Addressing opioid misuse through community-engaged strategy development: study protocol of a randomized controlled trial.

BACKGROUND: Involving stakeholders in the research process facilitates collaboration, increasing understanding of factors influencing their wellbeing and motivating community action. Currently, there is a need for randomized controlled trials to evaluate the effectiveness of community-engaged research approaches for health, well-being, and engagement outcomes. In this study, we evaluate the effectiveness of both the SEED Method and a modified Delphi method in a participatory project to develop local strategies to address the opioid epidemic in three rural communities. The purpose of this study is to increase the level of evidence for community-engaged research methods through a randomized controlled trial. METHODS: Two communities will use the SEED Method and one will use a modified Delphi method. We aim to recruit a total of 144 participants (48 per community). The evaluation team will randomize participants to an intervention group or a control group. In addition, we will collect outcome data from the participatory research team members leading the projects in each county (n = 18) and from additional community members who participate in focus groups (n = 32). The primary outcome for all participants will be the change in self-reported civic engagement as measured by the total score on the Individual Mobilization Scale. DISCUSSION: In the context of participatory action to address opioid misuse in rural counties, this study will provide an understanding of the effectiveness of two community engagement methods for increasing civic engagement, as well as the extent to which participants successfully create locally tailored action strategies. The study will also explore how the observed effects differ depending on the participant's role in the project (stakeholder participant, community research team member, or focus group participant), which is an important consideration for participatory research.

Community-engaged research has become increasingly popular, yet there remains a need for randomized controlled trials that focus on testing the effectiveness of community-engaged research methods for outcomes relevant to the health, well-being, or civic engagement of individuals. Community members and researchers will benefit from data on the effectiveness of engagement methods. This will help them make decisions about which community engagement methods are best suited to project aims and participants' expectations. This research protocol describes a study comparing the effectiveness of two community engagement methods, the SEED Method and the Delphi method, and a control intervention in three rural counties. In each of the counties, participants will be randomized to an intervention group using a community-engaged method or a control group using standard survey methods. Participants will create local strategies for addressing opioid misuse and prioritize those strategies for use in community action planning. For study purposes, we define opioid misuse as a problematic pattern of using opioids (prescription or illicit). Community members participating in the study represent a range of relevant stakeholders, such as people with Opioid Use Disorder, family members of people who use opioids, community service and health care providers, substance use treatment and recovery providers, and local policymakers. In each county, the research is being conducted by a diverse team of community members led by a Cooperative Extension member. We will assess changes in the self-rated civic engagement of participants and compare the number and types of strategies created and prioritized using the three methods evaluated.

A rural community's perspective on the causes of and solutions to the opioid crisis in southern Virginia: a qualitative study.

INTRODUCTION: Opioid use disorder is a leading public health issue in the USA, with complex drivers requiring a multi-level response. Rural communities are particularly affected by opioid misuse. Due to variability in local conditions and resources, they require community-specific responses. The aim of this study was to gain insight into the perceptions, knowledge, and experiences of members of a rural community impacted by the opioid crisis to inform the development of local strategies to address the crisis. METHODS: Stakeholder focus groups were conducted by a participatory research team as part of a larger project using the Stakeholder Engagement in Question Development and Prioritization (SEED) Method. RESULTS: Key findings from the focus groups included the importance of family dynamics and social networks as risk and resiliency factors, addressing hopelessness as a preventive strategy, the need for holistic approaches to treatment, childhood exposure resulting in intergenerational substance use, the needs of overburdened healthcare providers, the expansion of long-term rehabilitation programs, and the need for judicial reform towards those with opioid use disorder. Specific and well-defined strategies are needed for more comprehensive methods to address the complexity of opioid use disorder. Understanding factors that contribute to opioid use disorder in rural communities through a stakeholder engagement process should be the first responsive strategy in developing actions. CONCLUSION: This study shows that rural community stakeholders provide important perspectives that can be useful in solving the drug epidemic in their neighborhoods. Their understanding of the internal dynamics of the communities' needs offers a unique roadmap in which prioritized actions can be customized and adapted for improving health outcomes.

Implementation and outcomes of the Balanced Living with Diabetes program conducted by Cooperative Extension in rural communities in Virginia.

INTRODUCTION: Adult onset diabetes is a significant health issue in rural communities that are disproportionately suffering from the health, social and financial costs of the disease. Despite this, over half of rural counties in the USA lack access to diabetes self-management programs, which are effective at improving diabetes management. The Cooperative Extension System (CES) is a nationwide education network that provides research-based information and programs in nearly 3000 counties in the USA to improve the health and wellbeing of rural and urban communities. This study evaluated the implementation and outcomes of a lifestyle management program, Balanced Living with Diabetes (BLD) conducted by community-based educators who are part of the CES in rural Virginia, to address the gap in diabetes education in these communities. BLD is grounded in social cognitive theory and has shown efficacy to modify dietary and physical activity behaviors resulting in improved glycemic control in people with type 2 diabetes. METHODS: The study evaluated the implementation and effectiveness of BLD programs conducted by the CES in 16 rural counties over 2 years. Program adoption, reach, context, and barriers and facilitators to implementation were evaluated through program outcome data and extension educator interviews. Program outcomes included change in weight, glycosylated hemoglobin (A1C), diabetes knowledge, self-management practices, diet and physical activity behaviors, and self-efficacy from baseline to 12-week assessment. RESULTS: Extension educators conducted 30 programs, reaching 290 residents, with a 58% mean retention rate. The program resulted in a significant increase in diabetes and food knowledge, fruit, vegetable, and whole grain intake, use of the plate method, exercise, and diabetes management self-efficacy. A1C decreased significantly in participants with diabetes (mean reduction=0.345±1.013; p=0.001). The program was conducted twice in 11 counties, and once in five counties. Barriers to program adoption in the five counties included limited community interest, competing program priorities of the extension educator, and loss of extension personnel to conduct the program. Participant communication materials and systems to enhance program sustainability were developed in response to educator feedback. Process evaluation indicated that the program was highly acceptable to extension educators and program participants. CONCLUSION: The CES is an effective network for implementation of diabetes lifestyle-management programs in underserved communities, and the BLD program is effective at increasing lifestyle behaviors and self-efficacy that improve glycemic control in people with type 2 diabetes. Collaboration by Virginia's CES with a variety of community partners, including healthcare and social service providers, increases the reach and sustainability of extension diabetes programs. The CES in the USA is well positioned to fill the gap in diabetes education in rural communities as part of a chronic care model.

Participatory Action Planning to Address the Opioid Crisis in a Rural Virginia Community Using the SEED Method.

The SEED Method is a multi-stakeholder approach that was created to involve diverse stakeholders in the development and prioritization of research questions using community-based participatory research (CBPR) principles. Here we describe an adaptation of the SEED Method that focuses on developing and prioritizing strategies for addressing a health problem and bringing stakeholders together to develop and implement community action plans based on those strategies. We describe steps for implementing the SEED Method for community action planning and the results of a case study in a rural Virginia community with high opioid prescription and mortality rates. A participatory research team worked with three groups of Topic stakeholders to gather data, develop conceptual models, and create and prioritize strategies for reducing prescription and non-prescription opioid misuse and overdoses. Each group came up with 19 to 25 strategies and prioritized their top five, which included actions, services or programs, strategies, policies, and system changes. Attendees at community action planning meetings reviewed the 15 prioritized strategies, proposed three additional strategies, and prioritized their top choices. Community stakeholders started four work groups to implement the selected strategies in collaboration with the research team.

Creating a Workplace Culture of Preventive Health: Process and Outcomes of the Colon Cancer-Free Zone at Virginia Cooperative Extension.

Colorectal cancer is the third leading cause of cancer death in the USA, yet is highly preventable and detectable at an early stage through screening. Virginia Cooperative Extension (VCE) implemented a worksite colon cancer awareness program to increase colorectal cancer screening rates and preventive lifestyle behaviors among its employees. The Colon Cancer-Free Zone program is designed using best practice principles of worksite health programs and includes information sessions covering the topics of colorectal cancer, screening guidelines, insurance coverage, and preventive lifestyle behaviors. It is conducted in a campaign format that includes a strategic communication strategy targeting relevant screening barriers and facilitators, peer champions, and incentives. The program was implemented with VCE employees statewide utilizing a web-based system for the information sessions, and resulted in broad participation, a significant increase in screening self-efficacy (4.15 ± 0.64 vs 3.81 ± 0.76, ρ = 0.006), changes in diet and physical activity (50% and 40% of participants, respectively), and a 20.6% increase in the employee colorectal cancer screening rate. A Colon Cancer-Free Zone toolkit was developed for use by Extension Agents to implement the program at worksites in their service communities.

A lung cancer research agenda that reflects the diverse perspectives of community stakeholders: process and outcomes of the SEED method.

PLAIN ENGLISH SUMMARY: There is a need for methods that engage lay people and other stakeholders, such as patients and healthcare providers, in developing research questions about health issues important to them and their communities. Involving stakeholders helps ensure that funding goes to research that addresses their concerns. The SEED Method engages stakeholders in a systematic process to explore health issues and develop research questions. Diverse groups of stakeholders participate at three levels: as collaborators that lead the process throughout, as participants who use their expertise to develop the questions, and as consultants who provide additional perspectives about the health topic. We used the SEED Method to engage 61 stakeholders from different socioeconomic and professional backgrounds to create research questions on lung cancer outcomes. Participants included cancer patients and caregivers, healthcare providers and administrators, and policymakers from a rural Virginia community. They developed causal models that diagrammed factors that influence lung cancer outcomes and the relationships between them. They used these models to develop priority research questions. The questions reflect the participants' diverse perspectives and address different areas of inquiry related to lung cancer outcomes, including access to care, support systems, social determinants of health, and quality of care. Participants felt well prepared to perform the project tasks because they had the opportunity to review lung cancer information, receive causal model and research question development training, and participate in facilitated group activities. The SEED Method can be used in a variety of settings and applied to any health topic of interest to stakeholders. ABSTRACT: Background Engagement of stakeholders in prioritization of health research can help ensure that funding is directed to research that reflects their concerns and needs. The Stakeholder Engagement in quEstion Development and Prioritization (SEED) Method is a multi-stakeholder methodology that uses principles of community engagement and causal modeling to develop health research questions that reflect the priorities of patients, clinicians, and other community stakeholders. We conducted a demonstration of the SEED Method to generate research questions on lung cancer outcomes, and to evaluate the process, outcomes, and effectiveness of the method for generating a research agenda that reflects diverse stakeholder perspectives. Methods The SEED Method engages community members at three levels: collaboration, participation, and consultation. We conducted a demonstration project from November, 2015 to July, 2016, in a rural Virginia community that was experiencing a significant disparity in lung cancer outcomes. A community research team led the project and selected three distinct stakeholder groups (Topic groups, TG) for participatory engagement in analysis of the health issue, causal modeling, and research question development. We evaluated the quality of stakeholder engagement and compared TG causal models and research questions to evaluate the diversity of stakeholder perspectives resulting from the methodology. Results The resulting research agenda poses questions on how a broad range of topics including access to care, support systems and coping mechanisms, social determinants of health, and quality of care impacts lung cancer outcomes. Participants felt well prepared for the tasks they were asked to perform due to the technical trainings and facilitated modeling and question development activities that are part of the SEED Method. The causal models and research questions developed by the Topic Groups reflected the diverse perspectives of the stakeholders. Conclusions The SEED Method has the potential to generate relevant stakeholder-centered research agendas on a variety of health-related topics, and to create community capacity for sustained research engagement.

Impact of physical activity and sleep quality on quality of life of rural residents with and without a history of cancer: findings of the Day and Night Study.

BACKGROUND: Lifestyle behaviors may impact quality of life (QoL). The relative impact of physical activity and sleep quality on QoL of individuals with and without a history of cancer living in underserved rural communities requires further study to inform health care and public health initiatives. METHODS: Individuals with and without a history of cancer were recruited from rural Virginia. We collected information on physical activity level (PAL), sleep quality (Pittsburgh Sleep Quality Index), and QoL (Short Form-36). Additional dimensions of physical activity and sleep were measured including ambient light exposure and sleep duration via Actiwatch2, and serum vitamin D and urine melatonin, which are markers of outdoor activity and sleep. RESULTS: A total of 124 cancer survivors and 48 cancer-free individuals were enrolled in the study. Mean age was 59 years, with the majority being women (89%) and Caucasian (76%). Breast cancer was the most common cancer (72%), and mean time from diagnosis to the survey was 8.1 years. Survivors were significantly less active, more likely to be inactive, and had significantly worse sleep quality and physical and mental health relative to cancer-free individuals (P<0.05). Quality of sleep and average sleep time were associated with physical (r=-0.371, P<0.001; r=-0.327, P<0.000) and mental health (r=-0.442, P=<0.001; r=-0.265, P<0.004), as was PAL (r=0.181, P=0.019; r=0.288, P=0.003). Self-reported outdoor activity was associated with mental health (r=0.233, P=0.003) and vitamin D3 (r=0.193, P=0.015). No association was found between melatonin, sleep quality, and QoL. Sleep quality, cancer status, body mass index, and sleep time were predictive of physical health, while sleep quality, sleep time, and outdoor activity were predictive of mental health. CONCLUSION: Quality of sleep is a significant predictor of mental and physical health, and important for cancer survivors who experience poorer QoL. Outdoor activity should be encouraged to improve mental health and vitamin D status, and interventions to improve sleep for those with poor sleep quality should be considered in cancer survivorship planning.

Community perceptions and utilization of a consumer health center.

The purpose of this study was to understand factors that may affect the usage of a consumer health center located in a public library. More specifically, the authors wanted to know what health resources are of interest to the community, what patrons' perceptions of their experience at the center are, and finally, how staff can increase utilization of the center. In general, perceptions of the center were positive. The findings support that participants appreciate efforts to provide health information in the public library setting and that utilization could be improved through marketing and outreach.

Reaching Hard to Reach Populations with Hard to Communicate Messages: Efficacy of a Breast Health Research Champion Training Program.

A Breast Health Research Champion training program was a developed targeting self-identified community breast health advocates from a predominant African-American community with a significant breast cancer mortality disparity. Twelve individuals completed the program that provided training in breast cancer risk and screening, breast cancer research, biospecimen in cancer research, and human research subject protection. The training emphasized four key messages to be disseminated to the community. Trainees hosted a minimum of two social chats with individuals from their social networks and functioned as community researchers, acquiring consent and gathering follow-up data from attendees. Trainees reached 199 individuals from their social networks, and chats were diverse in the venue selected, mode of message transmission, and the audience reached. Post/pre questionnaire data from attendees at the chats showed significant improvement in knowledge, attitudes, and intended behaviors as it relates to breast cancer screening, clinical research, and biospecimen in research. Forty percent of attendees provided 4-week follow-up information. Of respondents eligible for mammography, 38 % had taken action to be screened, and 86 % of respondents had spoken about the information to someone else in their social network. Trainees expressed feelings of empowerment after completing the project, "feeling like the expert," and all trainees were surprised at the enthusiastic response from attendees of their chats. Trainees continued to disseminate the information learned from the training program during the 6 months following the training, reaching an additional 786 individuals in the community.

Physical activity and sedentary behavior of cancer survivors and non-cancer individuals: results from a national survey.

Increasing physical activity and decreasing sedentary behavior are associated with a higher quality of life and lower mortality rates for cancer survivors, a growing population group. Studies detailing the behavior of cancer survivors are limited. Therefore, we investigated physical activity and sedentary behavior of cancer survivors using data from the National Health and Nutrition Examination Survey (NHANES) 2007-2010. Participants were those who provided physical activity and sedentary behavior data. Those who were pregnant, <20 years old, or <3 years from their cancer diagnosis were excluded. A cancer case was a self-reported diagnosis by a physician. We identified 741 cancer survivors and 10,472 non-cancer participants. After adjustment for age, race, gender, education status, body mass index, and smoking status, cancer survivors (n = 10,472) reported significantly longer duration of sedentary behavior (OR = 1.42, 95% CI (1.12, 1.80) for 8 or more hours, p-value for trend = 0.09), compared to non-cancer participants (n = 741). They also reported non-significant increases in maximum intensity, duration, frequency, and energy expenditure, whereas they reported significant increases in moderate intensity (OR = 1.26, 95% CI (1.01, 1.57)), moderate frequency (1-4 times/week) (OR = 1.32, 95% CI (1.00, 1.74)), and moderate energy expenditure (4018.5-7623.5 kcal) (OR = 1.30, 95% CI (1.00, 1.71)) of physical activity, compared to non-cancer participants. These patterns are similar for breast and prostate cancer survivors, with prostate cancer survivors more likely to engage in physical activity for more than one hour per day (OR = 1.98, 95% CI (1.05, 3.71)). Our findings suggest that cancer survivors tend to have more physical activity, but they are also more likely to engage in sedentary behavior.

Opportunities to reduce cancer barriers: community town halls and provider focus groups.

This paper presents the findings from town hall meetings held with community residents and focus groups with health care providers. A total of five town halls (N = 139) were conducted. Four were conducted in English and a fifth was conducted in Spanish to obtain the input of the local Hispanic community. Surveys were provided to town hall participants to assess their perceptions of cancer and screening as well as their cancer screening behaviors. Participants were asked questions designed to determine local gaps and needs in health and cancer care, and their attitudes regarding breast cancer resources, education, treatment, and clinical trials. Additionally, four focus groups (N = 45) were held with a wide range of providers to obtain their perspectives on barriers to breast cancer screening, local cancer prevention and care, and clinical trials. Results indicate gaps in local resources and support services, particularly in terms of education and integrated care.

Cocaine reduces thymic endocrine function: another mechanism for accelerated HIV disease progression.

Thymulin is a thymic peptide important for the maturation and differentiation of immature thymocytes, which have been found to be depressed in patients with low-level CD4(+) cell recovery despite viral control. Substance use is associated with faster progression of HIV disease, which has been ascribed to poor adherence to antiretroviral medication. Recent findings of an association between cocaine use and decline in CD4(+) cell counts independent of antiretroviral adherence indicate alternative mechanisms for disease progression. We evaluated the relationship between thymulin activity, CD4(+) and CD8(+) cell counts and the CD4(+)/CD8(+) ratio, and the covariate effects of substance use cross-sectionally in 80 HIV(+) active substance users and over 12 months in 40 participants. Thymulin activity was analyzed in plasma using a modification of the sheep rosette bioassay. Thymulin activity was negatively associated with cocaine use (ß = -0.908,95% CI: -1.704, -0.112; p = 0.026). Compared to those who do not use cocaine, cocaine users were 37% less likely to have detectable thymulin activity (RR = 0.634, 95% CI: 0.406, 0.989 p = 0.045) and were 75 times more likely to show a decrease in thymulin activity (OR = 74.7, 95% CI: 1.59, 3519.74; p = 0.028) over time. CD4(+) cell count was positively associated with thymulin activity (ß = 0.127, 95% CI: 0.048,0.205; p = 0.002), detectable thymulin activity was 2.32 times more likely in those with a CD4 cell count ≥200 cells/µl (RR = 2.324, 95% CI: 1.196, 4.513, p = 0.013), and those with an increase in CD4 cell counts were more likely to show an increase in thymulin activity (OR = 1.02, 95% CI: 1.00, 1.034; p = 0.041) over time. Thymulin activity is predictive of HIV disease progression and is depressed in cocaine users independent of antiretroviral treatment (ART) and HIV viral load. Understanding the mechanisms for accelerated HIV disease progression provides opportunities to find alternative strategies to counteract immunosuppression.

Alcohol use accelerates HIV disease progression.

The effects of alcohol abuse on HIV disease progression have not been definitively established. A prospective, 30-month, longitudinal study of 231 HIV(+) adults included history of alcohol and illicit drug use, adherence to antiretroviral therapy (ART), CD4(+) cell count, and HIV viral load every 6 months. Frequent alcohol users (two or more drinks daily) were 2.91 times (95% CI: 1.23-6.85, p = 0.015) more likely to present a decline of CD4 to

Crack-cocaine use accelerates HIV disease progression in a cohort of HIV-positive drug users.

BACKGROUND: HIV infection is prevalent among substance abusers. The effects of specific illicit drugs on HIV disease progression have not been established. We evaluated the relationship between substances of abuse and HIV disease progression in a cohort of HIV-1-positive active drug users. METHODS: A prospective, 30-month, longitudinal study was conducted on 222 HIV-1 seropositive drug users in Miami, FL. History of illicit drug, alcohol, and medication use, CD4+ cell count, and viral load were performed every 6 months. RESULTS: Crack-cocaine users were 2.14 times [95% confidence interval (CI): 1.08 to 4.25, P = 0.029] more likely to present a decline of CD4 to

Quality of life, symptomatology and healthcare utilization in HIV/HCV co-infected drug users in Miami.

HIV/HCV co-infection is becoming one of the main causes of death in HIV+ persons. We determined quality of life, clinical symptoms and health care utilization in HIV mono-infected and HIV/HCV co-infected chronic drug users. After consenting 218 HIV+ drug users, a physical examination and questionnaires on demographics, quality of life, drugs of abuse, and healthcare utilization were completed. Blood was drawn for HCV status, CD4 cell count, HIV viral load, CBC and chemistry. HIV/HCV co-infected participants had significantly higher risk of having poorer perceived outlook and health, presented significantly more frequent depression and physical symptoms, and used significantly more healthcare services than those infected with HIV only, after adjusting for age, gender, ethnicity, CD4 cell count, and viral load. Diminished quality of life in the HIV/HCV co-infected group was explained by increased frequency of depression, physical symptoms, healthcare utilization, and poor access to HCV treatment in this population.

Coronary Heart Disease (CHD) Risk Factors and Metabolic Syndrome in HIV-Positive Drug Users in Miami.

The frequency of coronary heart disease (CHD) is increasing among HIV seropositive persons. This phenomenon may be related to HIV disease itself, the use of antiretroviral medications and increased length of survival, or the synergism of these factors. In this study we have calculated the 10-year CHD risk estimate and the prevalence of metabolic syndrome in a cohort of 118 HIV seropositive chronic drug users, including those who are on HAART with or without protease inhibitors (PI). The results showed that the 10-year coronary heart disease risk among the HIV seropositive drug users was 4.8 ± 5.7, which is within the range of results published for other HIV infected cohorts. The 10-year CHD risk was significantly higher in men (5.9±6.1, p<0.001) than in women (1.7±2.4), due to their gender and the pre-menopausal mean age of the women (39.4±7.3 years of age), despite a significantly higher rate of abdominal obesity (54.8% in women vs. 8.1% in men, p<0.001) and lower HDL (61.3% in women vs. 40% in men, p=0.042). The rate of metabolic syndrome among our female HIV seropositive drug users was significantly higher (29% vs 10.3%, p=0.013) compared to men (10.3%). Participants with metabolic syndrome had a significantly higher 10-year CHD risk (27.8% vs. 10.2%, p=0.041) and higher mean BMI (28.6 ± 4.1 vs. 24.2±4, p<0.001) than those without the syndrome. The predominant proportion of the cohort had a high viral load, suggesting that their use of illicit drugs has an influence on either adherence or effectiveness of antiretroviral medication. Increased viral load was significantly associated with metabolic syndrome (OR=2.23, 95% CI:1.12, 4.47; p=0.023), high fasting glucose (OR=1.61, 95% CI: 1.02, 2.55; p=0.042) and low HDL levels (OR=1.41, 95% CI: 1.01, 1.98; p=0.046), after controlling for age gender, smoking, PI exposure, BMI and CD4. HAART with or without PI did not significantly impact the 10-year CHD risk estimate or metabolic syndrome in this cohort. The estimated effect of PI, however, was positively and significantly related to triglyceride levels (effect estimate=95.81; 95% CI:39.40, 152.21; p<0.01) after controlling for age, gender, smoking, viral load, CD4 cell count and BMI. Heavy use of cigarettes and crack/cocaine was inversely associated with obesity (OR=0.84, 95% CI:0.67, 0.99; p=0.049; OR=0.43, 95% CI:0.19, 0.98; p=0.044, respectively), while use of marijuana tended to be associated with increased central obesity (p=0.08). Heavy cigarette smoking was significantly associated with low HDL (OR=3.06, 95% CI:1.18; 7.95, p=0.02). The significant association of higher viral load with CHD risk indicates that controlling viral load may be important in reducing CHD risk in HIV infected drug users.