Unwanted sexual activity among United States women early in the COVID-19 pandemic.

BACKGROUND: Female sexual activity and, accordingly, birth rates tend to decline in times of stress, such as a pandemic. In addition, when resources are scarce or exogenous conditions are threatening, some women may engage in sexual activity primarily to maintain socioeconomic security. Having unwanted sex may indicate sexual activity in exchange for economic security. OBJECTIVE: This study aimed to describe patterns and correlates of unwanted sex, defined as having sex more frequently than desired, among US women early in the COVID-19 pandemic. STUDY DESIGN: The National US Women's Health COVID-19 Study was conducted in April 2020, using a nested quota sample design to enroll 3200 English-speaking women (88% cooperation rate) aged 18 to 90 years recruited from a research panel. The quota strata ensured sufficient sample sizes in sociodemographic groups of interest, namely, racial and ethnic subgroups. Patterns of sexual activity, including unwanted sex early in the pandemic, were described. To further elucidate the experiences of women reporting unwanted sex, open-ended responses to an item querying "how the coronavirus pandemic is affecting your sex life" were assessed using conventional content analysis. Logistic regression analyses-adjusting for sociodemographic characteristics, self-reported health, and prepandemic health-related socioeconomic risk factors, including food insecurity, housing instability, utilities and transportation difficulties, and interpersonal violence-were used to model the odds of unwanted sex by a pandemic-related change in health-related socioeconomic risk factors. RESULTS: The proportion of women who were sexually active early in the pandemic (51%) was about the same as in the 12 months before the pandemic (52%), although 7% of women became active, and 7% of women became inactive. Overall, 11% of sexually active women were having unwanted sex in the early pandemic. The rates of anxiety, depression, traumatic stress symptoms, and each of the 5 health-related socioeconomic risk factors assessed were about 2 times higher among women having unwanted sex than other women (P<.001). Women having unwanted sex were also 5 times more likely than other women to report an increased frequency of sex since the pandemic (65% vs 13%; P<.001) and 6 times more likely to be using emergency contraception (18% vs 3%; P<.001). Women reporting unwanted sex commonly described decreased libido or interest in sex related to mood changes since the pandemic, having "more sex," fear or worry about the transmission of the virus because of sex, and having sex to meet the partner's needs. Among sexually active women, the odds of unwanted sex (adjusting for demographic, reproductive, and health factors) were higher among women with 1 prepandemic health-related socioeconomic risk factor (adjusted odds ratio, 2.0; 95% confidence interval, 1.1-3.8) and 2 or more prepandemic health-related socioeconomic risk factors (adjusted odds ratio, 6.0; 95% confidence interval, 3.4-10.6). Among sexually active women with any prepandemic health-related socioeconomic risk factor, those with new or worsening transportation difficulties early in the pandemic were particularly vulnerable to unwanted sex (adjusted odds ratio, 2.7; 95% confidence interval, 1.7-4.3). CONCLUSION: More than 1 in 10 sexually active US women was having unwanted sex early in the COVID-19 pandemic. Socioeconomically vulnerable women, especially those with new or worsening transportation problems because of the pandemic, were more likely than others to engage in unwanted sex. Pandemic response and recovery efforts should seek to mitigate unwanted sexual activity and related health and social risks among women.

Breast sensorisexual function: a novel patient-reported outcome measure of sexual sensory functions of the breast.

BACKGROUND: A validated measure assessing sexual sensory functions of the breast is needed to optimize sexual and other health outcomes after breast procedures. AIM: To describe the development of a patient-reported outcome measure (PROM) to assess breast sensorisexual function (BSF). METHODS: We applied the PROMIS standards (Patient Reported Outcomes Measurement Information System) for measure development and evaluation of validity. An initial conceptual model of BSF was developed with patients and experts. A literature review yielded a pool of 117 candidate items that underwent cognitive testing and iteration. Forty-eight items were administered to an ethnically diverse, national panel-based sample of sexually active women with breast cancer (n = 350) or without (n = 300). Psychometric analyses were performed. OUTCOMES: The main outcome was BSF, a measure that assesses affective (satisfaction, pleasure, importance, pain, discomfort) and functional (touch, pressure, thermoreception, nipple erection) sensorisexual domains. RESULTS: A bifactor model fit to 6 domains-excluding 2 domains with only 2 items each and 2 pain-related domains-revealed a single general factor representing BSF that may be adequately measured by the average of the items. This factor, with higher values denoting better function and with the standard deviation set to 1, was highest among women without breast cancer (mean, 0.24), intermediate among women with breast cancer but not bilateral mastectomy and reconstruction (-0.01), and lowest among those with bilateral mastectomy and reconstruction (-0.56). Between women with and without breast cancer, the BSF general factor accounted for 40%, 49%, and 100% of the difference in arousal, ability to orgasm, and sexual satisfaction, respectively. Items in each of 8 domains demonstrated unidimensionality (ie, they measured 1 underlying BSF trait) and high Cronbach's alphas for the entire sample (0.77-0.93) and the cancer group (0.71-0.95). Correlations with sexual function, health, and quality of life were positive for the BSF general factor and mostly negative for the pain domains. CLINICAL IMPLICATIONS: The BSF PROM can be used to assess the impact of breast surgery or other procedures on the sexual sensory functions of the breast in women with and without breast cancer. STRENGTHS AND LIMITATIONS: The BSF PROM was developed by using evidence-based standards, and it applies to sexually active women with and without breast cancer. Generalizability to sexually inactive women and other women warrants further study. CONCLUSION: The BSF PROM is a measure of women's breast sensorisexual function with evidence of validity among women affected and unaffected by breast cancer.

Physical examination of the female cancer patient with sexual concerns: What oncologists and patients should expect from consultation with a specialist.

Answer questions and earn CME/CNE Sexual concerns are prevalent in women with cancer or cancer history and are a factor in patient decision making about cancer treatment and risk-reduction options. Physical examination of the female cancer patient with sexual concerns, regardless of the type or site of her cancer, is an essential and early component of a comprehensive evaluation and effective treatment plan. Specialized practices are emerging that focus specifically on evaluation and treatment of women with cancer and sexual function problems. As part of a specialized evaluation, oncologists and their patients should expect a thorough physical examination to identify or rule out physical causes of sexual problems or dysfunction. This review provides oncology professionals with a description of the physical examination of the female cancer patient with sexual function concerns. This description aims to inform anticipatory guidance for the patient and to assist in interpreting specialists' findings and recommendations. In centers or regions where specialized care is not yet available, this review can also be used by oncology practices to educate and support health care providers interested in expanding their practices to treat women with cancer and sexual function concerns. CA Cancer J Clin 2016;66:241-263. © 2016 American Cancer Society.

Building and experimenting with an agent-based model to study the population-level impact of CommunityRx, a clinic-based community resource referral intervention.

CommunityRx (CRx), an information technology intervention, provides patients with a personalized list of healthful community resources (HealtheRx). In repeated clinical studies, nearly half of those who received clinical "doses" of the HealtheRx shared their information with others ("social doses"). Clinical trial design cannot fully capture the impact of information diffusion, which can act as a force multiplier for the intervention. Furthermore, experimentation is needed to understand how intervention delivery can optimize social spread under varying circumstances. To study information diffusion from CRx under varying conditions, we built an agent-based model (ABM). This study describes the model building process and illustrates how an ABM provides insight about information diffusion through in silico experimentation. To build the ABM, we constructed a synthetic population ("agents") using publicly-available data sources. Using clinical trial data, we developed empirically-informed processes simulating agent activities, resource knowledge evolution and information sharing. Using RepastHPC and chiSIM software, we replicated the intervention in silico, simulated information diffusion processes, and generated emergent information diffusion networks. The CRx ABM was calibrated using empirical data to replicate the CRx intervention in silico. We used the ABM to quantify information spread via social versus clinical dosing then conducted information diffusion experiments, comparing the social dosing effect of the intervention when delivered by physicians, nurses or clinical clerks. The synthetic population (N = 802,191) exhibited diverse behavioral characteristics, including activity and knowledge evolution patterns. In silico delivery of the intervention was replicated with high fidelity. Large-scale information diffusion networks emerged among agents exchanging resource information. Varying the propensity for information exchange resulted in networks with different topological characteristics. Community resource information spread via social dosing was nearly 4 fold that from clinical dosing alone and did not vary by delivery mode. This study, using CRx as an example, demonstrates the process of building and experimenting with an ABM to study information diffusion from, and the population-level impact of, a clinical information-based intervention. While the focus of the CRx ABM is to recreate the CRx intervention in silico, the general process of model building, and computational experimentation presented is generalizable to other large-scale ABMs of information diffusion.

Impact of a Low-Intensity Resource Referral Intervention on Patients' Knowledge, Beliefs, and Use of Community Resources: Results from the CommunityRx Trial.

BACKGROUND: Connecting patients to community-based resources is now a cornerstone of modern healthcare that supports self-management of health. The mechanisms that link resource information to behavior change, however, remain poorly understood. OBJECTIVE: To evaluate the impact of CommunityRx, an automated, low-intensity resource referral intervention, on patients' knowledge, beliefs, and use of community resources. DESIGN: Real-world controlled clinical trial at an urban academic medical center in 2015-2016; participants were assigned by alternating week to receive the CommunityRx intervention or usual care. Surveys were administered at baseline, 1 week, 1 month, and 3 months. PARTICIPANTS: Publicly insured adults, ages 45-74 years. INTERVENTION: CommunityRx generated an automated, personalized list of resources, known as HealtheRx, near each participant's home using condition-specific, evidence-based algorithms. Algorithms used patient demographic and health characteristics documented in the electronic health record to identify relevant resources from a comprehensive, regularly updated database of health-related resources in the study area. MAIN MEASURES: Using intent-to-treat analysis, we examined the impact of HealtheRx referrals on (1) knowledge of the most commonly referred resource types, including healthy eating classes, individual counseling, mortgage assistance, smoking cessation, stress management, and weight loss classes or groups, and (2) beliefs about having resources in the community to manage health. KEY RESULTS: In a real-world controlled trial of 374 adults, intervention recipients improved knowledge (AOR = 2.15; 95% CI, 1.29-3.58) and beliefs (AOR = 1.68; 95% CI, 1.07-2.64) about common resources in the community to manage health, specifically gaining knowledge about smoking cessation (AOR = 2.76; 95% CI, 1.07-7.12) and weight loss resources (AOR = 2.26; 95% CI 1.05-4.84). Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02). CONCLUSIONS: In a middle-age and older population with high morbidity, a low-intensity health IT intervention to deliver resource referrals promoted behavior change by increasing knowledge and positive beliefs about community resources for self-management of health. NIH TRIAL REGISTRY: NCT02435511.

CommunityRx: A Real-World Controlled Clinical Trial of a Scalable, Low-Intensity Community Resource Referral Intervention.

OBJECTIVES: To test the effect of CommunityRx, a scalable, low-intensity intervention that matches patients to community resources, on mental health-related quality of life (HRQOL) (primary outcome), physical HRQOL, and confidence in finding resources. METHODS: A real-world trial assigned publicly insured residents of Chicago, Illinois, aged 45 to 74 years to an intervention (n = 209) or control (n = 202) group by alternating calendar week, December 2015 to August 2016. Intervention group participants received usual care and an electronic medical record-generated, personalized list of community resources. Surveys (baseline, 1-week, 1- and 3-months) measured HRQOL and confidence in finding community resources to manage health. RESULTS: At 3 months, there was no difference between groups in mental (-1.03; 95% confidence interval [CI] = -3.02, 0.96) or physical HRQOL (0.59; 95% CI = -0.98, 2.16). Confidence in finding resources was higher in the intervention group (odds ratio = 2.08; 95% CI = 1.18, 3.63); the effect increased at each successive time point. Among intervention group participants, 65% recalled receiving the intervention; 48% shared community resource information with others. CONCLUSIONS: CommunityRx did not increase HRQOL, but its positive effect on confidence in finding resources for self-care suggests that this low-intensity intervention may have a role in population health promotion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02435511.

Community resource referral needs among African American dementia caregivers in an urban community: a qualitative study.

BACKGROUND: African American caregivers of community-residing persons with dementia are mostly unpaid and have high rates of unmet basic and health needs. The National Alzheimer's Project Act (NAPA) mandates improved coordination of care for persons with dementia and calls for special attention to racial populations at higher risk for Alzheimer's Disease or related dementias (ADRD) to decrease health disparities. The purpose of this study is to describe the perceptions of African American caregivers of people with dementia about community resources needed to support caregiving as well as their own self-care. METHODS: Using a qualitative study design, in-depth, semi-structured qualitative interviews were conducted with caregivers (N = 13) at an urban geriatric clinic to elicit community resource needs, barriers to and facilitators of resource use and how to optimize clinical referrals to community resources. Caregivers were shown a community resource referral list ("HealtheRx") developed for people with dementia and were queried to elicit relevance, gaps and insights to inform delivery of this information in the healthcare setting. Data were iteratively coded and analyzed using directed content analysis. Results represent key themes. RESULTS: Most caregivers were women (n = 10, 77%) and offspring (n = 8, 62%) of the person with dementia. Community resource needs of these caregivers included social, entertainment, personal self-care and hospice services. Main barriers to resource use were the inability to leave the person with dementia unsupervised and the care recipient's disinterest in participating in their own self-care. Facilitators of resource use included shared caregiving responsibility and learning about resources from trusted sources. To optimize clinical referrals to resources, caregivers wanted specific eligibility criteria and an indicator of dementia care capability. CONCLUSIONS: African American caregivers in this study identified ways in which community resource referrals by clinicians can be improved to meet their caregiving and self-care needs.

Sexual activity and counseling in the first month after acute myocardial infarction among younger adults in the United States and Spain: a prospective, observational study.

BACKGROUND: United States and European cardiovascular society guidelines recommend physicians counsel patients about resuming sexual activity after acute myocardial infarction (AMI), but little is known about patients' experience with counseling about sexual activity after AMI. METHODS AND RESULTS: The prospective, longitudinal Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study, conducted at 127 hospitals in the United States and Spain, was designed, in part, to evaluate gender differences in baseline sexual activity, function, and patient experience with physician counseling about sexual activity after an AMI. This study used baseline and 1-month data collected from the 2:1 sample of women (N=2349) and men (N=1152) ages 18 to 55 years with AMI. Median age was 48 years. Among those who reported discussing sexual activity with a physician in the month after AMI (12% of women, 19% of men), 68% were given restrictions: limit sex (35%), take a more passive role (26%), and/or keep the heart rate down (23%). In risk-adjusted analyses, factors associated with not discussing sexual activity with a physician included female gender (relative risk, 1.07; 95% confidence interval, 1.03-1.11), age (relative risk, 1.05 per 10 years; 95% confidence interval, 1.02-1.08), and sexual inactivity at baseline (relative risk, 1.11; 95% confidence interval, 1.08-1.15). Among patients who received counseling, women in Spain were significantly more likely to be given restrictions than U.S. women (relative risk; 1.36, 95% confidence interval, 1.11-1.66). CONCLUSIONS: Very few patients reported counseling for sexual activity after AMI. Those who did were commonly given restrictions not supported by evidence or guidelines. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00597922.

A manifesto on the preservation of sexual function in women and girls with cancer.

Malignancies that affect females who survive cancer commonly originate in, invade, and/or metastasize to the sexual organs, including the ovaries, uterine corpus, uterine cervix, vagina, vulva, fallopian tubes, anus, rectum, breast(s), and brain. Females comprise most of the population (in number and proportion) with cancers that directly affect the sexual organs. Most females in the age groups most commonly affected by cancer are sexually active in the year before diagnosis, which includes most menopausal women who have a partner. Among female cancer survivors, the vast majority have cancers that are treated with local or systemic therapies that result in removal, compromise, or destruction of the sexual organs. Additionally, female cancer survivors often experience abrupt or premature onset of menopause, either directly with surgery, radiation, or other treatments or indirectly through disruption of female sex hormone or other neuroendocrine physiology. For many female patients, cancer treatment has short-term and long-lasting effects on other aspects of physical, psychological, and social functioning that can interfere with normal sexual function; these effects include pain, depression, and anxiety; fatigue and sleep disruption; changes in weight and body image; scars, loss of normal skin sensation, and other skin changes; changes in bodily odors; ostomies and loss of normal bowel and bladder function; lymphedema, and strained intimate partnerships and other changes in social roles. In spite of these facts, female patients who are treated for cancer receive insufficient counseling, support, or treatment to preserve or regain sexual function after cancer treatment.

Food Insecurity and Community-Based Food Resources Among Caregivers of Hospitalized Children.

OBJECTIVE: Children's hospitals are implementing interventions to connect families to community-based resources. This study describes food insecurity (FI) and food resource knowledge, need, and use among families with a hospitalized child. METHODS: Between November 2020 and June 2022, 637 caregivers of hospitalized children in an urban 42-ZIP-code area were surveyed as part of a randomized controlled trial. The United States Department of Agriculture 18-item Household Food Security Survey was used to evaluate 12-month food security (food secure [score of 0=FS]; marginally secure [1-2=MFS]; insecure [3-18=FI]). Food resource knowledge, need, and use were described by food security status and examined using Cochran-Armitage tests. The distribution of local resources was obtained from a database and mapped by ZIP code. RESULTS: Comparing FI (35.0%) with MFS (17.6%) and FS (47.4%) groups, the rates of resource knowledge were lower (70.2% vs 78.5%, 80.5%), and the rates of need (55.1% vs 30.6%, 14.2%) and use (55.3% vs 51.4%, 40.8%) were higher. Rates of food resource knowledge increased linearly with increasing food security (FI to MFS to FS; P = .008), whereas the rates of resource need (P < .001) and use (P = .001) decreased with increasing food security. There were 311 community-based organizations across 36 ZIP codes with participants (range/ZIP code = 0-20, median = 8). CONCLUSIONS: Half of families with a hospitalized child experienced FI or MFS. Although families exhibited high food resource knowledge, nearly half of families with FI had unmet food needs or had never used resources.

Food Insecurity and Experiences of Discrimination Among Caregivers of Hospitalized Children.

BACKGROUND AND OBJECTIVES: Pediatric hospitals are adopting strategies to address food insecurity (FI), a stigmatizing condition, among families with children. We hypothesized that parents and other caregivers ("caregivers") from households with FI or marginal food security (MFS) are more likely to experience discrimination during their child's hospitalization. METHODS: We analyzed data from 319 caregivers of children admitted to an urban, academic children's hospital and randomly assigned to the control arm of the double-blind randomized controlled CommunityRx-Hunger trial (November 2020 to June 2022, NCT R01MD012630). Household food security in the 30 days before admission and discrimination during hospitalization were measured with the US Household Food Security Survey and the Discrimination in Medical Settings Scale, respectively. We used logistic regression to model the relationship between food security status and discrimination, adjusting for gender, race, ethnicity, income, and partner status. RESULTS: Most participants were African American or Black (81.5%), female (94.7%), and the parent of the hospitalized child (93.7%). FI and MFS were prevalent (25.1% and 15.1%, respectively). Experiences of discrimination during a child's hospitalization were prevalent (51.9%). Caregivers with FI had higher odds than caregivers with food security of experiencing discrimination (adjusted odds ratio = 2.0, 95% confidence interval 1.1-3.6, P = .03); MFS was not significantly associated with discrimination (P = .25). Compared with food secure caregivers, those with FI had higher odds of 5 of 7 experiences of discrimination assessed. CONCLUSIONS: Among parents and other caregivers, household FI is associated with experiences of discrimination during a child's hospitalization.

Importance of Breast Sensation After Mastectomy: Evidence from Three Sources.

Background: Every year, more than 90,000 U.S. women undergo mastectomy. More than 40% have reconstruction. Following reconstruction, most women experience persistent partial or complete numbness of the reconstructed breasts, and many experience pain. Yet, breast reconstruction procedures focus largely on esthetic outcomes with mixed impact on sensory outcomes and little attention to pain. This study examines whether and how breast sensation is important to women. Materials and Methods: Conventional content analysis of extant qualitative data from a clinical registry (29 women with prior breast surgery for cancer, 2008-2022), a volunteer community sample (qualitative interviews with 6 women with and 5 without breast cancer, 2019), and from a Twitter social media survey (N = 32, 2022). Results: Functions of the breast identified by women with and without cancer include breastfeeding, sexual function, and femininity. Five interrelated themes on the importance of breast sensation emerged among women with breast cancer history: sexual function, experience of partnered sex or relationship with one's sexual partner, breast embodiment, effect of breast pain on sexual function, and importance to psychological wellbeing. Women, advocates, and clinicians described a lack of patient-physician communication in this domain that exacerbates the negative impact of breast sensation loss on health and wellbeing. Conclusions: Breast sensation is important to women following mastectomy, yet a gap exists in patient-physician communication about the impact of mastectomy and reconstruction on breast sensory function. Lessons for physicians, scientists, and skeptics are conveyed about why the basic integrity of women's bodies matters for practice and science.

Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children: A Randomized Clinical Trial.

Importance: Health-related social risks (HRSRs), like food and housing insecurity, are stigmatized conditions that, when addressed in clinical settings, could inadvertently compromise health care experiences. Objective: To test the noninferiority hypothesis that a low-intensity, high-scale social care intervention does not promote experiences of discrimination or diminish satisfaction with care compared to usual care. Design, Setting, and Participants: This was a double-blind randomized clinical trial conducted from November 2020 to June 2022 with 12-month follow-up analyzing data obtained 1 week after baseline intervention at a 155-bed academic urban children's hospital with 5300 annual admissions. Participants were recruited from their children's hospital rooms during their children's inpatient hospital stays. Inclusion criteria were identifying as the primary caregiver of a child younger than 18 years who was hospitalized in the general, intensive care, or transplant units; living in 1 of 42 target zip codes; and consenting to receive text messages. Caregivers of healthy newborns and caregivers of children expected to be hospitalized for less than 24 hours or greater than 30 days were excluded. A total of 637 eligible parents and caregivers were enrolled. Interventions: Participants were randomized to usual care or usual care plus CommunityRx, a low-intensity, universally delivered, electronic medical record-integrated social care assistance intervention providing personalized information about local resources alongside education about HRSRs and how to access additional support. Usual care included an admission brochure about hospital-based free food options and nonsystematic provision of resource information. Main Outcomes and Measures: Experiences of discrimination, measured using the Discrimination in Medical Settings Scale (range 7-35; higher scores indicate more frequent discrimination) and satisfaction with hospital discharge 1 week postdischarge using Child HCAHPS (range 0-100; higher scores indicate higher satisfaction). The a priori noninferiority margins (control minus intervention) were -0.9 (discrimination) and 1.6 (satisfaction). Results: Of 637 eligible caregiver participants, most identified as female (n = 600 [94.3%]), Black (n = 505 [79.4%]), and had household income less than $50 000 per year (n = 488 [78.5%]). One-third were experiencing food insecurity (n = 223). Half of participants reported discrimination experiences during the pediatric hospitalization (n = 259). Discrimination experiences among the intervention group were noninferior to those among the control group (mean [SD] score: control, 10.3 [4.7] vs intervention, 10.0 [4.6]; difference, 0.2; 90% CI, -0.5 to 0.9). Mean (SD) satisfaction with discharge was high (control, 84.2 [23.8] vs intervention, 81.9 [24.8]), but evidence was insufficient to support intervention noninferiority for this end point (difference, 2.3; 90% CI, -1.2 to 5.8). Food security status did not moderate the relationship between intervention and either outcome. Conclusions and Relevance: The findings suggest that a universally delivered social care assistance intervention did not promote caregiver experiences of discrimination during a child's hospitalization but were inconclusive regarding satisfaction. Trial Registration: ClinicalTrials.gov Identifier: NCT04171999.

CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials.

BACKGROUND: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago's South Side, a predominantly African American/Black community. CommunityRx-Hunger is a double-blind RCT enrolling caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT enrolling caregivers of community-residing people with dementia. RCTs with caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify caregivers in clinical settings. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the protocols from in-person to remote operations. This study describes these protocols and methods used for successful iteration to overcome barriers. METHODS AND FINDINGS: CommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two in-person RCT protocols were pre-tested. In March 2020, when pandemic conditions prohibited face-to-face clinical enrollment, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Enabled by engaged Community Advisory Boards and ARCTICS, both RCTs quickly adapted to remote operations. To accommodate these adaptations, launch was delayed until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in the first 12 months than originally projected for in-person enrollment. DISCUSSION: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration of in-person trials to remote operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. TRIAL REGISTRATION: ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019).

Process of Engaging Community and Scientific Partners in the Development of the CIRCL-Chicago Study Protocol.

Objectives: Hypertension affects 1 in 3 adults in the United States and disproportionately affects African Americans. Kaiser Permanente demonstrated that a "bundle" of evidence-based interventions significantly increased blood pressure control rates. This paper describes a multiyear process of developing the protocol for a trial of the Kaiser bundle for implementation in under-resourced urban communities experiencing cardiovascular health disparities during the planning phase of this biphasic award (UG3/UH3). Methods: The protocol was developed by a collaboration of faith-based community members, representatives from community health center practice-based research networks, and academic scientists with expertise in health disparities, implementation science, community-engaged research, social care interventions, and health informatics. Scientists from the National Institutes of Health and the other grantees of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance also contributed to developing our protocol. Results: The protocol is a hybrid type 3 effectiveness-implementation study using a parallel cluster randomized trial to test the impact of practice facilitation on implementation of the Kaiser bundle in community health centers compared with implementation without facilitation. A central strategy to the Kaiser bundle is to coordinate implementation via faith-based and other community organizations for recruitment and navigation of resources for health-related social risks. Conclusions: The proposed research has the potential to improve identification, diagnosis, and control of blood pressure among under-resourced communities by connecting community entities and healthcare organizations in new ways. Faith-based organizations are a trusted voice in African American communities that could be instrumental for eliminating disparities.

CommunityRx: Optimizing a Community Resource Referral Intervention for Minority Dementia Caregivers.

Community resource referral systems have been implemented into care settings that serve persons with dementia but with little input from caregivers. Focus groups were conducted with African American, Hispanic, and Asian caregivers to describe their preferences for community resource referral information. Caregivers discussed the significance of a community resource list for dementia caregiving and self-care and articulated strategies for effective information delivery during a medical visit. Most caregivers acknowledged that resource needs change with progression of dementia, but no patterns emerged with regard to preference for information delivered incrementally based on disease stage or all at once. Hispanic and Asian caregivers felt that resource information should specify service providers' language and cultural capabilities. All caregivers agreed that delivery by a member of the care team with knowledge of dementia-specific resources would be most effective. Optimal delivery of community resource referrals is caregiver-centered and customizable to individual and subgroup preferences.

COVID-19-Related Food Insecurity Among Households with Dietary Restrictions: A National Survey.

BACKGROUND: Food insecurity dramatically increased because of the COVID-19 pandemic; however, little is known about pandemic-related food insecurity in households with dietary restrictions. OBJECTIVE: To examine pre-pandemic rates of and pandemic-related change in food insecurity among households with and without dietary restrictions. METHODS: A cross-sectional, panel-based survey of 3200 U.S. women was conducted in April 2020. Pre-pandemic food insecurity and early pandemic-related change in food insecurity were assessed using the adapted Hunger Vital Sign. Weighted, multivariate logistic regression was used to model the odds of pre-pandemic food insecurity and the odds of incident or worsening pandemic-related food insecurity among households with and without dietary restrictions. In models predicting pandemic-related outcomes, interaction effects between race/ethnicity and dietary restrictions were examined. RESULTS: Before the COVID-19 pandemic, households with self-reported food allergy (adjusted odds ratio [aOR]: 1.5, 95% confidence interval [CI]: 1.2-1.9), celiac disease (aOR: 2.3, 95% CI: 1.4-3.5), or both (aOR: 2.1, 95% CI: 1.2-3.6) were significantly more likely to be food insecure than households without restrictions. Households with dietary restrictions were also significantly more likely to experience incident or worsening food insecurity during the early pandemic (food allergy: aOR: 1.6, 95% CI: 1.3-2.1) (celiac disease: aOR: 2.3, 95% CI: 1.5-3.5) (both: aOR: 2.0, 95% CI: 1.2-3.4). Race/ethnicity was not a significant moderator of the relationship between dietary restrictions and pandemic-related food insecurity. CONCLUSION: Households with dietary restrictions were more likely to experience both pre-pandemic and pandemic-related incident or worsening food insecurity than households without restrictions. Clinical care for patients with dietary restrictions requires attention to food insecurity.

"I'm not just a heart, I'm a whole person here": a qualitative study to improve sexual outcomes in women with myocardial infarction.

BACKGROUND: Little is known about recovery of female sexual function following an acute myocardial infarction (MI). Interventions to improve sexual outcomes in women are limited. METHODS AND RESULTS: Semistructured, qualitative telephone interviews were conducted with 17 partnered women (aged 43 to 75 years) purposively selected from the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status Registry to deepen knowledge of recovery of female sexual function following an acute myocardial infarction (MI) and to improve sexual outcomes in women. Sixteen women had a monogamous relationship with a male spouse; 1 had a long-term female partner. Most women resumed sexual activity within 4 weeks of their MI. Sexual problems and concerns were prevalent, including patient and/or partner fear of "causing another heart attack." Few women received counseling about sexual concerns or the safety of returning to sex. Most women who discussed sex with a physician initiated the discussion themselves. Inquiry about strategies to improve sexual outcomes elicited key themes: need for privacy, patient-centeredness, and information about the timing and safe resumption of sexual activity. In addition, respondents felt that counseling should be initiated by the treating cardiologist, who "knows whether your heart is safe," and then reinforced by the care team throughout the rehabilitation period. CONCLUSIONS: Partnered women commonly resume sexual activity soon after an MI with fear but without directed counseling from their physicians. Proactive attention to women's concerns related to sexual function and the safety of sexual activity following an MI could improve post-MI outcomes for women and their partners.