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This cross-sectional multimethod study sought to examine the process of engaging in healthy behaviors, particularly related to stress management, in HIV-infected women with low incomes. Recruited from northeast Ohio, 42 women completed standardized research measures to assess healthy behaviors (via the Health-Promoting Lifestyle Profile II) and the processes of change espoused by the Transtheoretical Model of Behavior Change; 8 of those women participated in individual semistructured interviews conducted at a later point in time to gain additional insight into the phenomenon. Participants were 25 to 60 years of age (mean 38.44 +/- 8.08) and most of the frequently reported healthy behaviors related to spiritual growth and interpersonal relations. Self-reevaluation was the process of change most frequently reported. Qualitative analysis revealed several processes women use to enhance the adoption and maintenance of healthy behaviors; some themes were adequately reflected by the Transtheoretical Model's Processes of Change, whereas a few emerged as processes not usually associated with the Transtheoretical Model. This study yielded useful preliminary information to further explore the adoption and maintenance of health-promoting behavior for HIV-infected women. [ABSTRACT FROM AUTHOR]

Objective: Rates of preventive counseling remain below national guidelines. We explored physician and patient predictors of preventive counseling across multiple cancer risk behaviors in at-risk primary care patients.Methods: We surveyed 3557 patients, with at least one of four cancer risk behaviors: smoking, diet, sun exposure, and/or mammography screening, at baseline and 24 months. Patients reported receipt of 4A's (Ask, Advise, Assist, Arrange follow-up); responses were weighted and combined to reflect more thorough counseling (Ask=1, Advise=2, Assist=3, Arrange=4, score range 0-10) for each target behavior. A series of linear-regression models, controlling for office clustering, examined patient, physician and other situational predictors at 24 months.Results: Risk behavior topics were brought up more often for mammography (90%) and smoking (79%) than diet (56%) and sun protection (30%). Assisting and Arranging follow-up were reported at low frequencies across all behaviors. More thorough counseling for all behaviors was associated with multiple visits and higher satisfaction with care. Prior counseling predicted further counseling on all behaviors except smoking, which was already at high levels. Other predictors varied by risk behavior.Conclusions: More thorough risk behavior counseling can be delivered opportunistically across multiple visits; doing so is associated with more satisfaction with care. [ABSTRACT FROM AUTHOR]

Few prospective studies examine multilevel resilience resources and psychosocial factors in relation to cardiovascular health and disease. Recent research indicates that resilience resources are associated with a reduction in the incidence of cardiovascular disease-related events, but few studies have examined this relationship across different racial/ethnic populations or in large cohorts. Harmonization may address these limitations because it allows data from several cohorts to be analyzed together, potentially increasing sample size and in turn power overall and in minority populations. This paper describes the process involved in combining three cardiovascular health-focused cohorts: Jackson Heart Study, Multi-Ethnic Study of Atherosclerosis, and Mediators of Atherosclerosis in South Asians Living in America Study. Using a systematic process, we identified appropriate data harmonization techniques to use in harmonizing variables across cohorts. Variables included exposures (e.g., resilience resources), outcomes (e.g., American Heart Association's Life's Simple 7), and covariates (e.g., race and ethnicity). Post harmonization examinations included psychometric analyses of the harmonized variables. A total of 13,284 participants were included in the final harmonized dataset. This project provides opportunities for future research in resilience resources and informs future studies that need to harmonize data. Results based on the harmonized dataset could inform interventions and policies., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: To assess overall and by neighborhood risk environments whether multilevel resilience resources were associated with HIV virologic suppression among African American/Black adults in the Southeastern United States., Setting and Methods: This clinical cohort sub-study included 436 African American/Black participants enrolled in two parent HIV clinical cohorts. Resilience was assessed using the Multilevel Resilience Resource Measure (MRM) for African American/Black adults living with HIV, where endorsement of a MRM statement indicated agreement that a resilience resource helped a participant continue HIV care despite challenges or was present in a participant's neighborhood. Modified Poisson regression models estimated adjusted prevalence ratios (aPRs) for virologic suppression as a function of categorical MRM scores, controlling for demographic, clinical, and behavioral characteristics at or prior to sub-study enrollment. We assessed for effect measure modification (EMM) by neighborhood risk environments., Results: Compared to participants with lesser endorsement of multilevel resilience resources, aPRs for virologic suppression among those with greater or moderate endorsement were 1.03 (95% confidence interval: 0.96-1.11) and 1.03 (0.96-1.11), respectively. Regarding multilevel resilience resource endorsement, there was no strong evidence for EMM by levels of neighborhood risk environments., Conclusions: Modest positive associations between higher multilevel resilience resource endorsement and virologic suppression were at times most compatible with the data. However, null findings were also compatible. There was no strong evidence for EMM concerning multilevel resilience resource endorsement, which could have been due to random error. Prospective studies assessing EMM by levels of the neighborhood risk environment with larger sample sizes are needed., (© 2023. W. Montague Cobb-NMA Health Institute.)

We examined relationships between resilience resources (optimism, social support, and neighborhood social cohesion) and cardiovascular disease (CVD) incidence and assessed potential effect-measure modification by psychosocial risk factors (e.g., stress, depression) among adults without CVD in 3 cohort studies (2000-2018): the Jackson Heart Study, the Multi-Ethnic Study of Atherosclerosis, and the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study. We fitted adjusted Cox models accounting for within-neighborhood clustering while censoring at dropout or non-CVD death. We assessed for effect-measure modification by psychosocial risks. In secondary analyses, we estimated standardized risk ratios using inverse-probability-weighted Aalen-Johansen estimators to account for confounding, dropout, and competing risks (non-CVD deaths) and obtained 95% confidence intervals (CIs) using cluster bootstrapping. For high and medium (versus low) optimism (n = 6,243), adjusted hazard ratios (HRs) for incident CVD were 0.94 (95% CI: 0.78, 1.13) and 0.90 (95% CI: 0.75, 1.07), respectively. Corresponding HRs were 0.88 (95% CI: 0.74, 1.04) and 0.92 (95% CI: 0.79, 1.06) for social support (n = 7,729) and 1.10 (95% CI: 0.94, 1.29) and 0.99 (95% CI: 0.85, 1.16) for social cohesion (n = 7,557), respectively. Some psychosocial risks modified CVD HRs. Secondary analyses yielded similar findings. For optimism and social support, an inverse relationship was frequently most compatible with the data, but a positive relationship was also compatible. For neighborhood social cohesion, positive and null relationships were most compatible. Thus, specific resilience resources may be potential intervention targets, especially among certain subgroups., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: Social support may have benefits on cardiovascular health (CVH). CVH is evaluated using seven important metrics (Life's Simple 7; LS7) established by the American Heart Association (e.g., smoking, diet). However, evidence from longitudinal studies is limited and inconsistent. The objective of this study is to examine the longitudinal relationship between social support and CVH, and assess whether psychosocial risks (e.g., anger and stress) modify the relationship in a racially/ethnically diverse population., Methods: Participants from three harmonized cohort studies - Jackson Heart Study, Mediators of Atherosclerosis in South Asians Living in America, and Multi-Ethnic Study of Atherosclerosis - were included. Repeated-measures modified Poisson regression models were used to examine the overall relationship between social support (in tertiles) and CVH (LS7 metric), and to assess for effect modification by psychosocial risk., Results: Among 7724 participants, those with high (versus low) social support had an adjusted prevalence ratio (aPR) and 95% confidence interval (CI) for ideal or intermediate (versus poor) CVH of 0.99 (0.96-1.03). For medium (versus low) social support, the aPR (95% CI) was 1.01 (0.98-1.05). There was evidence for modification by employment and anger. Those with medium (versus low) social support had an aPR (95% CI) of 1.04 (0.99-1.10) among unemployed or low anger participants. Corresponding results for employed or high anger participants were 0.99 (0.94-1.03) and 0.97 (0.91-1.03), respectively., Conclusion: Overall, we observed no strong evidence for an association between social support and CVH. However, some psychosocial risks may be modifiers. Prospective studies are needed to assess the social support-CVH relationship by psychosocial risks in racially/ethnically diverse populations., Competing Interests: None., (© 2022 Published by Elsevier Ltd.)

Background: Psychosocial stressors increase the risks for cardiovascular disease across diverse populations. However, neighborhood level resilience resources may protect against poor cardiovascular health (CVH). This study used data from three CVH cohorts to examine longitudinally the associations of a resilience resource, perceived neighborhood social cohesion (hereafter referred to as neighborhood social cohesion), with the American Heart Association's Life's Simple 7 (LS7), and whether psychosocial stressors modify observed relationships., Methods: We examined neighborhood social cohesion (measured in tertiles) and LS7 in the Jackson Heart Study, Multi-Ethnic Study of Atherosclerosis, and Mediators of Atherosclerosis in South Asians Living in America study. We used repeated-measures, modified Poisson regression models to estimate the relationship between neighborhood social cohesion and LS7 (primary analysis, n = 6,086) and four biological metrics (body mass index, blood pressure, cholesterol, blood glucose; secondary analysis, n = 7,291). We assessed effect measure modification by each psychosocial stressor (e.g., low educational attainment, discrimination)., Results: In primary analyses, adjusted prevalence ratios (aPR) and 95% confidence intervals (CIs) for ideal/intermediate versus poor CVH among high or medium (versus low) neighborhood social cohesion were 1.01 (0.97-1.05) and 1.02 (0.98-1.06), respectively. The psychosocial stressors, low education and discrimination, functioned as effect modifiers. Secondary analyses showed similar findings. Also, in the secondary analyses, there was evidence for effect modification by income., Conclusion: We did not find much support for an association between neighborhood social cohesion and LS7, but did find evidence of effect modification. Some of the effect modification results operated in unexpected directions. Future studies should examine neighborhood social cohesion more comprehensively and assess for effect modification by psychosocial stressors., (© 2022. The Author(s).)

Importance: The prevalence of obesity has increased substantially among emerging adults, yet no previous large-scale behavioral weight loss trials have been conducted among this age group., Objective: To test the effect of 2 theory-based motivational enhancements on weight loss within a primarily digital lifestyle intervention designed for emerging adults., Design, Setting, and Participants: In this randomized clinical trial conducted at an academic medical research center, 382 participants aged 18 to 25 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45 were enrolled between February 2, 2016, and February 6, 2019. Data collection was completed February 8, 2020. Analysis was performed on an intention-to-treat basis., Interventions: Participants were randomized to 1 of 3 groups: developmentally adapted behavioral weight loss (aBWL), aBWL plus behavioral economics (aBWL + BE), or aBWL plus self-determination theory (aBWL + SDT). All groups received a 6-month intervention with 1 group session, 1 individual session, and a digital platform (digital tools for self-monitoring, weekly lessons, tailored feedback, text messages, and optional social media). The aBWL + BE group received modest financial incentives for self-monitoring and weight loss; the aBWL + SDT group received optional experiential classes. Coaching and message framing varied by group., Main Outcomes and Measures: The primary outcome was mean (SE) weight change (in kilograms) at 6 months. Secondary outcomes included proportion of participants achieving weight loss of 5% or more, percentage weight change, waist circumference, body composition, and blood pressure., Results: Among the 382 participants (mean [SD] age, 21.9 [2.2] years), 316 (82.7%) were female, mean (SD) BMI was 33.5 (4.9), 222 (58.1%) were of underrepresented race and/or ethnicity, and 320 (83.8%) were retained at the primary end point. There was a significant time effect for mean (SE) weight loss (-3.22 [0.55] kg in the aBWL group; -3.47 [0.55] kg in the aBWL + BE group; and -3.40 [0.53] kg in the aBWL + SDT group; all P < .001), but no between-group differences were observed (aBWL vs aBWL + BE: difference, -0.25 kg [95% CI, -1.79 to 1.29 kg]; P = .75; aBWL vs aBWL + SDT: difference, -0.18 kg [95% CI, -1.67 to 1.31 kg]; P = .81; and aBWL + SDT vs aBWL + BE: difference, 0.07 kg [95% CI, -1.45 to 1.59 kg]; P = .93). The proportion of participants achieving a weight loss of 5% or more was 40.0% in the aBWL group (50 of 125), 39.8% in the aBWL + BE group (51 of 128), and 44.2% in the aBWL + SDT group (57 of 129), which was not statistically different across groups (aBWL vs aBWL + BE, P = .89; aBWL vs aBWL + SDT, P = .45; aBWL + SDT vs aBWL + BE, P = .54). Parallel findings were observed for all secondary outcomes-clinically and statistically significant improvements with no differences between groups., Conclusions and Relevance: In this randomized clinical trial, all interventions produced clinically significant benefit, but neither of the motivational enhancements promoted greater reductions in adiposity compared with the developmentally adapted standard group. Continued efforts are needed to optimize lifestyle interventions for this high-risk population and determine which intervention works best for specific individuals based on sociodemographic and/or psychosocial characteristics., Trial Registration: ClinicalTrials.gov Identifier: NCT02736981.

Dual compartment suppositories are being developed to prevent HIV and other sexually transmitted infections. Such products, for use in the rectum, the vagina, or both, could have a significant public health impact by decreasing global incidence of these diseases. In this study, 16 women each used two rheologically distinct suppositories in their vagina and rectum. User Sensory Perception and Experience (USPE) scales assessed sensory experiences during sexual activity to understand whether, and how, women perceive formulation properties in the vagina and rectum. Qualitative data from individual in-depth interviews captured women's descriptions and comparisons of the experiences. Significant differences and large Cohen's d effect sizes between vaginal and rectal experiences of suppository-A were found for three scales: Application (APP): Product Awareness , SEX: Initial Penetration ; and SEX: Effortful . Qualitative data provided user experience details that credibly align with these score differences. Near significant differences and large effect sizes were found for two additional scales: SEX: Perceived Wetness with suppository-A and SEX: Messiness with suppository-B. In addition, other scale scores showed medium-to-large effect sizes that correspond to hypothesized sensations associated with biophysical properties of the suppositories. Statistical significance combined with large effect sizes and qualitative data accurately represent the hypothesized perceptibility of suppository properties and identifies performance characteristics relevant to acceptability and adherence; together these data provide discernment of factors that can guide the development of dual compartment products. The Clinical Trial Registration number: NCT02744261.

Understanding resilience in relation to HIV-related outcomes may help address racial/ethnic disparities, however, significant gaps in its measurement preclude in-depth study. Thus, this research aims to develop and evaluate the psychometric properties of long and short forms of the Multilevel Resilience Resource Measure for African American/Black Adults Living with HIV. To develop the items, we conducted a mixed methods study (N = 48) and reviewed published resilience measures. We completed content validity index analyses to ensure the items reflected the resilience construct. Next, we conducted 20 cognitive interviews and a field survey (N = 400). The long and short forms demonstrated acceptable to excellent psychometric properties based on factorial validity, internal consistency and convergent validity and on measurement invariance (conducted for the short form only). These measures provide a comprehensive framework to examine resilience and HIV-related outcomes and can inform resilience-building interventions to reduce racial and ethnic health disparities., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: This systematic review and meta-analysis aimed to quantify the relationship between resilience resources at the individual (e.g., optimism), interpersonal (e.g., social support), and neighborhood (e.g., social environment) levels, and cardiovascular outcomes among adults in the United States. Method: On 9/25/2020, electronic databases (PubMed, Embase, CINAHL, PsycINFO) were systematically searched for randomized controlled trials, nonrandomized intervention studies, and prospective cohort studies that examined the relationship between resilience resources at the individual, interpersonal, or neighborhood level and cardiovascular outcomes. Studies that met the eligibility criteria were summarized narratively and quantitatively. Because relevant search results yielded only observational studies, risk of bias was assessed using an adapted version of the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool. Results: From 4,103 unique records, 13 prospective cohort studies with a total of 310,906 participants met the eligibility criteria, and six of these studies were included in the meta-analyses. Most relevant studies found that higher levels of individual-level resilience resources were associated with lower incidence of adverse cardiovascular outcomes, with point estimates ranging from .46 to 1.18. Interpersonal-level resilience resources (i.e., social network) were associated with a lower coronary heart disease risk (risk ratio, .76; 95% CI [.56, 1.02]). Neighborhood-level resilience resources (i.e., perceived social cohesion and residential stability) were associated with a lower odds of stroke (odds ratio, .92; 95% CI [.84, 1.01]). Conclusions: Evidence suggests that higher levels of resilience resources are associated with better cardiovascular outcomes. However, more prospective studies with diverse populations are needed to strengthen the evidence. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Background: Optimism has been shown to be positively associated with better cardiovascular health (CVH). However, there is a dearth of prospective studies showing the benefits of optimism on CVH, especially in the presence of adversities, i.e., psychosocial risks. This study examines the prospective relationship between optimism and CVH outcomes based on the Life's Simple 7 (LS7) metrics and whether multilevel psychosocial risks modify the aforementioned relationship. Methods: We examined self-reported optimism and CVH using harmonized data from two U.S. cohorts: Multi-Ethnic Study of Atherosclerosis (MESA) and Jackson Heart Study (JHS). Modified Poisson regression models were used to estimate the relationship between optimism and CVH using LS7 among MESA participants ( N = 3,520) and to examine the relationship of interest based on four biological LS7 metrics (body mass index, blood pressure, cholesterol, and blood glucose) among JHS and MESA participants ( N = 5,541). For all CVH outcomes, we assessed for effect measure modification by psychosocial risk. Results: Among MESA participants, the adjusted risk ratio (aRR) for ideal or intermediate CVH using LS7 comparing participants who reported high or medium optimism to those with the lowest level of optimism was 1.10 [95% Confidence Interval (CI): 1.04-1.16] and 1.05 (95% CI: 0.99-1.11), respectively. Among MESA and JHS participants, the corresponding aRRs for having all ideal or intermediate (vs. no poor) metrics based on the four biological LS7 metrics were 1.05 (0.98-1.12) and 1.04 (0.97-1.11), respectively. The corresponding aRRs for having lower cardiovascular risk (0-1 poor metrics) based on the four biological LS7 metrics were 1.01 (0.98-1.03) and 1.01 (0.98-1.03), respectively. There was some evidence of effect modification by neighborhood deprivation for the LS7 outcome and by chronic stress for the ideal or intermediate (no poor) metrics outcome based on the four biological LS7 metrics. Conclusion: Our findings suggest that greater optimism is positively associated with better CVH based on certain LS7 outcomes among a racially/ethnically diverse study population. This relationship may be effect measure modified by specific psychosocial risks. Optimism shows further promise as a potential area for intervention on CVH. However, additional prospective and intervention studies are needed., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Park, Dulin, Needham, Sims, Loucks, Fava, Dionne, Scarpaci, Eaton and Howe.)

Pathologists often incorporate modifying phrases in their diagnosis to imply varying levels of diagnostic certainty; however, what is implied by the pathologists is not equivalent with what is perceived by the referring physicians and patients. This discordance can have significant implications in management, safety, and cost. We intend to identify lack of consistency in interpretation of modifying phrases by comparing perceived level of certainty by pathologists and non-pathologists, and introduce a standard scheme for reporting uncertainty in pathology reports using the experience with imaging reporting and data systems. In this study, a list of 18 most commonly used modifying phrases in pathology reports was distributed among separate cohorts of pathologists (N = 17) and non-pathology clinicians (N = 225) as a questionnaire survey, and the participants were asked to assign a certainty level to each phrase. All the participants had practice privileges in Brown University-affiliated teaching hospitals. The survey was completed by 207 participants (17 pathologists, 190 non-pathologists). It reveals a significant discordance between the interpretations of the modifying phrases between the two cohorts, with significant variations in subgroups of non-pathology clinicians. Also there is disagreement between pathologists and other clinicians regarding the causes of miscommunication triggered by pathology reports. Pathologists and non-pathology clinicians should be mindful of the potential sources of misunderstanding of pathology reports and take necessary actions to prevent and clarify the uncertainties. Using a standard scheme for reporting uncertainty in pathology reports is recommended., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: In the U.S., over 40% of 18-25 year olds meet criteria for overweight or obesity. Yet, no large-scale trials have targeted this age group for behavioral weight loss (BWL). Formative data revealed that existing BWL programs do not meet their unique needs and identified motivation as a fundamental barrier for weight management. The goal of the Richmond Emerging Adults Choosing Health (REACH) trial was to test the efficacy of two mHealth lifestyle interventions specifically focused on enhancing motivation, relative to adapted standard., Methods: Participants (N = 381, 18-25 years, body mass index 25-45 kg/m 2 ) will be randomized to 1) adapted BWL (aBWL), 2) aBWL + self-determination theory (aBWL+SDT), or 3) aBWL + behavioral economics (aBWL+BE). All arms will receive a 6-month intervention, delivered via one group session and one individual session, followed by an mHealth platform. Assessments will occur at baseline, 3-months, 6-months (post-treatment) and 12-months (following a no-contact period). The primary aim is to compare weight loss outcomes at 6 months. Secondary aims include changes at 6-months in physical and behavioral cardiometabolic risk factors, as well as psychosocial measures. We will also explore weight loss maintenance, change in hypothesized mediators, and moderators of treatment response., Discussion: REACH is the first large-scale BWL trial designed specifically for emerging adults. Further, it will be the first trial to compare a lifestyle intervention grounded in self-determination theory to one rooted in behavioral economics. If clinically significant reductions in adiposity are achieved, findings could inform a scalable treatment model to meet the needs of this vulnerable population., Trial Registration: NCT02736981., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Wayne Velicer is remembered for a mind where mathematical concepts and calculations intrigued him, behavioral science beckoned him, and people fascinated him. Born in Green Bay, Wisconsin on March 4, 1944, he was raised on a farm, although early influences extended far beyond that beginning. His Mathematics BS and Psychology minor at Wisconsin State University in Oshkosh, and his PhD in Quantitative Psychology from Purdue led him to a fruitful and far-reaching career. He was honored several times as a high-impact author, was a renowned scholar in quantitative and health psychology, and had more than 300 scholarly publications and 54,000+ citations of his work, advancing the arenas of quantitative methodology and behavioral health. In his methodological work, Velicer sought out ways to measure, synthesize, categorize, and assess people and constructs across behaviors and time, largely through principal components analysis, time series, and cluster analysis. Further, he and several colleagues developed a method called Testing Theory-based Quantitative Predictions, successfully applied to predicting outcomes and effect sizes in smoking cessation, diet behavior, and sun protection, with the potential for wider applications. With $60,000,000 in external funding, Velicer also helped engage a large cadre of students and other colleagues to study methodological models for a myriad of health behaviors in a widely applied Transtheoretical Model of Change. Unwittingly, he has engendered indelible memories and gratitude to all who crossed his path. Although Wayne Velicer left this world on October 15, 2017 after battling an aggressive cancer, he is still very present among us.

Resilience may help people living with HIV (PLWH) overcome adversities to disease management. This study identifies multilevel resilience resources among African American/Black (AA/B) PLWH and examines whether resilience resources differ by demographics and neighborhood risk environments. We recruited participants and conducted concept mapping at two clinics in the southeastern United States. Concept Mapping incorporates qualitative and quantitative methods to represent participant-generated concepts via two-dimensional maps. Eligible participants had to attend ≥ 75% of their scheduled clinic appointments and did not have ≥ 2 consecutive detectable HIV-1 viral load measurements in the past 2 years. Of the 85 AA/B PLWH who were invited, forty-eight participated. Twelve resilience resource clusters emerged-five individual, two interpersonal, two organizational/policy and three neighborhood level clusters. There were strong correlations in cluster ratings for demographic and neighborhood risk environment comparison groups (r ≥ 0.89). These findings could inform development of theories, measures and interventions for AA/B PLWH.

Implantable cardioverter defibrillators (ICDs) save lives, but often induce significant psychological distress among patients. Positive psychological constructs are associated with improved outcomes among cardiac patients. In this NHLBI-funded randomized controlled trial, one aim was to evaluate the feasibility and acceptability of a positive psychology intervention (Quality of Life Therapy; QOLT, n = 11), compared to a Heart Healthy Education (HHE) control (n = 10), among ICD patients. A majority of participants across groups attended all 12 sessions (71%) and completed homework assignments (80%). Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20). A greater proportion of QOLT participants rated their sessions was "very" helpful compared to HHE participants (63% vs. 10%, p = 0.19). These initial data support the feasibility and acceptability of QOLT. A larger-scale trial using positive psychology interventions among ICD patients is indicated to determine potential mechanisms underlying the relationship between positive psychological constructs and cardiovascular health.

Users' sensory perceptions and experiences (USPEs; perceptibility) of drug formulations can critically impact product adoption and adherence, especially when products rely on appropriate user behaviors (timing of administration, dosing measurement) for effectiveness. The use of topical gel formulations for effective antihuman immunodeficiency virus/sexually transmitted infection (HIV/STI) vaginal microbicides has been associated with messiness and other use-associated challenges, resulting in low adherence. Nonetheless, such formulations remain attractive due to good pharmacokinetics and resulting pharmacodynamics through their volume and surface contact for drug delivery into luminal fluids and mucosa. Consequently, advocates and scientists continue to pursue topical forms [semisolid (e.g., gel, suppository); solid (e.g., film)] to deliver select drugs and offer user choice in HIV/STI prevention. The current data build on previously validated USPE scales evaluating perceptibility of gels with various biophysical/rheological properties. Specifically, increased formulation parameter space adds a new set of properties inherent in quick-dissolving film. We compared film, a product adding no discernable volume to the vaginal environment, to 2 and 3.5 mL hydroxyethyl cellulose gel to consider the impact of volume on user experience. We also examined the USPE scales for evaluation of male sexual partners' experiences. The original USPE scales functioned as expected. Additionally, six new USPE scales were identified in this enhanced parameter space. Significant differences were noted between USPEs in pairwise comparisons, with largest differences between film and high-volume gel. Product developers and behavioral scientists can use these scales to design products, optimizing user experience and maximizing adherence and delivery of efficacious anti-HIV/STI pharmaceuticals. They can be extended to evaluation of additional formulations, devices, and compartments, as well as single- and multipurpose pharmaceuticals. In broader contexts, USPEs could be of value in evaluating formulations and devices to prevent/treat other diseases (e.g., ophthalmologic, dermatologic). Steadfast attention should be given to patient experience, and, where applicable, experiences of partners and/or caregivers.

Background: Most patient-reported outcome measures (PROMs) used to assess outcomes after anatomic total shoulder arthroplasty (aTSA) focus on pain and function. Although strength is considered an important component of function, only the Constant-Murley score (CMS) includes an objective measurement of shoulder strength. The purpose of this study was to evaluate the relationship between shoulder elevation strength (SES) and PROMs after aTSA for the treatment of primary glenohumeral osteoarthritis (GHOA)., Methods: This was a retrospective analysis of 605 patients enrolled in a multicenter clinical database who underwent aTSA to treat primary GHOA. Patients were evaluated preoperatively and at 24 months after surgery. Outcome was assessed with the CMS, American Shoulder and Elbow Surgeons score, Western Ontario Osteoarthritis of the Shoulder score, Single Assessment Numeric Evaluation score, and patient satisfaction. Relationships between SES and outcomes were investigated., Results: The correlations between SES and the PROMs before and after treatment were very weak and weak, respectively (r ≤ 0.262 for all). The strength of the correlations between the absolute and adjusted CMS and the other PROMs varied from weak to moderate (r = 0.180 to r = 0.455), and the strength of the correlations was greater postoperatively. With the strength component removed from the CMS, the correlations between the CMS and other PROMs were stronger (r = 0.194 to r = 0.495)., Conclusions: Although measurement of SES provides objective information about shoulder function and outcome related to the treatment of primary GHOA with aTSA, the actual relevance to patients is unclear as the correlations between SES and PROMs were weak. Furthermore, the variable correlations between the CMS and PROMs call into question the exclusive use of the CMS and support the use of other PROMs that may more accurately reflect patient perception of outcome., (Copyright © 2020 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Emerging adults (ages 18-25) are at high risk for overweight/obesity, yet traditional adult behavioural weight loss (BWL) interventions do not meet the needs of individuals at this developmental stage. Motivational interviewing (MI) is an evidence-based approach to promote behaviour change but has not been tested for weight loss in this population. The study aimed to test the feasibility and preliminary efficacy of an MI-enhanced weight loss programme to promote engagement, retention and weight loss in emerging adults., Methods: Emerging adults with overweight/obesity ( N = 47, 81% female, 47% racial/ethnic minority, body mass index [BMI] = 33.2 ± 4.6 kg/m 2 ) were randomized to either standard BWL or MI-enhanced BWL (MIBWL). Weight was assessed objectively at baseline and posttreatment (3 months). Engagement (in-person session attendance [weeks 1 and 2], online self-monitoring [weeks 3-12] and online content viewing [weeks 3-12]) was tracked throughout the program., Results: Though results did not reach the level of statistical significance, participants in MIBWL demonstrated greater programme engagement (77% vs. 61.0%, p = .11; Cohen d = .48), retention (71% vs. 48.0%, p = .10; Cohen h = .47) and intent-to-treat weight loss (-3.3% vs. -2.2%, p = .37; Cohen d = .26) compared with those in BWL., Conclusions: Effect sizes suggest that MI might be a viable approach to enhance engagement and retention in weight loss programmes targeting emerging adults. This finding is meaningful, given the documented challenges with engagement and retention in this vulnerable population and the relationship between engagement and better weight loss outcomes. The results of this small pilot study support efforts to replicate these findings within the context of a fully powered trial., Competing Interests: The authors have no conflicts of interest to disclose., (© 2020 The Authors. Obesity Science & Practice published by World Obesity and The Obesity Society and John Wiley & Sons Ltd.)

Background: In the United States, syphilis cases have increased dramatically over the last decade. Recognition and timely diagnosis by medical providers are essential to treating syphilis and preventing further transmission., Methods: From 2016 to 2017, a cross-sectional survey was performed among medical students, residents, fellows, and attending physicians in Rhode Island. Topics included demographics, level of medical training, experience diagnosing and treating syphilis, and familiarity with the reverse testing algorithm. Participants were asked 25 true/false questions to assess basic knowledge of syphilis, which covered five domains: epidemiology, transmission, clinical signs and symptoms, diagnosis, and treatment. Univariate and bivariate analyses were performed to determine knowledge levels across provider characteristics. Significance was defined as p  < 0.05., Results: Of the 231 participants, 45% were medical students, 34% were residents or fellows, 11% were medicine attendings (non-infectious diseases), and 10% were infectious diseases attendings. The overall mean score was 9.79 (out of 25; range = 0-23, p  ⩽ 0.001). Mean scores differed significantly ( p  < 0.001) across groups, including 7.68 for students (range = 0-16), 10.61 for residents/fellows (range = 3-17), 10.41 for non-infectious diseases attendings (range = 4-18), and 16.38 for infectious diseases attendings (range = 6-23). Familiarity with the reverse sequence algorithm was low with only 22% having heard of it. Infectious diseases attendings were significantly more knowledgeable compared to other groups. Overall and across domains, infectious diseases attendings had significantly higher scores except when compared to non-infectious diseases attendings in the epidemiology domain and residents/fellows in the transmission domain., Conclusion: Overall syphilis knowledge among non-infectious diseases medical providers was low. Improved education and clinical training are needed to promote early diagnosis, treatment, and prevention efforts., Competing Interests: Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2020.)

Introduction: There is evidence that Yoga may be helpful as an aid for smoking cessation. Yoga has been shown to reduce stress and negative mood and may aid weight control, all of which have proven to be barriers to quitting smoking. This study is the first rigorous, randomized clinical trial of Yoga as a complementary therapy for smokers attempting to quit., Methods: Adult smokers (N = 227; 55.5% women) were randomized to an 8-week program of cognitive-behavioral smoking cessation and either twice-weekly Iyengar Yoga or general Wellness classes (control). Assessments included cotinine-verified 7-day point prevalence abstinence at week 8, 3-month, and 6-month follow-ups., Results: At baseline, participants' mean age was 46.2 (SD = 12.0) years and smoking rate was 17.3 (SD = 7.6) cigarettes/day. Longitudinally adjusted models of abstinence outcomes demonstrated significant group effects favoring Yoga. Yoga participants had 37% greater odds of achieving abstinence than Wellness participants at the end of treatment (EOT). Lower baseline smoking rates (≤10 cigarettes/day) were also associated with higher likelihood of quitting if given Yoga versus Wellness (OR = 2.43, 95% CI = 1.09% to 6.30%) classes at EOT. A significant dose effect was observed for Yoga (OR = 1.12, 95% CI = 1.09% to 1.26%), but not Wellness, such that each Yoga class attended increased quitting odds at EOT by 12%. Latent Class Modeling revealed a 4-class model of distinct quitting patterns among participants., Conclusions: Yoga appears to increase the odds of successful smoking abstinence, particularly among light smokers. Additional work is needed to identify predictors of quitting patterns and inform adjustments to therapy needed to achieve cessation and prevent relapse., Implications: This study adds to our knowledge of the types of physical activity that aid smoking cessation. Yoga increases the odds of successful smoking abstinence, and does so in a dose-response manner. This study also revealed four distinct patterns of smoking behavior among participants relevant to quitting smoking. Additional work is needed to determine whether variables that are predictive of these quitting patterns can be identified, which might suggest modifications to therapy for those who are unable to quit., (© The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: Predictors of success among emerging adults (EAs; ages 18-25) within behavioral weight loss (BWL) trials are largely unknown. We examined whether early program engagement predicted overall engagement and weight loss in EAs. Methods: Data were pooled from 2 randomized controlled pilot trials in EAs. Participants (N = 99, 80% female, BMI = 33.7±5.1 kg/m²) received a 3-month BWL intervention. Weight was objectively assessed at 0 and 3 months; engagement was tracked weekly; retention was assessed at 3 months. Results: Greater engagement during the initial 4 weeks of treatment predicted greater weight loss (p = .001). Compared to those who did not engage in all 4 initial weeks, participants meeting this threshold experienced greater overall engagement (9.6 vs 4.2 weeks, p < .001), weight losses (intent-to-treat = -3.8% vs -1.3%, p = .004), and retention (78% vs 53%, p = .012). Conclusions: Early engagement in BWL is associated with better outcomes among EAs. Monitoring engagement in real-time during the initial 4 weeks of treatment may be necessary to intervene effectively. Early engagement did not vary by sex or race; future work should identify characteristics associated with poor early engagement.

Emerging adults are at high risk of obesity but behavioral weight loss programs do not meet their needs. Emerging adults ( N = 52, age = 22.3 ± 2 years, body mass index = 34.2 ± 5.5 kg/m 2 , 46.2% non-Hispanic White) were randomly assigned to one of three behavioral weight loss programs adapted based on formative work: face-to-face behavioral weight loss, web-based behavioral weight loss, or web plus optional community sessions (Hybrid). Assessments occurred at 0 and 3 months. Engagement and self-monitoring were highest in Hybrid. Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid. Percent achieving ⩾5 percent weight loss was highest in Hybrid (63%). Findings suggest potential for adapted behavioral weight loss to promote engagement and weight loss in emerging adults.

Introduction: Smoking cessation interventions delivered through mobile technologies offer promise as an effective intervention tool. However, most existing programs have not been empirically tested, were not developed with end-user participation, and/or do not address evidence-based cognitive and behavioral variables shown to enhance smoking cessation in clinical trials. In addition, many programs tested in research trials have required users to access the internet and/or a smartphone app to access all program features, limiting the potential reach of those programs., Methods/design: This study is a randomized controlled trial testing the efficacy of the TMQ intervention for smoking cessation. All participants are randomly assigned to receive 12 weeks of either; (1) a tailored smoking-cessation intervention delivered 100% through text messaging (TMQ), or (2) non-smoking-related text messages serving as a control for contact and subject burden (Mojo). Assessments are conducted at baseline, 3- and 6-month follow-up. The primary outcome is prolonged abstinence using an intent-to-treat approach. To understand why TMQ may be more effective than Mojo, we will test several posited mechanisms of action (i.e., mediators) that may underlie intervention efficacy and will examine use of the TMQ integrated social support (ISS) network. At the end of treatment, semi-structured interviews will be conducted with TMQ participants., Conclusions: This study will provide a rigorous test of an innovative smoking cessation program delivered 100% through text messages. Use of mixed methodologies will provide the opportunity to enhance our understanding of the user's experience with TMQ and identify areas for future enhancement and/or expansion., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: This study:Healthy Active and in Control (HA1C), examined the feasibility and acceptability of yoga as a complementary therapy for adults with Type-2 Diabetes (T2DM)., Design: A 2-arm randomized clinical trial comparing Iyengar yoga with a supervised walking program., Setting: Hospital based gym-type facility and conference rooms., Interventions: Participants were randomized to a 12-week program of either; (1) a twice weekly Iyengar yoga, or (2) a twice-weekly program of standard exercise (SE)., Main Outcome Measures: Primary outcomes assessed feasibility and acceptability, including enrollment rates, attendance, study completion, and participant satisfaction. Secondary outcomes included HbA1c, physical activity, and measures of diabetes-related emotional distress, self-care and quality of life (QOL). Assessments were conducted at baseline, end of treatment, 6-months and 9-months post-enrollment., Results: Of 175 adults screened for eligibility, 48 (30 women, 18 men) were eligible and enrolled. The most common reasons for ineligibility were orthopedic restrictions, HbA1c levels <6.5 and BMI > 42. Session attendance was high (82% of sessions attended), as was follow-up completion rates (92%). Program satisfaction rated on a 5-point scale, was high among both Yoga (M = 4.63, SD = 0.57) and SE (M = 4.77, SD = 0.52) participants. Overall 44 adverse events (26 Yoga, 18 SE) were reported. Of these, six were deemed "possibly related" (e.g., neck strain, back pain), and 1 "probably related" (ankle pain after treadmill) to the study. Yoga produced significant reductions in HbA1c. Median HbA1c at 6 months was 1.25 units lower for Yoga compared to SE (95% CI: -2.54 -0.04). Greater improvements in diabetes self-care, quality of life, and emotional distress were seen among Yoga participants than among SE participants. Increases in mindfulness were seen in Yoga but not in SE., Conclusions: The yoga intervention was highly feasible and acceptable, and produced improvements in blood glucose and psychosocial measures of diabetes management., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objectives: To determine if mean ultimate strength or failure mechanism differed between comminuted olecranon fractures created at the proximal 25% or 50% of the trochlear notch and fixed with precontoured posterior locking plates (PLPs)., Methods: Comminuted osteotomies were created in 10 matched pairs of cadaveric upper extremities at either the proximal 25% or 50% of the trochlear notch after quantitative computed tomography scans were performed to evaluate bone mineral density. Variable-angle olecranon PLPs were fixed to the specimens. The triceps tendon of each specimen was loaded cyclically and then to failure. Comparison of mean force at failure (displacement >2 mm) was performed using the 2-tailed t test., Results: There were no significant differences in specimen bone mineral density within matched pairs. Nineteen specimens failed by olecranon bisection fracture in the sagittal plane. Specimens in the 25% osteotomy group failed at lower ultimate forces of 808 N (SD ± 474 N) versus 1058 N (SD ± 480 N) in the 50% osteotomy group (P = 0.044)., Conclusions: The ultimate strength of comminuted olecranon fracture fixation with a PLP decreases significantly if the fracture is proximal to the midpoint of the trochlear notch. Fractures proximal to the midpoint of the trochlear notch may benefit from supplemental fixation or suture augmentation to prevent failure, particularly at force ranges higher than those experienced during active elbow range of motion.

Diabetes is the seventh leading cause of death in the United States. For most patients, medication alone is not sufficient to achieve glycemic control; attention must also be paid to multiple healthy behaviors including diet, regular physical activity, and stress management. Yoga, a mindfulness practice with emphasis on relaxation, meditation, and deep breathing, may have special relevance to people with type 2 diabetes mellitus (T2DM). Yoga practice may positively affect stress and other self-care tasks that will contribute to improved glycemic control. The Healthy, Active, and in Control (HA1C) study is designed to examine the feasibility and acceptability of yoga among adult patients with T2DM. In this pilot randomized controlled trial, adults with T2DM were randomly assigned to either a 12-week Iyengar Yoga intervention given twice weekly, or a twice-weekly 12-week program of traditional exercise (e.g., walking, stationary cycling). Assessments are conducted at the end of treatment (12 weeks) and at 3 and 6 months postintervention. The HA1C study will assess feasibility and acceptability (e.g., attendance/retention rates, satisfaction with program), glycemic outcomes (e.g., HbA1c, fasting blood glucose, postprandial blood glucose), and changes in physiological (e.g., salivary cortisol) and behavioral factors (e.g., physical activity, diet) relevant to the management of T2DM. Focus groups are conducted at the end of the intervention to explore participants' experience with the program and their perception of the potential utility of yoga for diabetes management.

We use a socioecological model of health to define resilience, review the definition and study of resilience among persons living with human immunodeficiency virus (PLWH) in the existing peer-reviewed literature, and discuss the strengths and limitations of how resilience is defined and studied in HIV research. We conducted a review of resilience research for HIV-related behaviors/outcomes of antiretroviral therapy (ART) adherence, clinic attendance, CD4 cell count, viral load, viral suppression, and/or immune functioning among PLWH. We performed searches using PubMed, PsycINFO and Google Scholar databases. The initial search generated 14,296 articles across the three databases, but based on our screening of these articles and inclusion criteria, n = 54 articles were included for review. The majority of HIV resilience research defines resilience only at the individual (i.e., psychological) level or studies individual and limited interpersonal resilience (e.g., social support). Furthermore, the preponderance of HIV resilience research uses general measures of resilience; these measures have not been developed with or tailored to the needs of PLWH. Our review suggests that a socioecological model of health approach can more fully represent the construct of resilience. Furthermore, measures specific to PLWH that capture individual, interpersonal, and neighborhood resilience are needed.

Background: Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms. Scales are composed of multiple items in the form of questions or statements that, when combined, measure a more complex construct that may not be directly observable. When psychometrically validated, such measures may better assess the multiple factors contributing to adherence/non-adherence. This study aimed to develop and psychometrically evaluate tools to screen and monitor trial participants' adherence to HIV prevention products within the context of clinical trial research., Methods and Findings: Based on an extensive literature review and conceptual framework, we identified and refined 86 items assessing potential predictors of adherence and 48 items assessing adherence experience. A structured survey, including adherence items and other variables, was administered to former ASPIRE and Ring Study participants and similar non-trial participants (n = 709). We conducted exploratory factor analyses (EFA) to identify a reduced set of constructs and items that could be used at screening to predict potential adherence, and at follow-up to monitor and intervene on adherence. We examined associations with other variables to assess content and construct validity. The EFA of screener items resulted in a 6-factor solution with acceptable to very good internal reliability (α: .62-.84). Similar to our conceptual framework, factors represent trial-related commitment (Distrust of Research and Commitment to Research); alignment with trial requirements (Visit Adherence and Trial Incompatibility); Belief in Trial Benefits and Partner Disclosure. The EFA on monitoring items resulted in 4 Product-specific factors that represent Vaginal Ring Doubts, Vaginal Ring Benefits, Ring Removal, and Side Effects with good to very good internal reliability (α = .71-.82). Evidence of content and construct validity was found; relationship to social desirability bias was examined., Conclusions: These scales are easy and inexpensive to administer, available in several languages, and are applicable regardless of randomization. Once validated prospectively, they could (1) screen for propensity to adhere, (2) target adherence support/counselling, and (3) complement biomarker measures in determining true efficacy of the experimental product.

Introduction: Cigarette smoking is associated with many adverse health effects and is an important public health concern. Increased understanding of smokers' behavior is central to developing effective interventions. Cigarette scavenging, a behavior that involves smoking shared or previously used cigarettes has thus far only been shown to be prevalent among homeless or incarcerated populations. The current study examines whether cigarette scavenging is prevalent in a more general population of adult smokers enrolling in a smoking cessation clinical trial, and whether engagement in this behavior is associated with demographic or smoking-related psychosocial factors., Methods: Baseline data was obtained from adult smokers (N=227) enrolling in a randomized clinical trial for smoking cessation. Cigarette scavenging was assessed using three items: a) sharing a cigarette with a stranger; b) smoking a "found" cigarette and c) smoking a previously used cigarette "butt". Participants who endorsed engaging in at least one of these three behaviors were categorized as a scavenger., Results: Approximately 32% of participants endorsed at least one cigarette scavenging behavior. A multiple logistic regression analysis found that scavengers were more likely to be: men (p<0.001), of younger age at smoking onset (p=0.012), unemployed (p=0.003), more likely to have used marijuana in the past 30days (p=0.005), single or living alone (p=0.003), and to have experienced higher withdrawal symptoms during previous quit attempts (p=0.044) as compared to non-scavengers., Conclusions: Scavenging is common among adult smokers. Interventions that address cigarette scavenging behaviors may better meet the needs of this unique smoking subgroup., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Objectives: Yoga may improve stress, affect, and weight control, all of which are commonly cited barriers to quitting smoking. However, the importance of these concerns may vary by sex, race, ethnicity, and age. We examined smoking-relevant characteristics of individuals enrolling in an 8-week randomized controlled trial testing yoga as a complementary treatment to standard smoking cessation., Methods: Of 958 callers, 227 were eligible and enrolled., Results: The sample was 55% female, 86% non-Hispanic white, with a mean age of 46 years (SD = 12). Males smoked more cigarettes/ day than females and had lower motivation to quit smoking. Females were more likely to smoke for weight control, social and mood-related reasons, and had higher expectations for the efficacy of yoga. Age was negatively associated with the presence of other smokers in the household, and smoking in response to negative moods, and was positively associated with smoking rate, and confidence in quitting., Conclusions: This study demonstrated that both males and females were interested in a program offering yoga as a complementary therapy for smoking cessation. However, there were both sex and age-related differences with respect to smoking-related variables that may suggest a need to adapt the intervention for sub-populations.

Objective: Our objective was to develop an instrument that can measure outcome expectations of yoga and to evaluate the instrument for internal consistency and initial construct validity., Methods: A 20-item scale was developed to assess physical, mental, and spiritual health benefits related to yoga practice among adults. The scale was tested in a baseline survey with adults participating in a clinical trial. Principal component analysis was used to investigate the internal structure of the measure. Outcome expectations for yoga were examined for demographic differences., Results: The sample (N = 185) was 54% women, 89% white and had a mean age of 46 years. The final 20-item scale had high item loadings that ranged from .57 to .88 with a Cronbach's alpha value of .96. Significant differences were found in outcome expectation score by sex., Conclusion: This newly developed scale can be used to assess outcome expectations for yoga and tailor interventions to promote adherence to yoga practice.

For persons at risk of HIV infection who practice receptive anal intercourse (RAI), topical rectal microbicides represent a promising option for coitally dependent protection. The study compared colorectal distribution and user sensory experiences of two different volumes of rectal gel for suitability as rectal microbicide. Eight HIV-negative men with a history of recent RAI were enrolled into a two-period, sequence-randomized dosing study comparing 3.5 and 10 ml of radiolabeled (1 mCi 99m Tc-DTPA) universal placebo, hydroxyethyl cellulose gel. Each participant received two doses in the research unit, one of each volume, separated by a washout period of at least 2 weeks. Each research unit dose was followed by a self-administered take-home dose in the context of preparing for RAI. Safety and gastrointestinal distribution were assessed after the research unit doses, safety, perceptibility, and acceptability, were assessed after take-home doses. There were no adverse effects of Grade 2 or higher and all resolved spontaneously. Both volumes were well tolerated and received high acceptability scores. Perceptibility scores showed meaningful effect size differences ranging from Cohen's d = 0.5 to d = 1.2. The 3.5 and 10 ml gel volumes distributed similarly (p > .2) within the rectosigmoid, ranging from 0.69 to 18.84 cm and 1.21 to 19.01 cm from the anorectal junction, respectively. Both volumes covered the typical gastrointestinal distribution of ejaculate following simulated intercourse based on other studies. Either of these gel volumes could reasonably be pursued for the next phase of development of rectal microbicides.

Identifying risk and protective factors associated with condomless sex among youth living with HIV is imperative for developing effective HIV prevention strategies. A cross-sectional sample of 1728 participants, 12-26 years of age, recruited from adolescent medicine clinics in 17 U.S. cities completed an audio-computer assisted self-interview with questions about their substance use, psychosocial factors, and attitudinal and behavioral factors. Guided by syndemics theory, a path analysis was used to assess the interrelations of these factors. Analyses of model fit statistics indicated statistically significant direct pathways between substance use, psychosocial factors, self-efficacy for risk-reduction, alternative risk-reduction attitudes and behaviors and condomless sex. The total indirect effect of self-efficacy for risk-reduction on condomless sex through alternative risk-reduction attitudes and behaviors was also significant. Multi-faceted, tailored interventions that address individual risk and protective factors and their combined synergistic effects are urgently needed to prevent condomless sex among this population.

Objectives: To examine whether (a) an obesity treatment involving financial incentives yields higher levels of extrinsic motivation for weight management compared to an identical intervention without incentives, (b) extrinsic motivation for weight management mediates, or accounts for, the difference in weight loss outcomes between the two interventions, and (c) there is any evidence that financial incentives and associated extrinsic motivation "crowd out" intrinsic motivation for weight control., Methods: Participants (N=153, 80.4% Female; BMI = 33.2 ± 5.9) were randomly assigned to a 3-month Web-based behavioral weight loss program (WBWL) or the same program plus small financial incentives delivered consistent with behavioral economics and behavior change theories (WBWL+$). Weight was objectively assessed at baseline, post-treatment (month 3), and after a 9-month no-treatment follow-up phase (month 12). Intrinsic and extrinsic motivation for weight management were assessed at months 3 and 12 using a modified version of the Treatment Self-Regulation Questionnaire, with questions added to specifically target extrinsic motivation related to incentives., Results: Compared to WBWL alone, WBWL+$ had better weight loss and higher levels of both extrinsic and intrinsic motivation for weight management (p's≤.02). Moreover, during the no-treatment follow-up phase, the trajectories of weight regain did not significantly differ between WBWL and WBWL+$ (p=.58). Extrinsic motivation was not a significant mediator of treatment outcomes., Conclusions: Modest financial incentives delivered consistent with behavioral economics and behavior change theories do not undermine intrinsic motivation for weight management during obesity treatment; in fact, they yield higher levels of both extrinsic and intrinsic motivation. Additional research is needed to better understand the mechanisms by which incentives improve outcomes in health behavior change interventions.

Background: Existing instruments that assess individuals' relationships with mobile phones tend to focus on negative constructs such as addiction or dependence, and appear to assume that high mobile phone use reflects pathology. Mobile phones can be beneficial for health behavior change, disease management, work productivity, and social connections, so there is a need for an instrument that provides a more balanced assessment of the various aspects of individuals' relationships with mobile phones., Objective: The purpose of this research was to develop, revise, and validate the Mobile Phone Affinity Scale, a multi-scale instrument designed to assess key factors associated with mobile phone use., Methods: Participants (N=1058, mean age 33) were recruited from Amazon Mechanical Turk between March and April of 2016 to complete a survey that assessed participants' mobile phone attitudes and use, anxious and depressive symptoms, and resilience., Results: Confirmatory factor analysis supported a 6-factor model. The final measure consisted of 24 items, with 4 items on each of 6 factors: Connectedness, Productivity, Empowerment, Anxious Attachment, Addiction, and Continuous Use. The subscales demonstrated strong internal consistency (Cronbach alpha range=0.76-0.88, mean 0.83), and high item factor loadings (range=0.57-0.87, mean 0.75). Tests for validity further demonstrated support for the individual subscales., Conclusions: Mobile phone affinity may have an important impact in the development and effectiveness of mobile health interventions, and continued research is needed to assess its predictive ability in health behavior change interventions delivered via mobile phones., Competing Interests: Conflicts of Interest: None declared., (©Beth C Bock, Ryan Lantini, Herpreet Thind, Kristen Walaska, Rochelle K Rosen, Joseph L Fava, Nancy P Barnett, Lori AJ Scott-Sheldon. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 15.12.2016.)

Background: Students at community colleges comprise nearly half of all U.S. college students and show higher risk of heavy drinking and related consequences compared to students at 4-year colleges, but no alcohol safety programs currently target this population., Objective: To examine the feasibility, acceptability, and preliminary efficacy of an alcohol risk-reduction program delivered through text messaging designed for community college (CC) students., Methods: Heavy drinking adult CC students (N=60) were enrolled and randomly assigned to the six-week active intervention (Text Message Alcohol Program: TMAP) or a control condition of general motivational (not alcohol related) text messages. TMAP text messages consisted of alcohol facts, strategies to limit alcohol use and related risks, and motivational messages. Assessments were conducted at baseline, week 6 (end of treatment) and week 12 (follow up)., Results: Most participants (87%) completed all follow up assessments. Intervention messages received an average rating of 6.8 (SD=1.5) on a 10-point scale. At week six, TMAP participants were less likely than controls to report heavy drinking and negative alcohol consequences. The TMAP group also showed significant increases in self-efficacy to resist drinking in high risk situations between baseline and week six, with no such increase among controls. Results were maintained through the week 12 follow up., Conclusions: The TMAP alcohol risk reduction program was feasible and highly acceptable indicated by high retention rates through the final follow up assessment and good ratings for the text message content. Reductions in multiple outcomes provide positive indications of intervention efficacy., (Copyright © 2016. Published by Elsevier Ltd.)

Weight loss maintenance is a significant challenge in obesity treatment. During maintenance the "costs" of adhering to weight management behaviors may outweigh the "benefits." This study examined the efficacy of a novel approach to weight loss maintenance based on modifying the cost-benefit ratio. Individuals who achieved a 5% weight loss (N=75) were randomized to one of three, 10-month maintenance interventions. All interventions were delivered primarily via the Internet. The Standard arm received traditional weight maintenance strategies. To increase benefits, or rewards, for maintenance behaviors, the two cost-benefit intervention conditions received weekly monetary rewards for self-monitoring and social reinforcement via e-coaching. To decrease behavioral costs (boredom) and increase novelty, participants in the cost-benefit conditions also monitored different evidence-based behaviors every two weeks (e.g., Weeks 1 & 2: steps; Week 3 & 4: red foods). The primary difference between the cost-benefit interventions was type of e-coach providing social reinforcement: Professional (CB Pro) or Peer (CB Peer). Study procedures took place in Providence, RI from 2013 to 2014. Retention was 99%. There were significant group differences in weight regain (p=.01). The Standard arm gained 3.5±5.7kg. In contrast, participants in CB Pro and CB Peer lost an additional 1.8±7.0kg and 0.5±6.4kg, respectively. These results suggest that an Internet delivered cost-benefit approach to weight loss maintenance may be effective for long-term weight control. In addition, using peer coaches to provide reinforcement may be a particularly economic alternative to professionals. These data are promising and provide support for a larger, longer trial., Competing Interests: statement. Dr. Leahey is currently Chief Scientist and a paid consultant at WayBetter, Inc.; however, the work presented herein is not at all related to her relationship with WayBetter. All remaining authors declare that there are no conflicts of interest to report., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The development of pericoital (on demand) vaginal HIV prevention technologies remains a global health priority. Clinical trials to date have been challenged by nonadherence, leading to an inability to demonstrate product efficacy. The work here provides new methodology and results to begin to address this limitation. We created validated scales that allow users to characterize sensory perceptions and experiences when using vaginal gel formulations. In this study, we sought to understand the user sensory perceptions and experiences (USPEs) that characterize the preferred product experience for each participant. Two hundred four women evaluated four semisolid vaginal formulations using the USPE scales at four randomly ordered formulation evaluation visits. Women were asked to select their preferred formulation experience for HIV prevention among the four formulations evaluated. The scale scores on the Sex-associated USPE scales (e.g., Initial Penetration and Leakage) for each participant's selected formulation were used in a latent class model analysis. Four classes of preferred formulation experiences were identified. Sociodemographic and sexual history variables did not predict class membership; however, four specific scales were significantly related to class: Initial Penetration, Perceived Wetness, Messiness, and Leakage. The range of preferred user experiences represented by the scale scores creates a potential target range for product development, such that products that elicit scale scores that fall within the preferred range may be more acceptable, or tolerable, to the population under study. It is recommended that similar analyses should be conducted with other semisolid vaginal formulations, and in other cultures, to determine product property and development targets., Competing Interests: Author Disclosure Statement No competing financial interests exist.

Background: Improving mental and physical health of patients with implantable cardioverter defibrillators (ICD) is critical because this group is at high risk for ventricular arrhythmias and sudden death and depressed or anxious cardiovascular disease (CVD) patients appear to be at even higher risk for mortality compared to nondepressed or nonanxious CVD patients. Further, autonomic dysfunction is present in these patients, and negative emotions and arrhythmias form a downward spiral further worsening mood, well-being, and cardiovascular health. Much research demonstrates that positive emotion is related to health benefits, improved physiology, and increased survival., Methods and Results: This is a two-arm randomized controlled trial aiming to recruit 60 adult ICD patients comparing 12 individually delivered, weekly sessions of: (1) a positive emotion-focused cognitive-behavioral therapy (Quality of Life Therapy [QOLT]), and (2) Heart Healthy Education. Autonomic functioning, heart rhythm indices, and psychosocial health are measured at baseline, 3 months, and 9 months. The first goal is feasibility and acceptability, with the primary outcome being arrhythmic event frequency data., Conclusion: This study is designed to test whether QOLT produces changes in mood, quality of life/well-being, autonomic function, and arrhythmic and ICD therapy event rates. This feasibility trial is a foundational step for the next trial of QOLT to help determine whether a 3-month QOLT trial can reduce arrhythmias occurrences among ICD patients, and examine a mechanism of autonomic functioning. This study may help to develop and implement new medical or psychological therapies for ICD patients., (©2016 Wiley Periodicals, Inc.)

Gleason score (GS) is an important factor in determining management and outcome of prostate adenocarcinoma. A standard GS scheme was introduced by ISUP 2005 consensus conference, but there is still significant discordance in grading prostate adenocarcinomas among pathologists, especially between genitourinary-trained (GU) and non-GU pathologists. All biopsies from outside institutions referred for definitive treatment in our hospital are reviewed by a GU pathologist for confirmation and quality assurance. From 2011 to 2013, 117 consecutive prostate consults were retrieved and compared with the initial outside reports as well as final radical prostatectomy (RP) results. Follow-up prostate specific antigen (PSA) was assessed pre- and post-RP, and the results were analyzed. The overall initial GS was higher for all specimens (p = 0.007) especially for the RP cases (p = 0.002). Overall, the modal GS on initial diagnosis was GS7(4 + 3) that was downgraded to the modal GS6(3 + 3) upon review. Despite an overall substantial agreement between the non-GU and GU pathologists [ICC = 0.66], GS by GU pathologist had higher correlation with the final GS in the RP specimen [ICC = 0.62] than non-GU pathologist [ICC = 0.48]. GS on all reviewed cases were found to correlate significantly with the pre-operative PSA (p = 0.002) but the same was not true for the initial report. A non-GU pathologist is more likely to assign a higher GS than a GU pathologist, with a trend to overcall Gleason pattern 4. Considering the implications on treatment, close attention must be paid to the ISUP 2005 consensus conference recommendations.

Currently available risk perception scales tend to focus on risk behaviors and overall risk (vs partner-specific risk). While these types of assessments may be useful in clinical contexts, they may be inadequate for understanding the relationship between sexual risk and motivations to engage in safer sex or one's willingness to use prevention products during a specific sexual encounter. We present the psychometric evaluation and validation of a scale that includes both general and specific dimensions of sexual risk perception. A one-time, audio computer-assisted self-interview was administered to 531 women aged 18-55 years. Items assessing sexual risk perceptions, both in general and in regards to a specific partner, were examined in the context of a larger study of willingness to use HIV/STD prevention products and preferences for specific product characteristics. Exploratory and confirmatory factor analyses yielded two subscales: general perceived risk and partner-specific perceived risk. Validity analyses demonstrated that the two subscales were related to many sociodemographic and relationship factors. We suggest that this risk perception scale may be useful in research settings where the outcomes of interest are related to motivations to use HIV and STD prevention products and/or product acceptability. Further, we provide specific guidance on how this risk perception scale might be utilized to understand such motivations with one or more specific partners.

This study compares the characteristics of men and women, respectively, participating in two randomized controlled pilot studies whose primary aims were to test the feasibility of yoga as a complementary therapy for smoking cessation. Participants were aged 18-65, generally healthy and were daily smokers. Analysis of variance (ANOVA) and chi-square tests examined gender differences in smoking rate, potential treatment mediators, and covariates (e.g., smoking history, health status, weight concerns, mood, and prior withdrawal symptoms). A total of 55 women and 38 men participated in the study. Differences between men and women at enrollment included: women reported significantly greater withdrawal (p<0.005), anxiety (p=0.032), and depression (p=0.027) symptoms than men. More women than men (91% vs . 66%) reported having been told by their doctor to quit smoking (p=0.003), had an existing smoking-related illness (33% vs . 13%; p=0.032), and reported smoking for weight control (15% vs . 0%; p=0.014). Results showed good feasibility for recruiting both men and women into a study using yoga as a complementary therapy for smoking cessation. Results also indicate that interventions may need to be tailored to meet different needs (e.g., addressing co-morbid depression) between men and women.

Existing instruments that assess the individual's relationship with technology tend to focus on negative constructs and assume that a high use of technology reflects pathology. Since technology use can be beneficial, there is a need for a more balanced instrument. An initial survey to assess the individual's relationship with their mobile phone was developed, checked for face validity and the resulting survey was administered online to students at local colleges. 146 adults (mean age=25.5 years) completed surveys. Principal Component Analysis with varimax rotation produced a final 27-item scale with factor loadings from .50 to .81, representing 4 components: "Usefulness", "Anxious Attachment", "Addiction" and "24/7" (continuous use). This study produced an instrument to assess multiple aspects of the individuals' relationship to their mobile phone. Additional work is needed to validate this measure in other populations, with larger samples, and to assess its predictive ability in mHealth interventions delivered through mobile phones.

Innovative treatments like yoga for men's smoking cessation (SC) are lacking. To examine the feasibility and acceptability of yoga for men's SC. We randomly assigned eligible men (smoker, ≥5 cigarettes/day, age 18-65) to receive cognitive behavioral therapy for SC, plus a yoga or wellness program. Measures included feasibility (recruitment, class attendance) and acceptability (customer satisfaction). We enrolled 38 of 49 eligible men of 167 screened in response to ads (mean age 39.9 years, ±13.7) who smoked on average 18.6 cigarettes/day (±8.3). Wellness (75.8 %) versus yoga (56 %) men attended more SC classes, p < 0.01. Sixty percent attended ≥1 yoga class. Men reported greater satisfaction with in-house versus community yoga classes. Wellness appears to be the preferred intervention; results indicated that it may be more feasible and showed increased attendance at smoking classes. To be fully feasible, yoga + SC may need to be a unified program offering all classes tailored for men and in the same location.