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Monoclonal antibody therapeutics to treat coronavirus disease (COVID-19) have been authorized by the US Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from 3 sites at medical centers in the United States supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

Background The hormonal Intrauterine Device (IUD) is a highly effective contraceptive option growing in popularity and availability in many countries. The hormonal IUD has been shown to have high rates of satisfaction and continuation among users in high-income countries. The study aims to understand the profiles of clients who choose the hormonal IUD in low- and middle-income countries (LMICs) and describe their continuation and satisfaction with the method after 12 months of use. Methods A prospective longitudinal study of hormonal IUD acceptors was conducted across three countries—Madagascar, Nigeria, and Zambia—where the hormonal IUD had been introduced in a pilot setting within the of a broad mix of available methods. Women were interviewed at baseline immediately following their voluntary hormonal IUD insertion, and again 3 and 12 months following provision of the method. A descriptive analysis of user characteristics and satisfaction with the method was conducted on an analytic sample of women who completed baseline, 3-month, and 12-month follow-up questionnaires. Kaplan–Meier time-to-event models were used to estimate the cumulative probability of method continuation rates up to 12 months post-insertion. Results Each country had a unique demographic profile of hormonal IUD users with different method-use histories. Across all three countries, women reported high rates of satisfaction with the hormonal IUD (67–100%) and high rates of continuation at the 12-month mark (82–90%). Conclusions Rates of satisfaction and continuation among hormonal IUD users in the study suggest that expanding method choice with the hormonal IUD would provide a highly effective, long-acting method desirable to many different population segments, including those with high unmet need., Plain language summary The hormonal IUD is a popular contraceptive method choice where it is available. While the method has been around for decades it remains out of reach for many populations in low- and middle-income countries. The hormonal IUD offers both highly effective protection from pregnancy as well as non-contraceptive benefits that appeal to users in the US and Europe, but there is limited evidence available to explore the acceptability and use of this method among users in lower resource settings. This research looks at the profile of users who chose to use the hormonal IUD during a pilot introduction in Madagascar, Nigeria, and Zambia. Over a period of 12 months, researchers followed up with these users to understand who continued to use the method over time and their satisfaction with the method. Findings show that the hormonal IUD was broadly appealing in these settings among users from multiple demographic segments, including among users who had not used other methods of contraception in the past. When followed-up at 3 and 12 months, satisfaction with the method was high and most users in all three countries were still using the method. The findings suggest that the hormonal IUD could be well received and may contribute to greater uptake of voluntary modern contraception in lower resource settings.

BackgroundThe COVID-19 pandemic caught the globe unprepared without targeted medical countermeasures, such as therapeutics, to target the emerging SARS-CoV-2 virus. However, in recent months multiple monoclonal antibody therapeutics to treat COVID-19 have been authorized by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). Despite these authorizations and promising clinical trial efficacy results, monoclonal antibody therapies are currently underutilized as a treatment for COVID-19 across the U.S. Many barriers exist when deploying a new infused therapeutic during an ongoing pandemic with limited resources and staffing, and it is critical to better understand the process and site requirements of incorporating monoclonal antibody infusions into pandemic response activities.MethodsWe examined the monoclonal antibody infusion site process components, resources, and requirements during the COVID-19 pandemic using data from three initial infusion sites at medical centers in the U.S. supported by the National Disaster Medical System. A descriptive analysis was conducted using process assessment metrics to inform recommendations to strengthen monoclonal antibody infusion site implementation.ResultsThe monoclonal antibody infusion sites varied in physical environment and staffing models due to state polices, infection control mechanisms, and underlying medical system structure, but exhibited a common process workflow. Sites operationalized an infusion process staffing model with at least two nurses per ten infusion patients. Monoclonal antibody implementation success factors included tailoring the infusion process to the patient community, strong engagement with local medical providers, batch preparing the therapy before patient arrival, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges stemmed from confirming patient SARS-CoV-2 positivity, strained staff, scheduling needs, and coordination with the pharmacy for therapy preparation.ConclusionsInfusion site processes are most effective when integrated into the pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources. As the pandemic and policy tools such as EUAs evolve, monoclonal antibody infusion processes must also remain adaptable, as practice changes directly affect resources, staffing, timing, and workflows. Future use may be aided by incorporating innovative emergency deployment techniques, such as vehicle and home-based therapy administration, and by developing drug delivery mechanisms that alleviate the need for observed intravenous infusions by medically-accredited staff.

ObjectivesEnding HIV by 2030 is a global priority. Achieving this requires alternative HIV testing strategies, such as HIV self-testing (HIVST) to reach all individuals with HIV testing services (HTS). We present the results of a trial evaluating the impact of community-based distribution of HIVST in community and facility settings on the uptake of HTS in rural and urban Zambia.DesignPair-matched cluster randomised trial.MethodsIn catchment areas of government health facilities, OraQuick HIVST kits were distributed by community-based distributors (CBDs) over 12 months in 2016–2017. Within matched pairs, clusters were randomised to receive the HIVST intervention or standard of care (SOC). Individuals aged ≥16 years were eligible for HIVST. Within communities, CBDs offered HIVST in high traffic areas, door to door and at healthcare facilities. The primary outcome was self-reported recent testing within the previous 12 months measured using a population-based survey.ResultsIn six intervention clusters (population 148 541), 60 CBDs distributed 65 585 HIVST kits. A recent test was reported by 66% (1622/2465) in the intervention arm compared with 60% (1456/2429) in SOC arm (adjusted risk ratio 1.08, 95% CI 0.94 to 1.24; p=0.15). Uptake of the HIVST intervention was low: 24% of respondents in the intervention arm (585/2493) used an HIVST kit in the previous 12 months. No social harms were identified during implementation.ConclusionDespite distributing a large number of HIVST kits, we found no evidence that this community-based HIVST distribution intervention increased HTS uptake. Other models of HIVST distribution, including secondary distribution and community-designed distribution models, provide alternative strategies to reach target populations.Trial registration numberClinicalTrials.gov Registry (NCT02793804).

During a mass media campaign accompanying the launch of the Maximum Diva Woman's Condom (WC) in Lusaka, Zambia, a cluster-randomized evaluation was implemented to measure the added impact of a peer-led interpersonal communication (IPC) intervention on the awareness and uptake of the new female condom (FC). The WC and mass media campaign were introduced simultaneously in 40 urban wards in April 2016; half of the wards were randomly assigned to the treatment (IPC intervention) with cross-sectional surveys conducted before (n = 2,364) and one year after (n = 2,430) the start of the intervention. A pre-specified intention-to-treat (ITT) analysis measured the impact of randomization to IPC at the community level. In adjusted ITT models, there were no statistically significant differences between intervention and control groups. Due to significant implementation challenges, we also conducted exploratory secondary analyses to estimate effects among those who attended an IPC event (n = 66) using instrumental variable and inverse probability weighting analyses. In addition to increases in FC identification (IPC attendees had higher reported use of any condom, improved perceptions of FC's, and were more likely to have discussed contraceptive use with their partner as compared to non-attendees). The introduction of a new FC product combined with an IPC intervention significantly increased general knowledge and awareness in the community as compared to media alone, but did not lead to detectable community level impacts on other primary outcomes of interest. Observational evidence from our study suggests that IPC attendance is associated with increased use and negotiation. Future studies should explore the intensity and duration of IPC programming necessary to achieve detectable community level impacts on behavior. Trial Registration: AEARCTR-0000899.

Family Interventions in Psychosis (FIP) have been promoted internationally but have been criticised for being based on western cultural models. This paper reports on a focus group study with 10 Integrated Mental Health Service Managers in Guangzhou, China using thematic analysis. Managers believed FIP might benefit families but identified potential difficulties due to (a) families avoiding services due to the ‘shame’ of mental illness (b) unrealistic expectations of services amongst families (c) deferral to ‘key decision-makers’ within families when discussing family issues with workers. The findings indicate that FIP work should focus on interaction between carers in the first instance with service users being introduced into sessions at a later date and that more attention needs to be given by the research community to how FIP may be adapted to cultural norms within China.

To assess the microarchitectural changes occurring during surgery for vitreomacular traction using intraoperative optical coherence tomography (iOCT).A retrospective, consecutive case series of eyes undergoing pars plana vitrectomy for vitreomacular traction with performance of concurrent iOCT. A custom, microscope-mounted portable spectral domain optical coherence tomography system was used. Clinical characteristics and iOCT images were analyzed.Twelve eyes of 12 patients were included with a mean preoperative visual acuity of 20/78 improving to 20/51 (P = 0.02), postoperatively. Intraoperative optical coherence tomography was successfully performed in 100% of cases. Microarchitectural changes were noted on iOCT after surgical release of the vitreomacular traction particularly in the outer retina with increased subretinal hyporeflectivity (e.g., expansion of the distance between the retinal pigment epithelium and photoreceptor layers). In 5 of 12 eyes (42%), iOCT findings altered the surgical procedure (e.g., internal limiting membrane peeling, gas tamponade) to address the subclinical findings (e.g., full-thickness macular hole formation, residual membrane).Intrasurgical imaging using iOCT during vitreomacular traction surgery may identify subclinical changes (e.g., occult full-thickness macular hole formation) that may impact surgical decision making. Architectural changes may occur after surgical maneuvers that are particularly noted in the outer retina. The functional significance of these changes requires further investigation.

Background: The majority of women in Sub-Saharan countries including Zambia use intramuscular Depot Medroxyprogesterone Acetate (DMPA IM) as their preferred method of contraception. However, nearly one-third of the women who start on DMPA IM discontinue within 12 months due to access barriers. Sayana® Press, low-dose, prefilled subcutaneous depot medroxyprogesterone acetate (DMPA-SC), suitable for even lower-level healthcare providers and potential for self-injection administration, has been developed. This pilot aimed to understand the feasibility of DMPA-SC in Zambia through use of community-based distributors (CBDs). Methods: The pilot was implemented from May 2017 to July 2017 in 29 public health facilities in three districts. A total of 161 CBDs received a comprehensive training in DMPA-SC, which included counselling about the method, potential side effects, correct administration and waste management. Post-training mentorship and supervision was conducted. Routine client level data was collected through Ministry of Health management information system. Results: During the pilot, 12,818 clients were provided with modern voluntary FP methods, with 16.4% (2,100) opting for DMPA-SC. The age range of clients opting for DMPA-SC was between 15 and 50 years, with an average of 31 years. Slightly less than half (43%) of DMPA-SC clients were adolescents and young women, with 11% aged 15–19 and 32% aged 20–24. No adverse events were reported during or immediately subsequent to the introduction of DMPA-SC administration by CBDs. Conclusion: The pilot demonstrated that CBDs can safely provide DMPA-SC at the community level with appropriate public sector coordination and oversight.

Introduction Social, structural and systems barriers inhibit uptake of HIV testing. HIV self‐testing (HIVST) has shown promising uptake by otherwise underserved priority groups including men, young people and first‐time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale‐up in three African countries. Methods Kit distributors collected individual‐level age, sex and testing history from all clients. These data were aggregated and analysed by country (Malawi, Zambia and Zimbabwe) for five distribution models: local community‐based distributor (CBD: door‐to‐door, street and local venues), workplace distribution (WD), integration into HIV testing services (IHTS), or public health facilities (IPHF) and during demand creation for voluntary male medical circumcision (VMMC). Used kits were collected and re‐read from CBD and IHTS recipients. Results Between May 2015 and July 2017, 628,705 HIVST kits were distributed in Malawi (172,830), Zambia (190,787) and Zimbabwe (265,091). Community‐based models, the first to be established, accounted for 519,658 (82.7%) of kits distributed, with 275,419 (53.0%) used kits returned. Subsequent model diversification delivered 54,453 (8.7%) test‐kits through IHTS, 23,561 (3.7%) through VMMC, 21,183 (3.4%) through IPHF and 9850 (1.7%) through WD. Men took 294,508 (48.2%) kits, and 263,073 (43.1%) went to young people (16 to 24 years). A higher proportion of male self‐testers (65,577; 22.3%) were first‐time testers than women (54,096; 17.1%) with this apparent in Zimbabwe (16.2% vs. 11.4%), Zambia (25.4% vs. 17.7%) and Malawi (27.9% vs. 25.9%). The highest proportions of first‐time testers were in young (16 to 24 years) and older (>50 years) men (country‐ranges: 18.7% to 35.9% and 13.8% to 26.8% respectively). Most IHTS clients opted for HIVST in preference to standard HTS in each of 12 delivery sites, with those selecting HIVST having lower HIV prevalence, potentially due to self‐selection. Conclusions HIVST delivered at scale using several different models reached a high proportion of men, young people and first‐time testers in Malawi, Zambia and Zimbabwe, some of whom may not have tested otherwise. As men and young people have limited uptake under standard facility‐and community‐based HIV testing, innovative male‐ and youth‐sensitive approaches like HIVST may be essential to reaching UNAIDS fast‐track targets for 2020.

Time-dependent SERS intensity recorded over a drop-coated coffee-ring pattern of p-MBA with gold colloids was investigated as a function of the specific laser power applied. Pure electromagnetic enhancement produced stochastic intensity variations of the whole SER spectra, which were mainly correlated with evolutions of the background intensity. Besides long-term, non-reversible spectral changes caused by plasmon-induced decarboxylation of p-MBA, transient original spectral profiles showing additional lines were also observed as the specific power reached 5.5 × 10(4) W cm(-2). An unprecedented qualitative and quantitative study of SERS intensity variations based on the complementary use of both extreme deviation and cross-correlation statistics is provided, which resulted in an improved understanding of SERS mechanisms. More precisely, cross-correlation analysis made it possible to follow the evolution of groups of modes assigned to one species or sharing the same symmetry while so-called individual events denote particular resonance structures, whose occurrence was tentatively related to a photo-thermally activated motion of the gold nanostructures.

This study was undertaken to determine the effects of stress on faculty in higher education teaching online classes. Few studies have been conducted to examine the impact of stress on faculty in online higher education. An anonymous survey of faculty was conducted at an online institution of higher learning to determine how prevalent stress was in their jobs, how stress impacted performance and morale, and what the symptoms were. The findings showed 67.6% of the 100 participants who completed the survey identified either a very high or high level of stress. The biggest stressors included time constraints, technical issues, and large class sizes. The top symptoms identified included sleep disturbances, impatience, tense, tight muscles, irritability, and the feeling of being overwhelmed. Recommendations were made to alleviate stress including physical activity, constructive self-talk, relaxation exercises, meditation, networking, quick and effective coping skills, and techniques for saying “no.” A certain amount of stress is desirable, but when stress is not addressed, it can lead to burnout, poor performance, and low morale.

This paper examines a number of barriers which in the past had led to the lack of introduction of Family Work for Psychosis service provision within local mental health services across Bath, North East Somerset and Western Wiltshire (all now within the Avon & Wiltshire Mental Health Partnership NHS Trust service). Barriers (and local solutions to them) are examined, relating to insufficient management and professional support, training and support needs, supervision, appropriate referral, coworking and case management, flexibility of delivery, and crisis versus strategic ways of working. Key elements, which have led to the successful implementation of family work for psychosis within local service provision are outlined. The utility of having a 'Service Champion' is emphasised. The service is currently an NHS Beacon Site, in recognition of its effective implementation of family work for psychosis within routine clinical practice.

Despite evidence for the effectiveness of structured psychological therapies for bipolar disorder no psychological interventions have been specifically designed to enhance personal recovery for individuals with recent-onset bipolar disorder.A pilot study to assess the feasibility and effectiveness of a new intervention, recovery-focused cognitive-behavioural therapy (CBT), designed in collaboration with individuals with recent-onset bipolar disorder intended to improve clinical and personal recovery outcomes.A single, blind randomised controlled trial compared treatment as usual (TAU) with recovery-focused CBT plus TAU (n = 67).Recruitment and follow-up rates within 10% of pre-planned targets to 12-month follow-up were achieved. An average of 14.15 h (s.d. = 4.21) of recovery-focused CBT were attended out of a potential maximum of 18 h. Compared with TAU, recovery-focused CBT significantly improved personal recovery up to 12-month follow-up (Bipolar Recovery Questionnaire mean score 310.87, 95% CI 75.00-546.74 (s.e. = 120.34), P = 0.010, d = 0.62) and increased time to any mood relapse during up to 15 months follow-up (χ2 = 7.64, P0.006, estimated hazard ratio (HR) = 0.38, 95% CI 0.18-0.78). Groups did not differ with respect to medication adherence.Recovery-focused CBT seems promising with respect to feasibility and potential clinical effectiveness. Clinical- and cost-effectiveness now need to be reliably estimated in a definitive trial.

Background There is increasing evidence for the effectiveness of structured psychological therapies for bipolar disorder. To date however there have been no psychological interventions specifically designed for individuals with early bipolar disorder. The primary objective of this trial is to establish the acceptability and feasibility of a new CBT based intervention (Recovery focused CBT; RfCBT) designed in collaboration with individuals with early bipolar disorder intended to improve clinical and personal recovery outcomes. Methods and design This article describes a single blind randomised controlled trial to assess the feasibility and acceptability of RfCBT compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of RfCBT as indicated by recruitment to target and retention to follow-up as well as absence of untoward incidents associated with RfCBT. We also intend to estimate the effect size of the impact of the intervention on recovery and mood outcomes and explore potential process measures (self appraisal, stigma, hope and self esteem). Discussion This is the first trial of recovery informed CBT for early bipolar disorder and will therefore be of interest to researchers in this area as well as indicating the wider potential for evaluating approaches to the recovery informed treatment of recent onset severe mental illness in general. Trial registration number ISRCTN43062149

Everyone has creativity, and it is central to survival itself; yet many don’t know this. Furthermore, our human creativity not only keeps us alive but can help us learn what we are living for. Nonetheless, in our culture, creativity—and especially everyday creativity, our “originality of everyday life”—often goes under-recognized, underdeveloped, and under-rewarded (the 3 U’s). Here are capacities, indeed a way of life, that can be both physically and psychologically healing, and not just for individuals, but for groups, cultures, and our greater environment. At Saybrook University, we are returning human creativity to its rightful place in the history of human growth and transformation, through inspired scholarship and dissemination. This article first describes the beginnings for one creativity scholar and the challenges of working off the beaten path—along with correction of misunderstandings about ways creativity contributes to mental health. It then moves to Saybrook University—a founding school in the crucial “third force” movement called humanistic psychology—where Dr. Richards fortunately became professor. Noted too are innovative Saybrook faculty and programs in creativity that have also pushed the mainstream and inspired Saybrook’s amazing students. It is our privilege to mentor and encourage them. The contributions of Drs. Stanley Krippner and Steven R. Pritzker are noted in particular, as well as the burgeoning Creativity Studies programs including a Certificate program, M.A. degree and, recently, a Ph.D.—unique offerings in this country. Ways to preserve these advances and build further on them are mentioned. Last but not least, in the second half of this presentation, we hear directly from the future—from ten remarkable Saybrook students or alumni, who tell us, first, about ways in which Saybrook mentorship and offerings have inspired them, and then, going forth from Saybrook, about ways in which they are truly changing the world.

A new wave of computerised therapy is under development which, rather than simulating talking therapies, uses bias modification techniques to target the core psychological process underlying anxiety. Such interventions are aimed at anxiety disorders, and are yet to be adapted for co-morbid anxiety in psychosis. The cognitive bias modification (CBM) paradigm delivers repeated exposure to stimuli in order to train individuals to resolve ambiguous information in a positive, rather than anxiety provoking, manner. The current study is the first to report data from a modified form of CBM which targets co-morbid anxiety within individuals diagnosed with schizophrenia. Our version of CBM involved exposure to one hundred vignettes presented over headphones. Participants were instructed to actively simulate the described scenarios via visual imagery. Twenty-one participants completed both a single session of CBM and a single control condition session in counter-balanced order. Within the whole sample, there was no significant improvement on interpretation bias of CBM or state anxiety, relative to the control condition. However, in line with previous research, those participants who engage in higher levels of visual imagery exhibited larger changes in interpretation bias. We discuss the implications for harnessing computerised CBM therapy developments for co-morbid anxiety in schizophrenia.

Background: The supply of recreational drugs has changed and users increasingly buy ‘legal highs’ over the Internet. Use of these is common and there is a potential for significant toxicity associated with their use. Aim: To determine the content of legal highs available for purchase in the UK and whether the content of these remains consistent. Methods: Twenty-six legal highs were purchased monthly from five different Internet sites over 6 months. These were analysed to determine the drugs in the products and whether there were any changes in their content over this time period. Results: All products were supplied initially, but there was a decline in supply of products month by month. The following drug classes were detected: piperazines, cathinones, caffeine/ephedrine or products in which no psychoactive drugs were detected. Of the products supplied on more than one occasion, 15 (75%) contained the same compounds on each occasion. In three products there was a change in the piperazine detected, with 1-benzylpiperazine being substituted for 1-methyl-4-benzylpiperazine or vice versa. In two other products there was a cathinone [4-fluorophenylpiperazine (pFPP) or 3-fluromethcathinone (3FMC)] detected in products purchased in Month 1 that was not present in the products purchased in subsequent months. Conclusions: Whilst there was no variation in the composition of most legal highs supplied over 6 month, there was significant variation in the piperazine or cathinone content of one quarter of the products. This variation could be of clinical significance as the cathinone and piperazine products can be associated with significant toxicity.

Objectives:This study examines home medical equipment (HME) receipt for 1,040 veterans considered appropriate for home health services. Methods:HME receipt was monitored for 12 months using the Department of Veterans Affairs’ Prosthetics database. Results:Eighty-three percent received at least one item; averaging 7.4 items ( SD= 6.8). The most common items included commodes/bath benches (9%), canes/walkers (7%), safety equipment (7%), liquid oxygen (6%), and wheelchairs (6%). Two functional status variables, home care use and race, correctly classified 69% of HME recipients. Logistic regressions were run for specific equipment; c-indices ranged from .64 to .75. Age, race, income, functional status, risk of hospital readmission, and home care use were significant predictors. Discussion:HME accounted for $4.5 billion in sales (16% of total) for medical products in 1996. As the HME market continues to expand, the characteristics of HME recipients are necessary to project future HME needs in a growing, elderly population.

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