Expanding the food environment framework to include family dynamics: A systematic synthesis of qualitative evidence using HIV as a case study.

Food environment changes in low- and middle-income countries are increasing diet-related noncommunicable diseases (NCDs). This paper synthesizes the qualitative evidence about how family dynamics shape food choices within the context of HIV (Prospero: CRD42021226283). Guided by structuration theory and food environment framework, we used best-fit framework analysis to develop the Family Dynamics Food Environment Framework (FDF) comprising three interacting dimensions (resources, characteristics, and action orientation). Findings show how the three food environment domains (personal, family, external) interact to affect food choices within families affected by HIV. Given the growing prevalence of noncommunicable and chronic diseases, the FDF can be applied beyond the context of HIV to guide effective and optimal nutritional policies for the whole family.

Returning individual research results to participants: Values, preferences, and expectations.

Background/objective: Disclosing individual research results to participants is not standard practice. The return of individual research results to participants may increase recruitment, retention, and engagement in research. This study's objective was to explore the preferences, expectations, and experiences of research participants receiving individual research results. Methods: A mixed-methods approach, consisting of semi-structured interviews and a health literacy assessment, was used with participants enrolled in a cohort study. The interviews were analyzed to produce an understanding of current experiences. Using descriptive analyses, responses were compared to identify alignments and divergences among participants. Results: Forty-three English-speaking and 16 Spanish-speaking participants enrolled. Ninety-eight percent of participants wanted to receive their individual research results. Seventy-five percent of participants reported they shared results with their healthcare providers. More participants aged 18-65 reported the need to follow up with their provider (70%) as compared to participants > 65 (20%). Two-thirds of participants reported a positive experience receiving their research results; however, 22% reported anxiety and worry. Most participants (69%) described the electronic medical record (EMR) as their preferred method for receiving their results. Yet only 50% of Spanish speakers preferred receiving research results through the EMR compared to 77% of English speakers. Participants with low health literacy preferred receiving study results in person or by phone. Conclusion: Research participants value receiving their individual research results, and this may increase recruitment and retention within the research enterprise. While more research is needed, the lessons learned from this study lay the groundwork for developing best practices and policies around the return of individual research results.

Identifying anticipated challenges when implementing group care: Context-analyses across seven countries to develop an anticipated challenges framework.

PROBLEM: Despite increasing interest in Group Care worldwide, implementation is challenging. BACKGROUND: Group Care is an evidence-based perinatal care model including three core components: health assessment, interactive learning, and community building. It has several advantages for service users and providers compared to individual perinatal care. AIM: We aimed to identify anticipated challenges when implementing Group Care, and to develop a supporting tool based on these challenges. METHODS: Context analyses through Rapid Qualitative Inquiries were conducted in 26 sites in seven countries to gain insight into the anticipated challenges when implementing Group Care. Data triangulation and investigator triangulation were applied. The context analyses generated 330 semi-structured interviews with service users and other stakeholders, 10 focus group discussions, and 56 review meetings with the research teams. FINDINGS: We identified six surface structure anticipated challenges categories (content, materials, facilitators, timing, location, group composition), and five deep structure anticipated challenges categories (health assessment, scheduling Group Care into regular care, enrolment, (possible) partner organisations, financials) occurring in all participating sites, leading to the development of the Anticipated Challenges Framework. CONCLUSION: Completing the Anticipated Challenges Framework raises awareness of anticipated challenges if sustainable Group Care implementation is to succeed and encourages the initiation of a concrete action plan to tackle these challenges. Application of the framework may offer important insights to health systems administrators and other key stakeholders before implementing Group Care. In the medium- and long-term, insights gained may lead to greater possibilities for sustainability and to the most cost-effective approaches for implementing Group Care.

Barriers and Facilitators to Integrating Acupuncture into the U.S. Health Care System: A Scoping Review.

Background: Acupuncture is a widely practiced complementary and integrative health modality that has multiple clinical applications. The use of acupuncture in the United States is rapidly increasing. Although studies have shown the efficacy and effectiveness of acupuncture for various ailments, the integration of acupuncture into the U.S. health care system remains a challenge. Little is known about the factors affecting this integration. Objective: To provide a systematic review of the barriers and facilitators affecting the integration of acupuncture into the U.S. health care system. Methods: Four electronic databases were searched. Three independent reviewers were involved in the screening and data charting processes. Findings were synthesized and categorized into four levels based on the Social Ecological Model. Results: A total of 22 studies were included in the final review. The barriers and facilitators affecting the integration of acupuncture were mapped into four levels (individual, interpersonal, organizational, and policy). The most frequently reported barriers and facilitators were mapped into the Social Ecological Model constructs within the "Individual" level (i.e., beliefs and attitudes of acupuncture, and practical issues) and the "Organizational" level (i.e., credentialing, space and facility, referral system). Conclusion: This review has identified and synthesized the breadth of evidence on the barriers and facilitators to the integration of acupuncture into the U.S. health care system. Results of this review will guide future implementation studies to develop and test implementation strategies to integrate acupuncture into the U.S. health care system.

Myanmar immigrant women's perceptions, beliefs, and information-seeking behaviors with nutrition and food practices during pregnancy in Thailand: a qualitative study.

BACKGROUND: Although nutrition is an essential contributor to the quality of pregnancy outcomes, little is known about the experiences and influences affecting dietary behaviors during pregnancy among migrant women, particularly those from Myanmar, the largest immigrant population in Thailand. To fill this gap, we conducted a descriptive qualitative study to explore Myanmar immigrant women's perceptions, beliefs, and information-seeking behaviors concerning nutrition and food practices during pregnancy. METHODS: We conducted focus group discussions (FGDs) with fifty Myanmar immigrant pregnant women aged 18-45 years across all trimesters, who were recruited using purposive sampling from a public tertiary hospital. The FGDs were conducted in Thai or Myanmar using semi-structured guides that probed women's pregnancy perceptions and experiences about nutrition and food patterns during pregnancy. The FGDs were audio-recorded, translated, and transcribed. Direct content analysis was used to guide the analysis through an ecological perspective framework. RESULTS: The seven FGDs with fifty women revealed four major themes involving perceptions, beliefs, and information-seeking behaviors. The qualitative results consisted of (1) a positive attitude toward better changes under difficult conditions (setting goals for infant health; uncertainty about changes); (2) beliefs about eating patterns and dietary practices during pregnancy (taboos aimed at protecting women's health and ensuring safe childbirth; taboos aimed at guaranteeing infant safety); (3) limited access to appropriate information about nutrition (unclear dietary information from healthcare providers; ease of learning from experiences in informal social networks); and (4) difficult living conditions in a non-native setting (work-related influences on dietary behaviors; lack of comprehensible language to gain food literacy). In addition, the results were highlighted across four levels of ecological perspectives. CONCLUSIONS: Immigrant pregnant women are a vulnerable population that should be treated with equity to ensure quality of life through optimal nutrition throughout pregnancy. Respectful care requires that healthcare providers develop culturally sensitive nutrition interventions to increase nutrition literacy, accessibility, and pregnancy outcomes.

Condom use increased after a peer group intervention implemented by community volunteers in Malawi.

BACKGROUND: HIV prevention remains a global priority, especially in sub-Saharan Africa. Our research team previously developed an evidence-based peer group program for HIV prevention called Mzake ndi Mzake (Friend to Friend). A community-engaged collaboration adapted the program for community ownership and implementation. Here we report whether this HIV prevention program, implemented by community volunteers, increased condom use among sexually active individuals in rural Malawi. METHODS: Three communities sequentially rolled out the program. Effectiveness was evaluated using a stepped wedge design. Repeated surveys 11-13 months apart were conducted between 2016 and 2019. At Time 1, no community had offered the intervention. At Time 2, the first community had offered the intervention and two had not (control group). At Time 3, two communities had offered the intervention and one had not (control group). We used two condom use indicators; condom use frequency in the last 2 months (N = 771) and condom use at last sex (N = 880). The analytical sample included all sexually active persons answering that question at one or more time points. Mixed-effects cumulative logit and Generalized Estimating Equation (GEE) models were used to model the two condom indicators over time, controlling for demographic factors, UNAIDS HIV knowledge, safer sex self-efficacy and partner communication. RESULTS: This peer group intervention implemented by trained community volunteers increased both condom use indicators at Times 2 and 3. In the final adjusted models with non-significant factors removed, condom use in the last two months increased for the intervention group vs. control group [Time 2: Adjusted Odds Ratio (AOR) = 1.59 (1.15, 2.21); Time 3: AOR 2.01 (1.23, 3.30)]. Similarly, condom use at last sex increased for the intervention group vs. control group [Time 2: AOR = 1.48 (1.08, 2.03); Time 3: AOR 1.81 (1.13, 2.90)]. Other significant predictors of greater condom use were also described. Although the intervention increased UNAIDS HIV knowledge, knowledge did not predict condom use. CONCLUSIONS: In this community-engaged implementation study, an evidence-based peer group program for HIV prevention increased condom use when delivered by trained community volunteers. Community ownership and program delivery by trained volunteers offer an innovative and cost-effective strategy to address ongoing HIV prevention needs without overburdening healthcare systems in sub-Saharan Africa. TRIAL REGISTRATION: Clinical Trials.gov NCT02765659 Registered May 6, 2016.

Critical Realism in Symptom Science - A Scoping Review.

There has been an increasing interest in research positioned within critical realism (CR). This analysis aimed to determine how CR has been applied in symptom science through a scoping review of the literature. Fifty-two articles were identified through searches in seven databases and search engines, and grey literature. Quantitative and qualitative analyses were performed using Excel and ATLAS.ti 8.0. Review findings indicate that CR has been used to examine two key aspects of symptoms - symptom experiences and symptom interventions. The details of how CR was operationalized are presented. This first scoping review highlights how a critical realist lens would help examine individual and contextual factors that influence symptom experiences, response to interventions, and outcomes.

'The way to obtain freedom and equality': Experiences and needs of Thai adolescent mothers in terms of the use smartphone applications for breastfeeding support.

BACKGROUND: Breastfeeding brings about a positive impact on both child and maternal health in the short and long terms. However, adolescent mothers have a lower breastfeeding initiation rate and a shorter breastfeeding duration than adult mothers. Although mobile applications have been found to be the most widely used platform for breastfeeding support, there is still a lack of design specific for adolescents. AIM: To explore the experiences, perspectives and needs of adolescent mothers and professional nurses using smartphone applications for breastfeeding support and the influence of this technology on healthcare in Thailand. METHODS: This formative qualitative research of the 'Development of smartphone application for promoting breastfeeding and learning of infant responsiveness for Thai teenage pregnant women' study intends to design a smartphone application and develop an implementation plan. A purposive sample was used to elicit experiences from adolescent mothers and nurses. Data were collected from 48 adolescent mothers through in-depth interviews with six focus group discussions and 12 nurses, following the data saturation principle. Thematic analysis was conducted, and potential factors and needs were mapped to the capability, opportunity, and motivation model of behaviour change (COM-B). RESULTS: Most adolescent mothers perceived the usefulness of smartphone apps as breastfeeding support resources. The qualitative findings of adolescent mothers were grouped into the following three themes: a friendly breastfeeding tool; allows them to manage their breastfeeding activities; and enhances the accessibility and equality of breastfeeding support. The professional nurses perceived the benefits of using smartphone applications in their work, which included the following three themes: reducing workload and making their work easier; preparation is always better; and increasing the standards of breastfeeding support. CONCLUSION: Adolescent mothers and professional nurses showed favourable attitudes toward smartphone apps for breastfeeding support. These smartphone apps should be tailored to these groups to achieve optimal BF outcomes.

Centering PrEP: utilizing ADAPT-ITT to inform group PrEP care for sex workers in Chicago.

BACKGROUND: Sex workers, those who trade sex for monetary or nonmonetary items, experience high rates of HIV transmission but have not been adequately included in HIV prevention and Pre-Exposure Prophylaxis (PrEP) adherence program development research. Community-empowered (C.E.) approaches have been the most successful at reducing HIV transmission among sex workers. Centering Healthcare (Centering) is a C.E. model proven to improve health outcomes and reduce health disparities in other populations, such as pregnant women, people with diabetes, and sickle cell disease. However, no research exists to determine if Centering can be adapted to meet the unique HIV prevention needs of sex workers. OBJECTIVE: We aim to explain the process by which we collaboratively and iteratively adapted Centering to meet the HIV prevention and PrEP retention needs of sex workers. METHODS: We utilized the Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, Testing (ADAPT-ITT) framework, a model for adapting evidence-based interventions. We applied phases one through six of the ADAPT-ITT framework (Assessment, Decision, Adaptation, Production, Topical Experts, Integration) to the design to address the distinct HIV prevention needs of sex workers in Chicago. Study outcomes corresponded to each phase of the ADAPT-ITT framework. Data used for adaptation emerged from collaborative stakeholder meetings, individual interviews (n = 36) and focus groups (n = 8) with current and former sex workers, and individual interviews with care providers (n = 8). In collaboration with our community advisory board, we used a collaborative and iterative analytical process to co-produce a culturally adapted 3-session facilitator's guide for the Centering Pre-exposure Prophylaxis (C-PrEP +) group healthcare model. RESULTS: The ADAPT-ITT framework offered structure and facilitated this community-empowered innovative adaptation of Centering Healthcare. This process culminated with a facilitator's guide and associated materials ready for pilot testing. CONCLUSIONS: In direct alignment with community empowerment, we followed the ADAPT-ITT framework, phases 1-6, to iteratively adapt Centering Healthcare to suit the stated HIV Prevention and PrEP care needs of sex workers in Chicago. The study represents the first time the first time Centering has been adapted to suit the HIV prevention and PrEP care needs of sex workers. Addressing a gap in HIV prevention care for sex workers, Centering PrEP harnesses the power of community as it is an iteratively adapted model that can be piloted and replicated regionally, nationally, and internationally.

Feasibility of implementing acupuncture in medically underserved breast cancer survivors (FAB): A protocol.

Nearly 94% of breast cancer survivors experience one or more symptoms or side effects during or after endocrine therapy. Joint pain, hot flashes, sleep disturbance, fatigue, depression, and anxiety are the most common concurrent symptoms, some of which can persist for 5 to 10 years. Acupuncture is a holistic modality that addresses multiple symptoms and side effects in a single therapy. Acupuncture has not yet been investigated for its effectiveness in treating the multiple symptoms experienced by breast cancer survivors receiving endocrine therapy. Medically underserved breast cancer survivors typically have limited access to acupuncture. The barriers limiting access to acupuncture need to be removed to enable equal access to breast cancer survivors for this evidence-based treatment. Thus, we developed a randomized controlled trial with a 5-week acupuncture intervention versus usual care for medically underserved breast cancer survivors. Mixed methods (semi-structured interviews, surveys, study notes) will be used to obtain in-depth understanding of barriers and facilitators for eventual implementation of the acupuncture intervention. This study will facilitate the widespread implementation, dissemination, and sustained utilization of acupuncture for symptom management among medically underserved breast cancer survivors receiving endocrine therapy.

Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 27 embedded pragmatic clinical trials, and many of the studies collect patient reported outcome measures as primary or secondary outcomes. Study teams have encountered challenges in the collection of these measures, including challenges related to competing health care system priorities, clinician's buy-in for adoption of patient-reported outcome measures, low adoption and reach of technology in low resource settings, and lack of consensus and standardization of patient-reported outcome measure selection and administration in the electronic health record. In this article, we share case examples and lessons learned, and suggest that, when using patient-reported outcome measures for embedded pragmatic clinical trials, investigators must make important decisions about whether to use data collected from the participating health system's electronic health record, integrate externally collected patient-reported outcome data into the electronic health record, or collect these data in separate systems for their studies.

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain.

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Adapting group care to the postpartum period using a human-centered design approach in Malawi.

BACKGROUND: Responsive and resilient strategies to reduce high rates of maternal and infant mortality and clinician shortages are needed in low- and middle-income countries (LMICs). Malawi has some of the highest maternal and infant mortality rates globally. Group healthcare is a service delivery model that integrates these strategies. Although primarily implemented during the prenatal period, its potential for improving both maternal and infant health outcomes during the postpartum period has not been realized. The purpose of this study was to adapt and co-design the prototype for an evidence-based group care model for the postpartum period using a human-centered design approach with key stakeholders in Malawi. METHODS: We completed steps of a framework guiding the use of human-centered design: 1) define the problem and assemble a team; 2) gather information through evidence and inspiration; 3) synthesize; and 4) intervention design: guiding principles and ideation. Qualitative methods were used to complete steps 2-4. In-depth interviews (n = 24), and incubator sessions (n = 6) that employed free listing, pile sorting and ranking were completed with key stakeholders. Data analysis consisted of content analysis of interviews and framework analysis for incubator sessions to produce the integrated group postpartum and well-child care model prototype. The fifth step is detailed in a separate paper. RESULTS: All stakeholders reported a desire to participate in and offer group care in the postpartum period. Stakeholders worked collaboratively to co-create the prototype that included a curriculum of health promotion topics and interactive activities and the service delivery structure. Health promotion topic priorities were hygiene, breastfeeding, family planning, nutrition, and mental health. The recommended schedule included 6 sessions corresponding with the child vaccination schedule over the 12-month postpartum period. CONCLUSIONS: Using a human-centered design approach to adapt an evidence-based group care model in an LMIC, specifically Malawi, is feasible and acceptable to key stakeholders and resulted in a prototype curriculum and practical strategies for clinic implementation.

Distinct Dysphagia Profiles in Patients With Oral Cancer After Surgery.

OBJECTIVES: To determine distinct profiles based on symptom severity in patients undergoing surgery for oral cancer and examine whether these profiles differ by participant characteristics. SAMPLE & SETTING: 300 patients who underwent surgery for oral cancer at two outpatient clinics between June and December 2021. METHODS & VARIABLES: Symptoms were assessed using the MD Anderson Symptom Inventory-Head and Neck Cancer Module. Sociodemographic and clinical characteristics were collected. Latent profile analysis was performed. RESULTS: Five distinct dysphagia profiles were identified, which qualitatively differed regarding co-occurrence patterns of dysphagia, mucus-related symptoms, speech disturbances, and psychoneurologic symptoms. Significant differences were reported in interference to function, number of co-occurring symptoms, time since diagnosis and treatment completion, use of symptom management medications, oral cancer stage and site, and treatment completed. IMPLICATIONS FOR NURSING: Identifying distinct dysphagia profiles can improve patient outcomes and help in planning specific nursing interventions to influence nutritional and functional status in oral cancer survivors. Dysphagia and dry mouth can persist beyond one year post-treatment, so follow-up dysphagia assessments are needed.

Condom use increased after a peer group intervention implemented by community volunteers in Malawi.

Background: HIV prevention remains a global priority, especially in sub-Saharan Africa. Our research team previously developed an evidence-based peer group program for HIV prevention called Mzake ndi Mzake (Friend to Friend). A community-engaged collaboration adapted the program for community ownership and implementation. Here we report whether this HIV prevention program, implemented by community volunteers, increased condom use among sexually active individuals in rural Malawi. Methods: Three communities sequentially rolled out the program. Effectiveness was evaluated using repeated surveys. At Time 1, no community had offered the intervention. At Time 2, the first community had offered the intervention and two had not (control group). At Time 3, two communities had offered the intervention and one had not (control group). We used two condom use indicators; condom use frequency in the last 2 months (N = 776) and condom use at last sex (N = 880). For each indicator, the sample included all sexually active persons answering that question at one or more time points. Regression analyses were used to model the two condom indicators over time, controlling for demographic factors, UNAIDS HIV knowledge, safer sex self-efficacy and partner communication. Results: This peer group intervention implemented by trained community volunteers increased both condom use indicators at Times 2 and 3. In the final regression models. Other predictors of greater condom use for at least one condom use indicator included younger age group (13-19), male gender, not married/cohabiting, high involvement in religiously affiliated activities, higher safer sex self-efficacy, and greater partner communication. Although the intervention increased UNAIDS HIV knowledge, knowledge did not predict condom use. Conclusions: This community engaged implementation study found that an evidence-based peer group program for HIV prevention increased condom use when delivered by trained community volunteers. Leveraging community strengths and human capital resources facilitated implementation of this effective HIV prevention program in rural Malawi. Community ownership and program delivery by trained local volunteers offers an innovative and cost-effective strategy to address ongoing HIV prevention needs without overburdening heathcare systems in sub. Trial registration: Clinical Trials.gov NCT02765659 Registered May 6, 2016.

Experiences of Sex Workers in Chicago during COVID-19: A Qualitative Study.

COVID-19 exacerbated health disparities, financial insecurity, and occupational safety for many within marginalized populations. This study, which took place between 2019 and 2022, aimed to explore the way in which sex workers (n = 36) in Chicago were impacted by COVID-19. We analyzed the transcripts of 36 individual interviews with a diverse group of sex workers using thematic analysis. Five general themes emerged regarding the detrimental impact of COVID-19 on sex workers: (1) the impact of COVID-19 on physical health; (2) the economic impact of COVID-19; (3) the impact of COVID-19 on safety; (4) the impact of COVID-19 on mental health; and (5) adaptive strategies for working during COVID-19. Participants reported that their physical and mental health, economic stability, and safety worsened due to COVID-19 and that adaptive strategies did not serve to improve working conditions. Findings highlight the ways in which sex workers are particularly vulnerable during a public health crisis, such as COVID-19. In response to these findings, targeted resources, an increased access to funding, community-empowered interventions and policy changes are needed to protect the health and safety of sex workers in Chicago.

Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory.

Embedded pragmatic clinical trials (ePCTs) play a vital role in addressing current population health problems, and their use of electronic health record (EHR) systems promises efficiencies that will increase the speed and volume of relevant and generalizable research. However, as the number of ePCTs using EHR-derived data grows, so does the risk that research will become more vulnerable to biases due to differences in data capture and access to care for different subsets of the population, thereby propagating inequities in health and the healthcare system. We identify 3 challenges-incomplete and variable capture of data on social determinants of health, lack of representation of vulnerable populations that do not access or receive treatment, and data loss due to variable use of technology-that exacerbate bias when working with EHR data and offer recommendations and examples of ways to actively mitigate bias.

Equity and bias in electronic health records data.

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities. We offer recommendations for how to increase generalizability of ePCT results and begin to mitigate bias to promote health equity.

How Perspectives on Food Safety of Vendors and Consumers Translate into Food-Choice Behaviors in 6 African and Asian Countries.

Background: Consumption of unsafe foods increases morbidity and mortality and is currently an issue, particularly in low- and middle-income countries. Policy actions to ensure food safety are dominated by mitigation of biological and chemical hazards through supply-side risk management, lessening the degree to which consumer perspectives of food safety are considered. Objectives: This study aimed to provide an in-depth understanding, from vendor and consumer perspectives, of how food-safety concerns of consumers translate into their subsequent food-choice behaviors in 6 diverse low- and middle-income countries. Methods: Six Drivers of Food Choice projects (2016-2022) provided transcripts from 17 focus group discussions and 343 interviews conducted in Ghana, Guinea, India, Kenya, Tanzania, and Vietnam. Qualitative thematic analysis was used to identify emerging themes important to food safety. Results: The analysis suggests that consumers constructed meaning about food safety through personal lived experience and social influences. Community and family members contributed knowledge about food safety. Concerns about food safety were influenced by reputations of and relationships with food vendors. Consumers' mistrust of food vendors was amplified by purposeful adulteration or unsafe selling practices and new methods used to produce food. Moreover, consumers were reassured of food safety by positive relationships with vendors; meals cooked at home; implementation of policies and following regulations; vendor adherence to environmental sanitation and food-hygiene practices; cleanliness of vendors' appearance; and vendors' or producers' agency to use risk mitigation strategies in production, processing, and distribution of food. Conclusions: Consumers integrated their meanings, knowledge, and concerns about food safety to achieve assurance about the safety of their foods when making food-choice decisions. The success of food-safety policies hinges on consideration of consumers' food-safety concerns in their design and implementation, alongside actions to reduce risk in food supply.

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

Objective: This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Design: Qualitative research design. Methods: We conducted 33 semistructured interviews with people with SCD and SCD clinic providers and staff. Interviews were transcribed and coded. A deductive content analysis process was used to identify themes. Results: Four themes were identified: Receptivity to Acupuncture and Guided Relaxation, Limited Awareness, Complementary and Integrative Health (CIH) Therapy Preference, and Access Barriers. Both patients and clinic providers and staff were open to the use of acupuncture and guided relaxation for chronic pain treatment. After learning about these CIH therapies, some patients expressed a preference for one therapy over the other. They also discussed their ability to successfully engage with each therapy. There is a need to dispel misconceptions about the therapies by increasing understanding of how each therapy is implemented and functions to reduce pain. We identified several potential barriers that might affect the success of the trial and future health system integration, including time, transportation, and technology. Conclusion: This study is one of the first to present perspectives of both patients with SCD and clinic providers and staff on the use of acupuncture and guided relaxation for chronic SCD pain. Stakeholders' early input and perspectives highlighted that they welcome nonpharmacological CIH therapies. Implementation of a clinical trial and future health system integration will require the addressing misinformation and identifying strategies to overcome access barriers. Clinical trial registration number: NCT04906447.