Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials.

Objectives: This study systematically reviewed the published literature from clinical trials on the efficacy and immunogenicity of single-dose HPV vaccination compared to multidose schedules or no HPV vaccination. Methods: Four databases were searched for relevant articles published from Jan-1999 to Feb-2023. Articles were assessed for eligibility for inclusion using pre-defined criteria. Relevant data were extracted from eligible articles and a descriptive quality assessment was performed for each study. A narrative data synthesis was conducted, examining HPV infection, other clinical outcomes and immunogenicity responses by dose schedule. Results: Fifteen articles reporting data from six studies (all in healthy young females) were included. One article was included from each of three studies that prospectively randomised participants to receive a single HPV vaccine dose versus one or more comparator schedule(s). The other 12 articles reported data from three studies that randomised participants to receive multidose HPV vaccine (or control vaccine) schedules; in those studies, some participants failed to complete their allocated schedule, and evaluations were conducted to compare participants who actually received one, two or three doses. Across all efficacy studies, the incidence or prevalence of HPV16/18 infection was very low among HPV-vaccinated participants, regardless of the number of doses received; with no evidence for a difference between dose groups. In immunogenicity studies, HPV16/18 antibody seropositivity rates were high among all HPV-vaccinated participants. Antibody levels were significantly lower with one dose compared to two or three doses, but levels with one dose were stable and sustained to 11 years post-vaccination. Conclusions: Results from this review support recent World Health Organization recommendations allowing either one- or two-dose HPV vaccination in healthy young females. Longer-term efficacy and immunogenicity data from ongoing studies are awaited. Randomised trials of single-dose HPV-vaccination are urgently needed in other populations, e.g. boys, older females and people with HIV.

Optimizing Neuroscience Mortality: A Collaborative Approach to Documentation Improvement.

Background and Objectives: Mortality index is the ratio of observed-to-expected mortality. Accurate and thorough documentation of patient comorbidities and conditions is the key determinant of neuroscience expected mortality. In this study, we focused on reviewing neuroscience documentation, as optimizing mortality index provides accurate assessment of the quality of care provided, improves service-line rankings, and affects reimbursement. Methods: We assembled an interprofessional team of a neurologist and clinical documentation integrity (CDI) specialists to review clinical documentation of all mortalities from the neuroscience service lines at a tertiary academic medical center over 9 months. We identified common documentation opportunities among high acuity neuroscience patients to improve accuracy of expected mortality. Using the mortality risk adjustment method from Vizient Inc., we compared baseline and postreview expected mortality. Results: We reviewed 70 mortality charts over a 9-month period. Opportunities to improve documentation were present in 60%. Common underreported comorbidities included aspiration pneumonia, shock, encephalopathy, thrombocytopenia, hemorrhagic disorder due to anticoagulation, and nontraumatic subarachnoid hemorrhage. The number of diagnoses identified per patient that affected mortality increased between the first and last quarter from 4.3 to 7.8 (p < 0.0001). Physician-identified additional diagnoses per patient decreased from 1.0 to 0.3 (p = 0.0037), as CDI specialists had increased capture of neuroscience specific diagnoses throughout the intervention. The average expected mortality significantly increased from baseline 0.33 to 0.42 (p < 0.0001). Discussion: Collaboration between physicians and CDI specialists optimizes expected mortality by identification of common gaps in documentation specific to neuroscience patients. Neurologist engagement is beneficial in CDI and lays the framework for clinical documentation education for neurology physicians.

Suitability of multifunction devices Myah and Myopia Master for monitoring myopia progression in children and adults.

PURPOSE: To assess the feasibility of using multifunction instruments to measure axial length for monitoring myopia progression in children and adults. METHODS: Axial length was measured in 60 children (aged 6-18 years) and 60 adults (aged 19-50 years) with multifunction instruments (Myah and Myopia Master) and stand-alone biometers (Lenstar LS900 and IOLMaster 700). Repeatability (measurements by the same examiner) and reproducibility (measurements by different examiners) were computed as the within-subject standard deviation (Sw) and 95% limits of agreement (LoA). Inter-instrument agreement was computed as intraclass correlation coefficients. The threshold for detecting myopic progression was taken as 0.1 mm. Measures were repeated only in children following the administration of 1% tropicamide to determine the impact of cycloplegia on axial length. RESULTS: Overall, the IOLMaster 700 had the best repeatability in children (0.014 mm) and adults (0.009 mm). Repeatability Sw values for all devices ranged from 0.005 to 0.021 mm (children) and 0.003 to 0.016 mm (adults). In children, reproducibility fell within 0.1 mm 95% of the time for the Myah, Myopia Master and IOLMaster 700. Agreement among all devices was classified as excellent (ICC 0.999; 95% CI 0.998-0.999), but the 95% LoA among the Myah, Myopia Master and Lenstar LS900 was ≥0.1 mm. Cycloplegia had no statistically significant effect on axial length (all p > 0.13). CONCLUSIONS: The Myah and Myopia Master multifunction instruments demonstrated good repeatability and reproducibility, and their accuracy was comparable to stand-alone biometers. Axial length measurements using different instruments can be considered interchangeable but should be compared with some caution. Accurate axial length measurements can be obtained without cycloplegia. The multifunction instruments Myah and Myopia Master are as well suited for monitoring myopia progression in children as the stand-alone biometers IOLMaster 700 and Lenstar LS900.

Urgent considerations for booster vaccination strategies against Ebola virus disease.

With two endorsed and prophylactic vaccines against Zaire ebolavirus (referred to hereafter as EBOV), the number of individuals vaccinated against EBOV worldwide is estimated to range between 500 000 and 1 000 000 individuals, increasing with every renewed EBOV threat and vaccination campaign. Therefore, re-exposure of previously vaccinated health-care workers, and possibly community members, could become more frequent. In the absence of long-term data on vaccine efficacy and duration of protection, we urgently need to understand revaccination strategies that could maximise the level of protection. In this Personal View, we highlight the scarcity of available evidence to guide revaccination recommendations for the accumulating groups of previously vaccinated communities or front-line health-care workers that could be redeployed or re-exposed in the next EBOV outbreak(s). This evidence base is crucial to identify optimal target populations and the frequency of booster doses, and guide vaccine interchangeability (especially in settings with limited or unpredictable vaccine supplies), while preventing vaccine mistrust, equity concerns, and exclusion of vulnerable populations. We discuss five priority gaps (to whom, when, and how frequently, to provide booster doses; long-term correlates and thresholds of protection; the effect of vector-directed immunity and viral variant protection; comparative research in mix-and-match schedules; and implementation concerns) that should be urgently tackled to adapt the initial EBOV prophylactic vaccination strategies considering potential booster dose vaccinations.

Engaging the public in decisions about emergency vaccine deployment strategies: Lessons from scenario-based discussions in Sierra Leone.

ABSTRACTThe COVID-19 pandemic has amplified discussions on emergency vaccine deployment strategies, with current perspectives often neglecting extensive community involvement in ethical, logistical and political aspects. Existing social science literature predominantly delves into factors influencing trust, overlooking the untapped potential for community engagement.Our study examines community preparedness in Sierra Leone's Kambia District, exploring diverse viewpoints on vaccine deployment strategies, emphasising Ebola and COVID-19 vaccinations. Utilising extensive ethnographic research from the Ebola vaccine trials (EBOVAC Salone) conducted in Kambia District from 2015 to 2021, including participant observation and tailored focus group discussions, we investigated various deployment scenarios with community leaders and citizens.Our findings underscore the multifaceted contributions of social science research with communities in shaping emergency vaccination strategies. These contributions span logistical insights, aligning campaigns with local livelihoods and social structures, and grounded ethical concerns assessing social justice outcomes across epidemic scenarios. This study emphasises the imperative of integrating discussions on vaccine confidence and deployment. It highlights communities' proficiency in epidemiological reasoning and their ability to bring this in conversation with salient socio-cultural, economic and religious dimensions. We therefore promote the cultivation of public dialogue, collaborative creation of impactful vaccination initiatives alongside relevant communities in recognition of their invaluable perspectives .

Low Levels of HIV Stigma Among Transgender Women Receiving HIV Care.

Despite the prevalence of HIV among transgender women (TGW), gaps exist in understanding the impact of HIV-related stigma (HRS) on TGW with HIV. This is a small cross-sectional pilot study examining HRS in TGW (n=18) with HIV in Miami, FL, who completed a survey during an HIV clinical visit. In contrast with previous studies, results demonstrated low levels of HRS and suggest the potential of increasing acceptance of TGW with HIV as a contributing factor. Larger studies are needed to explore factors underlying HRS with the aim of further reducing stigma among TGW with HIV.

Intersectional stigma and the non-communicable disease syndemic in the context of HIV: protocol for a multisite, observational study in the USA.

INTRODUCTION: The increasing burden of non-communicable diseases, such as hypertension, diabetes and dyslipidaemia, presents key challenges to achieving optimal HIV care outcomes among ageing people living with HIV. These diseases are often comorbid and are exacerbated by psychosocial and structural inequities. This interaction among multiple health conditions and social factors is referred to as a syndemic. In the USA, there are substantial disparities by social position (ie, racial, ethnic and socioeconomic status) in the prevalence and/or control of non-communicable diseases and HIV. Intersecting stigmas, such as racism, classism and homophobia, may drive these health disparities by contributing to healthcare avoidance and by contributing to a psychosocial syndemic (stress, depression, violence victimisation and substance use), reducing success along the HIV and non-communicable disease continua of care. Our hypothesis is that marginalised populations experience disparities in non-communicable disease incidence, prevalence and control, mediated by intersectional stigma and the psychosocial syndemic. METHODS AND ANALYSIS: Collecting data over a 4 year period, we will recruit sexual minority men (planned n=1800) enrolled in the MACS/WIHS Combined Cohort Study, a long-standing mixed-serostatus observational cohort in the USA, to investigate the following specific aims: (1) assess relationships between social position, intersectional stigma and the psychosocial syndemic among middle-aged and ageing sexual minority men, (2) assess relationships between social position and non-communicable disease incidence and prevalence and (3) assess relationships between social position and HIV and non-communicable disease continua of care outcomes, mediated by intersectional stigma and the psychosocial syndemic. Analyses will be conducted using generalised structural equation models using a cross-lagged panel model design. ETHICS AND DISSEMINATION: This protocol is approved as a single-IRB study (Advarra Institutional Review Board: Protocol 00068335). We will disseminate results via peer-reviewed academic journals, scientific conferences, a dedicated website, site community advisory boards and forums hosted at participating sites.

Correlation Between Student Performances on Case-Based Constructed-Response Formative Assessment and Summative Assessment.

OBJECTIVES: This study aimed to evaluate the impact of formative assessment with case-based constructed-response question (CRQ) formats on student performance on the final summative assessment in the second-year periodontics course. METHODS: Classroom quizzes with case-based CRQs were implemented as the formative assessment during the course. Each student received feedback on their responses from the course director. After all students (N = 128) took the second-year final examination, the Friedman test was conducted to compare student performances in each assessment over time. The multiple linear regression (MLR) model was used to evaluate the association between the second-year final examination score and plausible predictors-student gender, the second-year formative and midterm examination scores, and time spent on the final examination. RESULTS: The mean % scores in the formative assessment (51) and midterm (84) examination were significantly lower than that of the final (87) examination (P < .01). The number of students who failed the final (6) examination was significantly lower than the midterm (16) examination (P = .03). The midterm (P < .0001) and the formative assessment (P = .0009) scores significantly affected the second-year final examination score while student gender (P = .59) and time spending (P = .83) showed no correlations. CONCLUSION: Within the limitations of the study, student performance on case-based CRQs was correlated with student performance on the summative assessment.

Parent-child emotion dynamics in families presenting for behavioral parent training: Is there a link with child behavior, parenting, and treatment outcome?

OBJECTIVE: Behavioral parent training (BPT) is the standard of care for early onset behavior disorders (BDs), however, not all families benefit. Emotion regulation (ER) is one potential mechanism underlying BPT outcomes, yet there are challenges in capturing intra- and interpersonal aspects of emotion regulation within parent-child interactions that are central to BPT. This study examined how vocally encoded emotional arousal unfolds during parent-child interactions and how parents and children influence each other's arousal (Aim 1), the links between these emotion dynamics, child behavior, and parenting at baseline (Aim 2), and BPT outcome (Aim 3). METHOD: Families of children with BDs (N = 45) completed two interaction tasks and measures of parenting and child behavior. Parent-child dynamics of vocal fundamental frequency (f0) were modeled using actor-partner interdependence models (APIMs) and coupled linear oscillators (CLOs). RESULTS: When considering relative levels of f0 from one talk turn to the next (APIMs), parents and children showed intrapersonal regulation and synchronizing reactivity to each other's f0. When considering the shape of oscillations (CLOs), parents and children showed intrapersonal regulation but no reactivity. Intrapersonal regulation of f0 during the interaction was slowed for parents with more maladaptive parenting and children with more behavior problems at baseline. CONCLUSIONS: This preliminary characterization of f0 in families presenting for BPT provides insights into the emotion dynamics potentially underlying parenting behavior and child behavior. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study.

In this prospective, observational study (ClinicalTrials.gov Identifier: NCT02661464), long-term safety information was collected from participants previously exposed to the Ebola vaccines Ad26.ZEBOV and/or MVA-BN-Filo while enrolled in phase 1, 2, or 3 clinical studies. The study was conducted at 15 sites in seven countries (Burkina Faso, France, Kenya, Tanzania, Uganda, the United Kingdom, and the United States). Adult participants and offspring from vaccinated female participants who became pregnant (estimated conception ≤28 days after vaccination with MVA-BN-Filo or ≤3 months after vaccination with Ad26.ZEBOV) were enrolled. Adults were followed for 60 months after their first vaccination, and children born to female participants were followed for 60 months after birth. In the full analysis set (n = 614 adults; median age [range]: 32.0 [18-65] years), 49 (8.0%) had ≥1 serious adverse event (SAE); the incidence rate of any SAE was 27.4 per 1000 person-years (95% confidence interval: 21.0, 35.2). The unrelated SAEs of malaria were reported in the two infants in the full analysis set, aged 11 and 18 months; both episodes were resolved. No deaths or life-threatening SAEs occurred during the study. Overall, no major safety issues were identified; one related SAE was reported. These findings support the long-term clinical safety of the Ad26.ZEBOV and MVA-BN-Filo vaccines.

Using unsupervised machine learning to classify behavioral risk markers of bacterial vaginosis.

INTRODUCTION: This study used an unsupervised machine learning algorithm, sidClustering and random forests, to identify clusters of risk behaviors of Bacterial Vaginosis (BV), the most common cause of abnormal vaginal discharge linked to STI and HIV acquisition.  METHODS: Participants were 391 cisgender women in Miami, Florida, with a mean of 30.8 (SD = 7.81) years of age; 41.7% identified as Hispanic; 41.7% as Black and 44.8% as White. Participants completed measures of demographics, risk behaviors [sexual, medical, and reproductive history, substance use, and intravaginal practices (IVP)], and underwent collection of vaginal samples; 135 behavioral variables were analyzed. BV was diagnosed using Nugent criteria. RESULTS: We identified four clusters, and variables were ranked by importance in distinguishing clusters: Cluster 1: nulliparous women who engaged in IVPs to clean themselves and please sexual partners, and used substances frequently [n = 118 (30.2%)]; Cluster 2: primiparous women who engaged in IVPs using vaginal douches to clean themselves (n = 112 (28.6%)]; Cluster 3: primiparous women who did not use IVPs or substances [n = 87 (22.3%)]; and Cluster 4: nulliparous women who did not use IVPs but used substances [n = 74 (18.9%)]. Clusters were related to BV (p < 0.001). Cluster 2, the cluster of women who used vaginal douches as IVPs, had the highest prevalence of BV (52.7%). CONCLUSIONS: Machine learning methods may be particularly useful in identifying specific clusters of high-risk behaviors, in developing interventions intended to reduce BV and IVP, and ultimately in reducing the risk of HIV infection among women.

Comparing paediatric optometric vision care in Canada over a 14-year period.

PURPOSE: In Canada, teaching in paediatric eye care has increased in the past decade both within the optometry curriculum and as continuing education to optometrists. Paediatric vision care guidelines have also been established by North American optometric associations. This study examined whether this exposure was associated with changes in paediatric eye care in Canada over a 14-year period. METHODS: Canadian optometrists were invited to participate in an anonymous 35-item survey in 2007 and 2021. The surveys sought to investigate optometrist's recommendations for first eye examinations, the number of paediatric patients seen in a typical week and preparedness to provide eye examinations to children. Response frequencies were determined for each survey item. RESULTS: Across Canada, 133/1000 (13.3%) and 261/~6419 (~4.1%) optometrists responded to the survey in 2007 and 2021, respectively. No significant difference was found in the number of years practicing, days per week in practice and total number of patients seen per week. The modal age optometrists recommended children be seen for their first eye examination changed from 3-4 years in 2007 (53%) to 6-12 months in 2021 (61%). In 2007, 87% of respondents provided eye examinations to children <2 years, increasing to 94% in 2021 (p = 0.02). Despite a reduction in the recommended age between the two survey years, the most frequent age children were seen for their first eye examination was 3-4 years (30% in both surveys) and the most common age seen in a typical week remained unchanged (4-6 years-56% 2007; 66% 2021). CONCLUSION: Although optometrists' willingness to provide paediatric eye care increased over the past 14 years, the number of children seen in a typical week did not change. Barriers to determine why more children are not being seen at an earlier age need to be investigated.

Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose in young women aged 15-20 years in Kenya (KEN SHE): an immunobridging analysis of randomised controlled trials.

BACKGROUND: The first randomised controlled trial of single-dose human papillomavirus (HPV) vaccine efficacy, the Kenya single-dose HPV-vaccine efficacy (KEN SHE) trial, showed greater than 97% efficacy against persistent HPV16 and HPV18 infection at 36 months among women in Kenya. We compared antibody responses after one dose of HPV vaccine in the Dose Reduction Immunobridging and Safety Study (DoRIS), the first randomised trial of the single- dose regimen in girls aged 9-14 years, the target age range for vaccination, with those after one dose of the same vaccine in KEN SHE. METHODS: In the DoRIS trial, 930 girls aged 9-14 years in Tanzania were randomly assigned to one, two, or three doses of the 2-valent vaccine (Cervarix) or the 9-valent vaccine (Gardasil-9). The proportion seroconverting and geometric mean concentrations (GMCs) at month 24 after one dose were compared with those in women aged 15-20 years who were randomly assigned to one dose of the same vaccines at the same timepoint in KEN SHE. Batched samples were tested together by virus-like particle ELISA for HPV16 and HPV18 IgG antibodies. Non-inferiority of GMC ratios (DoRIS trial:KEN SHE) was predefined as a lower bound of the 95% CI less than 0·50. FINDINGS: Month 24 HPV16 and HPV18 antibody GMCs in DoRIS were similar or higher than those in KEN SHE. 2-valent GMC ratios were 0·90 (95% CI 0·72-1·14) for HPV16 and 1·02 (0·78-1·33) for HPV18. 9-valent GMC ratios were 1·44 (95% CI 1·14-1·82) and 1·47 (1·13-1·90), respectively. Non-inferiority of antibody GMCs and seropositivity was met for HPV16 and HPV18 for both vaccines. INTERPRETATION: HPV16 and HPV18 immune responses in young girls 24 months after a single dose of 2-valent or 9-valent HPV vaccine were comparable to those in young women who were randomly assigned to a single dose of the same vaccines and in whom efficacy had been shown. A single dose of HPV vaccine, when given to girls in the target age range for vaccination, induces immune responses that could be effective against persistent HPV16 and HPV18 infection at least two years after vaccination. FUNDING: The UK Department of Health and Social Care, the Foreign, Commonwealth, & Development Office, the Global Challenges Research Fund, the UK Medical Research Council and Wellcome Trust Joint Global Health Trials scheme, the Bill and Melinda Gates Foundation, the US National Cancer Institute; the US National Institutes of Health, and the Francis and Dorothea Reed Endowed Chair in Infectious Diseases. TRANSLATION: For the KiSwahili translation of the abstract see Supplementary Materials section.

Evaluation of student readiness for clinical dental education at the end of preclinical education.

OBJECTIVES: This study examined results of a summative objective structured clinical examination (OSCE) at the end of preclinical periodontal education to identify deficient areas for dental students in patient care and to explore factors affecting the probability of passing the OSCE. METHODS: The summative OSCE was administered to two consecutive cohorts, Classes A (class of 2024; n1 = 134) and B (class of 2025; n2 = 129). The questions for each station in the OSCEs were available to both classes 1 week before the OSCEs. Descriptive statistics were used to identify deficient areas. The multiple logistic regression model was built to predict the probability of passing the OSCE based on the cohort, gender, and the practical and written examination scores. RESULTS: Fifty-one (38%) students in Class A and 66 (51%) students in Class B completed the OSCE by passing all stations. Students undergoing remediation showed deficiencies in demonstrating how to detect tooth mobility, performing periodontal probing, drawing the healthy positive bony architecture and the mucogingival junction, and using a universal and a Gracey 13/14 curette. The probability of passing the OSCE was significantly correlated with Class B (p = 0.035) and the practical examination score (p = 0.03) while not associated with gender (p = 0.53) and the written examination score (p = 0.11). CONCLUSION: Students showed deficiencies in assessment skills at the end of preclinical education. The study findings suggest that the implementation of the OSCE at the conclusion of preclinical education would be beneficial since the written examination score might not accurately reflect student readiness for clinical patient care.

Dissemination and implementation of an evidence-based voluntary medical male circumcision program: The Spear & Shield program.

Despite compelling evidence linking voluntary medical male circumcision (VMMC) with 60-70% HIV risk reduction in sub-Saharan Africa, Zambian men have been especially reluctant to undergo VMMC. The Government of Zambia set targets for VMMC uptake and promoted community-level interventions. Spear & Shield (S&S) is an innovative, evidence-based, service program promoting VMMC uptake while ensuring both VMMC supply and demand. This study assessed the large-scale provincial rollout of the program (S&S2) utilizing the RE-AIM model for translating interventions into the community. The S&S2 study was conducted between November 2015 and December 2020, and sequentially rolled out over four Zambian provinces in 96 clinics; 24 observation clinics received VMMC training only. Local clinic healthcare workers were trained to conduct the VMMC procedure and HIV counselors were trained to lead S&S group sessions. Using the RE-AIM model, primary outcomes were: Reach, the number, proportion, and representativeness of S&S attendees; Effectiveness, the impact of S&S2 on VMMC uptake; Adoption, the number, proportion, and representativeness of clinics implementing S&S2; Implementation, fidelity to the S&S intervention manual; and Maintenance, the extent to which S&S2 became an element of standard care within community clinics. Initially, n = 109 clinics were recruited; 96 were sustained and randomized for activation (Adoption). A total of 45,630 clinic patients (n = 23,236 men and n = 22,394 women) volunteered to attend the S&S sessions (Reach). The S&S2 program ran over 2,866 clinic-months (Implementation). Although the study did not target individual-level VMMCs, ~58,301 additional VMMCs were conducted at the clinic level (Effectiveness). Fidelity to the S&S intervention by group leaders ranged from 42%-95%. Sustainability of the program was operationalized as the number of CHCs initially activated that sustained the program. Intervention delivery ended, however, when study funding ceased (Maintenance). The S&S2 program successfully utilized the RE-AIM model to achieve study goals for implementation and dissemination in four Zambian provinces. Innovative VMMC programs such as S&S2 can improve the uptake of VMMC, one of the most effective strategies in the HIV prevention arsenal.

Depression, Sleep Health & Sociodemographic Correlates in a Nationwide Survey: Implications for Depression Treatment During the COVID-19.

Purpose: The COVID-19 pandemic has had a profound impact on mental health worldwide, with depression and sleep problems among the most common issues experienced by many individuals. Depression can lead to sleep problems, which can increase the risk of developing depressive symptoms. However, it is unclear which United States (US) sub-population was most affected by depression and sleep problems during the pandemic. Methods: We conducted a secondary analysis using self-reported data from the 2021 National Health Interview Survey (NHIS), focusing on adults aged 18 years and above (n=29,763). We utilized self-reported responses to questions about prescription medication and frequency of depressive feelings to determine participants' depression status. Appropriate weights were applied to account for the sampling design of the surveys. Our analysis involved descriptive statistics and chi-squared tests to compare sociodemographic, clinical, behavioral, and sleep-related characteristics between US adults with and without depression. Additionally, logistic regression was used to examine the associations between sleep duration, sleep quality and depression. Results: The overall prevalence of depression in our sample was 44.4%. It were higher in certain demographic groups, including younger adults (18-39 years, 47.7%), non-Hispanic whites (47.9%), females (50.1%), those at the lower income bracket (52.2%), those with no college or degree (48.7%) uninsured individuals (45.2%), and those reporting poor general health (71.9%). Individuals with depression had a 12% increased odds of experiencing short sleep (aOR: 1.12, 95% CI:1.04-1.20, p<0.001), 34% increased odds of experiencing long sleep (aOR: 1.34, 95% CI: 1.20-1.50, p < 0.001) and more than 2.5 fold increased odds of reporting poor sleep quality (aOR:2.57, 95% CI: 2.40-2.78; p<0.0001). In the multivariate analysis, all variables (sex, race/ethnicity, education, health insurance coverage, marital status, general health status and use of sleep medications, smoking and alcohol use status) were significantly predictors of poor sleep quality, with the exceptions of age and family income. Conclusion: The findings emphasize the need to address sleep health in treating depression, especially during times of public health crises.

Factors influencing neonatal male circumcision uptake among expecting couples in Zambia: formative findings.

Male circumcision is a protective HIV prevention strategy. However, uncircumcised Zambian men are reluctant to undergo voluntary medical male circumcision (VMMC). Tailored interventions are necessary to stimulate the uptake of early infant male circumcision (EIMC) and VMMC in Zambia. This feasibility study presents the formative process of utilising the PRECEDE framework in the development of a family-centred EIMC/VMMC intervention, Like Father Like Son, and its application in an existing VMMC intervention, Spear & Shield. We found that fear of the pain associated with EIMC procedures, foreskin disposal, beliefs in children's autonomy and rights, and men's dominance in health decision-making were factors affecting EIMC uptake. Perceived benefits for infants included improved hygiene, protection from HIV infection, and faster recovery. Reinforcing factors included female partners and fathers' MC status. The availability and access to EIMC services and information, skill and experience of health workers, and engagement and belief in traditional circumcision practices were factors enabling EIMC uptake. These individual, interpersonal, and structural factors positively and negatively influencing EIMC uptake in the Zambian clinic context were integrated into the intervention for expecting parents. Feedback from community advisory boards suggested the process was effective in developing a culturally tailored and acceptable EIMC/VMMC promotion intervention.

Pivoting from in-person to phone survey assessment of alcohol and substance use: effects on representativeness in a United States prospective cohort of women living with and without HIV.

Background: Many clinical and population-based research studies pivoted from in-person assessments to phone-based surveys due to the COVID-19 pandemic. The impact of these transitions on survey response remains understudied, especially for people living with HIV. Given that there are gender-specific trends in alcohol and substance use, it is particularly important to capture these data for women.Objective: Identify factors associated with responding to an alcohol and substance use phone survey administered during the COVID-19 pandemic in the Women's Interagency HIV Study, a multicenter US prospective cohort of women living with and without HIV.Methods: We used multivariable logistic regression to assess for associations of pre-pandemic (April-September 2019) sociodemographic factors, HIV status, housing status, depressive symptoms, alcohol use, and substance use with response to an early-pandemic (August-September 2020) phone survey.Results: Of 1,847 women who attended an in-person visit in 2019, 78% responded to a phone survey during the pandemic. The odds of responding were lower for women of Hispanic ethnicity (aOR 0.47 95% CI 0.33-0.66, ref=Black/African American) and those who reported substance use (aOR 0.63 95% CI 0.41-0.98). By contrast, the odds were higher for White women (aOR 1.64 95% CI 1.02-2.70, ref=Black/African American) and those with stable housing (aOR 1.74 95% CI 1.24-2.43).Conclusions: Pivoting from an in-person to phone-administered alcohol and substance use survey may lead to underrepresentation of key subpopulations of women who are often neglected in substance use and HIV research. As remote survey methods become more common, investigators need to ensure that the study population is representative of the target population.

Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.

BACKGROUND: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older. METHODS: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR. RESULTS: In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2. CONCLUSIONS: A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).

Life course history of physical and sexual abuse is associated with cardiovascular disease risk among women living with and without HIV.

OBJECTIVE: Sexual and physical abuse predict cardiovascular disease (CVD) among women in the general population. Women living with HIV (WLWH) report more abuse and have higher CVD risk compared with other women, yet associations between abuse history and CVD have not been considered among WLWH. This study fills this gap, and describes possible pathways linking abuse to CVD risk among WLWH and women living without HIV (WLWOH). METHODS: Using 25 years of data from the Women's Interagency HIV Study (WIHS; n  = 2734; WLWH n  = 1963; WLWOH n  = 771), we used longitudinal generalized estimating equations (GEE) to test associations between sexual and physical abuse with CVD risk. Framingham (FRS-H) and the American College of Cardiology/American Heart Association-Pooled Cohort Equation (ACC/AHA-PCE) scores were examined. Analyses were stratified by HIV-serostatus. RESULTS: Among WLWH, childhood sexual abuse was associated with higher CVD risk ( ßFRS-H  = 1.25, SE = 1.08, P  = 0.005; ßACC/AHA-PCE  = 1.14, SE = 1.07, P  = 0.04) compared with no abuse. Adulthood sexual abuse was associated with higher CVD risk for WLWH ( ßFRS-H  = 1.39, SE = 1.08, P  < 0.0001) and WLWOH ( ßFRS-H  = 1.58, SE = 1.14, P  = 0.0006). Childhood physical abuse was not associated with CVD risk for either group. Adulthood physical abuse was associated with CVD risk for WLWH ( ßFRS-H  = 1.44, SE = 1.07; P  < 0.0001, ßACC/AHA-PCE  = 1.18, SE = 1.06, P  = 0.002) and WLWOH ( ßFRS-H  = 1.68, SE = 1.12, P  < 0.0001; ßACC/AHA-PCE  = 1.24, SE = 1.11, P  = 0.03). Several pathway factors were significant, including depression, smoking, and hepatitis C infection. CONCLUSION: Life course abuse may increase CVD risk among WLWH and women at high risk of acquiring HIV. Some comorbidities help explain the associations. Assessing abuse experiences in clinical encounters may help contextualize cardiovascular risk among this vulnerable population and inform intervention.