakeholder perspectives on research ethics despite the potential for meaningful differences. Our study examines the association between stakeholders' characteristics and their perception of the importance of 15 stakeholder-developed CEnR ethical statements. Design: Quantitative analysis of close-ended Delphi survey. Participants: We recruited a national, non-random, purposive sample of people who were eligible if they endorsed conducting CEnR in public health or biomedical fields. Participants were recruited from publicly available information, professional email distributions, and snowball sampling. Main Outcome Measures: We designed our close-ended Delphi survey from the results of 15 CEnR ethical statements, which were developed from a consensus development workshop with academic and community stakeholders. Results: 259 participants completed the Delphi survey. The results demonstrated that stakeholders' characteristics (affiliation, ethnicity, number of CEnR relationships, and duration of CEnR partnerships) were not associated with their perception of the importance of 15 ethical statements. Conclusions: The strong agreement among stakeholders on these broad, aspirational ethical statements can help guide partnerships toward ethical decisions and actions. Continued research about variability among stakeholders' ethics perspectives is needed to bolster the capacity of CEnR to contribute to health equity.

Heart Matters: a study protocol for a community based randomized trial aimed at reducing cardiovascular risk in a rural, African American community.

BACKGROUND: African Americans living in the rural south have the highest prevalence of cardiovascular disease (CVD) risk in the United States. Given this geographic and racial disparity, intervention implementation needs to be evaluated for effectiveness and feasibility with African Americans in the rural south. METHODS: The trial developed out of a community-based participatory research partnership, Project GRACE, and community partners who are collaborators throughout the study. Heart Matters is a randomized stepped wedge trial that will assess the effectiveness of a 12-month behavioral change intervention adapted from PREMIER, an evidence-based treatment targeting multiple CVD risk factors. 140 participants will be recruited through 8 community- or faith-based organizations to participate in the intervention. Through matched pair randomization, organizations will be randomized to begin immediately after baseline data collection (Arm 1) or delayed 6 months (Arm 2). Data collection will occur at baseline, 6, 12, and 18 months. The primary outcome is change in body weight. In addition to assessing effectiveness, the study will also evaluate process and feasibility outcomes through quantitative and qualitative data collection. DISCUSSION: This study will contribute to CVD prevention research and likely have a positive impact on the rural, African American community where the trial occurs. Our study is unique in its use of community partnerships to develop, implement, and evaluate the intervention. We expect that this approach will enhance the feasibility of the trial, as well as future dissemination and sustainability of the intervention. TRIAL REGISTRATION: Clinical Trials, NCT02707432 . Registered 13 March 2016.

Stakeholder-driven, consensus development methods to design an ethical framework and guidelines for engaged research.

Increasingly, researchers seek to engage communities, patients, and stakeholders as partners in the process and products of health research. However, there is no existing stakeholder-driven ethical framework for such engaged scholarship. We employed an iterative, stakeholder-engaged method to develop a data-driven framework for the ethical review and conduct of engaged scholarship. We used consensus development conference methods and a modified Delphi survey to engage 240 community members, ethicists, and academic researchers. This multi-staged process produced a framework with 4 domains: vision of equitable and just research, relationship dynamics, community-informed risk/benefits assessment, and accountability. Within the framework, 4 cross-cutting considerations and 15 statements explicate the stakeholders' priorities for the ethical review and conduct of engaged scholarship. Though the findings are promising, the study is limited in that it focuses on stakeholder perspectives, but does not actually evaluate or apply the findings in the field. The stakeholder-engaged framework provides a platform for further articulation of ethical practices and policy for engaged scholarship.

Understanding the relationship between religiosity and caregiver-adolescent communication about sex within African-American families.

Caregiver-adolescent communication about sex plays a critical role in the sexual socialization of youth. Many caregivers, however, do not engage their youth in such conversations, potentially placing them at risk for negative sexual health outcomes. Lack of caregiver-adolescent communication about sex may be particularly harmful for rural African American youth, as they often report early sex initiation and are disproportionately impacted by STIs. Moreover, sexual communication may be particularly challenging for families with strong religious backgrounds, potentially affecting the occurrence and breadth of topics covered during communication. Study aims were to: determine whether there was a relationship between caregiver religiosity and type of topics covered during communication about sex (e.g., general sexual health vs. positive aspects of sexuality) among 435 caregivers of early adolescent, African American youth; and if so, identify factors that might explain how religiosity affects communication about sex. Results indicated that caregiver religiosity was positively associated with communication about general, but not positive aspects of sexuality for caregivers of males. Attitudes towards communication about sex and open communication style mediated the relationship. There was no association between religiosity and communication about sex for caregivers of females. The findings from this study could provide a base to better understand and support the sexual socialization process within religious, African American families.

Evaluating Teach One Reach One-An STI/HIV Risk-Reduction Intervention to Enhance Adult-Youth Communication About Sex and Reduce the Burden of HIV/STI.

PURPOSE: Parents and caregivers play an important role in sexual socialization of youth, often serving as the primary source of information about sex. For African American rural youth who experience disparate rates of HIV/sexually transmitted infection, improving caregiver-youth communication about sexual topics may help to reduce risky behaviors. This study assessed the impact of an intervention to improve sexual topic communication. DESIGN: A Preintervention-postintervention, quasi-experimental, controlled, and community-based trial. SETTING: Intervention was in 2 rural North Carolina counties with comparison group in 3 adjacent counties. SUBJECTS: Participants (n = 249) were parents, caregivers, or parental figures for African American youth aged 10 to 14. INTERVENTION: Twelve-session curriculum for participating dyads. MEASURES: Audio computer-assisted self-interview to assess changes at 9 months from baseline in communication about general and sensitive sex topics and overall communication about sex. ANALYSIS: Multivariable models were used to examine the differences between the changes in mean of scores for intervention and comparison groups. RESULTS: Statistically significant differences in changes in mean scores for communication about general sex topics ( P < .0001), communication about sensitive sex topics ( P < .0001), and overall communication about sex ( P < .0001) existed. Differences in change in mean scores remained significant after adjusting baseline scores and other variables in the multivariate models. CONCLUSIONS: In Teach One Reach One intervention, adult participants reported improved communication about sex, an important element to support risk reduction among youth in high-prevalence areas.

Community Advisory Boards Guiding Engaged Research Efforts within a Clinical Translational Sciences Award: Key Contextual Factors Explored.

BACKGROUND: Engaging stakeholders in research carries the promise of enhancing the research relevance, transparency, and speed of getting findings into practice. By describing the context and functional aspects of stakeholder groups, like those working as community advisory boards (CABs), others can learn from these experiences and operationalize their own CABs. Our objective is to describe our experiences with diverse CABs affiliated with our community engagement group within our institution's Clinical Translational Sciences Award (CTSA). We identify key contextual elements that are important to administering CABs. METHODS: A group of investigators, staff, and community members engaged in a 6-month collaboration to describe their experiences of working with six research CABs. We identified the key contextual domains that illustrate how CABS are developed and sustained. Two lead authors, with experience with CABs and identifying contextual domains in other work, led a team of 13 through the process. Additionally, we devised a list of key tips to consider when devising CABs. RESULTS: The final domains include (1) aligned missions among stakeholders (2) resources/support, (3) defined operational processes/shared power, (4) well-described member roles, and (5) understanding and mitigating challenges. The tips are a set of actions that support the domains. CONCLUSIONS: Identifying key contextual domains was relatively easy, despite differences in the respective CAB's condition of focus, overall mission, or patient demographics represented. By contextualizing these five domains, other research and community partners can take an informed approach to move forward with CAB planning and engaged research.

Adolescents and parental caregivers as lay health advisers in a community-based risk reduction intervention for youth: baseline data from Teach One, Reach One.

The purpose of the current study is to describe the demographic, behavioral, and psychosocial characteristics of adolescent and caregiver lay health advisers (LHAs) participating in an intervention designed to reduce risk behaviors among rural African-American adolescents. Teach One, Reach One integrates constructs from the Theory of Planned Behavior and Social Cognitive Theory. It acknowledges that changing the sexual behaviors of African-American adolescents requires changing one's knowledge, attitudes, normative beliefs about the behavior of peers, and self-efficacy regarding adolescent sexual behavior, parent-teen communication about sex, and healthy dating relations among adolescents. Study participants completed baseline questionnaires assessing demographics and psychosocial determinants (knowledge, attitudes, perceived social norms, and self-efficacy) of sexual behaviors. Sixty-two adolescent and caregiver dyads participated. Caregivers included biological parents, legal guardians, or other parental figures. Strengths and areas in need of improvement were determined using median splits. Few adolescents had initiated sex. Their strengths included high levels of open parent-teen communication; positive attitudes and normative beliefs regarding both sex communication and healthy dating relationships; and high knowledge and self-efficacy for healthy dating behaviors. Areas needing improvement included low knowledge, unfavorable attitudes, poor normative beliefs, and low self-efficacy regarding condom use. Caregiver strengths included positive attitudes, normative beliefs, and self-efficacy for sex communication; positive attitudes and self-efficacy for condom use; and low acceptance of couple violence. Areas needing improvement included low levels of actual communication about sex and low knowledge about effective communication strategies and condom use. The current study highlights the value of assessing baseline characteristics of LHAs prior to intervention implementation, as it enables a better understanding of the key characteristics necessary for planning and implementing interventions, as well as engaging in targeted training activities.

Applying Cognitive Interviewing to Inform Measurement of Partnership Readiness: A New Approach to Strengthening Community-Academic Research.

BACKGROUND: Partnerships between academic and community-based organizations (CBOs) can richly inform the research process and speed translation of findings. Although immense potential exists to co-conduct research, a better understanding of how to create and sustain equitable relationships between entities with different organizational goals, structures, resources, and expectations is needed. OBJECTIVE: We sought to engage community leaders in the development of an instrument to assess CBOs' interest and capacity to engage with academia in translational research partnerships. METHODS: Leaders from CBOs partnered with our research team in the design of a 50-item instrument to assess organizational experience with applying for federal funding and conducting research studies. Respondents completed a self-administered, paper/pencil survey and a follow-up structured cognitive interview (n = 11). A community advisory board (CAB; n = 8) provided further feedback on the survey through guided discussion. Thematic analysis of the cognitive interviews and a summary of the CAB discussion informed survey revisions. RESULTS: Cognitive interviews and discussion with community leaders identified language and measurement issues for revision. Importantly, they also revealed an unconscious bias on the part of researchers and offered an opportunity, at an early research stage, to address imbalances in the survey perspective and to develop a more collaborative, equitable approach. CONCLUSIONS: Engaging community leaders enhanced face and content validity and served as a means to form relationships with potential community co-investigators in the future. Cognitive interviewing can enable a bidirectional approach to partnerships, starting with instrument development.

Data Collection and Management in Community Engaged Research: Lessons Learned From Two Community-Based Participatory Research Partnerships.

BACKGROUND: Data collection and data management (DCDM) within community-engaged research (CEnR) requires special considerations that differ from those of traditional research. To date, little guidance exists to preemptively help community-academic partnerships anticipate and resolve DCDM issues that may arise. OBJECTIVE: We sought to provide recommendations for DCDM based on two CEnR research projects. METHODS: We used a case study design to describe the DCDM process and lessons learned that were generated through formal and informal discussions between community and academic partners. LESSONS LEARNED: We identified 4 key lessons: 1) CEnR requires a flexible, iterative approach to DCDM, 2) there are trade-offs to having a flexible DCDM approach, 3) responsibilities for DCDM should consider the skill sets and priorities of all partners, and 4) nuances of DC within CEnR has important implications for human subjects and ethics training. CONCLUSIONS: Based on our lessons learned, we provide recommendations for how to approach DCDM within CEnR.

Beyond incentives for involvement to compensation for consultants: increasing equity in CBPR approaches.

BACKGROUND: Community-based participatory research (CBPR) strives for equitable collaboration among community and academic partners throughout the research process. To build the capacity of academia to function as effective research partners with communities, the North Carolina Translational and Clinical Sciences Institute (NC TraCS), home of the University of North Carolina at Chapel Hill (UNC-CH)'s Clinical and Translational Sciences Award (CTSA), developed a community engagement consulting model. This new model harnesses the expertise of community partners with CBPR experience and compensates them equitably to provide technical assistance to community-academic research partnerships. OBJECTIVES: This paper describes approaches to valuing community expertise, the importance of equitable compensation for community partners, the impact on the community partners, opportunities for institutional change, and the constraints faced in model implementation. METHODS: Community Experts (CEs) are independent contractor consultants. CEs were interviewed to evaluate their satisfaction with their engagement and compensation for their work. LESSONS LEARNED: (1) CEs have knowledge, power, and credibility to push for systems change. (2) Changes were needed within the university to facilitate successful consultation to community-academic partnerships. (3) Sustaining the CE role requires staff support, continued compensation, increased opportunities for engagement, and careful consideration of position demands. (4) The role provides benefits beyond financial compensation. (5) Opportunities to gather deepened relationships within the partnership and built collective knowledge that strengthened the project. CONCLUSIONS: Leveraging CE expertise and compensating them for their role benefits both university and community. Creating a place for community expertise within academia is an important step toward equitably including the community in research.

The role of public schools in HIV prevention: perspectives from African Americans in the rural South.

Though African-American youth in the South are at high risk for HIV infection, abstinence until marriage education continues to be the only option in some public schools. Using community-based participatory research methods, we conducted 11 focus groups with African-American adults and youth in a rural community in North Carolina with high rates of HIV infection with marked racial disparities. Focus group discussions explored participant views on contributors to the elevated rates of HIV and resources available to reduce transmission. Participants consistently identified the public schools' sex education policies and practices as major barriers toward preventing HIV infection among youth in their community. Ideas for decreasing youth's risk of HIV included public schools providing access to health services and sex education. Policymakers, school administrators, and other stakeholders should consider the public school setting as a place to provide HIV prevention education for youth in rural areas.

Project GRACE: a staged approach to development of a community-academic partnership to address HIV in rural African American communities.

The HIV epidemic is a health crisis in rural African American communities in the Southeast United States; however, to date little attention has been paid to community-academic collaborations to address HIV in these communities. Interventions that use a community-based participatory research (CBPR) approach to address individual, social, and physical environmental factors have great potential for improving community health. Project GRACE (Growing, Reaching, Advocating for Change and Empowerment) uses a CBPR approach to develop culturally sensitive, feasible, and sustainable interventions to prevent the spread of HIV in rural African American communities. This article describes a staged approach to community-academic partnership: initial mobilization, establishment of organizational structure, capacity building for action, and planning for action. Strategies for engaging rural community members at each stage are discussed; challenges faced and lessons learned are also described. Careful attention to partnership development has resulted in a collaborative approach that has mutually benefited both the academic and community partners.

Intervention mapping as a participatory approach to developing an HIV prevention intervention in rural African American communities.

Southeastern states are among the hardest hit by the HIV epidemic in this country, and racial disparities in HIV rates are high in this region. This is particularly true in our communities of interest in rural eastern North Carolina. Although most recent efforts to prevent HIV attempt to address multiple contributing factors, we have found few multilevel HIV interventions that have been developed, tailored or tested in rural communities for African Americans. We describe how Project GRACE integrated intervention mapping (IM) methodology with community-based participatory research (CBPR) principles to develop a multilevel, multigenerational HIV prevention intervention. IM was carried out in a series of steps from review of relevant data through producing program components. Through the IM process, all collaborators agreed that we needed a family-based intervention involving youth and their caregivers. We found that the structured approach of IM can be adapted to incorporate the principles of CBPR.