HIV Preexposure Prophylaxis and Sexual Satisfaction Among Men Who Have Sex With Men.

ABSTRACT: In this large online survey of primarily men who have sex with men, those who used preexposure prophylaxis reported greater sexual satisfaction than did nonusers, including sexual sensations, sexual presence/awareness, and sexual exchange. Person-centered care and messaging may require acknowledging that some people use preexposure prophylaxis for reasons beyond HIV prevention.

Primary Care Providers' Perspectives on Using Automated HIV Risk Prediction Models to Identify Potential Candidates for Pre-exposure Prophylaxis.

Identifying patients at increased risk for HIV acquisition can be challenging. Primary care providers (PCPs) may benefit from tools that help them identify appropriate candidates for HIV pre-exposure prophylaxis (PrEP). We and others have previously developed and validated HIV risk prediction models to identify PrEP candidates using electronic health records data. In the current study, we convened focus groups with PCPs to elicit their perspectives on using prediction models to identify PrEP candidates in clinical practice. PCPs were receptive to using prediction models to identify PrEP candidates. PCPs believed that models could facilitate patient-provider communication about HIV risk, destigmatize and standardize HIV risk assessments, help patients accurately perceive their risk, and identify PrEP candidates who might otherwise be missed. However, PCPs had concerns about patients' reactions to having their medical records searched, harms from potential breaches in confidentiality, and the accuracy of model predictions. Interest in clinical decision-support for PrEP was greatest among PrEP-inexperienced providers. Successful implementation of prediction models will require tailoring them to providers' preferences and addressing concerns about their use.

Risk factors for non-adherence to disease-modifying therapy in pediatric multiple sclerosis.

BACKGROUND: Adherence to disease-modifying therapies (DMTs) in pediatric multiple sclerosis (MS) is not well understood. We examined the prevalence and risk factors for poor adherence in pediatric MS. METHODS: This cross-sectional study recruited youth with MS from 12 North American pediatric MS clinics. In addition to pharmacy-refill data, patients and parents completed self-report measures of adherence and quality of life. Additionally, patients completed measures of self-efficacy and well-being. Factor analysis and linear regression methods were used. RESULTS: A total of 66 youth (mean age, 15.7 years) received MS DMTs (33% oral, 66% injectable). Estimates of poor adherence (i.e. missing >20% of doses) varied by source: pharmacy 7%, parent 14%, and patient 41%. Factor analysis yielded two composites: adherence summary and parental involvement in adherence. Regressions revealed that patients with better self-reported physical functioning were more adherent. Parents were more likely to be involved in adherence when their child had worse parent-reported PedsQL School Functioning and lower MS Self-Efficacy Control. Oral DMTs were associated with lesser parental involvement in adherence. CONCLUSION: Rates of non-adherence varied by information source. Better self-reported physical functioning was the strongest predictor of adherence. Parental involvement in adherence was associated with worse PedsQL School Functioning and lower MS Self-Efficacy-measured confidence in controlling MS.

The impact of extended half-life versus conventional factor product on hemophilia caregiver burden.

INTRODUCTION: Extended half-life factor products have reduced annualized bleeding rates in hemophilia patients. The impact of extended half-life versus conventional factor products on hemophilia caregiver burden has not been investigated. This study aimed to evaluate caregiver burden in extended half-life versus conventional factor products for hemophilia A and B. METHODS: This cross-sectional web-based study of caregivers of people with hemophilia A or B was recruited from a panel research company and by word of mouth. Participants completed the Hemophilia Caregiver Impact measure, the PedsQL Family Impact Module (PedsQL), and the Work Productivity and Activity Impairment Questionnaire (WPAI). We also collected demographic, insurance coverage, and medical information related to the hemophilia patient(s). Burden differences were assessed using linear regression and matched cohort analyses. RESULTS: The sample (n = 448) included 49 people who were caring for people on extended half-life factor products. Worse caregiver burden was associated with more infusions per week and more bleeds in the past 6 months. Regression analyses suggested that caring for someone who is on a extended half-life factor product is associated with lower emotional impact (ß = - 0.11, p < 0.05, Adjusted R2 = 0.06), and shows a trend association with lower practical impact (ß = - 0.09, p < 0.10, Adjusted R2 = 0.05). The matched cohort analysis also revealed that people on extended half-life factor product had lower Emotional Impact and Practical Impact scores (t = - 2.95 and - 2.94, respectively, p < 0.05 in both cases). No differences were detected on the PedsQL or the WPAI. CONCLUSION: The reduced required frequency of factor product infusions of extended half-life factor products appears to reduce the emotional distress and practical burden of caregiving. Future work should evaluate the longitudinal impact.

Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

The clinicaltrials.gov identifying number for the article titled "Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial" is NCT02234713 (https://clinicaltrials.gov/ct2/show/NCT02234713).

The Performance Scales disability measure for multiple sclerosis: use and sensitivity to clinically important differences.

BACKGROUND: In 1993, the Performance Scales© was created to assess multi-dimensional disability in multiple sclerosis (MS). This tool has been used in a variety of settings and study designs internationally. The present work provides an overview of the history and psychometric characteristics of the Performance Scales©, reviews its use over the past two decades, and summarizes its responsiveness to subgroup differences. METHODS: A Google Scholar and Ovid search yielded 230 articles citing the Performance Scales©, of which 82 studies used the tool in empirical research. Twelve articles provided sufficient information to enable computation of effect sizes. Forest plots were used to show effect sizes for the overall summary score and by domain by patient demographics, MS disease trajectory, and treatment adherence. RESULTS: The Performance Scales© evidenced sensitivity to clinically important differences by disease trajectory and age (for selected domains). In contrast, groups distinguished by patient adherence to disease-modifying therapies and ethnicity were relatively small. CONCLUSIONS: The Performance Scales© has been used in a large number of studies since its development, suggesting that this psychometrically sound tool is acknowledged to be a useful tool for MS clinical research. It is recommended that future work include the entire measure, so that the whole-person impact of MS can be characterized and considered in MS outcome research.

Measuring hemophilia caregiver burden: validation of the Hemophilia Caregiver Impact measure.

AIMS: The purpose of this article is to describe the psychometric development of the Hemophilia Caregiver Impact measure. METHODS: Qualitative interviews (n = 22) and a cross-sectional web-based study (n = 458) were implemented with caregivers of people with hemophilia. Classical test theory and item response theory analyses were implemented to evaluate the psychometric characteristics of the measure. RESULTS: The study sample had a mean age of 39 and a median level of college education. It was predominantly female (88%), and had an average of two children. 85% of this study sample had at least one child with hemophilia. The final 36-item Hemophilia Caregiver Impact measure is composed of seven subscales assessing relevant negative aspects of caregiver impact (Burden Summary) as well as one subscale reflecting a positive aspect of caregiver impact (Positive Emotions). These two summary scores are orthogonal and can be used together in analyses examining negative and positive aspects of caregiver impact. The items included within each subscale reflect a unidimensional construct, demonstrate good item information and trace lines, and lack of local dependence. The resulting subscales demonstrate high reliability, and good construct validity. They show moderate incremental and discriminant validity. CONCLUSIONS: The Hemophilia Caregiver Impact measure is a useful new tool for clinical research on hemophilia. In addition to having eight relevant subscales, the measure can also be summarized with two scores. This versatility can be useful in analyzing studies with very small samples, which is to be expected when dealing with a rare condition like hemophilia.

When global rating of change contradicts observed change: Examining appraisal processes underlying paradoxical responses over time.

AIMS: Interpreting change scores is challenging when patients' global rating of change (GRC) scores contradict their observed change scores. We examine appraisal processes associated with having GRC-observed change contradictions. METHODS: This secondary analysis of longitudinal multiple sclerosis (MS) registry data examined predictors of GRC scores in the whole sample (n = 858). Logistic modeling then examined predictors of membership in one of two paradoxical subgroups (n = 525): (a) Worsened GRC with unchanged observed Rand-12 Mental Component scores (MCS) (Symptom-Maximizers, n = 171) versus no change GRC among stable MCS subsample; and (b) same GRC with declined observed MCS scores (Symptom-Minimizers, n = 84) versus declining GRC among declining MCS subsample. Independent variables were cognitive appraisal processes from the Quality of Life (QOL) Appraisal Profile. RESULTS: GRC scores were more strongly associated with appraisal processes than with change in patient-reported outcomes (PROs) (R 2 = 11 and 2 %, respectively). Symptom-Maximizers tended to focus on MS-related experiences and emphasize big changes; over time, they decreasingly defined QOL in terms of independence, increasingly focused on their MS, and increasingly compared themselves to doctor's predictions (Pseudo R 2 = 0.20). In contrast, Symptom-Minimizers tended not to recall recent episodes; over time, they focused increasingly on goals related to living situation and emphasized long-term concerns (Pseudo R 2 = 0.25). CONCLUSIONS: Appraisal explains more variance in GRC scores than do changes in PROs. People whose GRC assessment contradicts their observed change can be characterized by distinct cognitive appraisal processes reflecting response shift.

Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

PURPOSE: To report the results of a randomized controlled trial using an electronic monitoring device (EM) plus a motivational interviewing (MI) intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS. METHODS: Fifty-two youth with MS (16.03 ± 2.2 years) were randomized to receive either MI (n = 25) (target intervention) or a MS medication video (n = 27) (attention control). Primary endpoint was change in adherence. Secondary outcomes included changes in quality of life, well-being and self-efficacy. Random effects modeling and Cohen's effect size computation evaluated intervention impact. RESULTS: Longitudinal random effect models revealed that the MI group decreased their EM adherence (GroupxTime interaction = -0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23). Parental reminders about medication increased in MI subjects vs controls (d = 0.59 at 3 months; d = 0.70 at 6 months). We found increases in self-reported adherence (d = 0.21) at 3 but not 6 months, fewer barriers to adherence at three (d = -0.58) and six months (d = -0.31), better physical (d = 0.23 at 3 months; d = 0.45 at 6 months), emotional (d = 0.25 at 3 months) and self-efficacy function (d = 0.55 at 3 months; 0.48 at 6 months), but worse well-being, including self-acceptance (d = -0.53 at 6 months) and environmental mastery (d = -0.42 at 3 and 6 months) in intervention as compared to control patients. CONCLUSIONS: Participants receiving MI + EM experienced worsening on objective measures of adherence and increased parental involvement, but improved on some self- and parent-reported measures. MI participants reported improvements in quality of life and self-efficacy, but worsened well-being.

Brief Report: "I Didn't Really Have a Primary Care Provider Until I Got PrEP": Patients' Perspectives on HIV Preexposure Prophylaxis as a Gateway to Health Care.

BACKGROUND: HIV prevention is the primary goal of preexposure prophylaxis (PrEP); however, ancillary benefits may exist, including PrEP as an entry point to primary care. OBJECTIVE: To explore PrEP users' perspectives on how PrEP use relates to broader engagement in health care. DESIGN: In-depth qualitative interviews. PARTICIPANTS: We recruited PrEP users aged 18 years or older from a social media group for people interested in PrEP information and a Boston community health center specializing in health care for sexual and gender minorities. APPROACH: Inductive content analysis to identify emergent themes. KEY RESULTS: All 25 participants were men who have sex with men, whose mean age was 34 years, and 84% were White. Three major themes emerged: (1) accessing PrEP was a strong motivator for initial and continued engagement in health care, which for some evolved over time into accessing comprehensive primary care; (2) provider awareness and attitudes about PrEP influenced participants' ongoing engagement in health care; and (3) PrEP engendered a positive sense of control over users' personal health, giving them agency in reducing their risk of HIV and engaging in other aspects of their health. Quarterly PrEP visits helped participants establish and maintain a relationship with a primary care provider, access non-HIV-related care services, and feel empowered to keep themselves healthy. CONCLUSIONS: The benefits of PrEP extend beyond HIV prevention to broader engagement in health care, including new relationships with primary care providers and use of other preventive health care services. To maximize those benefits, efforts are needed to ensure that providers are aware, nonjudgmental, and supportive of PrEP use.

Nondaily Use of HIV Preexposure Prophylaxis in a Large Online Survey of Primarily Men Who Have Sex With Men in the United States.

BACKGROUND: Event-driven dosing of HIV preexposure prophylaxis (PrEP) using a 2-1-1 regimen is efficacious for men who have sex with men (MSM). However, data are limited on the prevalence, correlates, and patterns of nondaily PrEP use in the United States. SETTING: Nationwide online survey. METHODS: We distributed a survey to assess experiences with PrEP, including nondaily use, in May 2019 on geosocial networking sites commonly used by MSM. RESULTS: Among 9697 respondents, the mean age was 43 years, 67% were non-Hispanic white, and 90% were MSM. Nearly all (91.0%) had heard of PrEP, 40.1% ever used PrEP, and 33.3% used PrEP in the past 6 months. Most (60.6%) were interested in nondaily PrEP. Those without health insurance and those with higher incomes were more likely to be interested in nondaily PrEP. Of the 3232 who used PrEP in the past 6 months, 176 (5.4%) reported nondaily use. Fewer sexual partners, frequent sex planning, and substance use were associated with nondaily use. Common reasons for nondaily use were inconsistent sexual activity (59%) and cost (49%). The most prevalent regimen was event driven (48.3%); of those, 64.7% used 2-1-1. Of nondaily users, 24.0% used PrEP on a regular schedule but not every day, including only on weekends or days starting with T or S. CONCLUSIONS: Given substantial interest in nondaily PrEP, and use of nondaily strategies that have not been evaluated in clinical studies, there is a need for US public health authorities to provide guidance on safe and effective nondaily dosing for MSM.

Drug Resistance During HIV Pre-Exposure Prophylaxis.

Clinical studies have demonstrated that use of tenofovir disoproxil fumarate with or without emtricitabine as antiretroviral pre-exposure prophylaxis (PrEP) can decrease the risk of human immunodeficiency virus (HIV) acquisition when medication adherence is high. However, the potential for PrEP to promote antiretroviral resistance remains an important public health consideration. We performed a search of the medical literature to identify studies that address HIV drug resistance during PrEP use. In this review, we summarize findings about emergent drug resistance during clinical trials of PrEP, case reports of seroconversions in patients adherent to PrEP, and animal studies of PrEP effectiveness against drug-resistant viral strains. We also discuss the potential utility of novel PrEP formulations for protection against drug-resistant HIV, the impact of drug resistance on HIV treatment options, and mathematical models that estimate the potential contribution of PrEP to population-level drug resistance. Evidence suggests that selection for HIV drug resistance with PrEP use is infrequent and most likely to occur when PrEP is used during undiagnosed acute HIV infection. Breakthrough infections during PrEP use with high adherence are possible, but appear to be rare. The prevalence of drug-resistant HIV strains needs to be monitored as PrEP is scaled up. However, the benefit of a decreased HIV incidence with wider PrEP use is likely to outweigh the risk of harms from possible increases in the prevalence of HIV drug resistance.

Update on HIV Preexposure Prophylaxis: Effectiveness, Drug Resistance, and Risk Compensation.

PURPOSE OF REVIEW: In 2019, the US government launched an initiative to decrease new HIV infections by 90% over the next decade. Studies have demonstrated the efficacy of HIV preexposure prophylaxis (PrEP) for high-risk populations, and the United States Preventative Services Task Force has issued a grade A recommendation for PrEP, indicating substantial net benefit. However, questions have been raised about the effectiveness of PrEP in clinical settings and whether PrEP use might promote antiretroviral drug resistance and increased sexual risk behaviors, which could increase transmission of bacterial sexually transmitted infections. In this narrative review, we summarize recent evidence of the effectiveness of PrEP when provided in clinical and community settings, the emergence of antiretroviral drug resistance during PrEP use, and associations between PrEP use and increased sexual risk behaviors. We also review novel PrEP modalities that are being developed to optimize PrEP acceptability, adherence, and effectiveness. RECENT FINDINGS: Studies suggest that PrEP is effective when provided in clinical settings. However, PrEP uptake and impact have been limited in the USA thus far, and major disparities in access to PrEP exist. In addition, there is evidence that drug resistance can occur with PrEP use, particularly with inadvertent PrEP use during undiagnosed acute HIV infection. Risk compensation can also occur with PrEP use and has been associated with increased sexually transmitted infections. Promising new modalities for PrEP could expand options. PrEP has strong potential to decrease HIV incidence. However, disparities in access must be addressed to ensure equity and impact for PrEP. While drug resistance and risk compensation can occur with PrEP use, these are not valid reasons to withhold PrEP from patients given its substantial protective benefits.

Patterns and clinical consequences of discontinuing HIV preexposure prophylaxis during primary care.

INTRODUCTION: Discontinuations of HIV preexposure prophylaxis (PrEP) by at-risk individuals could decrease the effectiveness of PrEP. Our objective was to characterize patterns of, reasons for, and clinical outcomes associated with PrEP discontinuations in primary care. METHODS: We conducted medical chart reviews for patients prescribed PrEP during 2011 to 2014 at a Boston community health centre specializing in healthcare for sexual and gender minorities. Patients were followed through 2015. We characterized patients' sociodemographics, relationship status, behavioural health conditions, patterns of and reasons for PrEP discontinuations, and HIV seroconversions. Cox proportional hazards models were used to assess patient factors associated with PrEP discontinuations. RESULTS: Of the 663 patients prescribed PrEP, the median age was 33 years, 96% were men who have sex with men (MSM) and 73% were non-Hispanic white; 40% were in committed relationships and 15% had HIV-infected partners. Patients either used PrEP continuously (60%), had 1 or more discontinuations (36%), or did not initiate PrEP (4%). Discontinuations were most often due to a decrease in HIV risk perception (33%), non-adherence to care plans (16%), or insurance barriers (12%). Of the 7 (1.1%) PrEP patients diagnosed with HIV, 1 was HIV-infected at baseline, 2 seroconverted while using PrEP, and 4 seroconverted after discontinuations. In a multivariable model adjusted for race/ethnicity, relationship status, substance use disorders, and insurance status, those who were less than 30 years old (aHR 2.0, 95% CI 1.4 to 2.9 for ages 18 to 24, aHR 2.2, 95% CI 1.6 to 3.1 for ages 25 to 29, vs. ages 30 to 39 years), who identified as transgender women (aHR 2.0, 95% CI 1.2 to 3.4, vs. cisgender men), and who had mental health disorders (aHR 1.2, 95% CI 1.1 to 1.4 for each additional disorder) were more likely to have discontinuations. CONCLUSIONS: Discontinuations of PrEP use among this American sample of predominately MSM were common, particularly among patients who were younger, identified as transgender women, or had behavioural health issues. As HIV seroconversions occurred after discontinuations of PrEP, strategies to prevent inappropriate discontinuations are needed.

Using HIV Risk Prediction Tools to Identify Candidates for Pre-Exposure Prophylaxis: Perspectives from Patients and Primary Care Providers.

Clinical guidelines for HIV pre-exposure prophylaxis (PrEP) include risk prediction tools to identify appropriate candidates. We conducted a qualitative interview study to explore the potential acceptability, interpretation, and anticipated impact of such tools from the perspectives of men who have sex with men (MSM) and primary care providers (PCPs). Our purposive sample of English-speaking participants included: (1) MSM reporting HIV risk behaviors (n = 32; median age = 38 years; 53% non-Hispanic white; 22% high school degree or less education); (2) PCPs specializing in health care for MSM (n = 12); and (3) PCPs in general practice (n = 19). MSM participants questioned the ability of risk tools to predict HIV acquisition, and their perceptions of what might constitute a high HIV risk score varied widely. Many MSM participants believed that receiving a high score would prompt them to consider PrEP or other risk reduction strategies. Some believed that the data would be useful, particularly if discussed with their providers, whereas others anticipated feeling fear, anxiety, or mistrust. PCPs expressed more confidence in HIV risk prediction and imagined integrating tools with medical histories and their clinical judgment to assess risk. PCPs were most enthusiastic about adopting HIV risk prediction as a teaching tool to help patients visualize and reduce risk, their concerns about time constraints notwithstanding. In conclusion, our findings suggest that PCPs' views of HIV risk prediction tools are generally positive, whereas MSM participants' are more mixed. Given that both groups emphasized the value of contextualizing risk, shared decision making may be needed to implement HIV risk prediction tools effectively.