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Being a victim of sexual violence (SV) is associated with risk for teen pregnancy in cross-sectional research. However, longitudinal data are necessary to determine if SV victimization plays a causal role in early pregnancy. To address this gap in research, we test whether experiencing SV victimization in early adolescence is associated with pregnancy and having children by mid-adolescence. The current sample comprised 4594 youth (58% female; 51% Hispanic; 39% Black) attending 44 schools in the southern United States. Self-reported data were collected via audio computer-assisted self-interview (ACASI) when students were in 7th or 8th grade and again approximately 24 months later. Approximately 2.9% of boys and 8.2% of girls reported SV victimization at baseline. At follow-up, 3.4% of boys and 4.0% of girls reported being involved with one or more pregnancies; 1.1% of boys and girls reported having one or more children. Being a victim of SV at baseline was associated with pregnancy and having a child at follow-up for girls. SV was not related to outcomes among boys. The present findings indicate that girls victimized by SV are at risk of becoming pregnant and becoming teen parents. The combined sequelae of SV and teen pregnancy impair health, economic, and social functioning across the lifespan and carry forward into future generations. Future research should explore mechanisms through which victimization confers risk for pregnancy to inform prevention strategies., Competing Interests: Declaration of Competing Interest The authors report no perceived or real financial conflicts of interest or partnership with commercial interests., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Exposures to environmental contaminants can be influenced by social determinants of health. As a result, persons living in socially disadvantaged communities may experience disproportionate health risks from environmental exposures. Mixed methods research can be used to understand community-level and individual-level exposures to chemical and nonchemical stressors contributing to environmental health disparities. Furthermore, community-based participatory research (CBPR) approaches can lead to more effective interventions., Objectives: We applied mixed methods to identify environmental health perceptions and needs among metal recyclers and residents living in disadvantaged neighborhoods near metal recycling facilities in Houston, Texas, in a CBPR study, Metal Air Pollution Partnership Solutions (MAPPS). Informed by what we learned and our previous findings from cancer and noncancer risk assessments of metal air pollution in these neighborhoods, we developed an action plan to lower metal aerosol emissions from metal recycling facilities and enhance community capacity to address environmental health risks., Methods: Key informant interviews, focus groups, and community surveys were used to identify environmental health concerns of residents. A diverse group from academia, an environmental justice advocacy group, the community, the metal recycling industry, and the local health department collaborated and translated these findings, along with results from our prior risk assessments, to inform a multifaceted public health action plan., Results: An evidence-based approach was used to develop and implement neighborhood-specific action plans. Plans included a voluntary framework of technical and administrative controls to reduce metal emissions in the metal recycling facilities, direct lines of communication among residents, metal recyclers, and local health department officials, and environmental health leadership training., Discussion: Using a CBPR approach, health risk assessment findings based on outdoor air monitoring campaigns and community survey results informed a multipronged environmental health action plan to mitigate health risks associated with metal air pollution. https://doi.org/10.1289/EHP11405.

Objectives: The diagnosis and continuous care of chronic conditions such as HIV infection present potential teachable moments for delivering smoking prevention and cessation interventions for patients. We designed and pre-tested a prototype of a smartphone application(app), Decision-T, specifically designed to assist healthcare providers when providing personalized smoking prevention and cessation services to their patients., Methods: We developed the Decision-T app based on transtheoretical algorithm for smoking prevention and cessation following the 5-A's model. We employed a mixed-methods approach among 18 HIV-care providers recruited from Houston Metropolitan Area for pre-testing the app. Each provider participated in three mock sessions, and the average time spent at each session was measured. We measured accuracy by comparing the smoking prevention and cessation treatment offered by the HIV-care provider using the app to that chosen by the tobacco specialist who designed the case. The system usability scale (SUS) was used to assess usability quantitatively , while individual interview transcripts were analyzed to determine usability qualitatively. STATA-17/SE and Nvivo-V12 were used for quantitative and qualitative analysis, respectively., Results: The average time for completing each mock session was 5 min 17 s. The participants achieved an overall average accuracy of 89.9%. The average SUS score achieved was 87.5(±10.26). After analyzing the transcripts, five themes (app's contents are beneficial and straightforward, design is easy to understand, user's experience is uncomplicated, tech is intuitive, and app needs improvements) emerged., Conclusions: The decision-T app can potentially increase HIV-care providers' engagement in offering smoking prevention and cessation behavioral and pharmacotherapy recommendations to their patients briefly and accurately., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)

The objective of the present study was to examine associations between variables of COVID-19-related concerns and changes in fruit and vegetable (FV) consumption among a sample of participants from the Brighter Bites program at risk for food insecurity. Cross-sectional data were collected during April-June 2020 using a rapid-response survey to understand social needs, COVID-19-related concerns and diet-related behaviours among families with children participating in Brighter Bites ( n 1777) in the 2019-2020 school year at risk for food insecurity, within the surrounding Houston, Dallas, Austin, Texas area; Southwest Florida; Washington, D.C., United States. Of the 1777 respondents, 92 % of households reported being at risk for food insecurity. Among those from food insecure households, the majority were of Hispanic/Mexican-American/Latino (84⋅1 %) ethnic background, predominantly from Houston, Texas (71⋅4 %). During the pandemic, among individuals from food insecure households, 41 % ( n 672) reported a decrease in FV intake, 32 % ( n 527) reported an increase in FV intake, and 27 % ( n 439) reported no change in FV intake. Those who reported concerns about financial stability had a 40 % greater risk of decreased FV intake compared to those not concerned about financial stability (RR 1⋅4; 95 % CI 1⋅0, 2⋅0; P = 0⋅03). The present study adds to this current body of sparse literature on how the initial phase of the pandemic impacted FV consumption behaviours among food insecure households with children. Effective interventions are needed to diminish the negative impact of COVID-19 on the population's health., (© The Author(s) 2023.)

Biological testing on the International Space Station (ISS) is necessary in order to monitor the microbial burden and identify risks to crew health. With support from a NASA Phase I Small Business Innovative Research contract, we have developed a compact prototype of a microgravity-compatible, automated versatile sample preparation platform (VSPP). The VSPP was built by modifying entry-level 3D printers that cost USD 200-USD 800. In addition, 3D printing was also used to prototype microgravity-compatible reagent wells and cartridges. The VSPP's primary function would enable NASA to rapidly identify microorganisms that could affect crew safety. It has the potential to process samples from various sample matrices (swab, potable water, blood, urine, etc.), thus yielding high-quality nucleic acids for downstream molecular detection and identification in a closed-cartridge system. When fully developed and validated in microgravity environments, this highly automated system will allow labor-intensive and time-consuming processes to be carried out via a turnkey, closed system using prefilled cartridges and magnetic particle-based chemistries. This manuscript demonstrates that the VSPP can extract high-quality nucleic acids from urine (Zika viral RNA) and whole blood (human RNase P gene) in a ground-level laboratory setting using nucleic acid-binding magnetic particles. The viral RNA detection data showed that the VSPP can process contrived urine samples at clinically relevant levels (as low as 50 PFU/extraction). The extraction of human DNA from eight replicate samples showed that the DNA extraction yield is highly consistent (there was a standard deviation of 0.4 threshold cycle when the extracted and purified DNA was tested via real-time polymerase chain reaction). Additionally, the VSPP underwent 2.1 s drop tower microgravity tests to determine if its components are compatible for use in microgravity. Our findings will aid future research in adapting extraction well geometry for 1 g and low g working environments operated by the VSPP. Future microgravity testing of the VSPP in the parabolic flights and in the ISS is planned.

Racial/ethnic and socioeconomic differences were shown to have an influence on child fruit and vegetable intake. This study examined the associations between parent and child fruit and vegetable intake and the home nutrition environment among Hispanic/Latino and African American families. Through a cross-sectional study design, self-reported surveys ( n = 6074) were obtained from adult-child dyad participants enrolled in Brighter Bites, an evidence-based health promotion program, in the fall of 2018. For every once/day increase in frequency of parent FV intake, there was an increase in child FV intake by 0.701 times/day (CI: 0.650, 0.751, p < 0.001) and 0.916 times/day (CI: 0.762, 1.07; p < 0.001) among Hispanic/Latinos and African Americans, respectively. In Hispanic/Latino participants, significant positive associations were found between fruits as well as vegetables served at mealtimes ≥3 times/week ( p < 0.001), family mealtimes 7 times/week ( p = 0.018), parent-child communication about healthy eating and nutrition at least sometimes during the past 6 months ( p < 0.05), and frequency of child FV intake, after adjusting for covariates. In African American participants, a significant positive association was found in fruits served at mealtimes ≥1 times/week ( p < 0.05), and vegetables served at mealtimes ≥5 times/week ( p < 0.05). Meals cooked from scratch a few times a day/all the time were significantly positively associated with frequency of child FV intake for both Hispanic/Latino ( p = 0.017) and African American ( p = 0.007) groups. The relationship between home nutrition environment and child FV intake varied by race and ethnicity. Future programs should consider designing culturally tailored interventions to address racial/ethnic-specific influences that match the child's race, culture, and ethnicity.

Human Papillomavirus (HPV) vaccination is of paramount importance to reduce HPV-associated cancers in both genders. In South Korea, the prophylactic vaccine is recognized as prevention of cervical cancer with little attention given to male HPV vaccination. The purpose of this study was to explore perceptions of male HPV vaccination and underlying factors for vaccine hesitancy among mothers of unvaccinated boys in Seoul, Korea using a qualitative method. We used a purposive sampling strategy to recruit mothers of unvaccinated middle school-aged boys living in one of the 25 districts in Seoul, supplemented by a snowball sampling approach. We conducted one-on-one telephone interviews with ten mothers using a semi-structured interview guide. Questions probed mothers' views on vaccinating boys against HPV and the reasons for not vaccinating their sons. We found that mothers were hesitant to vaccinate their sons against HPV due to high out-of-pocket costs, fear of side effects concerning the young age of their sons, and low awareness of HPV and HPV vaccine, all of which stemmed from the exclusion of male HPV vaccination in the national immunization program. Sociocultural factors, including vaccination norms, lack of HPV education, and values associated with sexually transmitted infections were also likely to negatively impact mothers' vaccination decision-making. Despite the barriers, mothers were willing to accept HPV vaccination when it was framed as cancer prevention for not only the sons but also their future spouses. In conclusion, reasons for Korean mothers' hesitancy for their sons' HPV vaccine uptake were multifaceted. Healthcare providers' role in emphasizing and conveying the importance of gender-neutral HPV vaccination will be essential to alleviate negative sentiments around the vaccine for boys and reduce their risk of compromised sexual health. As an effective public health strategy, tailored cancer prevention messages should be delivered heightening significant benefits of the HPV vaccine beyond the prevention of cervical cancer., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Choi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Digital technologies are being increasingly utilized in healthcare to provide pertinent and timely information for primary prevention, such as vaccination. This study aimed to conduct a systematic review to describe and assess current digital health interventions to promote HPV vaccination among adolescents and parents of adolescents, and to recommend directions for future interventions of this kind. Using appropriate medical subject headings and keywords, we searched multiple databases to identify relevant studies published in English between 1 January 2017 and 31 July 2022. We screened and selected eligible studies for inclusion in the final analysis. We reviewed a total of 24 studies, which included interventions using text messages (4), mobile apps (4), social media and websites (8), digital games (4), and videos (4). The interventions generally improved determinants of HPV vaccination, such as HPV-related knowledge, vaccine-related conversations, and vaccination intentions. In particular, text message and social media interventions targeted improved vaccine uptake behaviors, but little meaningful change was observed. In conclusion, digital health interventions can cost-effectively provide education about HPV vaccination, offer interactive environments to alleviate parental vaccine hesitancy, and ultimately help adolescents engage in HPV vaccine uptake.

Background and Purpose: Reduction of respiratory tumour motion is important in liver stereotactic body radiation therapy (SBRT) to reduce side effects and improve tumour control probability. We have assessed the distribution of use of voluntary exhale breath hold (EBH), abdominal compression (AC), free breathing gating (gating) and free breathing (FB), and the impact of these on treatment time., Materials and Methods: We assessed all patients treated in a single institution with liver SBRT between September 2017 and September 2021. Data from pre-simulation motion management assessment using fluoroscopic assessment of liver dome position in repeat breath holds, and motion with and without AC, was reviewed to determine liver dome position consistency in EBH and the impact of AC on motion. Treatment time was assessed for all fractions as time from first image acquisition to last treatment beam off., Results: Of 136 patients treated with 145 courses of liver SBRT, 68 % were treated in EBH, 20 % with AC, 7 % in gating and 5 % in FB. AC resulted in motion reduction < 1 mm in 9/26 patients assessed. Median treatment time was higher using EBH (39 min) or gating (42 min) compared with AC (30 min) or FB (24 min) treatments., Conclusions: Motion management in liver SBRT needs to be assessed per-patient to ensure appropriate techniques are applied. Motion management significantly impacts treatment time therefore patient comfort must also be taken into account when selecting the technique for each patient., Competing Interests: Nicholas Hardcastle and Mathieu Gaudreault receive research grant funding from Varian Medical Systems for kidney SBRT research, and from Reflexion Medical for biologically guided radiation therapy research., (© 2022 Published by Elsevier B.V. on behalf of European Society of Radiotherapy & Oncology.)

Low-income children and families do not meet the recommendations for fruit and vegetable (FV) intake. This study aimed to assess the association between FV shopping behavior and child FV intake through a cross-sectional study design analyzing self-reported surveys (n = 6074) from adult-child dyads of Hispanic/Latino and African American participants enrolled in the Brighter Bites co-op program. Through quantitative mixed effects linear regression models, accounting for school-level clustering and adjusting for covariates, child FV intake was positively associated with shopping for FV at large chain grocery stores (p < 0.001), natural/organic supermarkets (p < 0.001), warehouse club stores (p = 0.002), discount superstores (p < 0.001), small local stores/corner stores (p = 0.038), convenience stores (p = 0.022), ethnic markets (p = 0.002), farmers’ markets/co-op/school farm stands (p < 0.001), and gardens (p = 0.009) among Hispanic/Latinos participants. Among African American participants, there was significant positive association between child FV intake and shopping for FV at natural/organic supermarkets (p < 0.001), discount superstores (p = 0.005), and convenience stores (p = 0.031). The relationship between location and frequency of shopping for FV and child FV intake varied between races. Further research is needed to better understand the influence of cultural and physical environmental factors. Nutrition education programs are vital to encouraging families to make healthier food choices and purchases to improve child FV consumption.

This study examined how schools prioritize ten key health concerns among their student populations over time and whether schools' prioritization of alcohol and other drug use (AODU) corresponds to students' substance use behaviours and cannabis legalization as a major policy change. Data were collected from a sample of secondary schools in Ontario, Canada across four years (2015/16-2018/19 [N2015/16 = 65, N2016/17 = 68, N2017/18 = 61 and N2018/19 = 60]) as a part of the COMPASS study. School-level prevalence of cannabis and alcohol use between schools that did and did not prioritize student AODU as a health concern was examined. Ordinal mixed models examined whether student cannabis and alcohol use were associated with school prioritization of AODU. Chi-square tests examined changing health priorities among schools pre-post cannabis legalization. School priority ranking for AODU was mostly stable over time. While AODU was identified as an important health concern, most schools identified mental health as their first priority across the four years of the study. No significant changes to school AODU priorities were observed pre-post cannabis legalization nor was school prioritization of AODU associated with student cannabis and alcohol use behaviours. This study suggests that schools may benefit from guidance in identifying and addressing priority health concerns among their student population., (© The Author(s) 2022. Published by Oxford University Press.)

This study examined the empirical link between substance use, and family, school, and contextual factors relevant to emerging adulthood and Mexican-origin emerging adults' sexual risk-taking behavior using a longitudinal design that followed the respondents from adolescence to emerging adulthood (n = 520). Overall, we found that engaging in one high-risk sexual behavior was associated with higher odds of engaging in another. While alcohol and substance use was associated with higher odds of engaging in risky sexual behavior, living with parents, having at least one parent who was a college graduate, sharing a higher level of parental closeness, being more bicultural, starting college, a new school, or classes, and feeling like an adult were associated with lower odds of engaging in sexual risk-taking behavior. Contrary to the study hypothesis, a higher level of family cohesion was associated with higher odds of such behavior. Lastly, male respondents tended to have more than 3 sexual partners but were less likely to not use condoms compared with their female counterparts.

Herein, we present the US Food and Drug Administration (FDA) Office of Research and Standards' current thinking, challenges, and opportunities for comparative clinical endpoint bioequivalence (BE) studies of orally inhaled drug products (OIDPs). Given the product-associated complexities of OIDPs, the FDA currently uses an aggregate weight-of-evidence approach to demonstrate that a generic OIDP is bioequivalent to its reference listed drug. The approach utilizes comparative clinical endpoint BE or pharmacodynamic BE studies, pharmacokinetic BE studies, and in vitro BE studies to demonstrate equivalence, in addition to formulation sameness and device similarity. For the comparative clinical endpoint BE studies, metrics based on forced expiratory volume in the first second (FEV 1 ) are often the recommended clinical endpoints. However, the use of FEV 1 can pose a challenge due to its large variability and a relatively flat dose-response relationship for most OIDPs. The utility of applying dose-scale analysis was also investigated by the FDA but often not recommended, due to either flat dose-response relationships or insufficient clinical study data. As a potential way to reduce sample size, we found adapting covariate analysis only explained a limited portion of the variation based on further investigation. The FDA continues to develop alternative methods to make BE assessment of OIDPs more cost- and time-efficient. Prospective generic drug applicants and academia are encouraged to participate in this effort by proposing new approaches in pre-abbreviated new drug application meeting requests and collaborating in the form of grants and contracts under the Generic Drug User Fee Amendments (GDUFA) Regulatory Science and Research Program., (Published 2022. This article is a U.S. Government work and is in the public domain in the USA.)

Background: Individuals experiencing homelessness may be at a higher risk for hepatitis C infection because many are vulnerable to risk factors related to HCV. Screening is the very first step in the HCV care continuum, but it remains unclear how to improve HCV screening among this hard-to-reach population. Thus, the present study investigated the barriers and facilitators to HCV screening from the perspective of individuals experiencing homelessness within a non-residential social service setting., Methods: Individuals experiencing homelessness (aged 18+) were approached while they were seeking services at two community-based organizations in Houston, Texas, during August 2020. Participants ( N  = 31) completed an interviewer-administered demographic survey and a semi-structured interview about their experiences with healthcare, homelessness, and HCV screening. Following transcript coding and content analysis, a thematic analysis was conducted to identify HCV screening barriers and facilitators discussed by participants., Results: Participants were predominantly male ( n  = 25, 80.6%), and almost 40% of participants had no form of medical insurance. Participants identified the following as barriers to HCV screening: mistrust of the healthcare system and professionals and lack of knowledge of HCV prevention, harm reduction, and complications. Participants identified the following as facilitators to HCV screening: providing incentives and increasing access and convenience to HCV screening., Conclusion: Community-based HCV screening programs may wish to account for the lived experiences of individuals experiencing homelessness in order to minimize barriers to screening. Client-centered strategies that reduce wait times and incentivize participation should be considered to eliminate barriers and increase convenience for this high-risk population., Competing Interests: The authors have no relevant financial or non-financial interests to disclose., (© 2022 The Authors.)

Background: For non-treatment-seeking women who use substances during pregnancy, immediately postpartum may be an optimum time for intervention. Our study tested a novel, brief, hospital-initiated, adaptive motivational interviewing plus acceptance and commitment therapy (MIACT) intervention to facilitate treatment initiation and reproductive planning postpartum among mothers who used substances during pregnancy., Methods: Mothers (N = 64) with an infant admitted to a neonatal intensive care unit were enrolled if they or their infant tested positive for an illicit substance at delivery or had a documented positive drug screen during pregnancy. A parallel group, randomized controlled design assigned participants to MIACT or conventional care (CC), with assessments at week 2 and 4 during treatment and follow-up at 2 and 6 months post treatment. Bayesian generalized linear modeling was used to evaluate outcomes as a function of treatment., Results: Results indicated that during treatment the MIACT group demonstrated an 84% probability of benefit relative to CC with regard to initiating treatment (RR=1.5), however the effect was not seen at follow-up. MIACT was also associated with an increased probability of attending a postpartum obstetrics visit (RR=1.4), and receiving contraception during treatment and at both follow-ups, with posterior probabilities of 96% or higher and relative risks ranging from 1.5 to 5.1 at varying timepoints. Substance use rates for the MIACT versus CC were higher at follow-up., Conclusions: Brief, hospital-initiated interventions can assist postpartum mothers who use substances to enter treatment and obtain contraception in order to reduce future substance-exposed pregnancies., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Individuals experiencing homelessness may be at a disproportionately high risk for hepatitis C (HCV) because they may be more likely to engage in HCV risk behaviors. Community organizations that provide services to these vulnerable individuals can effectively screen, diagnose, and navigate them into HCV care. However, screening people experiencing homelessness for HCV at such organizations is limited by various challenges that remain understudied, including budgetary considerations and strategies to improve teamwork and communication. Accordingly, this study investigated the organizational challenges and facilitators to HCV screening of individuals experiencing homelessness as reported by homeless services providers., Methods: Staff (N = 21) at two community organizations in Houston, Texas, completed an interviewer-administered survey and a semi-structured interview in August 2020 to assess the challenges and facilitators to screening people experiencing homelessness for HCV. Interviews were coded, and a thematic analysis was conducted to identify challenges as well as facilitators to HCV screening among individuals experiencing homelessness., Results: Almost half of participants were employed in social services (42.86%; n = 9), while the remainder were employed in management/administration and health services. Barriers to HCV screening included funding, logistics, and resource-related challenges; and limited communication and collaboration around HCV screening. Facilitators to HCV screening included providing HCV education and training for all staff; and incentivizing, formalizing, and funding HCV screening., Conclusions: Community organizations can help minimize barriers to HCV screening among individuals experiencing homelessness by providing staff with training specific to HCV, client education around HCV and the screening process, and providing clients with incentives for participation, as well as by maximizing community and clinic partnerships to provide linkage to care and services to this high-risk population., Competing Interests: The authors have declared that no competing interests exist.

The purpose of this study was to evaluate the impact of a nutrition intervention on food insecurity among low-income households with children. Data were collected from 371 parent−child dyads in a quasi-experimental evaluation study of a 1-year intervention (n = 6 intervention schools receiving Brighter Bites, n = 6 wait-list control schools), and longitudinal follow-up of the intervention group 2 years post-intervention in Houston, Texas. Data were collected at three timepoints: at baseline and 1 year for all participants, and at 2 year follow-up for the intervention group (the wait-list control group received the intervention during that time). At baseline, most parents reported food insecurity (60.6%; 70% intervention group, 53.6% control). Food insecurity decreased significantly from 81.3% to 61.7% [(−0.32, −0.07) p = 0.002] among intervention participants immediately post-intervention. After adjusting for ethnicity, 2 years post-intervention the predicted percentage of participants reporting food insecurity decreased significantly by roughly 35.4% from 76.4% at baseline to 41.0% [(−0.49, −0.22), p < 0.001]. Between-group changes were not significant. The re-sults of this study demonstrated a significant positive impact of Brighter Bites on food security in the short and long-term among low-income households with children, albeit results should be in-terpreted with caution.

Approved generic drugs are therapeutically equivalent to a preidentified brand name product and are expected to have the same clinical effect and safety profile when administered to patients under conditions specified in the labeling. Availability of generic topical dermatologic drugs is expected to enhance patient access to such widely used drug products. Assessment of equivalence for a prospective generic product involves a systematic and rigorous comparative evaluation to ensure there is no significant difference in the rate and extent to which the active ingredients become available at the site of action for the prospective generic and corresponding brand name product., (Published by Elsevier Inc.)

In the United States, the Food and Drug Administration's (FDA's) regulatory authorities have significantly influenced the products available to treat dermatologic conditions, but at the same time, advances in dermatology have also influenced the FDA's approach, including the agency's evaluation of risks and its' communications to consumers, patients, and providers. This essay reviews significant milestones in the history of FDA's regulation of dermatologic products, with attention paid to significant products, impactful legal changes, and key personnel and organizational changes., (Published by Elsevier Inc.)

Roughly 40% of persons with HIV (PWH) are not consistently involved in HIV care in the US. Finding out-of-care PWH is difficult, but hospitalization is common and presents an opportunity to re-engage PWH in outpatient care. The aims of this study were to (1) develop an Acceptance and Commitment Therapy (ACT)-based intervention for hospitalized, out-of-care PWH who endorse avoidance-coping to improve HIV treatment engagement; (2) examine the intervention’s initial feasibility and acceptability; and (3) to revise the study protocol (including the intervention), based on stakeholder feedback, in preparation for a randomized controlled trial (RCT) comparing ACT to treatment as usual. Therapists and HIV care experts developed a four-session ACT-based intervention to be delivered during hospitalization. Fifteen hospitalized patients with poorly controlled HIV enrolled in the open trial, eight completed four sessions, two completed three sessions, and seven provided qualitative feedback. Patients universally liked the intervention and the holistic approach to mental health and HIV care. Refinements included repeating key concepts, including representative graphics, and translating to Spanish. Among the patients who attended ≥3 ACT sessions, 5/10 attended a HIV-care follow-up visit and 5/7 who had labs had a viral load <20 2-months post-intervention. Next steps include conducting a randomized clinical trial exploring the impact of the refined intervention to treatment as usual on retention in care and viral load. ClinicalTrials.gov Identifier: NCT04481373.

A loop-mediated isothermal amplification assay was evaluated as a surrogate marker of treatment failure in Chagas disease (CD). A convenience series of 18 acute or reactivated CD patients who received anti-parasitic treatment with benznidazole was selected-namely, nine orally infected patients: three people living with HIV and CD reactivation, five chronic CD recipients with reactivation after organ transplantation and one seronegative recipient of a kidney and liver transplant from a CD donor. Fifty-four archival samples (venous blood treated with EDTA or guanidinium hydrochloride-EDTA buffer and cerebrospinal fluid) were extracted using a Spin-column manual kit and tested by T. cruzi Loopamp kit (Tc-LAMP, index test) and standardized real-time PCR (qPCR, comparator test). Of them, 23 samples were also extracted using a novel repurposed 3D printer designed for point-of-care DNA extraction (PrintrLab). The agreement between methods was estimated by Cohen's kappa index and Bland-Altman plot analysis. The T. cruzi Loopamp kit was as sensitive as qPCR for detecting parasite DNA in samples with parasite loads higher than 0.5 parasite equivalents/mL and infected with different discrete typing units. The agreement between qPCR and Tc-LAMP (Spin-column) or Tc-LAMP (PrintrLab) was excellent, with a mean difference of 0.02 [CI = -0.58-0.62] and -0.04 [CI = -0.45-0.37] and a Cohen's kappa coefficient of 0.78 [CI = 0.60-0.96] and 0.90 [CI = 0.71 to 1.00], respectively. These findings encourage prospective field studies to validate the use of LAMP as a surrogate marker of treatment failure in CD.

Background: Despite the availability of culturally responsive sexual health educational programs for American Indian and Alaska Native (AI/AN) youth, barriers to their uptake and utilization persist in tribal communities. These challenges were exacerbated by the COVID-19 pandemic, which required flexible program delivery using both in-person and virtual classrooms., Objective: This exploratory study provides a preliminary understanding of the extent to which pre-existing challenges impact the delivery of culturally responsive sexual health education programs in Native communities and to what extent they were exacerbated by the COVID-19 pandemic. It also highlights the challenges faced by adolescent health advocates when adapting culturally responsive health curricula to online platforms. Finally, this study discloses major socioeconomic, health, and mental challenges experienced by AI/AN youth during the pandemic., Methods: An exploratory, descriptive, qualitative design approach was adopted to carry out 5 individual and 1 collective in-depth key informant interviews. A total of 8 Native and non-Native sexual health educators served as key informants and shared their personal experiences with the delivery of sexual health education programs for youth during the COVID-19 pandemic. The interviews were conducted virtually from October to November 2020 using Zoom to reach participants dispersed across different regions of the United States. We followed the consolidated criteria for reporting qualitative research (COREQ) as a reference for the study methodology. We also used the Braun and Clarke framework (2006) to conduct a thematic analysis., Results: Experts' opinions were structured according to 5 main themes: (1) competing community priorities during COVID-19; (2) moving to web-based programming: skills, training, support; (3) recruiting youth; and (4) challenges for implementation in a household environment; and (5) recommendations to overcome implementation challenges. These themes are complementary, connected, and should be considered holistically for the development, dissemination, and implementation of online sexual health programs for AI/AN youth, specifically during the COVID-19 pandemic. The results raised the following points for discussion: (1) Building partnerships with schools and community organizations facilitates program adaptation and implementation, (2) there is a need to adopt a holistic approach when addressing youth sexual health in AI/AN communities, (3) a systematic and culturally responsive adaptation approach ensures effective virtual program delivery, and (4) community and youth engagement is essential for the success of virtual sexual health programs., Conclusions: Findings can provide recommendations on actions to be taken by sexual health educators and guidelines to follow to ensure cultural sensitivity, effective adaptation, and successful implementation when setting out to advocate for online sexual health programs for AI/AN youth., (©Lea Sacca, Christine Markham, Belinda Hernandez, Ross Shegog, Melissa Peskin, Stephanie Craig Rushing, Hannah Warren, Monique Tsosie. Originally published in JMIR Formative Research (https://formative.jmir.org), 11.04.2022.)

Background: Existing sedentary behaviour guidelines for children and youth target overall sedentary behaviour and recreational screen time, without any specific recommendations regarding school-related sedentary behaviours (i.e., sedentary behaviours performed during the school day, or within the influence of school). The purpose of this paper is to describe the development of international evidence-based recommendations for school-related sedentary behaviours for children and youth, led by the Sedentary Behaviour Research Network (SBRN)., Methods: A panel of international experts was convened by SBRN in November 2020 to guide the development of these recommendations for children and youth aged ~ 5-18 years. The recommendations were informed by 1) age-relevant existing sedentary behaviour guidelines, 2) published research on the relationship between overall sedentary behaviour and health, 3) a de novo systematic review on the relationship between school-related sedentary behaviours and health and/or academic outcomes, and 4) a de novo environmental scan of the grey literature to identify existing recommendations for school-related sedentary behaviours. Draft recommendations were presented to the Expert Panel in June 2021. Following thorough discussion and modifications, updated recommendations were distributed for stakeholder feedback from July 9-26. Feedback was received from 148 stakeholders across 23 countries, leading to additional updates to the recommendations. Following further rounds of discussion and updates with the Expert Panel in August and September 2021, consensus was achieved on the final recommendations., Results: A healthy day includes breaking up extended periods of sedentary behaviour and incorporating different types of movement into homework whenever possible, while limiting sedentary homework. School-related screen time should be meaningful, mentally or physically active, and serve a specific pedagogical purpose that enhances learning. Replacing sedentary learning activities with movement-based learning activities, and replacing screen-based learning activities with non-screen-based learning activities, can further support students' health and wellbeing., Discussion: This paper presents the first evidence-based recommendations for school-related sedentary behaviours for children and youth. These recommendations will support the work of parents, caregivers, educators, school system administrators, policy makers, researchers and healthcare providers interested in promoting student health and academic success., (© 2022. The Author(s).)

Background: In the USA, drug costs associated with the inhaled corticosteroid (ICS) and long acting β agonist (LABA) combination products have been increasing since 2001. In January 2019, the first generic ICS/LABA drug product was approved by the U.S. Food and Drug Administration., Methods: We investigated retrospectively the effects of the first approved generic ICS/LABA drug from 2019 to 2020 on the wholesale cost-savings and prescription dispensing using the IQVIA data system in the USA., Results: The marketing of the first generic for fluticasone propionate and salmeterol xinafoate dry powder inhaler was associated with $941 million in drug cost-savings during the first year for this class of medications. Although the brand-name drug manufacturer concurrently introduced its authorized generic, these cost-savings were driven by the averaged unit cost of the approved generic at $115, compared to $169 for the authorized generic and $334 for the branded product. Generic initiation and substitution with the first generic were, respectively, higher compared to those with authorized generics; however, overall dispensing of the first generic was lower than that of its branded product. As in the case of budesonide and formoterol fumarate dry powder inhaler, marketing of authorized generics alone was not associated with any noticeable change in sales or prescription cost-saving., Conclusion: We estimated that more than 20% of prescription cost-saving was achieved for the ICS/LABA dry powder inhalers in the first year following the introduction of the first approved generic, even though generic utilization remained lower than that of the branded counterpart., (© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

Background: Many Indigenous communities across the USA and Canada experience a disproportionate burden of health disparities. Effective programs and interventions are essential to build protective skills for different age groups to improve health outcomes. Understanding the relevant barriers and facilitators to the successful dissemination, implementation, and retention of evidence-based interventions and/or evidence-informed programs in Indigenous communities can help guide their dissemination., Purpose: To identify common barriers to dissemination and implementation (D&I) and effective mitigating frameworks and strategies used to successfully disseminate and implement evidence-based interventions and/or evidence-informed programs in American Indian/Alaska Native (AI/AN), Native Hawaiian/Pacific Islander (NH/PI), and Canadian Indigenous communities., Methods: A scoping review, informed by the York methodology, comprised five steps: (1) identification of the research questions; (2) searching for relevant studies; (3) selection of studies relevant to the research questions; (4) data charting; and (5) collation, summarization, and reporting of results. The established D&I SISTER strategy taxonomy provided criteria for categorizing reported strategies., Results: Candidate studies that met inclusion/exclusion criteria were extracted from PubMed (n = 19), Embase (n = 18), and Scopus (n = 1). Seventeen studies were excluded following full review resulting in 21 included studies. The most frequently cited category of barriers was "Social Determinants of Health in Communities." Forty-three percent of barriers were categorized in this community/society-policy level of the SEM and most studies (n = 12, 57%) cited this category. Sixteen studies (76%) used a D&I framework or model (mainly CBPR) to disseminate and implement health promotion evidence-based programs in Indigenous communities. Most highly ranked strategies (80%) corresponded with those previously identified as "important" and "feasible" for D&I The most commonly reported SISTER strategy was "Build partnerships (i.e., coalitions) to support implementation" (86%)., Conclusion: D&I frameworks and strategies are increasingly cited as informing the adoption, implementation, and sustainability of evidence-based programs within Indigenous communities. This study contributes towards identifying barriers and effective D&I frameworks and strategies critical to improving reach and sustainability of evidence-based programs in Indigenous communities., Registration Number: N/A (scoping review)., (© 2022. The Author(s).)

Background: Shock-absorbing flooring may minimise impact forces incurred from falls to reduce fall-related injuries; however, synthesized evidence is required to inform decision-making in hospitals and care homes., Methods: This is a Health Technology Assessment mixed methods systematic review of flooring interventions targeting older adults and staff in care settings. Our search incorporated the findings from a previous scoping review, MEDLINE, AgeLine, and Scopus (to September 2019) and other sources. Two independent reviewers selected, assessed, and extracted data from studies. We assessed risk of bias using Cochrane and Joanna Briggs Institute tools, undertook meta-analyses, and meta-aggregation., Results: 20 of 22 included studies assessed our outcomes (3 Randomised Controlled Trials (RCTs); 7 observational; 5 qualitative; 5 economic), on novel floors (N = 12), sports floors (N = 5), carpet (N = 5), and wooden sub-floors (N = 1). Quantitative data related to 11,857 patient falls (9 studies), and 163 staff injuries (1 study). One care home-based RCT found a novel underlay produced similar injurious falls rates (high-quality evidence) and falls rates (moderate-quality evidence) to a plywood underlay with vinyl overlay and concrete sub-floors. Very low-quality evidence suggested that shock-absorbing flooring may reduce injuries in hospitals (Rate Ratio 0.55, 95% CI 0.36 to 0.84, 2 studies; 27.1% vs. 42.4%; Risk Ratio (RR) = 0.64, 95% CI 0.44 to 0.93, 2 studies) and care homes (26.4% vs. 33.0%; RR 0.80, 95% CI 0.70 to 0.91, 3 studies), without increasing falls. Economic evidence indicated that if injuries are fewer and falls not increased, then shock-absorbing flooring would be a dominant strategy. Fracture outcomes were imprecise; however, hip fractures reduced from 30 in 1000 falls on concrete to 18 in 1000 falls on wooden sub-floors (OR 0.59, 95% CI 0.45 to 0.78; one study; very low-quality evidence). Staff found moving wheeled equipment harder on shock-absorbing floors leading to workplace adaptations. Very low-quality evidence suggests staff injuries were no less frequent on rigid floors., Conclusion: Evidence favouring shock-absorbing flooring is uncertain and of very low quality. Robust research following a core outcome set is required, with attention to wider staff workplace implications., Trial Registration: PROSPERO CRD42019118834 ., (© 2022. The Author(s).)

Objectives: This study aims to assess the feasibility of using hemofiltration for ammonia clearance in low body weight infants with an inborn error of metabolism. Design: A study of two cases. Setting: Quaternary pediatric hospital (Saint Louis Children's Hospital) NICU and PICU. Patients: Infants <6 months of age with an ICD-9 diagnosis of 270.6 (hyperammonemia). Interventions: Continuous renal replacement therapy (CRRT). Measurements and Main Results: We measure serum ammonia levels over time and the rate of ammonia clearance over time. Continuous renal replacement therapy was more effective than scavenger therapy alone (Ammonul™) for rapid removal of ammonia in low weight infants (as low as 2.5 kg). Conclusions: Continuous renal replacement therapy is technically feasible in low weight infants with severe hyperammonemia secondary to an inborn error of metabolism., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Markham, Williams, Miller, Grange, Davis and Remy.)

The purpose of this communication is to describe the Brighter Bites produce voucher program, and its implementation and utilization across Brighter Bites families in four cities in the U.S., during the COVID-19 pandemic. The voucher program was implemented over nine weeks starting April 2020, with up to four USD 25 store-specific produce coupons sent bi-weekly to the homes of each participating Brighter Bites family (USD 100 total/family). Measures included type of produce purchased, amount of voucher that was used, number of vouchers distributed and redeemed by families, and a post-program participant satisfaction survey. Descriptive statistics, including count, frequency, and percent, were computed, both overall and stratified by city. During this time, Brighter Bites distributed a total of over 43,982 vouchers to 12,482 low-income families, with a redemption rate of 60% (at least one voucher redeemed) across all cities. During times of crisis, non-profit-for-profit partnerships, such as the one between Brighter Bites and the grocery retail industry, are feasible, and successful in providing produce to families in need.

Background: Early sexual debut among American Indian and Alaska Native (AI/AN) adolescents has been associated with an increased risk of teenage pregnancies and sexually transmitted infections, along with an increased risk of having multiple lifetime sexual partners, and engaging in greater frequency of sex, substance abuse, and lack of condom use. A major protective factor against early sexual debut among AI/AN youth is the familial system. Interventions aiming to improve parent-child communication and parental warmth toward adolescent sexual health topics were reported to contribute to positive youth sexual health outcomes, specifically among minority youth. Healthy Native Youth thus developed the Talking is Power text-messaging service to guide parents and caring adults on how to initiate sensitive topics with youth and how to support them in making informed decisions regarding sex and healthy relationships., Methods: Descriptive statistics were used to demonstrate website analytics and reach per views and time spent on each page, and for displaying participants' responses to the questions on the usability of the Talking is Power text-messaging series. To assess the perceived impact of the series, the differences in mean percentage scores of the question assessing parental comfort in engaging in sexual health topics with youth between pre- and post-intervention were calculated using two-sample t -tests of equal variances. Descriptive content analysis was adopted to highlight emerging themes from open-ended items., Results: When looking at reach, 862 entrances were recorded during the specified time period (5.8% of total entrances to HNY website), while the bounce rate was set at 73.1% (22.6% greater than the industry average), and the exit rate was 54.3% (15.2% greater than the industry average). Series usability was highly ranked on the 5-Likert scale in terms of signing up for a similar series on a different topic, quality of images, texts, and links, relating to prompts, and change in sparking sensitive conversations with youth. High likelihood of recommending the series to a friend or colleague was also reported by participants (0-10). No significant difference in parental comfort levels was reported ( p = 0.78 > 0.05). Main themes provided suggestions for improving the series mode of delivery, while others included positive feedback about the material, with the possibility of expanding the series to other adolescent health topics., Conclusion: Lessons learned during the design, dissemination, and evaluation of the resource's usability, reach, and perceived impact may be of interest to other Indigenous communities who are in the process of adapting and/or implementing similar approaches.

Dr. Gavril Pasternak, M.D., Ph.D. was an inspiration to many of his students, including myself. It was with great sadness that I learned about the passing of Dr. Gavril Pasternak in February 2019 after his brief battle with pancreatic cancer. I worked with Dr. Pasternak while I was an undergraduate chemistry student and as one of his technicians, collaborating with Dr. Charles Inturrisi and Dr. Eliot F. Hahn on opiate agonists and antagonists for opioid receptor subtypes. Dr. Pasternak inspired me and set me on the road to a career in pharmacology and encouraged me to pursue the fruitful paradigm of moving therapeutics from bench to bedside.

Growth in open-source hardware designs combined with the decreasing cost of high-quality 3D printers have supported a resurgence of in-house custom lab equipment development. Herein, we describe a low-cost (< $400), open-source CO2 incubator. The system is comprised of a Raspberry Pi computer connected to a 3D printer controller board that has controls for a CO2 sensor, solenoid valve, heater, and thermistors. CO2 is supplied through the sublimation of dry ice stored inside a thermos to create a sustained 5% CO2 supply. The unit is controlled via G-Code commands sent by the Raspberry Pi to the controller board. In addition, we built a custom software application for remote control and used the open-source Grafana dashboard for remote monitoring. Our data show that we can maintain consistent CO2 and temperature levels for over three days without manual interruption. The results from our culture plates and real-time PCR indicate that our incubator performed equally well when compared to a much more expensive commercial CO2 incubator. We have also demonstrated that the antibiotic susceptibility assay can be performed in this low-cost CO2 incubator. Our work also indicates that the system can be connected to incubator chambers of various chamber volumes., Competing Interests: AA, CM, SSA, MW are current or former employees of AI Biosciences, Inc., whose company performed this study. SW is the co-founder of AI Biosciences, Inc. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials. The other authors declare no competing interests.

New, brand-name, ophthalmology drug products are developed, investigated, and submitted for marketing approval through premarket interactions with the Food and Drug Administration (FDA). These drug applications for novel drugs are reviewed by FDA for safety and effectiveness before being allowed on the market. Many brand-name drugs are allowed a period of marketing exclusivity and/or have patent protections that can delay generic competition. When these exclusivity periods or patents expire or are challenged (in the case of patents), generic competitors may then market equivalent products, as allowed by U.S. law (eg, Drug Price Competition and Patent Term Restoration Act, often referred to as "the Hatch-Waxman Act"). To be approved as a therapeutic equivalent, a generic product must demonstrate that it is both pharmaceutically equivalent and bioequivalent to the brand-name drug product, which can involve innovative analytical methods and study designs. To facilitate generic drug assessment and approval, the FDA has negotiated the Generic Drug User Fee Amendments (GDUFA) program that funds a rigorous generic drug development program that includes pre-Abbreviated New Drug Application (pre-ANDA) correspondence and meetings, targeted bioequivalence research, and publication of product-specific guidances (PSGs) to support generic drug research and development for manufacturers interested in developing generic drugs for the U.S. market. FDA's regulatory practices include the monitoring of quality and postapproval adverse events of all marketed products, including those for use in and around the eyes.

Background: Parents play a pivotal role in adolescent sexual health and Human Papillomavirus (HPV) vaccination. Nurses are on the frontlines of healthcare and play a critical role in promoting HPV vaccination and parent-child sexual health communication. We enhanced the Families Talking Together (FTT) parent-based sexual health curriculum to include adolescent vaccinations herein, FTT + HPV, and trained student nurses to provide a strong HPV vaccination and parent-child sexual health communication endorsement., Methods: Using a randomized attention-controlled trial design, we examined the efficacy of FTT + HPV among 519 parents and their 11-14 year old youth recruited from medically underserved communities between 2015 and 2018. Participants were recruited from 22 after-school programs (e.g., Boys and Girls Clubs) and 19 charter schools. For parents, we examined protective factors including parent-child sexual health communication and parental involvement. For youth, we examined sexual health knowledge, parent-child sexual health communication, and parent-child connectedness. To assess HPV vaccination initiation and completion, we searched IMMTRAC immunization registry records for 85% of youth and used parental report for youth without registry records. Group differences were calculated using the estimated mean difference at one- and six months post-intervention with significance set at the p < 0.05 level., Results: Baseline rates of HPV vaccination were low at 55.7%. No significant difference between the groups was seen in vaccination initiation or completion rates by one-month post-intervention. However, by six-months post intervention, there was a significant difference between the groups with 70.3% of the intervention group initiating the HPV vaccination series vs. 60.6% for the control group (p = 0.02). No difference between the groups was found for HPV series completion at six-months. There were significant differences in condom knowledge (p = 0.04), parent-child connectedness (p = 0.04), and communication frequency (p = 0.001) with greater improvement in the intervention vs. the control group. Rates of sexual activity remained low in both groups throughout the six-month follow-up period., Conclusion: A brief parent-based adolescent sexual health and HPV vaccination intervention delivered by student nurses can improve sexual health outcomes including protective parental factors, adolescent sexual health knowledge, and HPV vaccination initiation rates., Trial Registration: ClinicalTrials.gov Identifier: NCT02600884 . Prospectively registered September 1, 2015.

We identified factors associated with student nurses' Human Papillomavirus Vaccine (HPV) vaccination status and their intention to counsel parents on HPV vaccination. Undergraduate student nurses ( N = 153) from a large university in the south participated. Descriptive statistics, chi-squared tests, and independent t-tests ( p ≤ 0.05) were used to characterize the students' vaccination status. Logistic regression was used to identify factors associated with vaccination status. HPV vaccination rates were low. Students who were older and married or living with a partner were less likely to have completed the HPV vaccine series. The most commonly cited reason for non-initiation and non-completion was the lack of provider endorsement. Vaccination status did not differ significantly according to race/ethnicity, religion, skills, or intention to counsel parents. While intentions to counsel parents on HPV vaccination are high among student nurses, interventions to improve vaccination rates among student nurses are needed.

Distractions external to a vehicle contribute to visual attention diversion that may cause traffic accidents. As a low-cost and efficient advertising solution, billboards are widely installed on side of the road, especially the motorway. However, the effect of billboards on driver distraction, eye gaze, and cognition has not been fully investigated. This study utilises a customised driving simulator and synchronised electroencephalography (EEG) and eye tracking system to investigate the cognitive processes relating to the processing of driver visual information. A distinction is made between eye gaze fixations relating to stimuli that assist driving and others that may be a source of distraction. The study compares the driver's cognitive responses to fixations on billboards with fixations on the vehicle dashboard. The measured eye-fixation related potential (EFRP) shows that the P1 components are similar; however, the subsequent N1 and P2 components differ. In addition, an EEG motor response is observed when the driver makes an adjustment of driving speed when prompted by speed limit signs. The experimental results demonstrate that the proposed measurement system is a valid tool in assessing driver cognition and suggests the cognitive level of engagement to the billboard is likely to be a precursor to driver distraction. The experimental results are compared with the human information processing model found in the literature.

VITAL Start is a video-based intervention aimed to improve maternal retention in HIV care and adherence to antiretroviral therapy (ART) in Malawi. We explored the experiences of pregnant women living with HIV (PWLHIV) not yet on ART who received VITAL Start before ART initiation to assess the intervention's acceptability, feasibility, fidelity of delivery, and perceived impact. Between February and September 2019, we conducted semi-structured interviews with a convenience sample of 34 PWLHIV within one month of receiving VITAL Start. The participants reported that VITAL Start was acceptable and feasible and had good fidelity of delivery. They also reported that the video had a positive impact on their lives, encouraging them to disclose their HIV status to their sexual partners who, in turn, supported them to adhere to ART. The participants suggested using a similar intervention to provide health-related education/counseling to people with long term conditions. Our findings suggest that video-based interventions may be an acceptable, feasible approach to optimizing ART retention and adherence amongst PWLHIV, and they can be delivered with high fidelity. Further exploration of the utility of low cost, scalable, video-based interventions to address health counseling gaps in sub-Saharan Africa is warranted.

Background: Early adolescent unintended pregnancy and sexually transmitted infection prevention are significant public health challenges in the United States. Parental influence can help adolescents make responsible and informed sexual health decisions toward delayed sexual debut; yet parents often feel ill equipped to communicate about sex-related topics. Intergenerational games offer a potential strategy to provide life skills training to young adolescents (aged 11-14 years) while engaging them and their parents in communication about sexual health., Objective: This study aims to describe the development of a web-based online sexual health intergenerational adventure game, the Secret of Seven Stones (SSS), using an intervention mapping (IM) approach for developing theory- and evidence-based interventions., Methods: We followed the IM development steps to describe a theoretical and empirical model for young adolescent sexual health behavior, define target behaviors and change objectives, identify theory-based methods and practical applications to inform design and function, develop and test a prototype of 2 game levels to assess feasibility before developing the complete 18-level game, draft an implementation plan that includes a commercial dissemination strategy, and draft an evaluation plan including a study design for a randomized controlled trial efficacy trial of SSS., Results: SSS comprised an adventure game for young adolescent skills training delivered via a desktop computer, a text-based notification system to provide progress updates for parents and cues to initiate dialogue with their 11- to 14-year-old child, and a website for parent skills training and progress monitoring. Formative prototype testing demonstrated feasibility for in-home use and positive usability ratings., Conclusions: The SSS intergenerational game provides a unique addition to the limited cadre of home-based programs that facilitate parent involvement in influencing young adolescent behaviors and reducing adolescent sexual risk taking. The IM framework provided a logical and thorough approach to development and testing, attentive to the need for theoretical and empirical foundations in serious games for health., (©Ross Shegog, Laura Armistead, Christine Markham, Sara Dube, Hsing-Yi Song, Pooja Chaudhary, Angela Spencer, Melissa Peskin, Diane Santa Maria, J Michael Wilkerson, Robert Addy, Susan Tortolero Emery, Jeffery McLaughlin. Originally published in JMIR Serious Games (http://games.jmir.org), 27.01.2021.)

Brighter Bites is a school-based health promotion program that delivers fresh produce and nutrition education to low-income children and their families across 6 locations in the US. This article provides a perspective on how, despite coronavirus disease 2019-related school closures, Brighter Bites pivoted rapidly to collaborate with medical and public health institutions to improve health and food literacy among their families. Through these partnerships, Brighter Bites was able to rapidly provide accurate, evidence-based information related to coronavirus disease 2019 and other social needs, including food, housing, transportation, and access to health care, to help fill a needed gap in vulnerable communities., (Copyright © 2020 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.)

Background: Adherence to antiretroviral therapy (ART) is particularly important for patients with HIV. Prior research on ART adherence has focused primarily on behavioral interventions targeting patients and providers. No study has focused on the pharmacy refill experience as a potential target for improving adherence to HIV medicines. Informed by patients' experiences, this study aimed to assess patients' experiences with refilling their HIV medicines and to explore facilitators and barriers to refilling medicines on time., Methods: We interviewed patients at three time points during their first year of care at an HIV clinic in Houston, TX. We analyzed interviews using directed and conventional content analysis., Results: Analyses revealed individual, interpersonal, and system-level barriers that affect patients' ability to pick up their HIV medicines on time. Many patients perceived the refill process as being difficult. For some patients, picking up their HIV medicines each month triggered anxiety. Positive interactions with pharmacists and pharmacy staff, as well as clear and consistent messaging, played a key role in augmenting patients' refill experience. Self-efficacy, social support, and workarounds to resolve issues were also key facilitators. Many patients said changing ART-dispensing protocols from 30- to 90-day refills could mitigate the anxiety experienced with picking up HIV medicines and decrease opportunities for missing a refill., Conclusion: Offering 90-day refills for HIV medicines may decrease anxiety concerning missed doses and improve medication adherence. Providing pharmacy staff with communication skills training is another strategy that may improve the patients' refill experience., (Copyright © 2020 The Permanente Press. All rights reserved.)

Long-term data on maintenance of intervention effects of health promotion programs targeting fruit and vegetable (F&V) intake in children is lacking. We conducted a two-year follow-up of Brighter Bites, a school-based nutrition education and food co-op intervention found to be effective in increasing child intake of F&V. A one-group, pre-post evaluation design was used to assess the two-year post intervention impact of the program on child and parent dietary intake and home nutrition environment. In 2016-2017 school year, we conducted a follow up of 262 parent-child dyads who had previously participated in Brighter Bites in a 2013-2015 evaluation study in six low-income Texas elementary schools. Child dietary intake was measured using a parent-reported food frequency questionnaire, and surveys measured parent F&V intake, and home nutrition environment. Results of a multi-level regression analysis showed that, two years post-intervention, as compared to baseline, there was a significant increase in child intake of fruit, vegetable, and fiber, and significant decreases in total fat intake and percent daily calories from sugary beverages (p < 0.05). Parent dietary data showed significant increases in fruit intake, and intake of F&V combined (p < 0.05). Changes in home nutrition environment included: increased frequency of cooking behaviors, increased usage of nutrition facts labels in making grocery purchasing decisions, and increased food availability of F&V (p < 0.05). This study demonstrates potential long-term sustained impact of a comprehensive school-based intervention among low-income children and their families., Competing Interests: Dr. Sharma is on the Board of Directors of Brighter Bites nonprofit organization, the goal of which is to improve access to fresh fruits and vegetables and nutrition education among underserved communities. This is an unpaid, advisory board position. The other authors have no conflicts of interest relevant to this article to disclose., (© 2020 The Authors.)

Introduction: Little is known about the social needs of low-income households with children during the coronavirus-2019 (COVID-19) pandemic. Our objective was to conduct a cross-sectional quantitative and qualitative descriptive analysis of a rapid-response survey among low-income households with children on social needs, COVID-19-related concerns, and diet-related behaviors., Methods: We distributed an electronic survey in April 2020 to 16,435 families in 4 geographic areas, and 1,048 responded. The survey asked families enrolled in a coordinated school-based nutrition program about their social needs, COVID-19-related concerns, food insecurity, and diet-related behaviors during the pandemic. An open-ended question asked about their greatest concern. We calculated descriptive statistics stratified by location and race/ethnicity. We used thematic analysis and an inductive approach to examine the open-ended comments., Results: More than 80% of survey respondents were familiar with COVID-19 and were concerned about infection. Overall, 76.3% reported concerns about financial stability, 42.5% about employment, 69.4% about food availability, 31.0% about housing stability, and 35.9% about health care access. Overall, 93.5% of respondents reported being food insecure, a 22-percentage-point increase since fall 2019. Also, 41.4% reported a decrease in fruit and vegetable intake because of COVID-19. Frequency of grocery shopping decreased and food pantry usage increased. Qualitative assessment identified 4 main themes: 1) fear of contracting COVID-19, 2) disruption of employment status, 3) financial hardship, and 4) exacerbated food insecurity., Conclusion: Our study highlights the compounding effect of the COVID-19 pandemic on households with children across the spectrum of social needs.

Objective: Brighter Bites is a school-based health promotion program that delivers fresh produce and nutrition education to low-income children and families. Due to COVID-19-related school closures, states were under "shelter in place" orders, and Brighter Bites administered a rapid assessment survey to identify social needs among their families. The purpose of this study is to demonstrate the methodology used to identify those with greatest social needs during this time ("high risk"), and to describe the response of Brighter Bites to these "high risk" families., Methods: The rapid assessment survey was collected in April 2020 across Houston, Dallas, Washington DC, and Southwest Florida. The survey consisted of items on disruption of employment status, financial hardship, food insecurity, perceived health status and sociodemographics. The open-ended question "Please share your greatest concern at this time, or any other thoughts you would like to share with us." was asked at the end of each survey to triage "high risk" families. Responses were then used to articulate a response to meet the needs of these high risk families., Results: A total of 1048 families completed the COVID-19 rapid response survey, of which 71 families were triaged and classified as "high risk" (6.8% of survey respondents). During this time, 100% of the "high risk" participants reported being food insecure, 85% were concerned about their financial stability, 82% concerned about the availability of food, and 65% concerned about the affordability of food. A qualitative analysis of the high-risk group revealed four major themes: fear of contracting COVID19, disruption of employment status, financial hardship, and exacerbated food insecurity. In response, Brighter Bites pivoted, created, and deployed a framework to immediately address a variety of social needs among those in the "high risk" category. Administering a rapid response survey to identify the immediate needs of their families can help social service providers tailor their services to meet the needs of the most vulnerable., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: Dr. Sharma is on the Board of Directors of Brighter Bites nonprofit organization, the goal of which is to improve access to fresh fruits and vegetables and nutrition education among underserved communities. This is an unpaid, advisory board position. The other authors have no conflicts of interest relevant to this article to disclose. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Quantitative reverse transcription polymerase chain reaction (RT-qPCR) assay is the gold standard recommended to test for acute SARS-CoV-2 infection. However, it generally requires expensive equipment such as RNA isolation instruments and real-time PCR thermal cyclers. As a pandemic, COVID-19 has spread indiscriminately, and many low resource settings and developing countries do not have the means for fast and accurate COVID-19 detection to control the outbreak. Additionally, long assay times, in part caused by slow sample preparation steps, have created a large backlog when testing patient samples suspected of COVID-19. With many PCR-based molecular assays including an extraction step, this can take a significant amount of time and labor, especially if the extraction is performed manually. Using COVID-19 clinical specimens, we have collected evidence that the RT-qPCR assay can feasibly be performed directly on patient sample material in virus transport medium (VTM) without an RNA extraction step, while still producing sensitive test results. If RNA extraction steps can be omitted without significantly affecting clinical sensitivity, the turn-around time of COVID-19 tests, and the backlog we currently experience can be reduced drastically. Furthermore, our data suggest that rapid RT-PCR can be implemented for sensitive and specific molecular diagnosis of COVID-19 in locations where sophisticated laboratory instruments are not available. Our USD 300 set up achieved rapid RT-PCR using thin-walled PCR tubes and a water bath setup using sous vide immersion heaters, a Raspberry Pi computer, and a single servo motor that can process up to 96 samples at a time. Using COVID-19 positive clinical specimens, we demonstrated that RT-PCR assays can be performed in as little as 12 min using untreated samples, heat-inactivated samples, or extracted RNA templates with our low-cost water bath setup. These findings can help rapid COVID-19 testing to become more accessible and attainable across the globe.

Workplace violence (WPV) has been extensively studied in hospitals, yet little is known about WPV in outpatient physician clinics. These settings and work tasks may present different risk factors for WPV compared to hospitals, including the handling/exchange of cash, and being remotely located without security presence. We conducted a systematic literature review to describe what is currently known about WPV in outpatient physician clinics. Six literature databases were searched and reference lists from included articles published from 2000-2019. Thirteen quantitative and five qualitative manuscripts were included which all focused on patient/family-perpetrated violence in outpatient physician clinics. No studies examined other violence types (e.g., worker-on-worker; burglary). The overall prevalence of Type II violence ranged from 9.5% to 74.6%, with the most common form being verbal abuse (42.1-94.3%), followed by threat of assault (14.0-57.4%), bullying (2.5-5.7%), physical assault, (0.5-15.9%) and sexual harassment/assault (0.2-9.3%). Worker consequences included reduced work performance, anger, and depression. Most workers did not receive training on how to manage a violent patient. More work is needed to examine the prevalence and risk factors of WPV in outpatient physician clinics for purposes of informing prevention efforts in these settings.

Using data from a nationally representative sample of school-aged teens ( n = 795), this study examined covariates associated with three subtypes of dating violence victimization (physical violence, emotional abuse, and imposed isolation). We asked the research questions: What were the family factors, dating attitudes, and risky behaviors associated with three subtypes of dating violence victimization across two time points? Second, were these relationships moderated by gender? Overall, we found widespread co-occurrence of victimization. Contrary to our predictions, not all earlier experiences with dating violence victimization worsened or persisted overtime. Regarding family factors, we did not find substantial statistically significant effects on victimization, with the exception that greater openness with parents was associated with increased occurrence of emotional abuse at Wave 1. In terms of dating attitudes, we found that when respondents condoned violence against a girlfriend, they were more likely to experience physical violence victimization at both waves. Respondents who believed that it is okay to use violence to control a boyfriend's behavior were more likely to report emotional abuse at Wave 1. Similarly, respondents who believed that it is okay to date more than one person, as well as those who condoned sexual intercourse outside of a romantic relationship, were more susceptible to emotional abuse. Regarding risky behaviors, we found that the respondents' victimization experience did not increase with a greater sexual partner acquisition; rather, it exerted the opposite effect on their experience with physical violence victimization. These risky behaviors, however, were only statistically significant at Wave 1. Finally, the moderating effect of gender is noted in the study. Implications from the study are discussed., (© Copyright 2020 Springer Publishing Company, LLC.)

Objective: Telemedicine uses video technology to communicate visual clinical information. This study aimed to implement telemedicine in pediatric and neonatal transport, assess its value, and identify barriers., Methods: This prospective study implemented telemedicine before transport to a tertiary care children's hospital. A preimplementation survey assessed attitudes toward telemedicine and perceived barriers. During the 12-week pilot, a video connection was initiated between transport and medical control. We collected survey results measuring telemedicine usefulness and hindrance after each use. A postimplementation survey assessed opinions about when telemedicine was useful., Results: Initially, 82% of users had no direct experience with telemedicine. Perceived utility and burden of telemedicine varied significantly by department. During the study, telemedicine was offered 65% of the time, initiated in 47% of cases, and successful in 30% of cases. The greatest barrier was connectivity. Over time, transport members and physicians found telemedicine to be significantly more useful. In 14 cases, telemedicine changed patient outcome or management. Providers who reported a change in management rated telemedicine as significantly more useful., Conclusion: This prospective pilot successfully implemented telemedicine before pediatric transport. Telemedicine was more useful in patients with visual findings on examination and, in some cases, changed the clinical outcome., (Copyright © 2020. Published by Elsevier Inc.)

Background: Food preparation interventions are an increasingly popular target for hands-on nutrition education for adults, children, and families, but assessment tools are lacking. Objective data on home cooking practices, and how they are interpreted through different data collection methods, are needed., Objective: The goal of this study was to explore the utility of the Healthy Cooking Index in coding multiple types of home food preparation data and elucidating healthy cooking behavior patterns., Design: Parent-child dyads were recruited between October 2017 and June 2018 in Houston and Austin, Texas for this observational study. Food preparation events were observed and video recorded. Participants also wore a body camera (eButton) and completed a questionnaire during the same event., Participants/setting: Parents with a school-aged child were recruited as dyads (n=40). Data collection procedures took place in participant homes during evening meal preparation events., Main Outcome Measures: Food preparation data were collected from parents through direct observation during preparation as well as eButton and paper questionnaires completed immediately after the event., Statistical Analyses Performed: All data sets were analyzed using the Healthy Cooking Index coding system and compared for concordance. A paired sample t test was used to examine significant differences between the scores. Cronbach's α and principal components analysis were conducted on the observed Healthy Cooking Index items to examine patterns of cooking practices., Results: Two main components of cooking practices emerged from the principal components analysis: one focused on meat products and another on health and taste enhancing practices. The eButton was more accurate in collecting Healthy Cooking Index practices than the self-report questionnaire. Significant differences were found between participant reported and observed summative Healthy Cooking Index scores (P<0.001), with no significant differences between scores computed from eButton images and observations (P=0.187)., Conclusions: This is the first study to examine nutrition optimizing home cooking practices by observational, wearable camera and self-report data collection methods. By strengthening cooking behavior assessment tools, future research will be able to elucidate the transmission of cooking education through interventions and the relationships between cooking practices, disease prevention, and health., (Copyright © 2020 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

This paper describes a novel method to measure the temporal latency of electroencephalography (EEG) systems using a customized photosensitive phantom. The system was evaluated with three different EEG devices, a medical grade (g.Tec), a consumer grade (Emotiv), and a low-cost device (Arduino SpikerShield). The temporal latencies of the three EEG devices were measured. The proposed method can be easily adapted to assess other EEG devices. The measurements obtained in this experiment provided concrete data for future experiments where accurate timing data are critical.