Depression at the intersection of race/ethnicity, sex/gender, and sexual orientation in a nationally representative sample of US adults: A design-weighted intersectional MAIHDA.

This study examined how race/ethnicity, sex/gender, and sexual orientation intersect under interlocking systems of oppression to socially pattern depression among US adults. With cross-sectional data from the 2015-2020 National Survey on Drug Use and Health (NSDUH; n=234,722), we conducted design-weighted multilevel analysis of individual heterogeneity and discriminatory accuracy (MAIHDA) under an intersectional framework to predict past-year and lifetime major depressive episode (MDE). With 42 intersectional groups constructed from seven race/ethnicity, two sex/gender, and three sexual orientation categories, we estimated age-standardized prevalence and excess/reduced prevalence attributable to two-way or higher interaction effects. Models revealed heterogeneity across groups, with prevalence ranging from 1.9-19.7% (past-year) and 4.5-36.5% (lifetime). Approximately 12.7% (past-year) and 12.5% (lifetime) of total individual variance were attributable to between-group differences, indicating key relevance of intersectional groups in describing the population distribution of depression. Main effects indicated, on average, people who were White, women, gay/lesbian, or bisexual had greater odds of MDE. Main effects explained most between-group variance. Interaction effects (past-year: 10.1%; lifetime: 16.5%) indicated a further source of heterogeneity around averages with groups experiencing excess/reduced prevalence compared to main effects expectations. We extend the MAIHDA framework to calculate nationally representative estimates from complex sample survey data using design-weighted, Bayesian methods.

Investigating the factor structure and measurement invariance of the eating disorder examination questionnaire (EDE-Q) among cisgender gay men and lesbian women from the United States.

BACKGROUND: Although the Eating Disorder Examination-Questionnaire (EDE-Q) is one of the most widely used self-report assessments of eating disorder symptoms, evidence indicates potential limitations with its original factor structure and associated psychometric properties in a variety of populations, including sexual minority populations. The aims of the current investigation were to explore several previously published EDE-Q factor structures and to examine internal consistency and measurement invariance of the best-fitting EDE-Q model in a large community sample of cisgender gay men and cisgender lesbian women. METHODS: Data were drawn from 1624 adults (1060 cisgender gay men, 564 cisgender lesbian women) who participated in The PRIDE Study, a large-scale longitudinal cohort study of sexual and gender minorities from the United States. A series of confirmatory factor analyses (CFAs) were conducted to explore the fit of eight proposed EDE-Q models; internal consistency (Cronbach's alphas, Omega coefficients) and measurement invariance (multi-group CFA) were subsequently evaluated. RESULTS: A brief seven-item, three-factor (dietary restraint, shape/weight overvaluation, body dissatisfaction) model of the EDE-Q from Grilo et al. (Obes Surg. 23:657-662, 2013), consistently evidenced the best fit across cisgender gay men and lesbian women. The internal consistencies of the three subscales were adequate in both groups, and measurement invariance across the groups was supported. CONCLUSIONS: Taken together, these findings support the use of the seven-item, three-factor version of the EDE-Q for assessing eating disorder symptomatology in cisgender gay men and lesbian women. Future studies can confirm the current findings in focused examinations of the seven-item, three-factor EDE-Q in diverse sexual minority samples across race, ethnicity, socioeconomic status, and age ranges.

We asked cisgender gay men and lesbian women in The PRIDE Study to fill out a widely used survey about eating disorders, the Eating Disorder Examination-Questionnaire. We found that a version of this questionnaire based on seven questions including three parts­(1) dietary restraint, (2) shape and weight overvaluation, and (3) body dissatisfaction­had the best fit. These findings can assist doctors and scientists in understanding eating disorders in cisgender gay men and lesbian women.

Cervical Cancer Screening Knowledge, Perceptions, and Behaviors in a Multiracial Cohort of Low-Income, Underscreened Women in North Carolina.

Background: Underscreened, low-income, and uninsured or publicly insured women in the United States bear a greater burden of cervical cancer morbidity and mortality and may face unique barriers that preclude screening adherence. Methods: Participants were 710 My Body My Test-3 clinical trial participants who were publicly insured or uninsured with incomes ≤250% of the U.S. Federal Poverty Level, aged 25-64 years, and not up to date on cervical cancer screening as per national guidelines. Using Health Belief Model constructs, we assessed screening-related knowledge, perceptions, and behaviors-overall and stratified by race and ethnicity-and estimated associations with past-year attempted screening using multivariable regression models. Results: Overall, knowledge was low about the human papillomavirus, purpose of a Pap test, and recommended screening interval. Perceived severity of cervical cancer was high (3.63 on a 4-point scale). Black and Latina/Hispanic women were more likely to perceive screening as lowering their risk of cervical cancer than White women. Black women reported lower perceived risk of cervical cancer compared with White women (p = 0.03), but Black women were more likely to have sought screening in the past year (p = 0.01). Having at least three doctor visits in the past year was associated with a screening attempt. Greater perceived risk of cervical cancer, more positive perceptions of screening, and feeling more nervousness about screening were also associated with a screening attempt (all p < 0.05). Conclusions: Addressing knowledge gaps and misconceptions about cervical cancer screening and leveraging positive perceptions of screening may improve screening uptake and adherence among diverse underscreened U.S. women. Clinical Trial Registration Number: NCT02651883.

Protocol for a scoping review of health equity frameworks and models applied in empirical studies of chronic disease prevention and control.

BACKGROUND: Chronic diseases, such as cancers and cardiovascular diseases, present the greatest burden of morbidity and mortality worldwide. This burden disproportionately affects historically marginalized populations. Health equity is rapidly gaining increased attention in public health, health services, and implementation research, though many health inequities persist. Health equity frameworks and models (FM) have been called upon to guide equity-focused chronic disease and implementation research. However, there is no clear synthesis of the health equity FM used in chronic disease research or how these are applied in empirical studies. This scoping review seeks to fill this gap by identifying and characterizing health equity FM applied in empirical studies along the chronic disease prevention and control continuum, describing how these FM are used, and exploring potential applications to the field of implementation science. METHODS: We follow established guidance for conducting scoping reviews, which includes six stages: (1) identify the research question; (2) identify relevant studies; (3) select studies for inclusion; (4) data extraction; (5) collating, summarizing, and reporting the results; and (6) consultation. This protocol presents the iterative, collaborative approach taken to conceptualize this study and develop the search strategy. We describe the criteria for inclusion in this review, methods for conducting two phases of screening (title and abstract, full text), data extraction procedures, and quality assurance approaches taken throughout the project. DISCUSSION: The findings from this review will inform health-equity focused chronic disease prevention and control research. FM identified through this review will be added to an existing website summarizing dissemination and implementation science frameworks, and we will offer case examples and recommendations for utilizing a health equity FM in empirical studies. Our search strategy and review methodology may serve as an example for scholars seeking to conduct reviews of health equity FM in other health disciplines. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework Registration https://doi.org/10.17605/OSF.IO/SFVE6.

Investigating the factor structure and measurement invariance of the Eating Disorder Examination-Questionnaire (EDE-Q) in a community sample of gender minority adults from the United States.

OBJECTIVE: The Eating Disorder Examination-Questionnaire (EDE-Q) is one of the most widely used self-report assessments of eating disorder symptoms. However, evidence indicates potential problems with its original factor structure and associated psychometric properties in a variety of populations, including gender minority populations. The aim of the current investigation was to explore several previously published EDE-Q factor structures and to examine internal consistency and measurement invariance of the best-fitting EDE-Q model in a large community sample of gender minority adults. METHODS: Data were drawn from 1567 adults (337 transgender men, 180 transgender women, and 1050 gender-expansive individuals) who participated in The PRIDE Study, a large-scale longitudinal cohort study of sexual and gender minorities from the United States. A series of confirmatory factor analyses (CFAs) were conducted to explore the fit of eight proposed EDE-Q models; internal consistency (Cronbach's alphas, Omega coefficients) and measurement invariance (multi-group CFA) were subsequently evaluated. RESULTS: A brief seven-item, three-factor (dietary restraint, shape/weight overvaluation, body dissatisfaction) model of the EDE-Q consistently evidenced the best fit across gender minority groups (transgender men, transgender women, gender-expansive individuals). The internal consistencies of the three subscales were adequate in all groups, and measurement invariance across the groups was supported. DISCUSSION: Taken together, these findings support the use of the seven-item, three-factor version of the EDE-Q for assessing eating disorder symptomatology in gender minority populations. Future studies can confirm the current findings in focused examinations of the seven-item, three-factor EDE-Q in diverse gender minority samples across race, ethnicity, socioeconomic status, and age ranges. PUBLIC SIGNIFICANCE STATEMENT: Although transgender individuals have greater risk of developing an eating disorder, the factor structure of the Eating Disorder Examination-Questionnaire, one of the most widely used eating disorder assessment measures, has not been explored in transgender adults. We found that a seven-item model including three factors of dietary restraint, shape and weight overvaluation, and body dissatisfaction had the best fit among transgender and nonbinary adults.

Depression at the intersection of race/ethnicity, sex/gender, and sexual orientation in a nationally representative sample of US adults: A design-weighted MAIHDA.

This study examined how race/ethnicity, sex/gender, and sexual orientation intersect to socially pattern depression among US adults. We used repeated, cross-sectional data from the 2015-2020 National Survey on Drug Use and Health (NSDUH; n=234,772) to conduct design-weighted multilevel analysis of individual heterogeneity and discriminatory accuracy (MAIHDA) for two outcomes: past-year and lifetime major depressive episode (MDE). With 42 intersectional groups constructed from seven race/ethnicity, two sex/gender, and three sexual orientation categories, we estimated group-specific prevalence and excess/reduced prevalence attributable to intersectional effects (i.e., two-way or higher interactions between identity variables). Models revealed heterogeneity between intersectional groups, with prevalence estimates ranging from 3.4-31.4% (past-year) and 6.7-47.4% (lifetime). Model main effects indicated that people who were Multiracial, White, women, gay/lesbian, or bisexual had greater odds of MDE. Additive effects of race/ethnicity, sex/gender, and sexual orientation explained most between-group variance; however, approximately 3% (past-year) and 12% (lifetime) were attributable to intersectional effects, with some groups experiencing excess/reduced prevalence. For both outcomes, sexual orientation main effects (42.9-54.0%) explained a greater proportion of between-group variance relative to race/ethnicity (10.0-17.1%) and sex/gender (7.5-7.9%). Notably, we extend MAIHDA to calculate nationally representative estimates to open future opportunities to quantify intersectionality with complex sample survey data.

Longitudinal association of homonegative school climate with body dysmorphic disorder among cisgender sexual minority adolescents: Testing mediation through proximal minority stressors.

In a US national cohort study of cisgender sexual minority adolescents (SMAs), we prospectively (1) assessed whether within-person changes in homonegative school climate (i.e., school contextual factors that lead SMAs to feel unsafe or threatened) were associated with risk of probable body dysmorphic disorder (BDD) and (2) tested whether internalized homonegativity and negative expectancies mediated this association. Data came from consecutive time points (18-month, 24-month, 30-month) of the Adolescent Stress Experiences over Time Study (ASETS; N = 758). The Body Dysmorphic Disorder Questionnaire measured probable BDD. Sexual Minority Adolescent Stress Inventory subscales measured past 30-day minority stress experiences. Multilevel models were specified with person mean-centered predictor variables to capture within-person effects. Across one year of follow-up, 26.86% screened positive for probable BDD at least once. Model results indicated significant total (risk ratio [RR]=1.43, 95% credible interval [CI]=1.35-1.52) and direct effects (RR=1.18, 95% CI=1.05-1.34) of homonegative school climate. Internalized homonegativity was independently associated with probable BDD (RR=1.28, 95% CI=1.12-1.46) and mediated 49.7% (95% CI=12.4-82.0) of the total effect. There was limited evidence of mediation via negative expectancies. Implementing SMA-protective school policies and targeting internalized homonegativity in clinical practice may reduce the prevalence and incidence of probable BDD among cisgender SMAs.

Who is trying to lose weight? Trends and prevalence in past-year weight loss attempts among US adults 1999-2018 at the intersection of race/ethnicity, gender, and weight status.

Common stereotypes of those who desire or attempt to lose weight often center on the experience of White, thin women. However, prior studies have neglected how systems of oppression at intersection of race/ethnicity, gender, and weight status may interact to place certain subpopulations at elevated risk. Repeated cross-sectional data from the National Health and Nutrition Examination Survey (NHANES) 1999-2018 (n = 53,528), a population-representative sample of US adults, were used to 1) assess trends in past-year weight loss attempts using the Kendall-Mann trend test stratifying by race/ethnicity, gender, and weight status, and 2) estimate the adjusted prevalence of weight loss attempts over the combined 20-year period for combinations of race/ethnicity, gender, and weight status using logistic regression. There were significant monotonic trends from 1999 to 2018 for non-Hispanic Black men (43.8% to 67.8%, FDR adjusted p = .022) with an obese BMI, but not for any other groups. After adjusting for covariates, weight loss attempt prevalence was positively associated with BMI category for all race/ethnicity-gender combinations, although the degree of association differed. These findings underscore the need to use an intersectional lens in weight-related research. Despite limited long-term beneficial health impact, certain population subgroups, particularly Black men with an obese BMI, are increasingly trying to lose weight.

Psychometric validation of the Muscle Dysmorphic Disorder Inventory (MDDI) among U.S. transgender men.

Muscle dysmorphia (MD) is characterized by a pervasive belief or fear of insufficient muscularity and an elevated drive for muscularity, representing the pathological and extreme pursuit of muscularity. Psychometric properties of one of the most widely used measures of MD symptoms-the Muscle Dysmorphic Disorder Inventory (MDDI)-have yet to be evaluated in transgender men despite emerging evidence suggesting differential risk for MD symptoms in this population. In this study, we assessed the psychometric properties of the MDDI in a sample of 330 transgender men ages 18-67 years who participated in a large-scale national longitudinal cohort study of sexual and gender minority adults in the U.S. Using a two-step, split-sample approach, an initial exploratory factor analysis supported a three-factor structure and a subsequent confirmatory factor analysis of a re-specified three-factor model demonstrated good overall fit (χ2/df = 1.84, CFI =0.94, TLI =0.92, RMSEA =0.07 [90% CI =0.05,.09], SRMR =0.08). Moreover, results supported the internal consistency and convergent validity of the MDDI subscales in transgender men. Findings inform the use of the MDDI among transgender men and provide a foundation to support further work on the MDDI and MD symptoms among gender minority populations.

Simulating the role of knowledge brokers in policy making in state agencies: An agent-based model.

OBJECTIVE: To model children's mental health policy making dynamics and simulate the impacts of knowledge broker interventions. DATA SOURCES: Primary data from surveys (n = 221) and interviews (n = 64) conducted in 2019-2021 with mental health agency (MHA) officials in state agencies. STUDY DESIGN: A prototype agent-based model (ABM) was developed using the PARTE (Properties, Actions, Rules, Time, Environment) framework and informed through primary data collection. In each simulation, a policy is randomly generated (salience weights: cost, contextual alignment, and strength of evidence) and discussed among agents. Agents are MHA officials and heterogenous in their properties (policy making power and network influence) and policy preferences (based on salience weights). Knowledge broker interventions add agents to the MHA social network who primarily focus on the policy's research evidence. DATA COLLECTION/EXTRACTION METHODS: A sequential explanatory mixed method approach was used. Descriptive and regression analyses were used for the survey data and directed content analysis was used to code interview data. Triangulated results informed ABM development. In the ABM, policy makers with various degrees of decision influence interact in a scale-free network before and after knowledge broker interventions. Over time, each decides to support or oppose a policy proposal based on policy salience weights and their own properties and interactions. The main outcome is an agency-level decision based on policy maker support. Each intervention and baseline simulation runs 250 times across 50 timesteps. PRINCIPAL FINDINGS: Surveys and interviews revealed that barriers to research use could be addressed by knowledge brokers. Simulations indicated that policy decision outcomes varied by policy making context within agencies. CONCLUSIONS: This is the first application of ABM to evidence-informed mental health policy making. Results suggest that the presence of knowledge brokers can: (1) influence consensus formation in MHAs, (2) accelerate policy decisions, and (3) increase the likelihood of evidence-informed policy adoption.

Appearance and performance-enhancing drugs and supplements, eating disorders, and muscle dysmorphia among gender minority people.

OBJECTIVE: Appearance and performance-enhancing drugs and supplements (APEDS) can be used to enhance muscle growth, athletic performance, and physical appearance. The aim of this study was to examine the lifetime use of APEDS and associations with eating disorder and muscle dysmorphia symptoms among gender minority people. METHOD: Participants were 1653 gender minority individuals (1120 gender-expansive [defined as a broad range of gender identities that are generally situated outside of the woman-man gender binary, e.g., genderqueer, nonbinary] people, 352 transgender men, and 181 transgender women) recruited from The Population Research in Identity and Disparities for Equality Study in 2018. Regression analyses stratified by gender identity examined associations of any APEDS use with eating disorder and muscle dysmorphia symptom scores. RESULTS: Lifetime APEDS use was common across groups (30.7% of gender-expansive people, 45.2% of transgender men, and 14.9% of transgender women). Protein supplements and creatine supplements were the most commonly used APEDS. Among gender-expansive people and transgender men, lifetime use of any APEDS was significantly associated with higher eating disorder scores, dietary restraint, binge eating, compelled/driven exercise, and muscle dysmorphia symptoms. Any APEDS use was additionally associated with laxative use among gender-expansive people. Among transgender women, use of any APEDS was not significantly associated with eating disorder or muscle dysmorphia symptoms. DISCUSSION: APEDS use is common and associated with eating disorder and muscle dysmorphia symptoms in gender-expansive people and transgender men, thus highlighting the importance of assessing for these behaviors and symptoms among these populations, particularly in clinical settings. PUBLIC SIGNIFICANCE: This study aimed to examine APEDS use among gender minority people. We found that 30.7% of gender-expansive (e.g., nonbinary) people, 45.2% of transgender men, and 14.9% of transgender women reported lifetime APEDS use, which was associated with eating disorder and muscle dysmorphia symptoms in transgender men and gender-expansive people. Clinicians should assess for these behaviors in gender minority populations.

Appearance and performance-enhancing drugs and supplements (APEDS): Lifetime use and associations with eating disorder and muscle dysmorphia symptoms among cisgender sexual minority people.

PURPOSE: Appearance and performance-enhancing drugs and supplements (APEDS) are used to enhance muscle growth, athletic performance, and physical appearance. The aim of this study was to examine the lifetime use of APEDS and associations with eating disorder and muscle dysmorphia symptoms among cisgender sexual minority people. METHODS: Participants were cisgender sexual minority people (1090 gay men, 100 bisexual plus men, 564 lesbian women, and 507 bisexual plus women) recruited from The PRIDE Study in 2018 who reported lifetime APEDS use and completed the Eating Disorder Examination-Questionnaire (EDE-Q) and the Muscle Dysmorphic Disorder Inventory (MDDI). Regression analyses stratified by gender and sexual orientation examined associations of any APEDS use with EDE-Q and MDDI scores. RESULTS: Lifetime APEDS use was common across the four groups of cisgender sexual minority people (44% of gay men, 42% of bisexual plus men, 29% of lesbian women, and 30% of bisexual plus women). Protein supplements and creatine supplements were the most commonly used APEDS. Any APEDS use was associated with higher EDE-Q scores on one or more subscales in all sexual minority groups. Further, any APEDS use was associated with higher MDDI Total Scores in all groups; any APEDS use was associated with all MDDI subscale scores in cisgender gay men only. DISCUSSION: APEDS use is common and associated with eating disorder and muscle dysmorphia symptoms in sexual minority men and women, thus highlighting the importance of assessing for these behaviors and symptoms among these populations in clinical settings.

Differences in Patient and Parent Informant Reports of Depression and Anxiety Symptoms in a Clinical Sample of Transgender and Gender Diverse Youth.

Purpose: We assessed characteristics of patients at a pediatric gender clinic and investigated if reports of mental health concerns provided by transgender and gender diverse (TGD) youth patients differed from reports provided by a parent informant on their behalf. Methods: This cross-sectional study included 259 TGD patients 8 to 22 years of age attending a pediatric gender clinic in the southeast United States from 2015 to 2020. Pearson correlations and paired sample t-tests compared patient-reported mental health concerns at patient intake with those provided by a parent informant. Clinical symptom severity was assessed with standardized T-scores. Level 2 Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Scale and Level 2 PROMIS Emotional Distress-Anxiety Scale assessed depression and anxiety symptoms of patients. Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure was used with parents. Results: Patients had a mean age of 14.9 at first visit, with most identifying as White (85.5%), non-Hispanic (91.1%), and as a boy or man (63.6%). Half had moderate-to-severe depression (51.2%) or anxiety (47.9%) symptoms. There was a moderate, positive correlation between patient-reported and parent-reported depression symptoms, with no correlation for anxiety symptoms. Informant type differences were statistically significant (patients reporting greater depression and anxiety symptoms). Conclusions: TGD youth patients reported more severe depression and anxiety symptoms compared with parent informants. Despite moderate agreement on depression symptoms, parents did not accurately detect their child's anxiety symptoms. These discrepancies highlight a need for interventions which increase parental recognition of child mental health status.

Community norms of the Muscle Dysmorphic Disorder Inventory (MDDI) among gender minority populations.

PURPOSE: Representing the pathological extreme pursuit of muscularity, muscle dysmorphia (MD) is characterized by a pervasive belief or fear around insufficient muscularity and an elevated drive for muscularity. Despite evidence of heightened body image-related concerns among gender minority populations, little is known about the degree of MD symptoms among gender minorities, particularly based on Muscle Dysmorphic Disorder Inventory (MDDI) scores. The objective of this study was to assess community norms of the MDDI in gender-expansive people, transgender men, and transgender women. METHOD: Data from participants in The PRIDE Study, an existing study of health outcomes in sexual and gender minority people, were examined. We calculated means, standard deviations, and percentiles for the MDDI total and subscale scores among gender-expansive people (i.e., those who identify outside of the binary system of man or woman; n = 1023), transgender men (n = 326), and transgender women (n = 177). The Kruskal-Wallis test was used to assess group differences and post hoc Dunn's tests were used to examine pairwise differences. RESULTS: Transgender men reported the highest mean MDDI total score (30.5 ± 7.5), followed by gender-expansive people (27.2 ± 6.7), then transgender women (24.6 ± 5.7). The differences in total MDDI score were driven largely by the Drive for Size subscale and, to a lesser extent, the Functional Impairment subscale. There were no significant differences in the Appearance Intolerance subscale among the three groups. CONCLUSIONS: Transgender men reported higher Drive for Size, Functional Impairment, and Total MDDI scores compared to gender-expansive people and transgender women. These norms provide insights into the experience of MD symptoms among gender minorities and can aid researchers and clinicians in the interpretation of MDDI scores among gender minority populations.

Transgender people have a gender identity or expression that differs from what is typically associated with the sex assigned to them at birth. Gender-expansive refers to gender identities that do not fit within the binary (woman/man) gender system. We asked gender-expansive people, transgender men, and transgender women in The PRIDE Study to fill out a widely used survey about muscle dysmorphia, a condition in which a person worries they are not muscular enough. The results showed that transgender men had the highest muscle dysmorphia symptoms, followed by gender-expansive people, then transgender women. These findings can help clinicians and researchers in interpreting a survey assessing muscle dysmorphia in gender-expansive people, transgender men, and transgender women. Characterizing muscle dysmorphia symptoms in these populations is an important step to improve mental wellness among transgender and gender-expansive people.

Willingness to participate in research among black patients with liver disease: A national cross-sectional study.

In the United States, Black people are disproportionately diagnosed with hepatitis C virus (HCV) compared with White people but are under-represented in HCV studies. In this US-based cross-sectional telephone survey study, we assessed willingness to participate (WTP) in health/medical research and attitudes and beliefs that may influence WTP among Black patients with HCV. Two hundred participants who had current or prior HCV diagnosis and self-identified as Black or African American were recruited from a national HCV cohort study and an outpatient hepatology clinic. WTP responses ranged from 1 (not at all willing) to 5 (very willing). Multivariable models were used to identify factors associated with the overall mean WTP score. In addition, an open-ended question solicited strategies to help increase research participation from the Black community. Overall, participants reported moderate WTP in research (Mean [95% Confidence Interval (CI)] = 3.78 [3.68, 3.88]). Of 13 types of research presented, participants reported lowest WTP for randomized controlled trials of medications (Mean [95% CI] = 2.31 [2.11, 2.50]). The initial multivariable model identified higher subjective knowledge of research as positively associated with WTP (Parameter estimate [95% CI] = 0.15 [0.02, 0.27]). Sensitivity analyses also identified higher perceived benefits of research as an additional factor associated with WTP. Qualitative findings indicate that greater community-based outreach efforts would increase accessibility of research opportunities. When given the opportunity to participate, Black participants with HCV reported moderate WTP in health/medical research. Research sponsors and investigators should employ community-based outreach to expand access and awareness of research opportunities.

More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant.

BACKGROUND: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. METHODS: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure quality conduct of clinical trials. Data were examined using applied thematic analysis. RESULTS: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants' health and safety. Respondents acknowledged that GCP principles address each of these critical tasks but also described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the perceived relevance of GCP training. CONCLUSION: Our findings indicate that although investigators and sponsors recognize that GCP training addresses tasks critical to the quality conduct of clinical trials, the need for significant improvement in the design, content, and presentation of GCP training remains.

Racial and Ethnic Differences in Acceptability of Urine and Cervico-Vaginal Sample Self-Collection for HPV-Based Cervical Cancer Screening.

Background: We compared women's acceptability of urine and cervico-vaginal sample self-collection for high-risk (oncogenic) human papillomavirus (hrHPV) testing and assessed whether acceptability varied across racial/ethnic groups. Methods: As part of a test accuracy study of urine-based hrHPV testing, we recruited a convenience sample of women 25-65 years of age at two colposcopy clinics in North Carolina between November 2016 and January 2019. After self-collection of urine and cervico-vaginal samples, women completed a questionnaire on the acceptability of the sample collection methods. We coded open-ended questions inductively. All results are presented stratified by racial/ethnic group. Results: We included 410 women (119 Hispanic, 115 non-Hispanic Black, 154 non-Hispanic White, and 22 women with other racial identities). Most women (79%, 95% confidence interval [CI] = 76%-83%) had positive feelings about urine-based hrHPV testing. Women generally preferred urine (78%, 95% CI = 74%-82%) over cervico-vaginal self-collection (18%, 95% CI = 14%-22%), but the degree differed by racial/ethnic group, increasing from 75% in non-Hispanic Black to 82% in Hispanic women (p = 0.011). Most women reported at least one positive aspect of urine (89%) and cervico-vaginal self-collection (85%) for hrHPV testing with the most common positive aspect being easy sample collection, although 16% of women were concerned about performing the cervico-vaginal self-collection correctly. Conclusions: Self-collection for hrHPV-based cervical cancer screening is highly acceptable to women across different racial/ethnic groups in the United States, and most women in our study would be more likely to attend future cervical cancer screening appointments if screening were urine based. Urine-based hrHPV testing is a promising approach to improve cervical cancer screening coverage.

Patient preferences for using mobile technologies in clinical trials.

The use of mobile technologies to collect participant data in clinical trials offers a number of scientific and logistical advantages. However, little is known about potential research participant preferences about how to incorporate mobile technologies into the design and conduct of a trial. Using a web-based survey which described hypothetical mobile clinical trial and traditional clinical trial scenarios, we explored patients' perceptions of and willingness to participate in mobile and traditional clinical trials, their preferred trial procedures related to the use of mobile technologies, and the preferred attributes of mobile technologies. The majority of survey respondents reported that they would prefer participating in a clinical trial that used mobile technology than a traditional trial that relied on standard in-clinic assessments. They expressed that mobile clinical trials offered greater convenience, a reduction of in-person clinic visits, and greater data collection accuracy. Respondents also reported preferences for the frequency of in-clinic visits during mobile clinical trials, device training and troubleshooting, data privacy and confidentiality, the location of data storage, and user access to data collected by the trial device. As research participants become more involved in capturing their own data to inform trial endpoints, their user-preferences of mobile technology, such as those described here, should be considered in the design and conduct of mobile clinical trials.