Safeguarding in Church: Children and Young People's Perceptions of Safety in Religious and Other Faith-Based Settings.

Organizations that interact with children and young people have a duty of care to ensure the safety of those children and young people from any manner of abuse, particularly from child sexual abuse. Faith-based ("religious") organizations are of particular interest due to the number of victims/survivors speaking out about their experiences of grooming, child sexual abuse, and other forms of harm in religious organizations. Focusing on addressing the risks and improving safeguarding efforts, prevention activities benefit from giving children agency and a voice. We conducted a study using two focus groups with children and young people involved with two different Christian denominations. We conducted activities and led discussions regarding their views about safety in the context of the faith-based organization with which they engage. Children and young people described different potentially unsafe situations, their likely frequency, and the level of impact such situations would have from their own point of view. They also described how they thought adults in their faith-based organization would see them. Thematic analysis of the data supported four themes related to young people's sense of safety: concerning behavior of adults and other young people, fear of judgment by others (adults and peers), sense of or lack of empowerment due to power dynamics, and the importance of a sense of "familiarity." Visual comparisons of the data on scatterplots suggested differences not only in the level of impact and frequency of potentially unsafe situations between young people and adults but also between the two denominations. Children and young people can provide a wealth of information regarding their safety concerns when involved in programs and services at faith-based organizations. Clergy and other faith-based organizational leaders should consider how the context in which young people are involved (including interdenominational and interfaith difference, as well as the diverse types of activities young people are involved with) can affect their safety concerns.

Canadian Adalimumab Postmarketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (COMPLETE-PsA): 12-month Results of Comparative Effectiveness of Adalimumab and nbDMARDs.

OBJECTIVE: COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active psoriatic arthritis (PsA) treated with adalimumab (ADA) or a nonbiologic disease-modifying antirheumatic drug (nbDMARD) regimen, after inadequate response/intolerance to a current nbDMARD treatment regimen. The aim of this analysis was to assess the 12-month effectiveness of ADA vs nbDMARDs. METHODS: Patients enrolled between March 2012 and November 2017 were included. The following clinical variables and patient-reported outcomes were collected/calculated per routine care: Disease Activity Index for Psoriatic Arthritis in 28 joints (DAPSA28), Disease Activity Score in 28 joints (DAS28), erythrocyte sedimentation rate (ESR), C-reactive protein, physician global assessment (PGA), patient global assessment (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), 12-item Short Form Health Survey, enthesitis, dactylitis, body surface area (BSA), and time to achieving American College of Rheumatology (ACR) 50, ACR70, and modified minimal disease activity (mMDA). RESULTS: Two hundred and seventy-seven ADA-treated and 148 nbDMARD-treated patients were included. At baseline, ADA-treated patients were less likely to be employed, had longer morning stiffness, higher DAPSA28, DAS28, PGA, PtGA, pain, and HAQ-DI, and lower prevalence of dactylitis (all P < 0.05). ADA-treated patients showed lower baseline-adjusted DAPSA28 (16.5 vs 26.6), DAS28 (2.8 vs 3.9), PGA (25.3 vs 37.1), and ESR (10.4 vs 15.0 mm/h) after 3 months compared to nbDMARD-treated patients, with observed improvements maintained to month 12. Time to achievement of ACR50, ACR70, and mMDA was significantly shorter (P < 0.001) among ADA-treated patients, with the likelihood of having dactylitis (odds ratio [OR] 0.4, 95% CI 0.2-0.6) and BSA< 3% (OR 2.7, 95% CI 1.5-5.0) significantly lower and higher, respectively. Switching to another biologic was less likely in ADA-treated vs nbDMARD-treated patients (hazard ratio 0.3, 95% CI 0.2-0.5). CONCLUSION: In a real-world Canadian population of patients with PsA, ADA was more effective than nbDMARDs at reducing disease activity and the severity of skin involvement, and demonstrated higher retention. [ClinicalTrials.gov: NCT01559038].

Evaluation of the effect of selecting gluteal injection site on the pain injection based on anthropometric indices and body shape pattern: A randomised controlled trial study.

AIMS AND OBJECTIVES: This study was aimed at comparing the effect of injection site selection based on anthropometric indices and body shape pattern on pain injection. BACKGROUND: Pain is one of the common complications of intramuscular injection. Selecting the right place for gluteal injection is one of the challenges of nursing which can increase the safety and success of the injection and thereby reduce the pain severity caused by it. DESIGN: Open-label randomized controlled trial study. METHODS: In this study, 162 eligible subjects referred to the emergency unit of Vasei Hospital of Sabzevar, Iran were randomly assigned to three groups of control, anthropometric indices and body shape pattern. Subjects in the control group received dorsogluteal injection (traditional way). In the anthropometric group, body mass index (BMI), waist circumference (WC) and anterior superior iliac spine to iliac tubercle (ASIS-IT), and in body shape pattern group, observed body shape indices (OBS), BMI and sex were used to select the gluteal injection site. Pain injection was assessed using the Visual Analogue Scale (VAS). The CONSORT checklist was used. RESULTS: The mean age of the participant was 39.43 ± 13.16 and 43.21% (n = 70) were male. Based on multiple linear regression analysis, the mean pain injection was substantially lower in body shape pattern as compared to the control group (r2 : .26; bxy = -0.41; 95% CI: -0.81, -0.01; p = .043). The mean pain injection was significantly greater in the left leg injection than right one (r2 : .26; bxy = 0.44; 95% CI: 0.06, 0.81; p = .021). CONCLUSIONS: Findings of this study suggest that the selection of a gluteal injection site based on body shape pattern in comparison with traditional dorsogluteal injection method has a significant effect on pain injection relief. RELEVANCE TO CLINICAL PRACTICE: Nurses can choose the appropriate gluteal injection site based on the body shape pattern to reduce the pain of the intramuscular (IM) gluteal injections.

Evaluation of the Impact of Handoff Based on the SBAR Technique on Quality of Nursing Care.

BACKGROUND: Effective communication, including the complete and accurate transfer of information and the prevention of misrepresentation and misinterpretation of patient-centered data during handoff, can enhance the quality of patient care and safety. PURPOSE: This study was aimed at evaluating the impact of bedside handoff using the Situation, Background, Assessment, Recommendation (SBAR) technique, on the quality of nursing care. METHODS: The Quality Patient Care Scale (QUALPACS) was completed by the patient while nurses performed a verbal bedside shift handoff and after receiving education on the purpose and proper use of the SBAR communication tool. RESULTS: The mean age of subjects was 51.29 ± 8.02 years. We found a significant increase in the mean score of QUALPACS dimensions, namely psychosocial (P < .001), physical (P < .001), and communication (P < .001) after SBAR implementation. CONCLUSIONS: Findings suggest that using the SBAR handoff technique increases the quality of nursing care in all QUALPACS dimensions.

Intimate Partner Violence and Food Insecurity Predict Early Behavior Problems Among South African Children over 5-years Post-Birth.

Households experiencing intimate partner violence (IPV) and food insecurity are at high risk of lifelong physical and behavioral difficulties. Longitudinal data from a perinatal home-visiting cluster-randomized controlled intervention trial in South Africa townships were used to examine the relationships between household settings and mothers' histories of risk and children's behavior problems at 3 and 5 years of age. IPV, food insecurity, maternal depressed mood, and geriatric pregnancy (at age of 35 or older) were consistently associated with children's internalizing and externalizing behavior problems. Aggressive behavior was more prevalent among 3- and 5-year olds boys, and was associated with maternal alcohol use. The effects of these factors on child behavior were more prominent than maternal HIV status. There is a continuing need to reduce IPV and household food insecurity, as well as supporting older, depressed, alcohol using mothers in order to address children's behavioral needs.

Nanoparticle interactions with immune cells dominate tumor retention and induce T cell-mediated tumor suppression in models of breast cancer.

The factors that influence nanoparticle fate in vivo following systemic delivery remain an area of intense interest. Of particular interest is whether labeling with a cancer-specific antibody ligand ("active targeting") is superior to its unlabeled counterpart ("passive targeting"). Using models of breast cancer in three immune variants of mice, we demonstrate that intratumor retention of antibody-labeled nanoparticles was determined by tumor-associated dendritic cells, neutrophils, monocytes, and macrophages and not by antibody-antigen interactions. Systemic exposure to either nanoparticle type induced an immune response leading to CD8+ T cell infiltration and tumor growth delay that was independent of antibody therapeutic activity. These results suggest that antitumor immune responses can be induced by systemic exposure to nanoparticles without requiring a therapeutic payload. We conclude that immune status of the host and microenvironment of solid tumors are critical variables for studies in cancer nanomedicine and that nanoparticle technology may harbor potential for cancer immunotherapy.

Evaluating the Use of a Modified Early Warning Score in Predicting Serious Adverse Events in Iranian Hospitalized Patients: A Prognostic Study.

INTRODUCTION: Assessment of early clinical warning signs and appropriate response can prevent serious adverse events in hospitalized patients. The Modified Early Warning Score (MEWS) is an applicable early warning sign system that can be used to predict serious adverse events. This study aimed to evaluate the predictive capacity of the MEWS to identify patients in an Iranian hospital who are at risk of developing serious adverse events. METHODS: In this prognostic study, 381 adult patients from the emergency department who were admitted to an inpatient hospital unit of an Iranian hospital from May 2018 to October 2018 were included. The MEWS tool was completed for each patient at the time of admission and then daily for a period of up to 30 continuous days after admission or until the development of a serious adverse event. Receiver operating characteristic, specificity, sensitivity, positive predictive values, and negative predictive values were calculated. RESULTS: In this study, a MEWS of ≥3 on admission was associated with an increased likelihood of developing serious adverse events within 30 days of admission with the area under the curve of 0.82 (95% confidence interval [CI]: 0.77-0.85), sensitivity of 82.81% (95% CI: 71.3-91.1), specificity of 75.39% (95% CI: 70.3-80), positive predictive value of 40.5% (95% CI: 35.2-45.9), and negative predictive value of 95.6% (95% CI: 92.7-97.4). DISCUSSION: A MEWS ≥3 on admission can predict the occurrence of serious averse events in patients admitted to an Iranian hospital for 30 continuous days.

Enhancing the abscopal effect of radiation and immune checkpoint inhibitor therapies with magnetic nanoparticle hyperthermia in a model of metastatic breast cancer.

Purpose: Enhancing immune responses in triple negative breast cancers (TNBCs) remains a challenge. Our study aimed to determine whether magnetic iron oxide nanoparticle (MION) hyperthermia (HT) can enhance abscopal effects with radiotherapy (RT) and immune checkpoint inhibitors (IT) in a metastatic TNBC model.Methods: One week after implanting 4T1-luc cells into the mammary glands of BALB/c mice, tumors were treated with RT (3 × 8 Gy)±local HT, mild (HTM, 43 °C/20 min) or partially ablative (HTAbl, 45 °C/5 min plus 43 °C/15 min),±IT with anti-PD-1 and anti-CTLA-4 antibodies (both 4 × 10 mg/kg, i.p.). Tumor growth was measured daily. Two weeks after treatment, lungs and livers were harvested for histopathology evaluation of metastases.Results: Compared to untreated controls, all treatment groups demonstrated a decreased tumor volume; however, when compared against surgical resection, only RT + HTM+IT, RT + HTAbl+IT and RT + HTAbl had similar or smaller tumors. These cohorts showed more infiltration of CD3+ T-lymphocytes into the primary tumor. Tumor growth effects were partially reversed with T-cell depletion. Combinations that proved most effective for primary tumors generated modest reductions in numbers of lung metastases. Conversely, numbers of lung metastases showed potential to increase following HT + IT treatment, particularly when compared to RT. Compared to untreated controls, there was no improvement in survival with any treatment.Conclusions: Single-fraction MION HT added to RT + IT improved local tumor control and recruitment of CD3+ T-lymphocytes, with only a modest effect to reduce lung metastases and no improvement in overall survival. HT + IT showed potential to increase metastatic dissemination to lungs.

Alcohol, But Not Depression or IPV, Reduces HIV Adherence Among South African Mothers Living with HIV Over 5 Years.

Alcohol, depression, and intimate partner violence (IPV) are endemic in sub-Saharan Africa. This article examines whether and how these conditions affect mothers living with HIV (MLH), compared to mothers without HIV (MWOH). In particular, we assess the influence of these comorbidities on engagement in HIV care and adherence to antiretroviral therapies (ARV) among MLH. Data on maternal HIV care are typically based on clinic samples, with substantial loss to follow-up. This study fills that gap by including all mothers in specified areas. A cohort study examines MLH in Cape Town, South Africa recruited in pregnancy and followed repeatedly for 5 years, compared to MWOH. Almost all (98%) pregnant women in 12 neighborhoods (N = 594) were recruited in pregnancy. Mothers and children were reassessed five times over 5 years with high retention rates at each of the six assessments, from 98.7% at 2 weeks to 82.8% at 5 years post-birth. MLH's uptake and adherence to HIV care was evaluated over time associated with maternal comorbidities of alcohol use, depressed mood, and IPV using mixed effects logistic regression. MLH have fewer resources (income, food, education) and are more likely to face challenges from alcohol, depression, and having seropositive partners over time than MWOH. Only 22.6% of MLH were consistently engaged in HIV care from 6 months to 5 years post-birth. At 5 years, 86.7% self-reported engaged in HIV care, 76.9% were receiving ARVs and 87% of those on ARV reported consistent ARV adherence. However, data on viral suppression are unavailable. Alcohol use, but not depressed mood or IPV, was significantly related to reduced uptake of HIV care and adherence to ARV over time. Adherence to lifelong ARV by MLH requires a combination of structural and behaviorally-focused interventions. Alcohol abuse is not typically addressed in low and middle-income countries, but is critical to support MLH.

Increased uptake of doxorubicin by cells undergoing heat stress does not explain its synergistic cytotoxicity with hyperthermia.

Purpose: A proposed mechanism for the enhanced effectiveness of hyperthermia and doxorubicin (Dox) combinations is increased intracellular Dox concentrations resulting from heat-induced cell stress. The purpose of this study was to determine whether specific varied Dox and heat combinations produce measurable effects greater than the additive combination, and whether these effects can be attributed to heat-induced increases in intracellular Dox concentrations. Methods: HCT116, HT29 and CT26 cells were exposed to Dox and water bath heating independently. A clonogenic survival assay was used to determine cell killing and intracellular Dox concentrations were measured in HCT116 cells with mass spectrometry. Cells were exposed to heating at 42 °C (60 min) and 0.5 µg/ml of Dox at varying intervals. Synergy was determined by curve-fitting and isobologram analysis. Results: All cell lines displayed synergistic effects of combined heating and Dox. A maximum synergistic effect was achieved with simultaneous cell exposure to Dox and heat. For exposures at 42 °C, the synergistic effect was most pronounced at Dox concentrations <0.5 µg/ml. Increased intracellular concentrations of Dox in HCT116 cells caused by heat-stress did not generate a concomitant thermal enhancement. Conclusions: Simultaneous exposure of HCT116 cells to heating and Dox is more effective than sequential exposure. Heat-induced cell responses are accompanied by increased intracellular Dox concentrations; however, clonogenic survival data do not support this as the cause for synergistic cytotoxicity.

The association of maternal alcohol use and paraprofessional home visiting with children's health: A randomized controlled trial.

OBJECTIVE: This study examines the effect of a home visiting intervention on maternal alcohol use, problematic drinking, and the association of home visiting and alcohol use on children's behavioral, cognitive, and health outcomes at 5 time points over 5 years. METHOD: We analyzed 5,099 observations of 1,236 mothers and their children from pregnancy to 5 years postbirth, within a longitudinal cluster-randomized trial evaluating the effect of a home visiting intervention on mothers in Cape Town, South Africa. Paraprofessional home visitors coached mothers on coping with multiple risk factors, including a brief, 1-visit intervention on alcohol prevention in pregnancy. We assessed changes in maternal drinking over time in relation to the intervention, and then examined the impact of these drinking patterns on child outcomes over five years. RESULTS: Drinking increased over the 5 years postbirth, but it was significantly lower in the intervention condition. Compared with abstinence, mothers' problematic drinking was associated with decreased child weight (-0.21 z-units) at all assessments, increased child aggressive behavior (3 to 7 additional symptoms), and decreased child performance on an executive functioning measure (the silly sounds task; odds ratio = .34) at 3 and 5 years. The intervention's effect was associated with increased child aggression (0.25 to 0.75 of 1 additional symptom), but the intervention appeared to decrease the effect of problem drinking on children's aggressive acts and executive functioning. CONCLUSION: These findings support the need for sustained interventions to reduce alcohol use, especially for mothers who exhibit problematic drinking. Maternal drinking influences children's health and development over time. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Gender-specific HIV and substance abuse prevention strategies for South African men: study protocol for a randomized controlled trial.

BACKGROUND: Young men in South Africa face concurrent epidemics of HIV, drug and alcohol abuse, and unemployment. Standard HIV prevention programs, located in healthcare settings and/or using counseling models, fail to engage men. Soccer and vocational training are examined as contexts to deliver male-specific, HIV prevention programs. METHODS: Young men (n = 1200) are randomly assigned by neighborhood to one of three conditions: 1) soccer league (n = 400; eight neighborhoods); 2) soccer league plus vocational training (n = 400; eight neighborhoods); or 3) a control condition (n = 400; eight neighborhoods). Soccer practices and games occur three times per week and vocational training is delivered by Silulo Ulutho Technologies and Zenzele Training and Development. At baseline, 6 months, 12 months, and 24 months, the relative efficacy of these strategies to increase the number of significant outcomes (NSO) among 15 outcomes which occur (1) or not (0) are summed and compared using binomial logistic regressions. The summary primary outcome reflects recent HIV testing, substance abuse, employment, sexual risk, violence, arrests, and mental health status. DISCUSSION: The failure of men to utilize HIV prevention programs highlights the need for gender-specific intervention strategies. However, men in groups can provoke and encourage greater risk-taking among themselves. The current protocol evaluates a male-specific strategy to influence men's risk for HIV, as well as to improve their ability to contribute to family income and daily routines. Both interventions are expected to significantly benefit men compared with the control condition. TRIAL REGISTRATION: ClinicalTrials.gov registration, NCT02358226 . Registered 24 November 2014.

Post-translational modifications clustering within proteolytic domains decrease mutant huntingtin toxicity.

Huntington's disease (HD) is caused in large part by a polyglutamine expansion within the huntingtin (Htt) protein. Post-translational modifications (PTMs) control and regulate many protein functions and cellular pathways, and PTMs of mutant Htt are likely important modulators of HD pathogenesis. Alterations of selected numbers of PTMs of Htt fragments have been shown to modulate Htt cellular localization and toxicity. In this study, we systematically introduced site-directed alterations in individual phosphorylation and acetylation sites in full-length Htt constructs. The effects of each of these PTM alteration constructs were tested on cell toxicity using our nuclear condensation assay and on mitochondrial viability by measuring mitochondrial potential and size. Using these functional assays in primary neurons, we identified several PTMs whose alteration can block neuronal toxicity and prevent potential loss and swelling of the mitochondria caused by mutant Htt. These PTMs included previously described sites such as serine 116 and newly found sites such as serine 2652 throughout the protein. We found that these functionally relevant sites are clustered in protease-sensitive domains throughout full-length Htt. These findings advance our understanding of the Htt PTM code and its role in HD pathogenesis. Because PTMs are catalyzed by enzymes, the toxicity-modulating Htt PTMs identified here may be promising therapeutic targets for managing HD.

Post-Translational Modifications (PTMs), Identified on Endogenous Huntingtin, Cluster within Proteolytic Domains between HEAT Repeats.

Post-translational modifications (PTMs) of proteins regulate various cellular processes. PTMs of polyglutamine-expanded huntingtin (Htt) protein, which causes Huntington's disease (HD), are likely modulators of HD pathogenesis. Previous studies have identified and characterized several PTMs on exogenously expressed Htt fragments, but none of them were designed to systematically characterize PTMs on the endogenous full-length Htt protein. We found that full-length endogenous Htt, which was immunoprecipitated from HD knock-in mouse and human post-mortem brain, is suitable for detection of PTMs by mass spectrometry. Using label-free and mass tag labeling-based approaches, we identified near 40 PTMs, of which half are novel (data are available via ProteomeXchange with identifier PXD005753). Most PTMs were located in clusters within predicted unstructured domains rather than within the predicted α-helical structured HEAT repeats. Using quantitative mass spectrometry, we detected significant differences in the stoichiometry of several PTMs between HD and WT mouse brain. The mass-spectrometry identification and quantitation were verified using phospho-specific antibodies for selected PTMs. To further validate our findings, we introduced individual PTM alterations within full-length Htt and identified several PTMs that can modulate its subcellular localization in striatal cells. These findings will be instrumental in further assembling the Htt PTM framework and highlight several PTMs as potential therapeutic targets for HD.

Quantitative Proteomic Analysis Reveals Similarities between Huntington's Disease (HD) and Huntington's Disease-Like 2 (HDL2) Human Brains.

The pathogenesis of HD and HDL2, similar progressive neurodegenerative disorders caused by expansion mutations, remains incompletely understood. No systematic quantitative proteomics studies, assessing global changes in HD or HDL2 human brain, were reported. To address this deficit, we used a stable isotope labeling-based approach to quantify the changes in protein abundances in the cortex of 12 HD and 12 control cases and, separately, of 6 HDL2 and 6 control cases. The quality of the tissues was assessed to minimize variability due to post mortem autolysis. We applied a robust median sweep algorithm to quantify protein abundance and performed statistical inference using moderated test statistics. 1211 proteins showed statistically significant fold changes between HD and control tissues; the differences in selected proteins were verified by Western blotting. Differentially abundant proteins were enriched in cellular pathways previously implicated in HD, including Rho-mediated, actin cytoskeleton and integrin signaling, mitochondrial dysfunction, endocytosis, axonal guidance, DNA/RNA processing, and protein transport. The abundance of 717 proteins significantly differed between control and HDL2 brain. Comparative analysis of the disease-associated changes in the HD and HDL2 proteomes revealed that similar pathways were altered, suggesting the commonality of pathogenesis between the two disorders.

PRMT5- mediated symmetric arginine dimethylation is attenuated by mutant huntingtin and is impaired in Huntington's disease (HD).

Abnormal protein interactions of mutant huntingtin (Htt) triggered by polyglutamine expansion are thought to mediate Huntington's disease (HD) pathogenesis. Here, we explored a functional interaction of Htt with protein arginine methyltransferase 5 (PRMT5), an enzyme mediating symmetrical dimethylation of arginine (sDMA) of key cellular proteins, including histones, and spliceosomal Sm proteins. Gene transcription and RNA splicing are impaired in HD. We demonstrated PRMT5 and Htt interaction and their co-localization in transfected neurons and in HD brain. As a result of this interaction, normal (but to a lesser extend mutant) Htt stimulated PRMT5 activity in vitro. SDMA of histones H2A and H4 was reduced in the presence of mutant Htt in primary cultured neurons and in HD brain, consistent with a demonstrated reduction in R3Me2s occupancy at the transcriptionally repressed promoters in HD brain. SDMA of another PRMT5 substrate, Cajal body marker coilin, was also reduced in the HD mouse model and in human HD brain. Finally, compensation of PRMT5 deficiency by ectopic expression of PRMT5/MEP50 complexes, or by the knock-down of H4R3Me2 demethylase JMJD6, reversed the toxic effects of mutant Htt in primary cortical neurons, suggesting that PRMT5 deficiency may mediate, at least in part, HD pathogenesis. These studies revealed a potential new mechanism for disruption of gene expression and RNA processing in HD, involving a loss of normal function of Htt in facilitation of PRMT5, supporting the idea that epigenetic regulation of gene transcription may be involved in HD and highlighting symmetric dimethylation of arginine as potential new therapeutic target.

Evaluation of the effect of the modified early warning system on the nurse-led activation of the rapid response system.

The modified early warning system (MEWS) is a scoring rubric used to detect the earliest signs of a change in a patient's condition. This mixed-methods study used pre- and postintervention data to describe the impact of the MEWS on the frequency of rapid response system activations and cardiopulmonary arrests among patients admitted to medical-surgical units. Focus groups of nursing staff provided insight into the factors that influence how nurses use the MEWS at the bedside as a framework to identify, intervene, and manage patients in need of an advanced level of care.

Multiple risk factors during pregnancy in South Africa: the need for a horizontal approach to perinatal care.

South African children's long-term health and well-being is jeopardized during their mothers' pregnancies by the intersecting epidemics of HIV, alcohol use, low birth weight (LBW; <2,500 g) related to poor nutrition, and depressed mood. This research examines these overlapping risk factors among 1,145 pregnant Xhosa women living in 24 township neighborhoods in Cape Town, South Africa. Results revealed that 66 % of pregnant women experienced at least one risk factor. In descending order of prevalence, 37 % reported depressed mood, 29 % were HIV+, 25 % used alcohol prior to knowing that they were pregnant, and 15 % had a previous childbirth with a LBW infant. Approximately 27 % of women had more than one risk factor: depressed mood was significantly associated with alcohol use and LBW, with a trend to significance with HIV+. In addition, alcohol use was significantly related to HIV+. These results suggest the importance of intervening across multiple risks to maternal and child health, and particularly with depression and alcohol use, to positively impact multiple maternal and infant outcomes.

Outcomes of home visits for pregnant mothers and their infants: a cluster randomized controlled trial.

OBJECTIVE: To evaluate the effect of home visits by community health workers (CHWs) on maternal and infant well being from pregnancy through the first 6 months of life for women living with HIV (WLH) and all neighborhood mothers. DESIGN AND METHODS: In a cluster randomized controlled trial in Cape Town townships, neighborhoods were randomized within matched pairs to either standard care, comprehensive healthcare at clinics (n=12 neighborhoods; n=169 WLH; n=594 total mothers); or Philani Intervention Program, home visits by CHWs in addition to standard care (PIP; n=12 neighborhoods; n=185 WLH; n=644 total mothers). Participants were assessed during pregnancy (2% refusal) and reassessed at 1 week (92%) and 6 months (88%) postbirth. We analyzed PIP's effect on 28 measures of maternal and infant well being among WLH and among all mothers using random effects regression models. For each group, PIP's overall effectiveness was evaluated using a binomial test for correlated outcomes. RESULTS: Significant overall benefits were found in PIP compared to standard care among WLH and among all participants. Secondarily, compared to standard care, PIP WLH were more likely to complete tasks to prevent vertical transmission, use one feeding method for 6 months, avoid birth-related medical complications, and have infants with healthy height-for-age measurements. Among all mothers, compared to standard care, PIP mothers were more likely to use condoms consistently, breastfeed exclusively for 6 months, and have infants with healthy height-for-age measurements. CONCLUSION: PIP is a model for countries facing significant reductions in HIV funding whose families face multiple health risks.

Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): results from the CanACT study.

BACKGROUND: This multicenter, open-label, prospective, single cohort study evaluated the effectiveness and safety of adalimumab in a clinical setting reflecting the Canadian standard of care for the treatment of patients with rheumatoid arthritis (RA). METHODS: Patients ≥ 18 years of age with a history of active RA ≥ 3 months and fulfilling Canadian requirements for biological therapy received adalimumab 40 mg subcutaneously every other week for 12 weeks. Pre-study DMARD treatment regimens, corticosteroids, or NSAIDs were allowed throughout the study. The primary effectiveness outcome measure was the mean change in 28-joint disease activity score (DAS28) from baseline to Week 12. Secondary measures included the proportion of patients achieving joint remission (DAS28 < 2.6) and low-disease activity (DAS28 < 3.2) at Week 12, and European League Against Rheumatism (EULAR: moderate and good) and American College of Rheumatology (ACR: ACR20, 50, and 70) responses, as well as responses in ACR core components at Weeks 4, 8, and 12. Subgroup analysis included a comparison of patients naïve to biological DMARD (BDMARD) therapy versus BDMARD-experienced patients. Safety was assessed in terms of adverse and serious adverse events. RESULTS: A total of 879 patients (mean disease duration > 12 years) were enrolled; 772 (87.9%) completed the 12-week period. Adalimumab treatment was associated with rapid and sustained improvements in the signs and symptoms of RA. Significant improvements in mean DAS28 score were observed as early as Week 4. After 12 weeks of adalimumab treatment, 15.3% and 28.9% of patients achieved clinical remission and low-disease activity, respectively. Similarly, significant improvements in ACR core components were observed as early as Week 4, with continued improvements occurring through 12 weeks. Patients naïve to BDMARD therapy demonstrated numerically greater clinical responses when compared with patients who had experienced prior BDMARD therapy, although both subgroups were associated with significant improvements from baseline. The rates and types of adverse events, as well as the results of laboratory measures, demonstrated that adalimumab was generally safe and well-tolerated. CONCLUSIONS: This study demonstrated that, under conditions reflective of the normal clinical practice in Canada, adalimumab is an effective and safe treatment for patients with RA. TRIAL REGISTRATION: NCT00649545.