Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial.

BACKGROUND: Cabotegravir plus rilpivirine is the only approved complete long-acting regimen for the maintenance of HIV-1 virological suppression dosed every 2 months. The SOLAR study aimed to compare long-acting cabotegravir plus rilpivirine every 2 months with continued once-daily bictegravir, emtricitabine, and tenofovir alafenamide for the maintenance of HIV-1 virological suppression in adults living with HIV. METHODS: SOLAR is a randomised, open-label, multicentre, phase 3b, non-inferiority study. The study was done in 118 centres across 14 countries. Participants with HIV-1 RNA less than 50 copies per mL were randomly assigned (2:1), stratified by sex at birth and BMI, to either long-acting cabotegravir (600 mg) plus rilpivirine (900 mg) dosed intramuscularly every 2 months or to continue daily oral bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg). Participants randomly assigned to long-acting therapy had a choice to receive cabotegravir (30 mg) plus rilpivirine (25 mg) once daily as an optional oral lead-in for approximately 1 month. The primary efficacy endpoint was the proportion of participants with virological non-response (HIV-1 RNA ≥50 copies per mL; the US Food and Drug Administration snapshot algorithm, 4% non-inferiority margin; modified intention-to-treat exposed population) at month 11 (long-acting start with injections group) and month 12 (long-acting with oral lead-in group and bictegravir, emtricitabine, and tenofovir alafenamide group). The study is registered with ClinicalTrials.gov, NCT04542070, and is ongoing. FINDINGS: 837 participants were screened between Nov 9, 2020, and May 31, 2021, and 687 were randomly assigned to switch treatment or continue existing treatment. Of 670 participants (modified intention-to-treat exposed population), 447 (67%) switched to long-acting therapy (274 [61%] of 447 start with injections; 173 [39%] of 447 with oral lead-in) and 223 (33%) continued bictegravir, emtricitabine, and tenofovir alafenamide. Baseline characteristics were similar; median age was 37 years (range 18-74), 118 (18%) of 670 were female sex at birth, 207 (31%) of 670 were non-White, and median BMI was 25·9 kg/m2 (IQR 23·3-29·5). At month 11-12, long-acting cabotegravir plus rilpivirine showed non-inferior efficacy versus bictegravir, emtricitabine, and tenofovir alafenamide (HIV-1 RNA ≥50 copies per mL, five [1%] of 447 vs one [<1%] of 223), with an adjusted treatment difference of 0·7 (95% CI -0·7 to 2·0). Excluding injection site reactions, adverse events and serious adverse events were similar between groups. No treatment-related deaths occurred. More long-acting group participants had adverse events leading to withdrawal (25 [6%] of 454 vs two [1%] of 227). Injection site reactions were reported by 316 (70%) of 454 long-acting participants; most (98%) were grade 1 or 2. INTERPRETATION: These data support the use of long-acting cabotegravir plus rilpivirine dosed every 2 months as a complete antiretroviral regimen that has similar efficacy to a commonly used integrase strand transfer inhibitor-based first-line regimen, while addressing unmet psychosocial issues associated with daily oral treatment. FUNDING: ViiV Healthcare.

Expanded Multivariable Models to Assist Patient Selection for Long-Acting Cabotegravir + Rilpivirine Treatment: Clinical Utility of a Combination of Patient, Drug Concentration, and Viral Factors Associated With Virologic Failure.

BACKGROUND: Previously reported post hoc multivariable analyses exploring predictors of confirmed virologic failure (CVF) with cabotegravir + rilpivirine long-acting (CAB + RPV LA) were expanded to include data beyond week 48, additional covariates, and additional participants. METHODS: Pooled data from 1651 participants were used to explore dosing regimen (every 4 or every 8 weeks), demographic, viral, and pharmacokinetic covariates as potential predictors of CVF. Prior dosing regimen experience was accounted for using 2 populations. Two models were conducted in each population-baseline factor analyses exploring factors known at baseline and multivariable analyses exploring baseline factors plus postbaseline model-predicted CAB/RPV trough concentrations (4 and 44 weeks postinjection). Retained factors were evaluated to understand their contribution to CVF (alone or in combination). RESULTS: Overall, 1.4% (n = 23/1651) of participants had CVF through 152 weeks. The presence of RPV resistance-associated mutations, human immunodeficiency virus-1 subtype A6/A1, and body mass index ≥30 kg/m2 were associated with an increased risk of CVF (P < .05 adjusted incidence rate ratio), with participants with ≥2 of these baseline factors having a higher risk of CVF. Lower model-predicted CAB/RPV troughs were additional factors retained for multivariable analyses. CONCLUSIONS: The presence of ≥2 baseline factors (RPV resistance-associated mutations, A6/A1 subtype, and/or body mass index ≥30 kg/m2) was associated with increased CVF risk, consistent with prior analyses. Inclusion of initial model-predicted CAB/RPV trough concentrations (≤first quartile) did not improve the prediction of CVF beyond the presence of a combination of ≥2 baseline factors, reinforcing the clinical utility of the baseline factors in the appropriate use of CAB + RPV LA.

Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults With Human Immunodeficiency Virus 1 Type 1 Infection: 152-Week Results From ATLAS-2M, a Randomized, Open-Label, Phase 3b, Noninferiority Study.

BACKGROUND: Cabotegravir (CAB) + rilpivirine (RPV) dosed intramuscularly monthly or every 2 months is a complete, long-acting (LA) regimen for the maintenance of HIV-1 virologic suppression. Here, we report the antiretroviral therapy as long acting suppression (ATLAS)-2M study week 152 results. METHODS: ATLAS-2M is a phase 3b, randomized, multicenter study assessing the efficacy and safety of CAB+RPV LA every 8 weeks (Q8W) versus every 4 weeks (Q4W). Virologically suppressed (HIV-1 RNA <50 copies/mL) individuals were randomized to receive CAB+RPV LA Q8W or Q4W. Endpoints included the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL and <50 copies/mL, incidence of confirmed virologic failure (CVF; 2 consecutive measurements ≥200 copies/mL), safety, and tolerability. RESULTS: A total of 1045 participants received CAB+RPV LA (Q8W, n = 522; Q4W, n = 523). CAB+RPV LA Q8W demonstrated noninferior efficacy versus Q4W dosing, with 2.7% (n = 14) and 1.0% (n = 5) of participants having HIV-1 RNA ≥50 copies/mL, respectively, with adjusted treatment difference being 1.7% (95% CI: 0.1-3.3%), meeting the 4% noninferiority threshold. At week 152, 87% of participants maintained HIV-1 RNA <50 copies/mL (Q8W, 87% [n = 456]; Q4W, 86% [n = 449]). Overall, 12 (2.3%) participants in the Q8W arm and 2 (0.4%) in the Q4W arm had CVF. Eight and 10 participants with CVF had treatment-emergent, resistance-associated mutations to RPV and integrase inhibitors, respectively. Safety profiles were comparable, with no new safety signals observed since week 48. CONCLUSIONS: These data demonstrate virologic suppression durability with CAB+RPV LA Q8W or Q4W for ∼3 years and confirm long-term efficacy, safety, and tolerability of CAB+RPV LA as a complete regimen to maintain HIV-1 virologic suppression.

Medications for Opioid Use Disorder During Incarceration.

ABSTRACT: The opioid epidemic has had a devastating impact on incarcerated individuals, with significantly higher rates of opioid use disorder (OUD) and risk of opioid overdose than the general public. Medications for OUD (MOUDs) are currently used with an interdisciplinary approach with good outcomes, but MOUD-approved medications are grossly underutilized in this population. Post incarceration, individuals without MOUDs have lessened their opioid tolerance after abstinence, resulting in staggering death rates or reincarceration from OUD. This article will describe the barriers within the criminal justice system that impede the provision of appropriate treatment for OUD. A structural intervention approach that addresses the barriers will be discussed, as well as patient outcomes associated with MOUDs, and recommendations for education, practice, and future research.

The influence of social determinants of education on nursing student persistence and professional values.

BACKGROUND: Schools of Nursing are challenged to increase student diversification as there continues to be documented college achievement gaps in students who come from under-resourced, low socioeconomic communities with difficult environmental constraints and lifestyle issues. PURPOSE: The purpose of this 3-year study was to test a social determinants of education (SDE) model with 400 diverse nursing students. METHOD: The SDE framework was analyzed using structural equation modeling (SEM)) to estimate the influence of background social determinants, emotional intelligence and lifestyle on students' ability to integrate into collegiate academic and social support systems and to persist to graduation with professional values. Qualitative analysis was completed on student input on support. RESULTS: Social determinants student lifestyles and emotional intelligence explained over 26% of the variance of academic integration, and academic integration explained over 19% of the variance of the student outcome of persistence. 11% of professional values was accounted for by the combination of parent education, social support, lifestyle and emotional intelligence, academic integration, and persistence. Qualitative analyses also supported the SDE Framework with themes that included life balance, academic relationships and communication, and career. CONCLUSION: The SDE Framework offers faculty and administrators with targeted factors to consider when assessing and providing resources to enable students to achieve their maximal capacity to succeed in college and in their careers.

Transforming Students' Educational Experience Through Cultural Mindedness, Peer Mentoring, and Student Input.

BACKGROUND: Increasing student diversity within schools of nursing requires a shift in the educational environment to consider student challenges, need for support, and other cultural variances. METHOD: This article describes a three-pronged process of instilling cultural mindfulness training to faculty, staff, and administrators, augmenting student support through peer mentoring and a new method of sharing student perspectives of the educational environment with administration to co-design new approaches to support students. RESULTS: The entire process resulted in an increased sensitization to the importance of student perspectives as key players in the pursuit of a culture of inclusion for nursing education. CONCLUSION: A sustainable model was created for ongoing cultural humility education of school of nursing personnel and a new structure for student peer mentoring and student input to ensure appropriate support, recognition, and respect for diversity. [J Nurs Educ. 2020;59(4):194-202.].

Holistic Care of Hemodialysis Access in Patients with Kidney Failure.

Kidney failure requiring hemodialysis is a chronic illness that has physical, psychosocial, and financial consequences. Patients with kidney failure receiving hemodialysis need a renewed focus on self-care, prevention, and community-based health management to reduce healthcare costs and complications, and improve outcomes and quality of life, while living with an altered lifestyle. A holistic chronic care model was applied as a guideline for healthcare professionals involved with this population to more effectively engage people with kidney failure in their management of their hemodialysis access.

Enhancing the Educational Environment for Diverse Nursing Students Through Mentoring and Shared Governance.

BACKGROUND: A structured peer-mentoring program for diverse nursing students culminated in shared governance meetings between mentors and program coordinators to address mentees' concerns and issues. METHOD: After informed consent, mentees reviewed mentor profiles online and selected mentors. Baseline data were collected on ethnic identity, lifestyle, social support, and academic habits. Outcome data included mentors' self-reflective journal themes and student satisfaction surveys and focus group evaluation of the program. RESULTS: Students reported weak scores in the areas of wellness, exercise, and stress management. Journaling revealed valuable information about challenges faced by mentees that could impair their success. Mentors' proactive suggestions to handle major mentee journal themes were shared with nursing school administrators using a shared governance approach. CONCLUSION: The mentoring program supported students and culminated in a shared governance process to discuss ways to address mentee challenges that might improve the educational environment for future students. [J Nurs Educ. 2016;55(11):605-614.].

Transition Program to Promote Incoming Nursing Student Success in Higher Education.

A new model for addressing first-generation and minority student issues when starting nursing school was implemented using an interactive, peer-developed, 2-day program to create a sense of community and relieve anxiety. The program focused on students' needs, engagement, networking, first-hand experience with resources and methods to reduce cultural dissonance. Participation included critiquing modeling of proper clinical attire, meeting with peer mentors, and locating important campus resources. The program, conducted by minority students under the supervision and guidance of faculty mentors, received excellent evaluations.

Professional writing in nursing education: creating an academic-community writing center.

Contemporary professional nursing requires competency in both oral and written communication. Outside of writing for publication, instructional methods to teach professional writing in baccalaureate nursing programs are not well documented in the literature. The need for professional writing, coupled with the need to diversify the workforce with students from varying ethnic and educational backgrounds, creates some additional challenges to meet programmatic requirements for scholarly, evidence-based writing outcomes. As two new prelicensure programs were initiated, a comprehensive assessment was conducted that included student focus groups and writing assessment tools to assess writing quality and student support needs. As a result of these data, faculty implemented curricular and instructional revisions and created a writing center that was staffed by older adult volunteers who had careers in writing. The processes, tools, and preliminary outcomes of these faculty-initiated changes to improve student support for writing are presented.

Predictors of diabetes outcomes in Mexico: testing the Hispanic health protection model.

Given the high morbidity and mortality rate of Hispanic immigrants to the United States, a study of the Hispanic Health Protection Model (HHPM) was replicated with 109 residents in Mexico who were newly diagnosed with diabetes. People with diabetes from rural clinics in Tlaxcala underwent a three-phase interview process with laboratory and weight follow-up over 4 to 6 months following a confirmed diagnosis of diabetes. This predictive, correlational study replicated the HHPM and the previous U.S. findings, including relationships between lifestyle profile, health beliefs, professional and social support, self-efficacy, diabetes knowledge, quality of life (self-satisfaction and impact of diabetes), and changes in HbA1c and body mass index. The study found that participants frequently followed good lifestyle practices while continuing to adhere to culturally based treatment and attribution beliefs. There were moderate perceptions of diabetes self-care efficacy, low ratings of support, very poor understanding of diabetes, continued obesity, acceptable quality of life ratings, and near-normal HbA1c levels.

Professionalization and retention outcomes of a university-service mentoring program partnership.

With the use of a university-service partnership to introduce mentoring and shared governance, the aim of this study was to evaluate the effect of these interventions on nurse perceptions of the supportive culture of the workplace environment, professional skill development, decisional involvement, and retention and vacancy rates. A nonequivalent pretest-posttest, noncontrol group design was used with mentors of newly hired mentees to evaluate their workplace perspectives following mentor classes, ongoing mentor support, and a formal mentor-management workforce governance board. A convenience sample of 89 RNs from two acute care facilities attended mentoring and professionalization classes and worked with 109 mentees over 1-3 years. Mentors reported improved teamwork and the ability to deal with conflict but wanted more administrative oversight of the quality and scope of practice of support staff and additional interdepartmental collaboration. One hospital's vacancy rate decreased by 80%, and the other facility's retention rate improved by 21%. The data suggest that a mentor program with comprehensive education and mentor-management alliances through formal workforce environment governance enhances professionalization of frontline nurses and helps sustain a positive, constructive workplace environment. Mentoring classes on communication and cultural sensitivity skills and other leadership concepts, followed by mentor support and mentor-administrative forums, have positive implications for sustained improvement of a supportive culture as perceived by hospital-based RNs and new nurse graduates.

Predictors of successful diabetes management in low-income Hispanic people.

The specific aim of this predictive, correlational study was to test a culturally sensitive diabetes-specific health protection model to determine predictors of successful diabetes management in a newly diagnosed, type 2, low-income Hispanic population. Using a research-based Hispanic Health Protection Model (HHPM) as a framework, 240 adult participants with low levels of acculturation, strong beliefs about illness attribution and control of health, and low literacy levels were interviewed in a three-phase process over 4 to 6 months. The data analysis resulted in support of the HHPM based on relationships between 11 variables in four partial structural equation models, including lifestyle profile, acculturation, health beliefs, professional and social support, self-efficacy, diabetes knowledge, quality of life (self-satisfaction and impact of diabetes), and changes in hemoglobin( a1c) and body mass index. The study established carefully translated measures that held up to strong psychometric criteria. There was support for the HHPM for this population, and the results suggest future intervention with strengthening enablers, such as professional support and diabetes self-efficacy, in relation to this group's health beliefs.

Nurses supporting nurses: creating a mentoring program for staff nurses to improve the workforce environment.

BACKGROUND: The hospital workforce environment has been recognized as an important factor for nurse retention and patient safety, yet there is ongoing evidence that inadequate communication, intraprofessional oppression, and lack of collaboration and conflict resolution continue to disempower nurses and hinder improvement of workforce conditions. PURPOSE: A 3-year academic-hospital partnership developed and used a registered nurse (RN) mentor and advocacy program to improve the RN work environment and selected patient outcomes. METHOD: The partnership initiated mentor-mentee teams and a Workforce Environment Governance Board, and obtained preliminary data on outcomes related to mentor-mentee teamwork, changes in the level of support within each unit, and the impact of improved working conditions on nurse and patient satisfaction, nurse vacancy and turnover rates, and 3 patient safety outcomes related to fall and pressure ulcer prevention and use of restraints. DISCUSSION: Dedicated mentors not only engaged in supporting fellow nurses but also assisted with enhancing the overall work environment for RNs. The partnership enhanced mutual respect between frontline RNs and managers, and allowed frontline RNs to improve the culture of support. CONCLUSIONS: The comprehensive approach to incorporating mentor-mentee teams changes the way fellow nurses and others perceive nurses, augments support by managers and coworkers, and improves patient care outcomes.

A health protection model for Hispanic adults with Type 2 diabetes.

AIMS: The Hispanic Health Protection Model (HHPM) was designed to assist practitioners' systematic assessment of Hispanic people to establish baselines and evaluate the success of early diabetes treatment. This article provides the research basis of the HHPM and related assessment tools. BACKGROUND: The treatment of diabetes incorporates lifestyle change, and this adjustment is particularly important to follow with vulnerable groups. One such group is the Hispanic population, since the impact of diabetes is greatest on economically disadvantaged segments of this population, who suffer disproportionately higher Type 2 diabetes prevalence and higher levels of morbidity and mortality as compared with other populations. Traditional Hispanic health beliefs are often in conflict with Western medicine, so the adjustments to the lifestyle demands of this disease need to be evaluated. METHODS: To understand this discrepancy fully in patient outcomes, a culturally sensitive assessment framework was developed based on health protection theories and research with Hispanic people with diabetes and, based on this framework, assessment tools were translated for use during interviews with low literacy, Spanish-speaking patients. CONCLUSIONS: The HHPM translated measures of premorbid lifestyle, health beliefs, support, self-efficacy, quality of life, knowledge of diabetes, and physiological parameters can be used during consecutive clinic visits during the first six months of therapy to map the success of patients' understanding of and psychological adjustment to diabetes. RELEVANCE TO CLINICAL PRACTICE: The HHPM is a culturally-relevant, systematic, and holistic approach to assessing adjustment of Hispanic people to a new diagnosis of diabetes, including their psychological, cognitive, and physiological outcomes. Using this type of systematic approach will allow practitioners to target barriers to therapy, such as a lack of self-efficacy or incomplete knowledge of the disease and its treatment in a strategic manner to improve patient success in managing the complex lifestyle changes of diabetes mellitus.