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Introduction Rapid initiation of ART after HIV diagnosis is recommended for individual and public health benefits. However, certain clinical and ART-related considerations hinder immediate initiation of therapy. Methods An open-label, single-arm, single-centre 48-week prospective clinical trial involving ART-naïve HIV-diagnosed adults who started bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) within a week from the first hospital visit, before the availability of baseline laboratory and genotype results. The primary aim was to determine the proportion of people with at least one condition that would hinder immediate initiation of any recommended ART regimen other than BIC/FTC/TAF. Clinicaltrials.gov : NCT04416906. Results We included 100 participants: 79% men, 64% from Latin America, median age 32 years. According to European AIDS Clinical Society (EACS) and US Department of Health and Human Services 2023 guidelines, 11% (95%CI 6; 19) of participants had at least one condition that made any ART different from BIC/FTC/TAF less appropriate for a rapid ART strategy. Seventy-nine percent of the people started BIC/FTC/TAF within the first 48 hours of their first hospital visit. There were 16 early discontinuations (11 lost to follow-up). By week 48, 92% (95%CI 86; 98) of the participants of the ITT population with observed data achieved viral suppression. Eight grade 3–4 adverse events (AEs), five serious AEs and six ART-related AEs were identified. Adherence remained high. Conclusions BIC/FTC/TAF is an optimal treatment for rapid initiation of ART. However, additional strategies to improve retention in care must be implemented. [ABSTRACT FROM AUTHOR]

CONTEXT: Educational interventions can help individuals increase their knowledge of available contraceptive methods, enabling them to make informed decisions and use contraception correctly. This review updates a previous review of contraceptive education. EVIDENCE ACQUISITION: Multiple databases were searched for articles published March 2011-November 2016. Primary outcomes were knowledge, participation in and satisfaction/comfort with decision making, attitudes toward contraception, and selection of more effective methods. Secondary outcomes included contraceptive behaviors and pregnancy. Excluded articles described interventions that had no comparison group, could not be conducted feasibly in a clinic setting, or were conducted outside the U.S. or similar country. EVIDENCE SYNTHESIS: A total of 24,953 articles were identified. Combined with the original review, 37 articles met inclusion criteria and described 31 studies implementing a range of educational approaches (interactive tools, written materials, audio/videotapes, and text messages), with and without healthcare provider feedback, for a total of 36 independent interventions. Of the 31 interventions for which knowledge was assessed, 28 had a positive effect. Fewer were assessed for their effect on attitudes toward contraception, selection of more effective methods, contraceptive behaviors, or pregnancy-although increased knowledge was found to mediate additional outcomes (positive attitudes toward contraception and contraceptive continuation). CONCLUSIONS: This systematic review is consistent with evidence from the broader healthcare field in suggesting that a range of interventions can increase knowledge. Future studies should assess what aspects are most effective, the benefits of including provider feedback, and the extent to which educational interventions can facilitate behavior change and attainment of reproductive health goals. THEME INFORMATION: This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

ContextCommunity education and engagement are important for informing family planning projects. The objective of this study was to update two prior systematic reviews assessing the impact of community education and engagement interventions on family planning outcomes.Evidence acquisitionSixteen electronic databases were searched for studies relevant to a priori determined inclusion/exclusion criteria in high development settings, published from March 2011 through April 2016, updating two reviews that included studies from 1985 through February 2011.Evidence synthesisNine relevant studies were included in this updated review related to community education, in addition to 17 from the prior review. No new community engagement studies met inclusion criteria, as occurred in the prior review. Of new studies, community education modalities included mass media, print/mail, web-based, text messaging, and interpersonal interventions. One study on mass media intervention demonstrated a positive impact on reducing teen and unintended pregnancies. Three of four studies on interpersonal interventions demonstrated positive impacts on medium-term family planning outcomes, such as contraception and condom use. Three new studies demonstrated mostly positive, but inconsistent, results on short-term family planning outcomes.ConclusionsFindings from this systematic review update are in line with a previous review showing the positive impact of community education using traditional modalities on short-term family planning outcomes, identifying additional impacts on long-term outcomes, and highlighting new evidence for education using modern modalities, such as text messaging and web-based education. More research is necessary to provide a stronger evidence base for directing community education and engagement efforts in family planning contexts.Theme informationThis article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

ContextThe objective of this systematic review was to update a prior review and summarize the evidence (newly identified and cumulative) on the impact of contraceptive counseling provided in clinical settings.Evidence acquisitionMultiple databases, including PubMed, were searched during 2016-2017 for articles published from March 1, 2011, to November 30, 2016.Evidence synthesisThe search strategy identified 24,953 articles; ten studies met inclusion criteria. Two of three new studies that examined contraceptive counseling interventions (i.e., enhanced models to standard of care) among adolescents and young adults found a statistically significant positive impact on at least one outcome of interest. Five of seven new studies that examined contraceptive counseling, in general, or specific counseling interventions or aspects of counseling (e.g., personalization) among adults or mixed populations (adults and adolescents) found a statistically significant positive impact on at least one outcome of interest. In combination with the initial review, six of nine studies among adolescents and young adults and 16 of 23 studies among adults or mixed populations found a statistically significant positive impact of counseling on at least one outcome of interest.ConclusionsOverall, evidence supports the utility of contraceptive counseling, in general, and specific interventions or aspects of counseling. Promising components of contraceptive counseling were identified. The following would strengthen the evidence base: improved documentation of counseling content and processes, increased attention to the relationships between client experiences and behavioral outcomes, and examining the comparative effectiveness of different counseling approaches to identify those that are most effective.Theme informationThis article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

ContextProviders can help clients achieve their personal reproductive goals by providing high-quality, client-centered contraceptive counseling. Given the individualized nature of contraceptive decision making, provider attention to clients' preferences for counseling interactions can enhance client centeredness. The objective of this systematic review was to summarize the evidence on what preferences clients have for the contraceptive counseling they receive.Evidence acquisitionThis systematic review is part of an update to a prior review series to inform contraceptive counseling in clinical settings. Sixteen electronic bibliographic databases were searched for studies related to client preferences for contraceptive counseling published in the U.S. or similar settings from March 2011 through November 2016. Because studies on client preferences were not included in the prior review series, a limited search was conducted for earlier research published from October 1992 through February 2011.Evidence synthesisIn total, 26 articles met inclusion criteria, including 17 from the search of literature published March 2011 or later and nine from the search of literature from October 1992 through February 2011. Nineteen articles included results about client preferences for information received during counseling, 13 articles included results about preferences for the decision-making process, 13 articles included results about preferences for the relationship between providers and clients, and 11 articles included results about preferences for the context in which contraceptive counseling is delivered.ConclusionsEvidence from the mostly small, qualitative studies included in this review describes preferences for the contraceptive counseling interaction. Provider attention to these preferences may improve the quality of family planning care; future research is needed to explore interventions designed to meet preferences.Theme informationThis article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Context: The "community-based workforce" is an umbrella term used by a workgroup of U.S. Department of Health and Human Services (HHS) leaders to characterize a variety of job titles and descriptions for positions in the public health, health care delivery, and human service sectors across local communities., Approach: Definitions, expectations of the scope of work, and funding opportunities for this workforce vary. To address some of these challenges, a workgroup of HHS agencies met to define the roles of this workforce and identify existing opportunities for training, career advancement, and compensation., Discussion: The community-based workforce has demonstrated success in improving poor health outcomes and addressing the social determinants of health for decades. However, descriptions of this workforce, expectations of their roles, and funding opportunities vary. The HHS workgroup identified that comprehensive approaches are needed within HHS and via public health sectors to meet these challenges and opportunities., Conclusion: Using the common term "community-based workforce" across HHS can encourage alignment and collaboration. As the environment for this public health and health care community-based workforce shifts, it will be important to understand the value and opportunities available to ensure long-term sustainability for this workforce to continue to advance health equity., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: This study estimated the benefits and costs of the U.S. Department of Health and Human Services' We Can Do This COVID-19 public education campaign (the Campaign) and associated vaccination-related impacts., Methods: Weekly media market and national Campaign expenditures were used to estimate weekly first-dose vaccinations that would not have occurred absent the Campaign, weekly Campaign-attributed complete vaccinations, and corresponding COVID-19 cases, hospitalizations, and deaths averted. Benefits were valued using estimated morbidity and mortality reductions and associated values of a statistical life and a statistical case. Costs were estimated using Campaign paid media expenditures and corresponding vaccination costs. The net Campaign and vaccination benefit and return on investment were calculated. Analyses were conducted from 2022 to 2024., Results: Between April 2021 and March 2022, an estimated 55.9 million doses of COVID-19 vaccines would not have been administered absent the Campaign. Campaign-attributed vaccinations resulted in 2,576,133 fewer mild COVID-19 cases, 243,979 fewer nonfatal COVID-19 hospitalizations, and 51,675 lives saved from COVID-19. The total Campaign benefit was $740.2 billion, and Campaign and vaccination costs totaled $8.3 billion, with net benefits of approximately $732.0 billion. For every $1 spent, the Campaign and corresponding vaccination costs resulted in benefits of approximately $89.54., Conclusions: The We Can Do This COVID-19 public education campaign saved more than 50,000 lives and prevented hundreds of thousands of hospitalizations and millions of COVID-19 cases, representing hundreds of billions of dollars in benefits in less than one year. Findings suggest that public education campaigns are a cost-effective approach to reducing COVID-19 morbidity and mortality., (Copyright © 2024. Published by Elsevier Inc.)

The United States (U.S.) Food and Drug Administration (FDA) oversees the safety and quality of drugs and vaccines that are used in the U.S. Administration of the FDA falls under the jurisdiction of the U.S. Department of Health and Human Services (HHS). The regulatory oversight of the FDA is complex and comprehensive, requiring the various roles and responsibilities to be divided across six main centers. The activities of two of these centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the primary focus of this review., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: The United States has high and increasing rates of maternal morbidity and mortality, large proportions of which are related to cardiovascular health (CVH). Methods: We searched for National Institutes of Health (NIH) supported research as well as that of two other Agencies in the U.S. Department of Health and Human Services (DHHS) for fiscal years (FY) 2016-2021. Grants included maternal health conditions or exposures across all pregnancy stages, but excluded grants that focused entirely on birth, neonatal, infant/childhood outcomes. Results were manually curated by reviewing the abstract and specific aims. Grants deemed to be relevant were grouped by category. Results: Between FY 2016-2021, overall Maternal Health grants remained unchanged at an average of 1.4% of total DHHS grant funding. Maternal CVH-specific (MCVH) funding amounted to $278,926,105 for 755 grants, $191,344,649 was for 534 Type-1 grants, representing a twofold increase. Non-NIH DHHS agencies most commonly funded general Maternal Health related to CVH; NIH focused funding classified as hypertensive disorders of pregnancy, maternal morbidity and mortality, obesity, and diabetes. Non-NIH DHSS Agencies most commonly funded clinical applied research. In addition to clinical applied grants, NIH funded substantial proportions of grants classified as basic research, clinical trials, and/or translational. National Heart, Lung, and Blood Institute (NHLBI) MCVH grants studied participants in the pre-partum period (78.5%), followed by the post-partum period (50.5%), with relatively few in pre-pregnancy and peri-partum periods (10.8% and 9.7%, respectively); at the NIH level, the peri-partum period had better representation at 20.3%, whereas the pre-pregnancy period remained low at 9.9%. Conclusions: Federal grant funding for maternal health including MCVH increased at the same rate as its funding for overall research, and represented only 1.4% of overall total funding. The pre-pregnancy period was understudied in overall NIH funding and represents a gap area whereby funding agencies could further foster research advances.

With increasing numbers of people with Alzheimer's and other dementias across the globe, many countries have developed national plans to deal with the resulting challenges. In the United States, the National Alzheimer's Project Act, signed into law in 2011, required the creation of such a plan with annual updates thereafter. Pursuant to this, the US Department of Health and Human Services (HHS) released the National Plan to Address Alzheimer's Disease in 2012, including an ambitious research goal of preventing and effectively treating Alzheimer's disease by 2025. To guide investments, activities, and the measurement of progress toward achieving this 2025 goal, in its first annual plan update (2013) HHS also incorporated into the plan a set of short, medium and long-term milestones. HHS further committed to updating these milestones on an ongoing basis to account for progress and setbacks, and emerging opportunities and obstacles. To assist HHS as it updates these milestones, the Alzheimer's Association convened a National Plan Milestone Workgroup consisting of scientific experts representing all areas of Alzheimer's and dementia research. The workgroup evaluated each milestone and made recommendations to ensure that they collectively constitute an adequate work plan for reaching the goal of preventing and effectively treating Alzheimer's by 2025. This report presents these Workgroup recommendations.

With increasing numbers of people with Alzheimer's and other dementias across the globe, many countries have developed national plans to deal with the resulting challenges. In the United States, the National Alzheimer's Project Act, signed into law in 2011, required the creation of such a plan with annual updates thereafter. Pursuant to this, the US Department of Health and Human Services (HHS) released the National Plan to Address Alzheimer's Disease in 2012, including an ambitious research goal of preventing and effectively treating Alzheimer's disease by 2025. To guide investments, activities, and the measurement of progress toward achieving this 2025 goal, in its first annual plan update (2013) HHS also incorporated into the plan a set of short, medium and long-term milestones. HHS further committed to updating these milestones on an ongoing basis to account for progress and setbacks, and emerging opportunities and obstacles. To assist HHS as it updates these milestones, the Alzheimer's Association convened a National Plan Milestone Workgroup consisting of scientific experts representing all areas of Alzheimer's and dementia research. The workgroup evaluated each milestone and made recommendations to ensure that they collectively constitute an adequate work plan for reaching the goal of preventing and effectively treating Alzheimer's by 2025. This report presents these Workgroup recommendations.

We estimated US Department of Health and Human Services (DHHS)-approved human immunodeficiency virus (HIV) indicators. Among patients, 71% were retained in care, 82% were prescribed treatment, and 78% had HIV RNA ≤200 copies/mL; younger adults, women, blacks, and injection drug users had poorer outcomes. Interventions are needed to reduce retention- and treatment-related disparities.

Although chemical and radiological agents cause toxicity through different mechanisms, the multiorgan injuries caused by these threats share similarities that convene on the level of basic biological responses. This publication will discuss these areas of convergence and explore "multi-utility" approaches that could be leveraged to address common injury mechanisms underlying actions of chemical and radiological agents in a threat-agnostic manner. In addition, we will provide an overview of the current state of radiological and chemical threat research, discuss the US Government's efforts toward medical preparedness, and identify potential areas for collaboration geared toward enhancing preparedness and response against radiological and chemical threats. We also will discuss previous regulatory experience to provide insight on how to navigate regulatory paths for US Food and Drug Administration (FDA) approval/licensure/clearance for products addressing chemical or radiological/nuclear threats. This publication follows a 2022 trans-agency meeting titled, "Overlapping Science in Radiation and Sulfur Mustard Exposures of Skin and Lung: Consideration of Models, Mechanisms, Organ Systems, and Medical Countermeasures," sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). Discussions from this meeting explored the overlapping nature of radiation and chemical injury and spurred increased interest in how preparedness for one threat leads to preparedness for the other. Herein, subject matter experts from the NIAID and the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR), summarize the knowledge gained from recently funded biomedical research, as well as insights from the 2022 meeting. These topics include identification of common areas for collaboration, potential use of biomarkers of injury to identify injuries caused by both hazards, and common and widely available treatments that could treat damage caused by radiological or chemical threats.

Process evaluation of public health interventions is important for understanding intervention results and can help explain why interventions succeed or fail. This study evaluated implementation of a school-based intervention combining educational and environmental strategies to prevent stress among Danish high school students. We investigated dose delivered, dose received, fidelity, appreciation, barriers and facilitators at the 15 intervention schools using mixed methods and multiple data sources: questionnaires among students, teachers and school coordinators; semi-structured interviews with school coordinators; telephone interviews with student counsellors; and focus group interviews with students and teachers. Implementation varied by schools and classes. Half of the intervention schools delivered the environmental strategies. For the educational strategies, dose delivered differed according to intervention provider. Students reported a lower dose received compared with dose delivered reported by school staff. Overall, student counsellors, school coordinators and students—especially those with low perceived stress—were satisfied with the stress preventive initiatives while teacher satisfaction varied. Five main barriers and three facilitators for implementation were identified. The use of multiple data sources and data methods created new knowledge of the implementation process which is important for the interpretation of effect evaluation and development of future interventions. [ABSTRACT FROM AUTHOR]

The aim of this scoping review was to assist researchers who want to use survey data, either in academic or community settings, to identify and comprehend health disparities affecting Native Hawaiian (NH), Pacific Islander (PI), and/or Filipino populations, as these are groups with known and numerous health disparities. The scoping review methodology was used to identify survey datasets that disaggregate data for NH, PI, or Filipinos. Healthdata.gov was searched, as there is not an official index of databases. The website was established by the United States (US) Department and Health and Human Services to increase accessibility of health data for entrepreneurs, researchers, and policy makers, with the ultimate goal of improving health outcomes. Using the search term 'survey,' 332 datasets were retrieved, many of which were duplicates from different years. Datasets were included that met the following criteria: (1) related to health; (2) disaggregated NH, PI, and/or Filipino subgroups; (3) administered in the US; (4) publicly available; (5) individual-level data; (6) self-reported information; and (7) contained data from 2010 or later. Fifteen survey datasets met the inclusion criteria. Two additional survey datasets were identified by colleagues. For each dataset, the dataset name, data source, years of the data availability, availability of disaggregated NH, PI, and/or Filipino data, data on health outcomes and social determinants of health, and website information were documented. This inventory of datasets should be of use to researchers who want to advance understanding of health disparities experienced by NH, PI, and Filipino populations in the US., Competing Interests: None of the authors identify a conflict of interest., (©Copyright 2023 by University Health Partners of Hawai‘i (UHP Hawai‘i).)

Background: Immune reconstitution inflammatory syndrome (IRIS) can manifest with initiation or reintroduction of antiretroviral therapy (ART) in persons living with HIV (PLWH). In 2012, updated United States treatment guidelines recommended initiation of ART for all PLWH regardless of CD4 count. The objectives of this study were to quantify hospital usage attributable to IRIS and assess the reasons for hospitalization in PLWH before and after the guideline update. Methods: Subjects were PLWH between 18-89 years of age who were hospitalized between November 1, 2009 and July 31, 2014. Equivalent time periods before and after updated treatment guidelines were considered, and designated as Time Period 1 and Time Period 2, respectively. IRIS-attributable hospitalizations were identified by ICD9 codes and electronic medical record searches with subsequent review and confirmation. For hospitalizations that were not confirmed as being IRIS-attributable, primary discharge diagnoses were reviewed. Results: A total of 278 PLWH were hospitalized 521 times throughout the study period. Time Period 1 had 9 PLWH with 12 IRIS-attributable hospitalizations while Time Period 2 had 6 PLWH with 9 IRIS-attributable hospitalizations. A larger proportion of IRIS-attributable hospital days was observed in Time Period 1 compared to Time Period 2 (7.5 vs 4.2%; p < 0.001). Median length of stay for IRIS-attributable hospitalizations was longer than for other diagnoses, particularly during Time Period 1 (12.0 vs 4.0; p = 0.05). The most common causes for hospitalizations in PLWH were non AIDS-defining infection, AIDS-defining malignancy, and gastrointestinal. PLWH who had HIV viral suppression (<200 copies/mL) accounted for 34 and 24% of hospitalizations in Time Periods 1 and 2 respectively. Conclusions: Hospitalizations for PLWH continue at high rates and IRIS is a significant contributing factor. In our single-center study, there was a lower number of IRIS-attributable hospitalizations and IRIS-attributable hospital days in Time Period 2 compared with Time Period 1. The hospital burden of IRIS may decrease over time as more PLWH are started on ART earlier in the course of infection. This study highlights the continued importance of early diagnosis and linkage to care of those infected with HIV, so that morbidity and costs associated with IRIS continue to decline. [ABSTRACT FROM AUTHOR]

Background: Over 1 million people in the United States have died of COVID-19. In response to this public health crisis, the US Department of Health and Human Services launched the We Can Do This public education campaign in April 2021 to increase vaccine confidence. The campaign uses a mix of digital, television, print, radio, and out-of-home channels to reach target audiences. However, the impact of this campaign on vaccine uptake has not yet been assessed., Objective: We aimed to address this gap by assessing the association between the We Can Do This COVID-19 public education campaign's digital impressions and the likelihood of first-dose COVID-19 vaccination among US adults., Methods: A nationally representative sample of 3642 adults recruited from a US probability panel was surveyed over 3 waves (wave 1: January to February 2021; wave 2: May to June 2021; and wave 3: September to November 2021) regarding COVID-19 vaccination, vaccine confidence, and sociodemographics. Survey data were merged with weekly paid digital campaign impressions delivered to each respondent's media market (designated market area [DMA]) during that period. The unit of analysis was the survey respondent-broadcast week, with respondents nested by DMA. Data were analyzed using a multilevel logit model with varying intercepts by DMA and time-fixed effects., Results: The We Can Do This digital campaign was successful in encouraging first-dose COVID-19 vaccination. The findings were robust to multiple modeling specifications, with the independent effect of the change in the campaign's digital dose remaining practically unchanged across all models. Increases in DMA-level paid digital campaign impressions in a given week from -30,000 to 30,000 increased the likelihood of first-dose COVID-19 vaccination by 125%., Conclusions: Results from this study provide initial evidence of the We Can Do This campaign's digital impact on vaccine uptake. The size and length of the Department of Health and Human Services We Can Do This public education campaign make it uniquely situated to examine the impact of a digital campaign on COVID-19 vaccination, which may help inform future vaccine communication efforts and broader public education efforts. These findings suggest that campaign digital dose is positively associated with COVID-19 vaccination uptake among US adults; future research assessing campaign impact on reduced COVID-19-attributed morbidity and mortality and other benefits is recommended. This study indicates that digital channels have played an important role in the COVID-19 pandemic response. Digital outreach may be integral in addressing future pandemics and could even play a role in addressing nonpandemic public health crises., (©Christopher J Williams, Elissa C Kranzler, Joseph N Luchman, Benjamin Denison, Sean Fischer, Thomas Wonder, Ronne Ostby, Monica Vines, Jessica Weinberg, Elizabeth L Petrun Sayers, Allison N Kurti, Sarah Trigger, Leah Hoffman, Joshua F A Peck. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.05.2023.)