Effects of Modified Risk Tobacco Product Claims on Consumer Responses.

INTRODUCTION: US tobacco manufacturers can seek authorization from the US Food and Drug Administration (FDA) to market products using modified risk tobacco product (MRTP) claims. To inform regulatory decisions, we examined the impact of MRTP claim specificity and content, including whether the claims produced halo effects (ie, inferring health benefits beyond what is stated). AIMS AND METHODS: Participants were 3161 US adult cigarette smokers. Using a two (general vs. specific) × 2 (risk vs. exposure) plus independent control design, we randomized participants to view one message from these conditions: general risk claim (eg, "smoking-related diseases"), general exposure claim (eg, "chemicals in smoke"), specific risk claim (eg, "lung cancer"), specific exposure claim (eg, "arsenic"), or control. Claims described the benefits of completely switching from cigarettes to the heated tobacco product IQOS. RESULTS: MRTP claims of any sort elicited a higher willingness to try IQOS relative to control (d = 0.09, p = .043). Claims also elicited lower perceived risk of disease and exposure to harmful chemicals for completely switching from cigarettes to IQOS (d = -0.32 and -0.31) and partially switching (d = -0.25 and d = -0.26; all p < .05). Relative to specific MRTP claims, general MRTP claims led to lower perceived risk and exposure for complete switching (d = -0.13 and d = -0.16) and partial switching (d = -0.14 and d = -0.12; all p < .05). Risk and exposure MRTP claims had similar effects (all p > .05). DISCUSSION: MRTP claims led to lower perceived risk and exposure, and higher willingness to try IQOS. General claims elicited larger effects than specific claims. MRTP claims also promoted unintended halo effects (eg, lower perceived risk of disease and chemical exposure for partial switching). IMPLICATIONS: We found evidence that MRTP claims promoted health halo effects. In light of these findings, the FDA should require research on halo effects prior to authorization. Further, if an MRTP claim is authorized, FDA should require tobacco manufacturers to conduct post-market surveillance of how the claim affects consumer understanding, including partial switching perceived risk and exposure beliefs, as well as monitoring of dual-use behaviors.

Acute Effects of Hypothermia and Inhalant Anesthesia on Ultrasonic Vocalizations and Neuroendocrine Markers in Neonatal Rats.

Neonatal rodents undergo anesthesia for numerous procedures and for euthanasia by anesthetic overdose. However, data regarding whether neonatal anesthesia is humane are limited. Hypothermia (cryoanesthesia) is the most commonly used anesthetic protocol for neonatal rats 10 d of age or younger. However, hypothermia has recently been restricted in several countries due to perceived painful effects, including pain on rewarming. Minimizing the potential pain and distress of neonates in research is imperative, although very challenging. Traditional validated and nonvalidated behavioral and physiologic outcome measures used for adult rats undergoing anesthesia are unsuitable for evaluating neonates. Therefore, we investigated the effects of several anesthetic methods on neonatal rats by using the innovative objective approaches of noninvasive ultrasonic vocalizations and more invasive neuroendocrine responses (i. e., serum corticosterone, norepinephrine, glucose). Our results show that hypothermia leads to heightened acute distress in neonatal rats as indicated by prolonged recovery times, increased duration of vocalizations, and elevated corticosterone levels, as compared with neonates undergoing inhalational anesthesia. We demonstrate that inhalational anesthesia is preferable to cryoanesthesia for neonatal rats, and researchers using hypothermia anesthesia should consider using inhalational anesthesia as an alternative method.

Patient Reported Outcome Assessments Used in the Evaluation of Patients after Ileal Pouch-Anal Anastomosis: A Systematic Review.

BACKGROUND AND AIMS: There is a paucity of validated measures to evaluate how patients feel and function after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis. We performed a systematic review to evaluate all published patient reported outcomes (PROs) to assess symptom burden, functional status, and quality of life (QoL) after IPAA. METHODS: An electronic literature search on PubMed, Embase, and Web of Science was performed from inception through October 12, 2021. Eligible full texts were further characterized by the type of assessment as well as the individual domains assessed by questions in the PRO measure. RESULTS: Among the 129 full texts analyzed, 51 specific PRO measures were utilized. In the evaluation of all PRO measures, 46% included an assessment of disease-specific QoL with 27% evaluating more general QoL, and 15% assessing symptoms related to pouch function. Among the studies using disease-specific instruments, the Cleveland Clinic Global Quality of Life (42%) and the Inflammatory Bowel Disease Questionnaire (21%) were the most commonly used PRO measures. PRO questions were mapped to individual domains using binning methodology, with the greatest number of questions from individual PRO measures mapped to the bowel function domain (122). CONCLUSION: In our assessment of PRO measures among patients after IPAA, the studies and individual measures varied widely in both the patient populations being evaluated as well as outcomes and specific domains being assessed. A valid measure that assesses the range of outcomes after IPAA could standardize assessment and advance the study of patients after IPAA.

A Cost Analysis of Rethink the Strip: De-implementing a Low-value Practice in Primary Care.

BACKGROUND: Routine self-monitoring of blood glucose is a low-value practice that provides limited benefit for patients with non-insulin-treated type 2 diabetes mellitus. OBJECTIVES: We estimated the costs of Rethink the Strip (RTS), a multistrategy approach to the de-implementation of self-monitoring of blood glucose in primary care. RESEARCH DESIGN: RTS was conducted among 20 primary care clinics in North Carolina. We estimated the non-site-based and site-based costs of the 5 RTS strategies (practice facilitation, audit and feedback, provider champions, educational meetings, and educational materials) from the analytic perspective of an integrated health care system for 12 and 27-month time horizons. Material costs were tracked through project records, and personnel costs were assessed using activity-based costing. We used nationally based wage estimates. RESULTS: Total RTS costs equaled $68,941 for 12 months. Specifically, non-site-based costs comprised $16,560. Most non-site-based costs ($11,822) were from the foundational programming and coding updates to the electronic health record data to develop the audit and feedback reports. The non-site-based costs of educational meetings, practice facilitation, and educational materials were substantially lower, ranging between ~$400 and $1000. Total 12-month site-based costs equaled $2569 for a single clinic (or $52,381 for 20 clinics). Educational meetings were the most expensive strategy, averaging $1401 per clinic. The site-based costs for the 4 other implementation strategies were markedly lower, ranging between $51 for educational materials and $555 for practice facilitation per clinic. CONCLUSIONS: This study provides detailed cost information for implementation strategies used to support evidence-based programs in primary care clinics.

Microbial ß-glucuronidases drive human periodontal disease etiology.

Periodontitis is a chronic inflammatory disease associated with persistent oral microbial dysbiosis. The human ß-glucuronidase (GUS) degrades constituents of the periodontium and is used as a biomarker for periodontitis severity. However, the human microbiome also encodes GUS enzymes, and the role of these factors in periodontal disease is poorly understood. Here, we define the 53 unique GUSs in the human oral microbiome and examine diverse GUS orthologs from periodontitis-associated pathogens. Oral bacterial GUS enzymes are more efficient polysaccharide degraders and processers of biomarker substrates than the human enzyme, particularly at pHs associated with disease progression. Using a microbial GUS-selective inhibitor, we show that GUS activity is reduced in clinical samples obtained from individuals with untreated periodontitis and that the degree of inhibition correlates with disease severity. Together, these results establish oral GUS activity as a biomarker that captures both host and microbial contributions to periodontitis, facilitating more efficient clinical monitoring and treatment paradigms for this common inflammatory disease.

Perceived effectiveness of objective elements of vaping prevention messages among adolescents.

INTRODUCTION: In recent years, vaping prevention campaigns have proliferated in response to a surge of e-cigarette use among adolescents in the USA. To date, the research literature has provided minimal guidance as to what vaping prevention message elements have the greatest potential for discouraging vaping, are ineffective or have unintended negative effects. The purpose of the current study was to identify and test a large set of vaping prevention ads used by federal, state, local and non-governmental agencies, examining how objectively coded message elements of vaping prevention messages might affect youth. METHODS: A convenience sample of adolescents (N=1501) completed an online survey with each participant rating seven randomly selected vaping prevention ads from a pool of 220 ads on perceived message effectiveness (PME) and vaping appeal. Ads were coded on 37 objective elements in three message categories: themes, imagery and other features. Analyses examined how objective elements predicted PME. RESULTS: Addiction, chemicals, negative health symptoms and effects, and cigarette comparison themes were associated with higher PME, as were graphic images and warning symbols. Industry targeting, environmental impact, flavour themes, images of food and people's faces were associated with lower PME, as were hashtags, statistics and first-person language or the word 'teen'. Most elements were not associated with appeal, but ads with a flavour theme were associated with increased vaping appeal. CONCLUSION: Promising vaping prevention messages focus on the adverse consequences of vaping, use negative imagery and avoid speaking for teens using their vernacular or perspective.

Impact of Brief Quality Improvement Coaching on Adolescent HPV Vaccination Coverage: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Health departments in the United States routinely conduct quality improvement (QI) coaching to help primary care providers optimize vaccine delivery. In a prior trial focusing on multiple adolescent vaccines, this light-touch intervention yielded only short-term improvements in HPV vaccination. We sought to evaluate the impact of an enhanced, HPV vaccine-specific QI coaching intervention when delivered in person or virtually. METHODS: We partnered with health departments in three states to conduct a pragmatic cluster randomized trial in 2015 to 2016. We randomized 224 primary care clinics to receive no intervention (control), in-person coaching, or virtual coaching. Health department staff delivered the brief (45-60 minute) coaching interventions, including HPV vaccine-specific training with assessment and feedback on clinics' vaccination coverage (i.e., proportion of patients vaccinated). States' immunization information systems provided data to assess coverage change for HPV vaccine initiation (≥1 doses) at 12-month follow-up, among patients ages 11 to 12 (primary outcome) and 13 to 17 (secondary outcome) at baseline. RESULTS: Clinics served 312,227 patients ages 11 to 17. For ages 11 to 12, coverage change for HPV vaccine initiation was higher in the in-person and virtual coaching arms than in the control arm at 12-month follow-up (1.2% and 0.7% point difference, both P < 0.05). For ages 13 to 17, coverage change was higher for virtual coaching than control (1.4% point difference, P < 0.001), but in-person coaching did not yield an intervention effect. CONCLUSIONS: Our brief QI coaching intervention produced small long-term improvements in HPV vaccination. IMPACT: Health departments may benefit from targeting QI coaching to specific vaccines, like HPV vaccine, that need them most.

Patient-level information underlying overdiagnosis of urinary tract infections in nursing homes: A discrete choice experiment.

The overdiagnosis of urinary tract infections (UTIs) in nursing home residents is a significant public health threat. Using a discrete choice experiment and a diagnostic guideline, we examined which patient-level information was associated with the overdiagnosis of UTIs and found that urinalysis results and lower urinary tract status were most associated.

The mechanics of implementation strategies and measures: advancing the study of implementation mechanisms.

BACKGROUND: There is a fundamental gap in understanding the causal mechanisms by which strategies for implementing evidence-based practices address local barriers to effective, appropriate service delivery. Until this gap is addressed, scientific knowledge and practical guidance about which implementation strategies to use in which contexts will remain elusive. This research project aims to identify plausible strategy-mechanism linkages, develop causal models for mechanism evaluation, produce measures needed to evaluate such linkages, and make these models, methods, and measures available in a user-friendly website. The specific aims are as follows: (1) build a database of strategy-mechanism linkages and associated causal pathway diagrams, (2) develop psychometrically strong, pragmatic measures of mechanisms, and (3) develop and disseminate a website of implementation mechanisms knowledge for use by diverse stakeholders. METHODS: For the first aim, a combination of qualitative inquiry, expert panel methods, and causal pathway diagramming will be used to identify and confirm plausible strategy-mechanism linkages and articulate moderators, preconditions, and proximal and distal outcomes associated with those linkages. For the second aim, rapid-cycle measure development and testing methods will be employed to create reliable, valid, pragmatic measures of six mechanisms of common strategies for which no high-quality measures exist. For the third aim, we will develop a user-friendly website and searchable database that incorporates user-centered design, disseminating the final product using social marketing principles. DISCUSSION: Once strategy-mechanism linkages are identified using this multi-method approach, implementation scientists can use the searchable database to develop tailored implementation strategies and generate more robust evidence about which strategies work best in which contexts. Moreover, practitioners will be better able to select implementation strategies to address their specific implementation problems. New horizons in implementation strategy development, optimization, evaluation, and deployment are expected to be more attainable as a result of this research, which will lead to enhanced implementation of evidence-based interventions for cancer control, and ultimately improvements in patient outcomes.

When Less Is More: Identifying Patients With Type 2 Diabetes Engaging in Unnecessary Blood Glucose Monitoring.

This study examined whether certain patient characteristics are associated with the prescribing of self-monitoring of blood glucose for patients with type 2 diabetes who are not using insulin and have well-controlled blood glucose. Against recommendations, one-third of the patient sample from a large health network in North Carolina (N = 9,338) received a prescription for testing supplies (i.e., strips or lancets) within the prior 18 months. Women, African Americans, individuals prescribed an oral medication, nonsmokers, and those who were underweight or normal weight all had greater odds of receiving such a prescription. These results indicate that providers may have prescribing tendencies that are potentially biased against more vulnerable patient groups and contrary to guidelines.

Coaching and Communication Training for HPV Vaccination: A Cluster Randomized Trial.

BACKGROUND AND OBJECTIVES: US health departments routinely conduct in-person quality improvement (QI) coaching to strengthen primary care clinics' vaccine delivery systems, but this intervention achieves only small, inconsistent improvements in human papillomavirus (HPV) vaccination. Thus, we sought to evaluate the effectiveness of combining QI coaching with remote provider communication training to improve impact. METHODS: With health departments in 3 states, we conducted a pragmatic 4-arm cluster randomized clinical trial with 267 primary care clinics (76% pediatrics). Clinics received in-person QI coaching, remote provider communication training, both interventions combined, or control. Using data from states' immunization information systems, we assessed HPV vaccination among 176 189 patients, ages 11 to 17, who were unvaccinated at baseline. Our primary outcome was the proportion of those, ages 11 to 12, who had initiated HPV vaccination at 12-month follow-up. RESULTS: HPV vaccine initiation was 1.5% points higher in the QI coaching arm and 3.8% points higher in the combined intervention arm than in the control arm, among patients ages 11 to 12, at 12-month follow-up (both P < .001). Improvements persisted at 18-month follow-up. The combined intervention also achieved improvements for other age groups (ages 13-17) and vaccination outcomes (series completion). Remote communication training alone did not outperform the control on any outcome. CONCLUSIONS: Combining QI coaching with remote provider communication training yielded more consistent improvements in HPV vaccination uptake than QI coaching alone. Health departments and other organizations that seek to support HPV vaccine delivery may benefit from a higher intensity, multilevel intervention approach.

A Self-management SMS Text Messaging Intervention for People With Inflammatory Bowel Disease: Feasibility and Acceptability Study.

BACKGROUND: Mobile health technologies can be useful for providing disease self-management information and support to people with inflammatory bowel disease (IBD). OBJECTIVE: The aim of this study was to test a self-management SMS text messaging intervention for people with IBD. Our goal was to examine intervention feasibility, acceptability, and engagement and to preliminarily evaluate improvements in certain self-reported health outcomes among participants. METHODS: We developed an SMS text messaging program called Text4IBD. The program sent daily support messages and resources about disease self-management over the course of a 2-week, single-group, pretest-posttest intervention to participants (N=114) diagnosed with IBD. We examined intervention feasibility, acceptability, and engagement through Text4IBD message topic recall and use of resources (ie, visiting supplemental websites recommended by the Text4IBD program). We also assessed pretest-posttest measures of IBD-related distress, self-efficacy, perceived support, use of coping strategies, and medication adherence. Analyses examined participants' evaluations of the intervention and compared pretest-posttest changes in secondary outcomes using paired-samples statistics. RESULTS: Approximately all participants who completed the intervention (n=105) were receptive to Text4IBD and viewed the program as feasible and acceptable. In addition, most participants (103/105, 98.1%) recalled at least one of the message topics sent by the program, and 79% (83/105) of them self-reported engaging with at least one of the external self-management resources recommended by the Text4IBD program. Pretest-posttest results showed reduced IBD-related distress (mean 3.33, SD 0.68 vs mean 2.86, SD 0.73; P<.001) and improvements in most other secondary outcomes. CONCLUSIONS: Findings from this study highlight the value of SMS text messaging as a useful digital medium for providing support to people with IBD, particularly to those who may struggle with disease-related distress. Text4IBD was highly feasible and acceptable and may help people self-manage their IBD. Future studies should aim to evaluate this program in a randomized controlled trial in clinical settings.

What's in the message? An analysis of themes and features used in vaping prevention messages.

Introduction: Federal, state, local, and non-government officials have developed and implemented a variety of vaping prevention messages to curtail the vaping epidemic among youth in the US. This study sought to collect a comprehensive set of vaping prevention messages and characterize the themes and features of those messages. Methods: We used a two-fold search strategy to identify messages, utilizing the existing content database from Vaping Prevention Resource (vapingprevention.org) and supplementing those messages with web searches. Potential messages were included if they were vaping prevention-oriented, appropriate or relevant for youth, and in a static web or print format. Results: A total of 220 messages met criteria. Messages were coded on the presence or absence of 37 objective features within five categories: message themes, imagery, text features, message perspective, and other (e.g., source). The most common themes were nicotine addiction (32%), chemicals (30%), health effects (24%), and industry targeting (19%). Eighty-five percent of messages included imagery, with 27% showing a vaping device, 22% showing smoke or vapor, and 21% showing a person's face. Just over half (56%) included a message source. Conclusions: Vaping prevention messages for youth have commonly focused on addiction and health risks of vaping, and they vary on a series of text and image features. Further research is needed to understand the efficacy of messaging approaches in preventing vaping among youth.

Preferences for different features of ENDS products by tobacco product use: a latent class analysis.

BACKGROUND: From a public health perspective, electronic nicotine delivery devices (ENDS) use may be beneficial for some populations (e.g., smokers who fully switch to ENDS) but detrimental for others (e.g., nonsmokers). Understanding the importance placed on different ENDS product features by user groups can guide interventions and regulations. METHODS: Participants were US adults who had used ENDS at least once and from a convenience sample drawn from a market research software in 2016. Participants chose between 9 different ENDS product features (harms of use, general effects of use, use as a cessation aid, initial purchase price, monthly cost, nicotine content, flavor availability, device design, and modifiability). A latent class analysis (LCA) identified subgroups of feature preferences and examined differences between groups by socio-demographics and tobacco product use. RESULTS: Of the 636 participants, 81% were White, the median age was 42, and 65% were current cigarette smokers. The LCA identified a 4-class solution as the most appropriate model: (1) people with high nicotine dependence who preferred ENDS similar to combustible cigarettes, (2) people with moderate tobacco use who were interested in low nicotine ENDS (3) people who use ENDS and combustible tobacco who preferred lower price and flavored ENDS products, and (4) people who used ENDS predominantly, without a strong preference for any of the features presented. CONCLUSIONS: Tobacco use classes were associated with differences in preferences for ENDS features. These findings can inform regulations to reduce ENDS use among specific groups of people who use ENDS products.

Development and Validation of the Trust in My Doctor, Trust in Doctors in General, and Trust in the Health Care Team Scales.

RATIONALE: Historic and present-day racism and inequity in the United States (U.S.) have resulted in diminished trust in health care among many populations. A key barrier to improving trust in health care is a dearth of well-validated measures appropriate for diverse populations. Indeed, systematic reviews indicate a need to develop and test updated trust measures that are multidimensional and inclusive of relevant domains (e.g., fairness). OBJECTIVE: We developed three trust measures: the Trust in My Doctor (T-MD), Trust in Doctors in General (T-DiG), and Trust in the Health Care Team (T-HCT) scales. METHODS: After developing an initial item pool, expert reviewers (n = 6) provided feedback on the face validity of each scale. We conducted cognitive interviews (n = 21) with a convenience sample of adults to ensure items were interpreted as intended. In 2020, we administered an online survey to a convenience sample of U.S. adults recruited through the Qualtrics Panel (n = 801) to assess scale reliability and validity. RESULTS: Exploratory and confirmatory factor analyses indicated acceptable model fit for second order latent factor models for each scale (root mean square error of approximation: <0.07, comparative fit index: ≥0.98, and standardized root mean square residual: ≤0.03). The T-MD contained 25 items and six subscales: communication competency, fidelity, systems trust, confidentiality, fairness, and global trust. The T-DiG and T-HCT each contained 29 items and seven subscales (the same subscales in the T-MD plus an additional subscale related to stigma-based discrimination). Each scale was strongly correlated with existing trust measures and perceived racism in health care and was significantly associated with delayed health care seeking and receipt of a routine health exam. CONCLUSIONS: The multidimensional T-MD, T-DiG, and T-HCT scales have sound psychometric properties and may be useful for researchers evaluating trust-related interventions or conducting studies where trust is an important construct or main outcome.

Overdiagnosis of urinary tract infections by nursing home clinicians versus a clinical guideline.

PURPOSE: To inform overprescribing and antibiotic stewardship in nursing homes (NHs), we examined the concordance between clinicians' (NH primary care providers and registered nurses) diagnosis of suspected UTI with a clinical guideline treated as the gold standard, and whether clinician characteristics were associated with diagnostic classification. METHODS: We conducted a cross-sectional web-based survey of a U.S. national convenience sample of NH clinicians. The survey included a discrete choice experiment with 19 randomly selected clinical scenarios of NH residents with possible UTIs. For each scenario, participants were asked if they thought a UTI was likely. Responses were compared to the guideline to determine the sensitivity and specificity of clinician judgment and performance indicators. Multivariable logistic mixed effects regression analysis of demographic, work, personality, and UTI knowledge/attitudes characteristics was conducted. RESULTS: One thousand seven hundred forty-eight NH clinicians responded to 33,212 discrete choice scenarios; 867 (50%) were NH primary care providers and 881 (50%) were NH registered nurses, 39% were male, and the mean age was 45 years. Participants were uncertain about diagnosis in 30% of scenarios. Correct classification occurred for 66% of all scenarios (providers: 70%; nurses: 62%). Respondent judgment had a sensitivity of 78% (providers: 81%; nurses: 74%) and specificity of 54% (providers: 59%; nurses: 49%) compared to the clinical guideline. Adjusting for covariates in multivariable models, being a nurse and having higher closemindedness were associated higher odds of false positive UTI (odds ratio [OR] 1.61, p < 0.001; and OR 1.09, p = 0.039, respectively), although higher UTI knowledge and conscientiousness were associated with lower odds of false positive UTI ratings (OR 0.80, p < 0.001; OR 0.90, p = 0.005, respectively). CONCLUSIONS: Clinicians tend to over-diagnose urinary tract infections, necessitating systems-based interventions to augment clinical decision-making. Clinician type, UTI knowledge, and personality traits may also influence behavior and deserve further study.

Mortality Risk Factors among Infants Receiving Dialysis in the Neonatal Intensive Care Unit.

OBJECTIVES: To identify risk factors associated with mortality for infants receiving dialysis in the neonatal intensive care unit (NICU). STUDY DESIGN: In this retrospective cohort study, we extracted data from the Pediatrix Clinical Data Warehouse on all infants who received dialysis in the NICU from 1999 to 2018. Using a Cox proportional hazards model with robust SEs we estimated the mortality hazard ratios associated with demographics, birth details, medical complications, and treatment exposures. RESULTS: We identified 273 infants who received dialysis. Median gestational age at birth was 35 weeks (interquartile values 33-37), median birth weight was 2570 g (2000-3084), 8% were small for gestational age, 41% white, and 72% male. Over one-half of the infants (59%) had a kidney anomaly; 71 (26%) infants died before NICU hospital discharge. Factors associated with increased risk of dying after dialysis initiation included lack of kidney anomalies, Black race, gestational age of <32 weeks, necrotizing enterocolitis, dialysis within 7 days of life, and receipt of paralytics or vasopressors (all P < .05). CONCLUSION: In this cohort of infants who received dialysis in the NICU over 2 decades, more than 70% of infants survived. The probability of death was greater among infants without a history of a kidney anomaly and those with risk factors consistent with greater severity of illness at dialysis initiation.

Provider response and follow-up to parental declination of HPV vaccination.

OBJECTIVE: Parents often decline HPV vaccination, but little is known about how healthcare providers should promote vaccination at a later visit for secondary acceptance. We examined the associations of two factors, providers' response to declination during the visit and follow-up after the visit, with secondary acceptance. METHODS: We conducted a cross-sectional survey of US parents whose 9- to 17-year-old child had not yet completed the HPV vaccination series. Parents who declined HPV vaccination during an initial discussion with a provider (n = 447) reported whether their provider engaged in any active response during the visit (e.g., giving information, trying to change their mind) or any follow-up after the visit (e.g., scheduling another visit). We conducted multivariable logistic regression to determine whether an active response or follow-up was associated with secondary acceptance of HPV vaccination. RESULTS: Only about one-third of parents reported an active response during the visit (35%) or follow-up after the visit (39%) following HPV vaccination declination. Parents had higher odds of secondary acceptance of HPV vaccine if they received any provider follow-up after the visit (43% vs. 20%, aOR:3.19; 95% CI:2.00:5.07). Receipt of an active provider response was not associated with secondary acceptance. More parents thought a provider should actively respond and follow-up (61% and 68% respectively), compared with those who received such a response (both p < .01). CONCLUSIONS: Providers' follow-up after the visit may be important for promoting secondary acceptance of HPV vaccination. Parents who decline HPV vaccination often prefer to receive an active response or follow-up from a provider.

The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care.

BACKGROUND: Unhealthy alcohol use is a leading cause of preventable deaths in the USA and is associated with many societal and health problems. Less than a third of people who visit primary care providers in the USA are asked about or ever discuss alcohol use with a health professional. METHODS/DESIGN: This study is an adaptive, randomized, controlled trial to evaluate the effect of primary care practice facilitation and telehealth services on evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use in small-to-medium-sized primary care practices. Study participants will include primary care practices in North Carolina with 10 or fewer providers. All enrolled practices will receive a practice facilitation intervention that includes quality improvement (QI) coaching, electronic health record (EHR) support, training, and expert consultation. After 6 months, practices in the lower 50th percentile (based on performance) will be randomized to continued practice facilitation or provision of telehealth services plus ongoing facilitation for the next 6 months. Practices in the upper 50th percentile after the initial 6 months of intervention will continue to receive practice facilitation alone. The main outcome measures include the number (and %) of patients in the target population who are screened for unhealthy alcohol use, screen positive, and receive brief counseling. Additional measures include the number (and %) of patients who receive pharmacotherapy for AUD or are referred for AUD services. Sample size calculations determined that 35 practices are needed to detect a 10% increase in the main outcome (percent screened for unhealthy alcohol use) over 6 months. DISCUSSION: A successful intervention would significantly reduce morbidity among adults from unhealthy alcohol use by increasing counseling and other treatment opportunities. The study will produce important evidence about the effect of practice facilitation on uptake of evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use when delivered on a large scale to small and medium-sized practices. It will also generate scientific knowledge about whether embedded telehealth services can improve the use of evidence-based screening and interventions for practices with slower uptake. The results of this rigorously conducted evaluation are expected to have a positive impact by accelerating the dissemination and implementation of evidence related to unhealthy alcohol use into primary care practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT04317989 . Registered on March 23, 2020.

A Multidimensional Model of Sexual Empowerment Among Young Black Men Who have Sex with Men: A Latent Profile Analysis.

Sexual empowerment is a key strategy in HIV prevention intervention design, yet its measurement has been conceptualized as homogeneous. To date, no studies have examined whether young Black men who have sex with men (YBMSM) exhibit heterogeneity across sexual empowerment. Using baseline data from a randomized controlled trial (N = 275, HIV-negative YBMSM), we classified YBMSM into sexual empowerment profiles based on five indicators using a latent profile analysis and assessed the associations between the sexual empowerment profiles and stigma-related experiences using multinomial logistic regression. Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3). YBMSM reporting fewer stigma-related experiences were more likely to be profile 1 than profile 2 and profile 3. To empower YBMSM, interventions based on sexual empowerment profile targeting the psychological/behavioral aspects of empowerment and addressing stigma are needed.