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Levin and Leu (2021) introduced some key inequalities that underlie the lower bound formula for the probability of lattice events when using adaptive members of the Levin-Robbins-Leu family of sequential subset selection procedures for binary outcomes. Here we provide a rigorous proof of the key inequality for each adaptive procedure in the special case of equal odds parameters. We also provide some further insight into why the key inequality holds for arbitrary odds parameters and we present a complete proof in that case for a simple yet non-trivial prototype example. Two errata in the abovementioned publication are also corrected herein. [ABSTRACT FROM AUTHOR]

The objective of this study was to evaluate the effects of using Community Health Workers (CHWs) to deliver the home-based Wee Wheezers asthma education program on asthma symptoms among children with persistent asthma. In this randomized controlled trial of 151 children aged 2–9 years with persistent asthma, we assigned 75 to the intervention and 76 to the control. The primary outcome was caregiver-reported asthma symptom days. Secondary outcomes included asthma-related healthcare utilization, caregivers' asthma knowledge, illness perception and management behaviors, MDI-spacer administration technique, and home environmental triggers. Outcomes were collected at baseline, 3, 6, 9 and 12 months. A repeated measurements analytic approach with generalized estimating equations was used. To account for missing data, multiple imputation methods were employed. At 3 and 6 months, improvement in symptom days was not significantly different between groups. However, at 9 and 12 months, the reduction in asthma symptom days was 2.15 and 2.31 days more respectively for those in the intervention group compared to the control. Improvements in MDI-spacer technique, knowledge and attitudes were significant throughout follow-up. Improvement in habits regarding MDI use was significant at 3 and 6 months, and asthma routines were improved at 3 months. However, there was no change in asthma-related healthcare utilization or home environmental triggers. Using CHWs to deliver a home-based asthma education program to caregivers of children with persistent asthma led to improvements in symptom days and several secondary outcomes. Expanding the use of CHWs to provide home-based interventions can help reduce disparities in children's health outcomes. [ABSTRACT FROM AUTHOR]

We introduce and discuss some key inequalities that underlie the lower bound formula for the probability of lattice events in the Levin-Robbins-Leu family of sequential subset selection procedures for binary outcomes. The present work combines the notion of lattice events—as previously discussed for the nonadaptive member of the family—with the positive cumulative sum property for the adaptive members—as previously discussed for the special lattice event of correct selection, thereby extending the key inequality to its broadest scope. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the effects of a one-time, apartment-level Integrated Pest Management (IPM) intervention on healthcare utilization and asthma symptoms among children with persistent asthma living in households with a pest infestation. Study design: In a randomized controlled trial of 384 children aged 5–12 years with persistent asthma, we assigned 183 to receive IPM and 197 to usual care (UC). The primary outcome was healthcare utilization from hospital and Medicaid claims records. Secondary outcomes included caregiver-reported asthma symptoms, pest infestation levels, missed days of school due to asthma, and rescue medication use. Results: The entire cohort improved over the study period, with significant but equivalent declines in mean healthcare utilization in both groups. IPM group had fewer days with reduced activity due to asthma (p = 0.04) and larger declines that fell short of statistical significance in asthma symptom days (p = 0.22), severe symptoms (p = 0.16), missed school (p = 0.27) and rescue medication use (p = 0.27). Both roach (p = 0.001) and mice (p = 0.11) infestations decreased much more in the IPM group than the UC group. Conclusions: After a one-time, apartment-level IPM intervention, we found no difference in health care utilization, but fewer days of reduced activity and consistent suggestive evidence of clinically meaningful improvements relative to usual care across other secondary outcomes. Coupled with the established effectiveness of IPM in reducing allergens and scientific consensus on pest-related allergens as asthma triggers, these findings support adding home pest control to traditional medical management of children with severe asthma. [ABSTRACT FROM AUTHOR]

We exhibit some strong positivity properties of a certain function that implies a key inequality that in turn implies the lower bound formula for the probability of correct selection in the Levin-Robbins-Leu family of sequential subset selection procedures for binary outcomes. These properties provide a more direct and comprehensive demonstration of the key inequality than was discussed in Levin and Leu (2013a). [ABSTRACT FROM AUTHOR]

We examined product adherence among 187 men who have sex with men and transgender women enrolled in a phase II, crossover trial comparing safety and acceptability of an oral tablet and a rectal gel used daily for HIV prevention. Participants reported adherence via daily text messages during 8-week periods. Trajectory analysis identified weekly patterns. Polytomous logistic regression identified characteristics associated with higher probability of trajectory group membership. We identified 3 groups per product: high-adherers (72% daily oral, 70% daily gel); decreasing-adherers (20% daily oral, 22% daily gel); and low-adherers (8% daily oral, 9% daily gel). Daily oral high-adherers (compared with low-adherers) were more likely to self-identify as male (OR = 4.76, 95% CI:1.35-16.67), to have more sexual partners (OR = 1.67, 95% CI:1.04-2.63), and to find the tablet easy to swallow (OR = 2.22, 95% CI:1.08-4.76). Daily gel high-adherers (compared with low-adherers) were more likely to be older (OR = 1.16, 95% CI:1.05-1.28), to find gel application easier at the last few applications (OR = 2.27, 95% CI:1.01-5.00), and to report a change in routine if gel was not used (OR = 5.26, 95% CI:1.23-100.00). Characteristics of participants likely to be high-adherers to product use vary according to product. Evaluation of acceptability prior to phase II/III trials could identify participants likely to maintain high adherence. [ABSTRACT FROM AUTHOR]

We introduce a new family of sequential selection procedures wherein the subsets selected have random sizes. In comparison to subset selection procedures that select subsets of fixed size, the new procedures alleviate the need to specify the subset size prior to the experiment. We discuss the application of such procedures in the context of early phase clinical trials. The new procedures retain the adaptive features of the Levin-Robbins-Leu family of sequential subset selection procedures for selecting subsets of fixed size, namely, sequential elimination of inferior treatments and sequential recruitment of superior treatments. These two adaptive features respectively address ethical concerns that diminish interest in nonadaptive procedures and also allow promising treatments to be brought forward for further testing without having to wait until the end of the trial. The new procedures differ from the classical subset selection procedures of Shanti S. Gupta in terms of their respective goals and operating characteristics and we compare the two approaches in a simulation study. The findings suggest that whereas Gupta’s procedure achieves its goal of including the single best treatment in the final selected subset with high probability, it does so by virtue of a nonadaptive, fixed sample size procedure that lacks necessary flexibility in the context of clinical research. By contrast, the new procedures aim to select treatment subsets that satisfy a different criterion, that ofacceptable subset selectionwith high probability, while allowing adaptive elimination and recruitment and other flexibilities which we discuss to fit the practical needs of selection methods in clinical research. [ABSTRACT FROM PUBLISHER]

The Levin-Robbins-Leu (LRL) family of sequential subset selectionprocedures admits of a simple formula that provides a lower bound for the probability of various types of subset selection events. Here we demonstrate that a corresponding lower bound formula holds forlattice eventswhen using the nonadaptive family member with binary outcomes. Lattice events are more general than the type of events that we previously considered in demonstrating that the nonadaptive LRL procedure selects “acceptable” subsets with an arbitrarily large prespecified probability irrespective of the true population parameters. Interestingly, the proof of the lower bound formula for lattice events that we present here simplifies the methods previously used and sheds additional light on why the lower bound formula holds. As for acceptable subset selection, we conjecture that the other LRL family members, which allow for adaptive elimination of inferior candidates and/or recruitment of superior candidates, obey the same lower bound formulas for lattice events. [ABSTRACT FROM AUTHOR]

We study a key inequality that implies the lower bound formula for the probability of correct selection and other selection-related events of interest in the Levin-Robbins-Leu family of sequential binomial subset selection procedures. We present a strategy for the proof of the key inequality, and a mostly complete general proof is given. The strategy provides an entirely complete and rigorous proof of the inequality for as many as seven competing populations using computer-assisted symbolic manipulation. [ABSTRACT FROM AUTHOR]

Abstract: We compare the selection procedure of Levin and Robbins [1981. Selecting the highest probability in binomial or multinomial trials. Proc. Nat. Acad. Sci. USA 78, 4663–4666.] with the procedure of Paulson [1994. Sequential procedures for selecting the best one of k Koopman–Darmois populations. Sequential Analysis 13, 207–220.] to identify the best of several binomial populations with sequential elimination of unlikely candidates. We point out situations in which the Levin–Robbins procedure dominates the Paulson procedure in terms of the duration of the experiment, the expected total number of observations, and the expected number of failures. Because the Levin–Robbins procedure is also easier to implement than Paulson''s procedure and gives a tighter guarantee for the probability of correct selection, we conclude that it holds a competitive edge over Paulson''s procedure. [Copyright &y& Elsevier]

The two one-sided tests (TOST) procedure is the common method for assessing bioequivalence between two different drugs or formulations of the same drug. Several solutions to Behrens-Fisher problem have been extended to establish statistical equivalence under variance heterogeneity. Unlike other existing studies that rely exclusively on simulation results, the analytical formulas of power and Type I error rate are derived. Exact numerical investigations were conducted to evaluate the behavior of the Welch–Satterthwaite, Cochran–Cox, and Banerjee–McCullough TOST methods. The results show that the Type I error rates of the Cochran–Cox and Banerjee–McCullough tests never exceed the nominal significance level. The Banerjee–McCullough technique is actually more conservative than the Cochran–Cox procedure. The extended Welch–Satterthwaite approach maintains closest to the preassigned significance level and is almost equal to the target error probability. The exact power levels of the Cochran–Cox and Banerjee–McCullough tests are completely or nearly identical, and are always less than that of the Welch–Satterthwaite method. On the basis of excellent control of Type I error and greater power performance, the extended Welch–Satterthwaite procedure is recommended over the other two heteroscedastic TOST methods. These findings provide an update of previous studies that endorse the somehow inferior Banerjee–McCullough method. [ABSTRACT FROM AUTHOR]

This research letter, published in the journal Circulation, explores the effects of phosphodiesterase (PDE) inhibitors on cardiac contractility. The study reveals that PDE inhibitors enhance intrinsic cardiomyocyte contractility and arterial dilation, resulting in increased cardiac output and reduced workload on the heart. The researchers also discovered that the phosphorylation of a protein called Rad is necessary for the augmentation of cardiac contractility by PDE inhibitors, leading to increased calcium influx and cardiomyocyte contraction. These findings have potential implications for the development of targeted therapeutics for heart failure. [Extracted from the article]

Objective: To evaluate how asthma-related emergency department visits (AREDV), air pollutant levels, pollen counts, and weather variables changed from 2001 to 2008 in the Bronx, NY. Methods: 42,065 daily AREDV values (1 January 2001 to 31 December 2008) were collected using our institution's Clinical Looking Glass software. Daily values of sulfur dioxide (SO2), carbon monoxide (CO), ozone (O3), nitrogen dioxide (NO2), temperature, and humidity were obtained from the National Climatic Data Center's Bronx station. Daily tree pollen counts were obtained from the Armonk counting station near the Bronx. Median values for each variable were analyzed using the Mann-Whitney test to compare 2001–2004 and 2005–2008 values. Simple linear regression examined associations between AREDV and individual pollutants. Due to seasonal variations of the variables, each season was considered separately. Results: There were significant decreases for AREDV, SO2, CO, and humidity for all seasons, and for NO2 in the spring and winter. Significant increases occurred for O3 in the spring, fall, and winter; for temperature in the summer and winter; and for tree pollen in the spring. Significant positive associations were found between AREDV and SO2, CO, NO2, and humidity, respectively, while significant negative associations were found between AREDV and O3 and temperature, respectively. Conclusions: From 2001 to 2008, significant: a) decreases in AREDV, SO2, CO, and humidity for all seasons, and decreases in NO2 for the spring and winter; and b) increases in O3, temperature, and spring tree pollen were observed. By tracking and anticipating environmental and pollutant changes, efforts can be made to minimize AREDV. [ABSTRACT FROM AUTHOR]

The global population of perinatally HIV-exposed but uninfected (HEU) children is growing, with relatively little known about their psychosocial outcomes, particularly across adolescence and young adulthood. Using data from a longitudinal cohort study of HEU youth in New York City (N = 134), we examine rates of substance use disorders (SUD) and non-SUD psychiatric disorders (mood, anxiety, and behavioral) at five time-points during adolescence and young adulthood, as well as associated demographic and environmental factors and the association of ever having a disorder with young adult developmental milestones. HEU participants in this study experienced high rates of psychiatric disorders, particularly SUD in young adulthood. During the entire study period (2003–2018), over one third were diagnosed at least once with a SUD, and 69% were diagnosed with a non-SUD psychiatric disorder. Older age and female gender were associated with higher rates of non-SUD diagnoses. A history of meeting criteria for any disorder at any time point was associated with reduced odds in young adulthood of working or being in school and increased odds of reporting incarceration, homelessness, and recent condomless sex. There is an urgent need to develop systems to follow HEU youth and provide services to intervene and treat psychiatric disorders, including substance use. [ABSTRACT FROM AUTHOR]

Purpose: Evaluate the behavior of lung nodules occurring in areas of pulmonary fibrosis and compare them to pulmonary nodules occurring in the non-fibrotic lung parenchyma. Methods: This retrospective review of chest CT scans and electronic medical records received expedited IRB approval and a waiver of informed consent. 4500 consecutive patients with a chest CT scan report containing the word fibrosis or a specific type of fibrosis were identified using the system M*Model Catalyst (Maplewood, Minnesota, U.S.). The largest nodule was measured in the longest dimension and re-evaluated, in the same way, on the follow-up exam if multiple time points were available. The nodule doubling time was calculated. If the patient developed cancer, the histologic diagnosis was documented. Results: Six hundred and nine patients were found to have at least one pulmonary nodule on either the first or the second CT scan. 274 of the largest pulmonary nodules were in the fibrotic tissue and 335 were in the non-fibrotic lung parenchyma. Pathology proven cancer was more common in nodules occurring in areas of pulmonary fibrosis compared to nodules occurring in areas of non-fibrotic lung (34% vs 15%, p < 0.01). Adenocarcinoma was the most common cell type in both groups but more frequent in cancers occurring in non-fibrotic tissue. In the non-fibrotic lung, 1 of 126 (0.8%) of nodules measuring 1 to 6 mm were cancer. In contrast, 5 of 49 (10.2%) of nodules in fibrosis measuring 1 to 6 mm represented biopsy-proven cancer (p < 0.01). The doubling time for squamous cell cancer was shorter in the fibrotic lung compared to non-fibrotic lung, however, the difference was not statistically significant (p = 0.24). 15 incident lung nodules on second CT obtained ≤ 18 months after first CT scan was found in fibrotic lung and eight (53%) were diagnosed as cancer. Conclusions: Nodules occurring in fibrotic lung tissue are more likely to be cancer than nodules in the nonfibrotic lung. Incident pulmonary nodules in pulmonary fibrosis have a high likelihood of being cancer. [ABSTRACT FROM AUTHOR]

Hope for the future has been found protective against suicidal ideation (SI) in adolescents and young adults (AYA) yet has not been examined in AYA with perinatal HIV-infection (PHIV) or AYA who were perinatally HIV-exposed but uninfected (PHEU), who are at higher risk for SI than general populations. Using data from a New York City-based longitudinal study of AYAPHIV and AYAPHEU enrolled when 9–16 years old, we examined associations between hope for the future, psychiatric disorders, and SI over time using validated measures. Generalized estimating equations were used to estimate differences in mean hope for the future scores by PHIV-status and to estimate adjusted odds ratios for associations between hope for the future and SI. AYA reported high hope for the future scores and low SI across visits, irrespective of PHIV-status. Higher hope for the future scores were associated with lower odds of SI (AOR = 0.48, 95% CI: 0.23, 0.996). Mood disorder was associated with increased odds of SI (AOR = 13.57, 95% CI: 5.11, 36.05) in a model including age, sex, follow-up, PHIV-status, mood disorder, and hope for the future. Understanding how hope can be cultivated and how it protects against SI can help to inform preventive interventions for HIV-affected AYA. [ABSTRACT FROM AUTHOR]

Background: Triple‐combination therapy of elexacaftor‐tezacaftor‐ivacaftor (ETI) has been shown to reduce morbidity and mortality in people with cystic fibrosis (PwCF). Although patient body mass index (BMI) favorably increases with ETI treatment, factors contributing to this improvement are poorly characterized. Olfaction contributes to appetite stimulation and anticipation of eating, where higher rates of olfactory impairment (OI) in PwCF may contribute to malnutrition and BMI instability in this population. Methods: The authors performed a prospective cohort study analyzing 41 CF patient responses to the Cystic Fibrosis Questionnaire‐Revised (CFQR) and the 22‐Item Sino‐Nasal Outcome Test (SNOT‐22) and used generalized estimating equations to understand the change in survey variables from being untreated (baseline) to undergoing 3 months of ETI therapy (follow‐up). Results: Patients reported significant improvement in their sense of smell at follow‐up (p = 0.0036). Their improvements in sense of smell were not confounded by changes in rhinologic or extranasal rhinologic symptoms. Self‐reported quality of life (QoL) improved after 3 months of ETI therapy (p = < 0.0001) as did BMI (p = < 0.0001), but improved sense of smell did not independently mediate these changes in QoL and BMI. Conclusion: Our results support the impression that ETI therapy improves CF‐associated rhinologic symptoms and reverses OI, while contributing to improvement in rhinologic QoL. Sense of smell is not an independent mediator of improved QoL and BMI in this population, suggesting that other factors may have a stronger role in these realms. However, given the subjective improvement in sense of smell, additional evaluation of OI using psychophysical chemosensory assessment will clarify the connection between olfaction, BMI, and QoL in PwCF. [ABSTRACT FROM AUTHOR]

We investigated the psychometric properties of the Children's Hope Scale among a sample of 1,118 South Sudanese refugee children (570 girls, 548 boys) aged 9 to 14 years displaced in Uganda. We assessed the underlying factor structure and model fit through exploratory and confirmatory factor analyses and measurement invariance by sex and developmental stage. Confirmatory factor analysis revealed good fit for a one-factor model with the error terms of items 1 and 3 and items 4 and 6 allowed to covary. There was no evidence of differential item functioning by group. Evidence from this study supports the use of a unidimensional model of hopefulness across groups and signifies the importance of confirming these properties for measures used to evaluate humanitarian interventions. [ABSTRACT FROM AUTHOR]

Objective: Hispanics continue to face challenges when trying to access health care, including epilepsy care and genetic‐related health care services. This study examined epilepsy genetic knowledge and beliefs in this historically underserved population. Methods: Questionnaires were completed by 641 adults with epilepsy without identified cause, of whom 122 self‐identified as Hispanic or Latino and 519 as non‐Hispanic. Participants were asked about their views on the contribution of genetics to the cause of their epilepsy ("genetic attribution"), optimism for advancements in epilepsy genetic research ("genetic optimism"), basic genetic knowledge, and epilepsy‐specific genetic knowledge. Generalized linear models were used to compare the two groups in the means of quantitative measures and percents answered correctly for individual genetic knowledge items. Analyses were adjusted for age, sex, education, religion, family history of epilepsy, and time since last seizure. Results: Hispanics did not differ from non‐Hispanics in genetic attribution, genetic optimism, or number of six basic genetic knowledge items answered correctly. The number of nine epilepsy‐specific genetic knowledge items answered correctly was significantly lower for Hispanics than non‐Hispanics (adjusted mean = 6.0 vs. 6.7, p <.001). After adjustment for education and other potential mediators, the proportion answered correctly was significantly lower for Hispanics than non‐Hispanics for only two items related to family history and penetrance of epilepsy‐related genes. Only 54% of Hispanics and 61% of non‐Hispanics answered correctly that "If a person has epilepsy, his or her relatives have an increased chance of getting epilepsy." Significance: Despite large differences in sociodemographic variables including education, most attitudes and beliefs about genetics were similar in Hispanics and non‐Hispanics. Epilepsy‐specific genetic knowledge was lower among Hispanics than non‐Hispanics, and this difference was mostly mediated by differences in demographic variables. Genetic counseling should address key concepts related to epilepsy genetics to ensure they are well understood by both Hispanic and non‐Hispanic patients. [ABSTRACT FROM AUTHOR]

Background: Electronic adherence (EA) and tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) are objective measures of antiretroviral therapy (ART) adherence. We characterized the association between these measures in a prospective cohort of persons with HIV (PWH) on ART. Setting: Four primary health clinics in Cape Town, South Africa. Methods: We enrolled 250 virally suppressed PWH receiving tenofovir-based ART. We collected EA data, monthly viral load, and TFV-DP in DBS for 12 months. We used logistic regression to estimate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) for future viral breakthrough (VB) (>400 copies/mL) for each adherence measure. Receiver operating characteristics (ROCs) provided the predictive power of these measures. Results: Participants had a median (IQR) age of 34 (27–42); 78% were women. Twenty-one (8%) developed VB. Logistic regression showed that when percent EA and TFV-DP concentrations increased, the odds of VB decreased. This relationship was consistent at the time of VB (aOR of 0.41 [95% CI: 0.25 to 0.66] for TFV-DP and aOR of 0.64 [95% CI: 0.54 to 0.76] for EA) and for up to 2 months before VB. Both adherence measures predicted future VB at both 1 month and 2 months before viral load measurement. Conclusion: We established that 2 objective adherence measures, EA and TFV-DP in DBS, have a positive association with, and are both strongly predictive of, VB in a community-based South African cohort on ART. Future research is needed to determine the feasibility of implementing these adherence measures in resource-limited settings to facilitate adherence interventions. [ABSTRACT FROM AUTHOR]

Background: The effects of conflict and displacement on adolescent mental health and protection are profound and can have lasting consequences. We aimed to investigate the effectiveness of two group‐based psychosocial interventions on mental health and protection of South Sudanese refugee adolescents. Methods: A randomized controlled trial was done in four villages within the Omugo extension of Rhino Camp refugee settlement in the West Nile region of Uganda. Male and female adolescents (aged 9–14 years) were randomly assigned to attend 12 weeks of either a Standard psychosocial intervention delivered in a child‐friendly space (CFS) or a more structured sequential delivery of psychosocial sessions guided by a newly developed Toolkit for Child‐Friendly Spaces in Humanitarian Settings. The primary outcomes were psychological distress and resilience 12 months after baseline assessment. The trial is registered with ClinicalTrials.gov, NCT03897894. Results: Between May 28, 2019, and February 20, 2020, 1,280 eligible adolescents were recruited. With 70.2% retention at follow‐up, 214 assigned to the Standard, 211 assigned to the Toolkit, and 370 assigned to the waitlist control were included in the intention‐to‐treat and as‐treated analysis. Both the Toolkit and Standard approaches were more effective in reducing psychological distress and perceived protection risks reported by adolescents compared to no intervention. Differential intervention impacts are indicated in subgroup analyses. Conclusions: The trial found that both psychosocial interventions when implemented in a CFS are well suited as a first‐line mental health and violence prevention intervention for adolescent populations exposed to conflict and forced displacement. Where feasible, CFS should be implemented as a primary response strategy soon after displacement to improve psychological health and reduce the risk environment for adolescents. [ABSTRACT FROM AUTHOR]

In 8 public New York City sexual health clinics that implemented an HIV preexposure prophylaxis (PrEP) program in 2016, clinical providers' beliefs about PrEP varied; however, negative beliefs did not reduce provider likelihood of initiating eligible patients on PrEP. Women and Black and Latinx patients were less likely to be initiated on PrEP. Background: Oral HIV preexposure prophylaxis (PrEP) is safe and effective but underutilized. Health care providers' beliefs about PrEP and attitudes toward people who could benefit may affect PrEP access. Methods: This mixed-methods study (2016–2018) was conducted in 8 New York City public sexual health clinics that implemented a PrEP program. Data included 32 in-depth qualitative interviews with clinicians, quantitatively coded to reflect their PrEP beliefs; a provider questionnaire; and 6 months of medical record visit data for these providers. Among patients with a PrEP indication, we examined the odds of a patient being initiated on PrEP associated with providers' PrEP beliefs and demographic characteristics, and patient characteristics. Results: Providers reported strong support for offering PrEP to eligible patients. The majority denied concerns about possible development of drug-resistant viral strains, giving PrEP to people who might not benefit, and PrEP toxicity. Nevertheless, about one-third agreed with each of these concerns, and 55% thought PrEP use might limit condom use. Of 2176 patients with a PrEP indication, 20% were initiated. Providers with more restrictive PrEP beliefs did not have lower odds of initiating patients on PrEP. Women as well as Black and Latinx patients were less likely to be initiated on PrEP. Conclusions: Contrary to our hypotheses, providers' negative PrEP beliefs did not seem to reduce initiation of PrEP for eligible patients. This may be attributable to clear clinical protocols, strong staff support, and training on implementing PrEP in this setting. Racial and gender disparities in PrEP uptake urgently require attention. [ABSTRACT FROM AUTHOR]

An abstract of the article "Project control- evaluation of a brief HIV counseling video to improve risk reduction behavior of teenagers," by Yvette Calderon, Cheng-Shiun Leu, Ethan Cowan, Jillian Nickerson, and Christopher Brusalis is presented.

Right atrial pressure (RAP) reflects right-sided cardiac hemodynamics and is useful in management of patients with cardiac and systemic disease. Studies in older adults demonstrated that inferior vena cava (IVC) diameter, IVC collapsibility index, hepatic vein systolic filling fraction (SFF), and right atrial volume (RAV) correlated with mean RAP at catheterization. This study aimed to assess the utility of echocardiographic parameters for assessment of RAP in children and young adults. Patients with pulmonary hypertension or heart transplantation undergoing right heart catheterization were recruited for this prospective observational pilot study. Transthoracic echocardiographic assessment of RAP was performed simultaneously with catheterization. For each parameter, three consecutive cardiac cycles were recorded. Long- and short-axis images of the IVC were obtained. RAV was assessed by area-length and biplane methods. IVC diameters and RAV were indexed to body surface area (BSA) and (BSA), respectively. Relationships between echocardiographic parameters and mean RAP were correlated using 'Pearson's r.' Fifty subjects aged 0.3-23 years (median 13, mean 12.3 ± 7 years) were enrolled. Mean RAP correlated modestly with RAV ( r = 0.51, p < 0.001). Long-axis IVC ( r = 0.30, p < 0.05) and tricuspid E wave velocity ( r = 0.36, p < 0.01) also correlated with mean RAP. RV free wall tissue Doppler velocities, IVC collapsibility index, and hepatic vein SFF had no relation to mean RAP. In a pediatric and young adult population with pulmonary hypertension or heart transplantation, echocardiographic assessment of RAV and long-axis IVC provided a reasonable estimate of mean RAP. IVC collapsibility index and hepatic vein SFF demonstrated no association with mean RAP. [ABSTRACT FROM AUTHOR]

We examined youth-caregiver adherence report concordance and association of different adherence self-report items with HIV RNA viral load (VL) in perinatally HIV-infected adolescents assessed in 2003-2008. Youth ( n=194; 9-19 years) and their caregivers completed a multi-step 2-day recall, one item on last time medications were missed, and one item on responsibility for managing youths' medications. Across early (9-12 years), middle (13-15 years), and late (16+years) adolescence, both youth and caregivers reported having primary responsibility for youths' medication regimens and demonstrated poor to moderate youth-caregiver concordance on adherence items. Responses to the last-time-missed item had greater association with VL than did the 2-day recall, particularly for longer times (e.g., past month). By age group, significant associations with VL were found for caregiver reports in early adolescence, caregiver and youth reports in middle adolescence, and youth reports in late adolescence, suggesting that caregivers offer better reports of youth adherence during early adolescence, but by later adolescence, youth are better informants. Although design limitations preclude definitive conclusions about the reliability and validity of specific adherence items, this study suggests important issues related to age group, caregiver vs. youth informants of adherence, and recall periods for child adherence assessment that warrant further research. [ABSTRACT FROM AUTHOR]

• A retrospective analysis revealed mortality in patients with CF requiring advanced support is 37%. • Survival was similar with mechanical ventilation (MV) and extracorporeal membrane oxygenation (ECMO). • Length of stay after lung transplantation was significantly longer in patients supported with ECMO. • One and two year survival for those surviving ICU stay was similar in both groups. Despite therapeutic advances, people with cystic fibrosis (CF) develop progressive worsening and exacerbations of their lung disease, which can lead to acute respiratory failure. Historically, survival after mechanical ventilation (MV) has been poor. Outcomes related to use of extracorporeal membrane oxygenation (ECMO) have not been well described in CF. We conducted a retrospective analysis of adult patients with CF admitted to the ICU for acute respiratory failure and requiring invasive MV with or without ECMO between July 1, 2006 and June 30, 2016. Separate analysis for the subgroup of MV patients who were eligible for transplant was conducted. Mortality for all patients with respiratory failure requiring advanced support was 37%. Ten of 28 (36%) MV patients, 10 of 26 (38%) ECMO+MV patients and 7 of the 21 (33%) transplant eligible MV patients died. Intensive care unit (ICU) length of stay (LOS) was 24.5±16.6 days for ECMO+MV; 12.9±9.0 days for MV (p=0.001), and 12.3 ±10 days for transplant eligible MV patients (p=0.005 for ECMO+MV comparison). Seven transplant eligible MV patients (33%) and 16 ECMO+MV patients (62%) underwent lung transplantation (p<0.001) during the hospital admission. One and 2-year survival for individuals who survived ICU admission was similar regardless of mode of support. Cox-proportional hazards model did not yield any variables that significantly influenced ICU mortality, 1-year or 2-year mortality. Survival for CF patients with acute respiratory failure requiring MV with or without ECMO has improved over time. ECMO may be an appropriate modality for respiratory support in patients with CF and acute respiratory failure who have greater risk of death from MV alone. [ABSTRACT FROM AUTHOR]

Objectives. To use the Children’s Sleep Habits Questionnaire (CSHQ) to characterize sleep problems in a group of 5- to 6-year-old minority children living in urban communities and to compare our findings with data from 5- to 6-year-old children in the original CSHQ validation study. Methods. A cross-sectional study design was used to collect sleep data from parents using the CSHQ. Results. The CSHQ was completed by 160 parents; 150 (94%) scored ≥41, indicating a sleep problem. The prevalence of having sleep problems for our minority community sample was significantly higher than the original community sample (94% vs 23%, P < .001). The minority sample also had significantly higher mean total CSHQ scores (51.5 vs 37.9, P < .001) and higher scores across all 8 subscales of the CSHQ (P < .001 for all comparisons). Conclusions. The results suggest that sleep problems may be more prevalent in urban, early-school-aged minority children than previously reported. [ABSTRACT FROM PUBLISHER]

As the pediatric HIV epidemic in resource-rich countries evolves into an adolescent epidemic, there is a substantive need for studies elucidating mental health needs of perinatally HIV-infected (PHIV + ) youth as they transition through adolescence. This article examines the role of perinatal HIV infection in influencing mental health by comparing the changes in psychiatric disorders and substance use disorders (SUD) in PHIV + and perinatally HIV-exposed, but uninfected (PHIV − ) youth over time. Participants were recruited from four medical centers in New York City. Individual interviews were administered at baseline and 18-month follow-up to 166 PHIV + and 114 PHIV– youth (49% male, age 9–16 years at baseline). Youth psychiatric disorder was assessed using the caregiver and youth versions of the Diagnostic Interview Schedule for Children (DISC-IV). Over two-thirds of participants met criteria for at least one psychiatric disorder at either baseline or follow-up, with few group differences. Among PHIV + youth, there was a significant decrease in the prevalence of any psychiatric disorder, as well as anxiety disorders specifically over time, whereas the prevalence of any psychiatric disorder among PHIV– youth remained the same and mood disorders increased. Rates of SUD were low in both groups, increasing slightly by follow-up. PHIV + youth reported more use of mental health services at follow-up. CD4 count and HIV RNA viral load were not associated with the presence or absence of disorder at either time point. In conclusion, among PHIV + and PHIV− youth, the rates of psychiatric disorder were high, even compared to other vulnerable populations, suggesting that factors other than perinatal HIV infection may be important determinants of mental health. PHIV + youth were more likely to improve over the observation period. The data underscore the critical need for mental health interventions for both PHIV + and PHIV− youth. [ABSTRACT FROM PUBLISHER]

Background: The purpose of this study was to examine 1) the prevalence of psychiatric and substance use disorders in perinatally HIV-infected (HIV+) adolescents and 2) the association between HIV infection and these mental health outcomes by comparing HIV+ youths to HIV exposed but uninfected youths (HIV-) from similar communities. Methods: Data for this paper come from the baseline interview of a longitudinal study of mental health outcomes in 9-16 year old perinatally HIV-exposed youths (61% HIV+) and their caregivers. Three hundred forty youths and their primary adult caregivers were recruited from four medical centers and participated in separate individual interviews. Youth psychiatric disorder was assessed using the caregiver and youth versions of The Diagnostic Interview Schedule for Children (DISC-IV). Results: According to caregiver or youth report, a high percentage of HIV+ and HIV- youths met criteria for a non-substance use psychiatric disorder, with significantly higher rates among the HIV+ youths (61% vs. 49%, OR = 1.59; CI = 1.03,2.47; p < .05). The most prevalent diagnoses in both groups were anxiety disorders (46% for total sample) which included social phobia, separation anxiety, agoraphobia, generalized anxiety disorder, panic disorder, obsessive- compulsive disorder, and specific phobias. One quarter of the sample met criteria for a behavioral disorder (ADHD, conduct disorders, and oppositional defiant disorders), with ADHD being most prevalent. HIV+ youths had significantly higher rates of ADHD (OR = 2.45; CI = 1.20, 4.99, p < .05). Only 7% of youths met criteria for a mood disorder and 4% for a substance abuse disorder. Several caregiver variables (caregiver type and HIV status) were also associated with both child HIV status and mental health outcomes. Conclusions: Our data suggest that HIV+ youths are at high risk for mental health disorders. Further longitudinal research is necessary to understand the etiology, as well as potential protective factors, in order to inform efficacy-based interventions. [ABSTRACT FROM AUTHOR]

Objectives. We evaluated female-condom use among women participating in an HIV/STD intervention designed to reduce unprotected sex and expand prevention strategies. Methods. Women (n=360) were recruited from a family-planning clinic and were randomized into an 8- or 4-session intervention group or a control group. We conducted follow-up interviews at 1, 6, and 12 months. Results. At 1 month, the odds ratios of first-time female-condom use were 9.49 (95% confidence interval [Cl]=4.01, 22.20) in the 8-session group and 4.39 (95% Cl=1.84, 10.49) in the 4-session group relative to controls. Repeated use (n=21) was predicted by perceived ability to use, by self and partner satisfaction, by dislike of male condoms, and by previous diaphragm use. Conclusions. Gender sensitive cognitive-behavioral interventions can influence women to try the female condom. To increase long-term use, interventions may need to include self-insertion practice and involvement of male partners. (Am J Public Health. 2003; 93:1897-1903) [ABSTRACT FROM AUTHOR]

Background: Suicide is a leading cause of death among adolescents and young adults (AYA). AYA living with perinatally acquired HIV infection (AYALPHIV) are at higher risk of attempted suicide when compared with AYA who were perinatally HIV-exposed but uninfected (AYAPHEU). To inform interventions, we identified risk and protective factors of attempted suicide among AYALPHIV and AYAPHEU. Setting: Data were obtained from a longitudinal New York City–based study of AYALPHIV and AYAPHEU (n = 339; enrollment age 9–16 years) interviewed approximately every 12–18 months. Method: Our main outcome was suicide attempt at any follow-up. The DISC was used to assess psychiatric disorder diagnoses and attempted suicide and the Child Depression Inventory to assess depressive symptoms. Psychosocial and sociodemographic risk factors were also measured. Analyses used backward stepwise logistic regression modeling. Results: At enrollment, 51% was female individuals, 49% Black, 40% Latinx, and 11% both Black and Latinx. Attempted suicide prevalence was significantly higher among AYALPHIV compared with AYAPHEU (27% vs 16%, P = 0.019), with AYALPHIV having 2.21 times the odds of making an attempt [95% confidence interval: (1.18 to 4.12), P = 0.013]. Higher Child Depression Inventory scores were associated with an increased risk of attempted suicide in both groups and the total sample. The presence of DISC-defined behavior disorder increased the risk of attempted suicide in the total sample and the AYALPHIV subgroup. Religiosity was protective of attempted suicide in AYALPHIV. Conclusions: AYALPHIV had increased suicide attempts compared with AYAPHEU. Religiosity was protective in AYALPHIV. Highlighting a need for prevention of early mental health challenges was associated with risk. [ABSTRACT FROM AUTHOR]

Despite calls for evidence-based HIV/STI prevention programs for youth aged 12 to 14 transitioning to adolescence, few effective programs exist. In a two-group intent-to-treat randomized trial in the Bronx, NY, 397 participants were randomly assigned to Project Prepared or an attention control, TEEN. Participants completed surveys at baseline, 6 months, and 12 months. Prepared had two components, an 11-session program and a 3-week internship. Content covered sexual risk behavior, social cognitions, gender norms, relationships, and resilience. TEEN built communication skills and had the same intensity and structure as Prepared but no sexual content. In both, boys and girls were trained together in mixed groups of ~ 11 teens. Primary outcomes were HIV knowledge, self-efficacy, condom outcome expectancy, and behavioral intentions. Secondary outcomes were relationship expectations and endorsement of risky gender norms. Generalized estimating equation analyses showed youth randomized to Prepared had significant improvements compared to TEEN at T2 in HIV knowledge, sexual self-efficacy, and outcome expectancy for condom use. At T3, there were significant differences favoring Prepared in outcome expectancy for condom use, sexual self-efficacy, and intention for partner communication about HIV/AIDS or STIs. Analyses by gender showed program effects in both boys (intention to talk to a partner about condom use, abstinence self-efficacy, sexual self-efficacy, and condom outcome expectancy) and girls (gender norms, and abstinence outcome expectancy). Prepared effectively reduced risk in young adolescents. ClinicalTrials.gov ID: NCT01880450, Protocol ID: 2008-551 [ABSTRACT FROM AUTHOR]

First-time antiretroviral therapy (ART) initiators may be more vulnerable to poor ART adherence because they may be coping with a new HIV diagnosis, facing logistical challenges to accessing and adhering to ART for the first time, and have not yet developed support networks or the skills to support long-term adherence. We recruited 324 participants in two HIV clinics near Cape Town, South Africa. Sociodemographic/psychosocial factors were measured at baseline and self-reported adherence at the 6 month follow-up. We conducted multivariable regression to determine which baseline factors were associated with 6-month adherence. A better patient-clinic relationship score (OR: 1.08 [95% CI: 1.05–1.11]) was associated with higher adherence. A drug use problem (0.51 [0.29–0.87]), higher social isolation (0.93 [0.87–0.99]), and greater number of years living with HIV before initiating ART (0.92 [0.86–1.00]) were associated with adherence levels below 90%. Patient-clinic relationships and social support are key psycho-social factors in early adherence behavior. Reducing drug use problems through targeted screening and early intervention may improve ART adherence. [ABSTRACT FROM AUTHOR]

Artificial intelligence technology is becoming more prevalent in health care as a tool to improve practice patterns and patient outcomes. This study assessed ability of a commercialized artificial intelligence (AI) mobile application to identify and improve bodyweight squat form in adult participants when compared to a physical therapist (PT). Participants randomized to AI group (n = 15) performed 3 squat sets: 10 unassisted control squats, 10 squats with performance feedback from AI, and 10 additional unassisted test squats. Participants randomized to PT group (n = 15) also performed 3 identical sets, but instead received performance feedback from PT. AI group intervention did not differ from PT group (log ratio of two odds ratios = − 0.462, 95% confidence interval (CI) (− 1.394, 0.471), p = 0.332). AI ability to identify a correct squat generated sensitivity 0.840 (95% CI (0.753, 0.901)), specificity 0.276 (95% CI (0.191, 0.382)), PPV 0.549 (95% CI (0.423, 0.669)), NPV 0.623 (95% CI (0.436, 0.780)), and accuracy 0.565 95% CI (0.477, 0.649)). There was no statistically significant association between group allocation and improved squat performance. Current AI had satisfactory ability to identify correct squat form and limited ability to identify incorrect squat form, which reduced diagnostic capabilities. Trial Registration NCT04624594, 12/11/2020, retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Evidence is conflicting regarding differential health outcomes in racial and ethnic minorities with cystic fibrosis (CF), a rare genetic disease affecting approximately 28,000 Americans. We performed a cross-sectional analysis of health outcomes in Black/Latinx patients compared with non-Hispanic Caucasian patients cared for in a CF center in New York City. Adult patients enrolled in the CF Foundation Patient Registry at the Columbia University Adult CF Program and seen at least once during 2019 were included. Health metrics were compared between Black/Latinx and non-Hispanic Caucasian patients.Results: 262 patients were eligible. 39 patients (15%) identified as Black/Latinx or non-Hispanic Caucasian. Descriptive statistics are reported with mean (standard deviation). Current age was 35.9 (13.3) years for non-Hispanic Caucasian and 32.0 (9.3) years for Black/Latinx patients (p = 0.087). Age of diagnosis did not differ between groups; 9.56 (15.96) years versus 11.59 (15.8) years for non-Hispanic Caucasian versus Black/Latinx respectively (p = 0.464). Pulmonary function, measured as mean forced expiratory volume in one second (FEV1) was 70.6 (22.5) percent predicted in non-Hispanic Caucasian versus 59.50 (27.9) percent predicted in Black/Latinx patients (p = 0.010). Number of visits to the CF clinic were similar between groups. When controlled for age, gender, co-morbidities, median income, and insurance status, there was a continued association between minority status and lower FEV1.Conclusions: Minorities with CF have significantly lower pulmonary function, the major marker of survival, than non-Hispanic Caucasians, even when controlled for a variety of demographic and socioeconomic factors that are known to affect health status in CF. Significant health disparities based on race and ethnicity exist at a single CF center in New York City, despite apparent similarities in access to guideline based care at an accredited CF Center. This data confirms the importance of design of culturally appropriate preventative and management strategies to better understand how to direct interventions to this vulnerable population with a rare disease. [ABSTRACT FROM AUTHOR]

Despite expanded antiretroviral therapy (ART) eligibility in South Africa, many people diagnosed with HIV do not initiate ART promptly, yet understanding of the reasons is limited. Using data from an 8-month prospective cohort interview study of women and men newly-diagnosed with HIV in three public-sector primary care clinics in the eThekwini (Durban) region, South Africa, 2010–2014, we examined if theoretically-relevant social-structural, social-cognitive, psychosocial, and health status indicators were associated with time to ART initiation. Of 459 diagnosed, 350 returned to the clinic for their CD4+ test results (linkage); 153 (33.3%) were ART-eligible according to treatment criteria at the time; 115 (75.2% of those eligible) initiated ART (median = 12.86 weeks [95% CI: 9.75, 15.97] after linkage). In adjusted Cox proportional hazard models, internalized stigma was associated with a 65% decrease in the rate of ART initiation (Adjusted hazard ratio [AHR] 0.35, 95% CI: 0.19–0.80) during the period less than four weeks after linkage to care, but not four or more weeks after linkage to care, suggesting that stigma-reduction interventions implemented shortly after diagnosis may accelerate ART uptake. As reported by others, older age was associated with more rapid ART initiation (AHR for 1-year age increase: 1.04, 95% CI: 1.01–1.07) and higher CD4+ cell count (≥300μL vs. <150μL) was associated with a lower rate of initiation (AHR 0.38, 95% CI: 0.19–0.80). Several other factors that were assessed prior to diagnosis, including stronger belief in traditional medicine, higher endorsement of stigma toward people living with HIV, food insecurity, and higher psychological distress, were found to be in the expected direction of association with ART initiation, but confidence intervals were wide and could not exclude a null finding. [ABSTRACT FROM AUTHOR]

Objective: Human immunodeficiency virus (HIV) prevention efficacy trials with psychiatric patients have been conducted in research settings in high-resourced countries, establishing short-term efficacy for reducing sexual risk behavior. None has been implemented within systems of care. In the last decade, overcoming this research-to-practice gap has become a focus of implementation science. This paper describes the first and only HIV Prevention intervention trial for psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers. Methods: The HIV Prevention intervention, which uses the Information-Motivation-Behavioral Skills model to achieve sexual risk-reduction, was rigorously adapted to the local context and clinic services' needs. Participants from eight clinics were randomized to HIV Prevention or Health Promotion conditions. Results: HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions. Conclusion: Our trial was conducted before implementation studies became widely funded. Transporting an intervention to a new culture or into real-world practice settings may require adaptations. Our results demonstrate that clear guidelines are needed regarding whether to conduct efficacy, effectiveness, and/or implementation research as the most appropriate next step. [ABSTRACT FROM AUTHOR]

We introduce a family of sequential test procedures in the context of a futility study design, or as we prefer to call it, a formal test of promise, suitable for use with time-to-event data. The procedures are motivated by an actual trial that was undertaken to test the promise of very early antiretroviral therapy to achieve viral remission in infants with perinatally-acquired HIV. Important gains in efficiency are illustrated in terms of early stopping and statistical power compared with other methods such as Simon's two-stage design with binary outcomes. We show how to calculate the operating characteristics of the proposed sequential tests of promise and provide optimal or near-optimal boundaries for small or medium size samples which provide the typical context for the tests under consideration. The design features discussed in this article are also of immediate pertinence to trials designed to test disease cures which may require treatment interruption and small numbers of participants. [ABSTRACT FROM AUTHOR]

Within Asia, HIV prevalence is highest in Thailand, including thousands of children and adolescents. Care for children born with HIV [perinatal transmission of HIV (PHIV)] will need to focus on adolescents for the foreseeable future. Thai PHIV adolescents experience significant mental health and psychosocial challenges, including treatment adherence. Yet, few, if any, comprehensive interventions for them exist. CHAMP+, an evidence-based intervention adapted for Thailand, was evaluated with a pilot randomized control trial at four HIV clinics. Eighty-eight dyads of 9- to 14-year-old PHIV young adolescents/caregivers were randomized to CHAMP+ or standard of care (SOC). Eleven cartoon-based sessions were delivered over 6 months. Participants completed baseline, 6-month (postintervention), and 9-month surveys, measuring youth outcomes (e.g., mental health and adherence), contextual factors (e.g., demographics and caregiver factors), and self- and social-regulation factors (e.g., HIV knowledge and youth-caregiver communication). Multi-level modeling to account for clustering within individuals was used to assess longitudinal changes within and between groups. All families randomized to CHAMP+ completed the intervention. Although the study was not statistically powered to detect differences in treatment effects, the CHAMP+ group significantly improved at 6 months in youth mental health and adherence, HIV knowledge, youth-caregiver communication, internalized stigma, and HIV-related social support, with most improvements sustained at 9 months and significantly better improvements than the SOC group on a number of outcomes. High levels of baseline viral suppression highlight the importance of reaching these young PHIV adolescents at a period of lower risk before adherence and other challenges emerge. Designed to be delivered with limited cost/resources, CHAMP+ Thailand holds scale-up potential. [ABSTRACT FROM AUTHOR]

Greater acknowledgement of the ways in which social determinants influence health has led to increased engagement of Community Health Workers (CHWs) in health promotion activities. This study sought to evaluate changes in CHW knowledge and beliefs via pre-/post-training surveys immediately following a four-day (∼20 hour) oral health intervention training and to gather CHW feedback on training. Significant increases in summary scores for 19 knowledge (t(9) = −6.715, p < .001) and four belief (t(9) = −2.994, p = .015) measures, using four-point Likert scales, were observed post-training. Feedback was overwhelmingly positive, with the majority of CHWs reporting confidence in understanding the material and study purpose. Findings support the effectiveness and acceptability of a brief training program to prepare CHWs to deliver an oral health intervention. CHWs hold promise to effectively engage populations in which the impact of interventions delivered by traditional oral healthcare team members has shown limited success. [ABSTRACT FROM AUTHOR]

Objective: A cross-sectional study was conducted to determine if in-school physical activity (PA) varied by age, gender, weight and asthma status, participation in physical education (PE), outdoor recess, and other in-school PA among urban schoolchildren with asthma. Methods: PA was measured by tri-axial accelerometers. Height and mass were measured and overweight defined as BMI ≥85th percentile. Asthma impairment and risk were assessed as per national guidelines, and asthma status variable with three categories (mild, moderate, and severe) was created. Multivariable generalized linear mixed models adjusting for clustering due to school and student were fitted to identify variables predictive of PA. Results: 108 children with asthma participated. Children spent 374 minutes in school, of which 253 minutes were sedentary, 105 minutes in light PA, and 16 minutes in moderate-to-vigorous PA (MVPA). Only 3 participants reached the recommended ≥30 minutes/day of MVPA. Multivariable analysis revealed age, gender, participation in PE class, outdoor recess, and other in-school PA as independent predictors of PA. BMI and asthma status were not associated with PA. Conclusions: Children with asthma were mostly sedentary at school. Older children and girls were particularly at risk for inactivity. PE, recess, and other in-school PA participation are modifiable factors that should be targeted in school-based interventions aimed at increasing PA in this population. [ABSTRACT FROM AUTHOR]

• A quarter of patients gave responses indicating that they had high adherence to their ASM regimen. • The odds of high adherence increased with increases in patients' understanding of their epilepsy. • The odds of high adherence decreased with increases in overall life impact and emotional impact of epilepsy. We assessed the relationship of epilepsy illness perceptions to antiseizure medication (ASM) adherence. Surveys were completed by 644 adult patients with epilepsy of unknown cause. We used the Morisky Medication Adherence Scale-8 (MMAS-8) to define "high" adherence (score = 8) and "low-medium" adherence (score < 8). We evaluated epilepsy illness perceptions using seven items from the Brief Illness Perception Questionnaire (BIPQ), each scored from 0-10, measuring participants' views of the overall effect of epilepsy on their lives, how long it would last, how much control they had over their epilepsy, the effectiveness of their treatment, level of concern about epilepsy, level of understanding of epilepsy, and emotional impact of epilepsy. We investigated the association of each BIPQ item with medication adherence using logistic regression models that controlled for potential confounders (age, race/ethnicity, income, and time since the last seizure). One hundred forty-nine patients (23%) gave responses indicating high adherence. In the adjusted models, for each 1-unit increase in participants' BIPQ item scores, the odds of high adherence increased by 17% for understanding of their epilepsy (OR = 1.17, 95% CI 1.07–1.27, p < 0.001), decreased by 11% for overall life impact of epilepsy (OR = 0.89, 95% CI 0.82–0.97, p = 0.01) and decreased by 6% for emotional impact of epilepsy (OR = 0.94, 95% CI 0.86–0.99, p = 0.03). No other illness perception was associated with high adherence. Depression, anxiety, and stigma mediated the inverse relationships of high adherence to the overall life impact of epilepsy and the emotional impact of epilepsy. These measures did not mediate the relationship of high adherence to the perceived understanding of epilepsy. These results indicate that a greater perceived understanding of epilepsy is independently associated with high ASM adherence. Programs aimed at improving patients' understanding of their epilepsy may help improve medication adherence. [ABSTRACT FROM AUTHOR]

Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)—if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18–64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP. [ABSTRACT FROM AUTHOR]

Among South African university students, HIV prevalence is lower than in age-peers, but at 3.8% it is not negligible. We examined prevalence of factors potentially associated with HIV risk, focusing on partnership characteristics and consistent condom use. We hypothesised that contraceptive-related factors, for example, desire to prevent pregnancy and not using hormonal contraceptives, would be positively associated with consistent condom use. Data were drawn from a representative interviewer-administered survey of 2nd to 4th year students conducted during registration at a university campus in KwaZulu-Natal. Of 576 students, 218 (83 women, 135 men) reported vaginal intercourse in the past 2 months. Of these, 7% of women and 43% of men reported past-year concurrent partnerships, and 24% knew/ suspected partner non-monogamy. Although reported condom use at last intercourse was 90%, 2-month consistent use was 53% (women) and 73% (men). Reported hormonal contraception use was low (women: 36.8%; men: 16.7%), and 68% used condoms for dual protection. In gender-stratified multivariable analyses, consistent condom use was higher for men who reported their partner did not use (vs. used) hormonal contraception (aOR = 5.84; 95%CI = 2.71, 12.57;p< 0.001) and who reported using condoms for dual protection (vs. single protection) (aOR = 2.46; 95%CI = 1.43, 4.25;p= 0.001). No contraception-related factors were associated with consistent condom use among women. Sexual partnership characteristics potentially place sexually active university students at high HIV risk and should be investigated further. Among men, but not women, contraceptive concerns were associated with consistent condom use. Promoting condoms for dual protection may resonate with students and should be continued. [ABSTRACT FROM AUTHOR]

Background Given the high prevalence of mental health (MH) and substance abuse problems in low-to-middle income countries, the scarcity of MH professionals and the negative impact of psychiatric disorders on caregivers of young children, there is significant need for brief evidence-based screening tools for lay counselors to assist with MH assessment. This study aimed to validate a brief screening tool to assess psychiatric and substance use disorders, the Client Diagnostic Questionnaire (CDQ), in South Africa (SA). Methods Data are from a longitudinal study of health and psychosocial needs in preschool children in SA. Participants included 322 Zulu-speaking, female caregivers. Following procedures of the US CDQ validation study, lay counselors interviewed participants using the translated Zulu CDQ. Subsequently a psychologist conducted a full psychiatric assessment guided by the CDQ questions. Analyses examined sensitivity, specificity and overall accuracy, comparing lay counselor and psychologist assessment. Results Sensitivity (73%), specificity (81%) and overall accuracy (79%) were good for the variable indicating presence of 'any diagnosis.' Among those cases identified by the psychologist as having any psychiatric diagnosis, over 70% were correctly identified by lay counselors using the CDQ (i.e., positive predictive value was greater than 70%). The false positive rate was relatively low (19%). Specificity for 'any disorder' (including substance use) and 'any psychiatric disorder' were 81% and 79%. Conclusions The isiZulu CDQ is a sensitive and valid MH diagnostic screener that can be used by lay counselors with limited MH training to identify those in need of treatment and target extremely scarce MH professionals. Copyright © 2016 John Wiley & Sons, Ltd. Key Practitioner Messages South Africa (SA), a country heavily impacted by poverty, HIV and the legacy of Apartheid, has a high prevalence of mental health (MH) and substance abuse problems., In SA and other low-and-middle-income-countries (LMIC) there is a dearth of MH professionals., This study examined use and validity of the Client Diagnostic Questionnaire (CDQ), a brief diagnostic MH screening tool designed for use by lay counselors in HIV-affected populations., Comparing lay counsellor diagnoses on the CDQ to clinician assessment, sensitivity, specificity and overall accuracy were good at the level of 'any diagnosis.', The CDQ can be used effectively in SA and other LMIC with limited MH services to enable appropriate and efficient referral of individuals in primary care settings, supporting caregivers and the children in their care. [ABSTRACT FROM AUTHOR]

Background: Timely linkage to care by newly-diagnosed HIV+ individuals remains a significant challenge to achieving UNAIDS 90-90-90 goals. Current World Health Organization (WHO) guidelines recommend initiating anti-retroviral treatment (ART) regardless of CD4+ count, with priority given to those with CD4+ <350 cells/μl. We evaluated the impact of not having a day-of-diagnosis CD4+ count blood draw, as recommended by South African guidelines, on time to linkage, using data from a prospective cohort study. Methods: Individuals (N = 2773) were interviewed prior to HIV counseling and testing at three public sector primary care clinics in the greater Durban area; 785 were newly-diagnosed and eligible for the cohort study; 459 (58.5%) joined and were followed for eight months with three structured assessments. Linkage to care, defined as returning to clinic for CD4+ count results, and day-of-diagnosis blood draw were self-reported. Results: Overall, 72.5% did not have a day-of-diagnosis CD4+ count blood draw, and 19.2% of these never returned. Compared with a day-of-diagnosis blood draw, the adjusted hazard ratio of linkage (AHRlinkage) associated with not having day-of-diagnosis blood draw was 0.66 (95%CI: 0.51, 0.85). By 4 months, 54.8% of those without day-of-diagnosis blood draw vs. 75.2% with one were linked to care (chi-squared p = 0.004). Of those who deferred blood draw, 48.3% cited clinic-related and 51.7% cited personal reasons. AHRlinkage was 0.60 (95%CI: 0.44, 0.82) for clinic-related and 0.53 (95%CI: 0.38, 0.75) for personal reasons relative to having day-of-diagnosis blood draw. Conclusions: Newly-diagnosed HIV+ individuals who did not undergo CD4+ count blood draw on the day they were diagnosed—regardless of the reason for deferring—had delayed linkage to care relative to those with same-day blood draw. To enhance prompt linkage to care even when test and treat protocols are implemented, all diagnostic testing required before ART initiation should be performed on the same day as HIV testing/diagnosis. This may require modifying clinic procedures to enable overnight blood storage if same-day draws cannot be performed, and providing additional counseling to encourage newly-diagnosed individuals to complete day-of-diagnosis testing. Tracking HIV+ individuals via clinic registries should commence immediately from diagnosis to reduce these early losses to care. [ABSTRACT FROM AUTHOR]

Increasing numbers of perinatally HIV (PHIV+)-infected youth are surviving into adulthood with better access to treatment. However, few studies examine positive outcomes in the face of adversity (resilience) for PHIV+ youth. Social Action Theory (SAT) provided the theoretical framework for this study of PHIV + youth in South Africa (SA), allowing examination of contextual, social, and self-regulatory factors that influence behavioral health. Data were from youth and caregiver baseline interviews, simply pooled from a pilot (N=66) and larger (n=111) randomized control trial (RCT) of the VUKA Family program. For this analysis, outcomes included emotional and behavioral functioning (total difficulties), and prosocial behaviors. Potential SAT correlates included socio-demographics; caregiver health and mental health; parent-child relationship factors; stigma, and child coping, support; and self-esteem. Regression analyses adjusted for age, gender, and study revealed significant associations at the contextual, social, and self-regulation level. Lower total child difficulties scores were associated with lower caregiver depression (β = 3.906,p < .001), less caregiver-reported communication about difficult issues (β = 1.882, p = .009) and higher youth self-esteem (β =-0.119, p = .020). Greater prosocial behaviors were associated with greater caregiver-reported communication (β = 0.722, p = .020) and child use of wishful thinking for coping (β = 5.532, p = .009). Less youth depression was associated with higher caregiver education (β =−0.399, p = .010), greater caregiver supervision (β =−1.261, p = .012), more social support seeking (β =−0.453, p = .002), higher youth self-esteem (β =−0.067, p < .001), lower internalized stigma (β = 0.608, p = .040), and child use of resignation for coping (β = 1.152, p = .041). Our data support evidence-based family interventions that also promote youth self-regulation skills to enhance the health and mental health of PHIV+ youth. [ABSTRACT FROM PUBLISHER]

Objectives: The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. Methods: MSM and TGW aged 18–30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel. Results: 248 participants were enrolled into Stage 1A. Participants’ average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity. Conclusions: In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population. Trial Registration: ClinicalTrials.gov [ABSTRACT FROM AUTHOR]

This pilot study evaluated a 15-session classroom intervention for HIV and pregnancy prevention among grade 8–10 boys and girls (aged 14–17 years) in rural South Africa, guided by gender-empowerment theory and implemented by teachers, nurses, and youth peer educators. Pre- and post-intervention surveys included 933 male and female students in two intervention and two comparison schools. The main outcome was condom use at last sex; secondary outcomes were partner communication, gender beliefs and values, perceived peer behaviors, and self-efficacy for safer sex. At 5 months post-intervention, change in condom use did not differ between intervention and comparison schools. Intervention school youth had greater increases in self-efficacy for unsafe sex refusal (odds ratio [OR] 1.61, 95% confidence interval [CI] 1.01–2.57) and condom use (OR 1.76, 95% CI 1.07–2.89), partner communication (OR 2.42, 95% CI 1.27–4.23), and knowledge of HIV testing opportunities (OR 1.76, 95% CI 1.08–2.87). This gender-focused pilot intervention increased adolescents’ self-efficacy and partner communication and has potential to improve preventive behaviors. [ABSTRACT FROM AUTHOR]

This study describes sexual health knowledge in perinatally HIV-infected (PHIV+) and perinatally exposed uninfected (PHIV−) ethnic-minority youth, aged 9–16 years, residing in New York City (N = 316). Data on youth sexual health knowledge (e.g., pregnancy, sexually transmitted diseases, birth control) and caregiver–adolescent communication about sexual health were examined. Participants in both groups answered only 35% of the sexual health knowledge questions correctly (mean = 6.6 of 19). Higher scores were found among youth who reported more communication about sex with caregivers (vs. those who did not report talking about sex with caregivers; 8.54 vs. 5.84,p < .001) and among PHIV+ youth who were aware of their status (vs. PHIV+ youth who were not; 7.27 vs. 4.70,p < .001). Age was positively correlated with sexual health knowledge (β = .489,p < .001). Both PHIV+ and PHIV− youth had poor sexual health knowledge, suggesting a need for sexual health education for both groups. Data suggest that interventions focused on caregiver–child risk communication may be important for prevention. [ABSTRACT FROM AUTHOR]