Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study.

Background: Long-acting cabotegravir and long-acting rilpivirine constitute a completely intramuscular antiretroviral therapy (ART) regimen for adults with HIV. We aimed to assess the safety, antiviral activity, and pharmacokinetics of oral cabotegravir and rilpivirine followed by a combination of long-acting cabotegravir and long-acting rilpivirine in virologically suppressed adolescents with HIV.

Methods: The IMPAACT 2017/MOCHA study is a phase 1/2, multicentre, open-label, non-comparative, dose-finding trial being conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA.

Cognitive Behavioral Therapy Factors Related to Outcomes in Depression Among Youth with HIV.

Purpose: This is a secondary analysis of a multi-site, cluster (site) randomized trial of the efficacy of a combined Health and Wellness Cognitive Behavior Therapy (H&W CBT) and medication management approach for depression in youth with HIV (YWH) compared to standard care. In this study, we explored the association between H&W CBT factors and depression outcomes after 24 weeks of treatment to discover treatment elements associated with symptom reduction.

Methods: Participants (12-24 years of age) were YWH in the United States (US) diagnosed with moderate to severe depression [Quick Inventory of Depressive Symptomatology (QIDS), Clinician-Rated score ≥ 11].

Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study.

Background: Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents.

Methods: In this phase 1/2, multicentre, open-label, non-comparative, dose-finding study, virologically suppressed adolescents (aged 12-17 years; weight ≥35 kg; BMI ≤31·5 kg/m) with HIV-1 on daily oral ART were enrolled at 15 centres in four countries (Botswana, South Africa, Thailand, and the USA).

Bone and Renal Health in Infants With or Without Breastmilk Exposure to Tenofovir-Based Maternal Antiretroviral Treatment in the PROMISE Randomized Trial.

Background: We assessed bone and kidney outcomes in infants randomized postdelivery as mother-infant pairs within the IMPAACT PROMISE trial to maternal tenofovir disoproxil fumarate-based antiretroviral treatment (mART) or infant nevirapine prophylaxis (iNVP) to prevent breastfeeding HIV transmission.

Methods: Infants were coenrolled in the P1084s substudy on randomization day and followed through Week 74. Lumbar spine bone mineral content (LS-BMC) was assessed at entry (6-21 age days) and Week 26 by dual-energy x-ray absorptiometry.

Forty-Eight Week Outcomes of a Site-Randomized Trial of Combined Cognitive Behavioral Therapy and Medication Management Algorithm for Treatment of Depression Among Youth With HIV in the United States.

Background: Studies suggest that manualized, measurement-guided, depression treatment is more efficacious than usual care but impact can wane. Our study among youth with HIV (YWH), aged 12-24 years at US clinical research sites in the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, found a significant reduction in depressive symptoms among YWH who received a manualized, measurement-guided treatment. This paper reports outcomes up to 24 weeks after the intervention.

Healthcare-Seeking Behavior for Respiratory Illness Among Flu Near You Participants in the United States During the 2015-2016 Through 2018-2019 Influenza Seasons.

Background: Flu Near You (FNY) is an online participatory syndromic surveillance system that collects health-related information. In this article, we summarized the healthcare-seeking behavior of FNY participants who reported influenza-like illness (ILI) symptoms.

Methods: We applied inverse probability weighting to calculate age-adjusted estimates of the percentage of FNY participants in the United States who sought health care for ILI symptoms during the 2015-2016 through 2018-2019 influenza season and compared seasonal trends across different demographic and regional subgroups, including age group, sex, census region, and place of care using adjusted χ 2 tests.

Radiomics of Coronary Artery Calcium in the Framingham Heart Study.

Purpose: To extract radiomic features from coronary artery calcium (CAC) on CT images and to determine whether this approach could improve the ability to identify individuals at risk for a composite endpoint of clinical events.

Materials And Methods: Participants from the Offspring and Third Generation cohorts of the community-based Framingham Heart Study underwent noncontrast cardiac CT (2002-2005) and were followed for more than a median of 9.1 years for composite major events.

Differences in Regional Patterns of Influenza Activity Across Surveillance Systems in the United States: Comparative Evaluation.

Background: The Centers for Disease Control and Prevention (CDC) tracks influenza-like illness (ILI) using information on patient visits to health care providers through the Outpatient Influenza-like Illness Surveillance Network (ILINet). As participation in this system is voluntary, the composition, coverage, and consistency of health care reports vary from state to state, leading to different measures of ILI activity between regions. The degree to which these measures reflect actual differences in influenza activity or systematic differences in the methods used to collect and aggregate the data is unclear.

Density and morphology of coronary artery calcium for the prediction of cardiovascular events: insights from the Framingham Heart Study.

Objectives: To investigate the association between directly measured density and morphology of coronary artery calcium (CAC) with cardiovascular disease (CVD) events, using computed tomography (CT).

Methods: Framingham Heart Study (FHS) participants with CAC in noncontrast cardiac CT (2002-2005) were included and followed until 2016. Participants with known CVD or uninterpretable CT scans were excluded.

Comparison of crowd-sourced, electronic health records based, and traditional health-care based influenza-tracking systems at multiple spatial resolutions in the United States of America.

Background: Influenza causes an estimated 3000 to 50,000 deaths per year in the United States of America (US). Timely and representative data can help local, state, and national public health officials monitor and respond to outbreaks of seasonal influenza. Data from cloud-based electronic health records (EHR) and crowd-sourced influenza surveillance systems have the potential to provide complementary, near real-time estimates of influenza activity.

Accurate Influenza Monitoring and Forecasting Using Novel Internet Data Streams: A Case Study in the Boston Metropolis.

Background: Influenza outbreaks pose major challenges to public health around the world, leading to thousands of deaths a year in the United States alone. Accurate systems that track influenza activity at the city level are necessary to provide actionable information that can be used for clinical, hospital, and community outbreak preparation.

Objective: Although Internet-based real-time data sources such as Google searches and tweets have been successfully used to produce influenza activity estimates ahead of traditional health care-based systems at national and state levels, influenza tracking and forecasting at finer spatial resolutions, such as the city level, remain an open question.

Pubertal Progression in Female Adolescents with Progeria.

Study Objective: This study identified the prevalence of menarche and coincident sexual characteristics in female adolescents with Hutchinson-Gilford Progeria Syndrome (HGPS).

Design: Data were examined to determine the prevalence of menarche in female adolescents older than 12 years; all were participants in clinical trials between 2007 and 2016.

Setting: Pediatric hospital in Boston, Massachusetts.

Coronary Artery Calcium Distribution Is an Independent Predictor of Incident Major Coronary Heart Disease Events: Results From the Framingham Heart Study.

Background: The presence and extent of coronary artery calcium (CAC) are associated with increased risk for cardiovascular events. We determined whether information on the distribution of CAC and coronary dominance as detected by cardiac computed tomography were incremental to traditional Agatston score (AS) in predicting incident major coronary heart disease (CHD).

Methods And Results: We assessed total AS and the presence of CAC per coronary artery, per segment, and coronary dominance by computed tomography in participants from the offspring and third-generation cohorts of the Framingham Heart Study.

Determinants of Participants' Follow-Up and Characterization of Representativeness in Flu Near You, A Participatory Disease Surveillance System.

Background: Flu Near You (FNY) is an Internet-based participatory surveillance system in the United States and Canada that allows volunteers to report influenza-like symptoms using a brief weekly symptom report.

Objective: Our objective was to evaluate the representativeness of the FNY population compared with the general population of the United States, explore the demographic and behavioral characteristics associated with FNY's high-participation users, and summarize results from a user survey of a cohort of FNY participants.

Methods: We compared (1) the representativeness of sex and age groups of FNY participants during the 2014-2015 flu season versus the general US population and (2) the distribution of Human Development Index (HDI) scores of FNY participants versus that of the general US population.

Flu Near You: Crowdsourced Symptom Reporting Spanning 2 Influenza Seasons.

Objectives: We summarized Flu Near You (FNY) data from the 2012-2013 and 2013-2014 influenza seasons in the United States.

Methods: FNY collects limited demographic characteristic information upon registration, and prompts users each Monday to report symptoms of influenza-like illness (ILI) experienced during the previous week. We calculated the descriptive statistics and rates of ILI for the 2012-2013 and 2013-2014 seasons.