Objectives. HIV preexposure prophylaxis (PrEP) use has increased since its US Food and Drug Administration approval in 2012. Our objective was to describe trends in PrEP use by US women. Methods. Using national pharmacy and HIV surveillance data, we calculated the PrEP-to-diagnosis ratio (PDR), a measure of PrEP prescriptions each year compared with HIV diagnoses the previous year, for women from 2017 to 2023. We also calculated PDRs in 2023 for the 20 counties with the highest numbers of diagnosed HIV infections among women and reviewed reports of public health activities conducted by recipients of Centers for Disease Control and Prevention HIV prevention funding. Results. The PDR for women was 1.5 in 2017, and it increased to 5.8 by 2023. In the 20 counties with the highest number of diagnosed HIV infections among women, PDRs ranged from 2.2 to 16.9. Counties with the highest PDRs conducted PrEP activities designed for women. Conclusions. PrEP is a highly effective HIV prevention intervention that can empower women to protect their health, but its use has been low. Public health and clinical interventions designed for women can increase their PrEP use and support ending the US HIV epidemic. (Am J Public Health. Published online ahead of print April 24, 2025:e1-e4. https://doi.org/10.2105/AJPH.2025.308056).

The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Here, we aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. We completed a scoping review and developed a project-specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators and other reviewers.

IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

IMPORTANCE: The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. OBSERVATIONS: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (harms, outcomes, nonpharmacological treatment) and other reporting guidelines (Template for Intervention Description and Replication [TIDieR]). The potential modifications were rated in a 3-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of 2 new protocol items, revision to 5 items, deletion/merger of 5 items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open-science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policy makers, regulators, and other reviewers.

IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

BACKGROUND: Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. METHODS: We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. RESULTS: We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. CONCLUSIONS: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.

ARTICLE SUMMARY: Prescribed early physical activity and behavioral management did not improve outcomes in youth following acute concussion compared to the standard of care. OBJECTIVE: To determine the efficacy of early physical activity and behavioral management for acute concussion in pediatric patients. STUDY DESIGN: A multicenter, prospective, 2x2 factorial randomized controlled trial was conducted among patients aged 11-24 years who presented within 72 hours of injury. Participants were randomized into four groups based on early physical activity (or usual care) and behavioral management (or none). The early activity group was encouraged to meet step targets despite symptoms. The primary outcomes were post-concussion symptom severity and quality of life at 14 days post-enrollment. RESULTS: A total of 239 participants were randomized, and 210 completed all study procedures. The early activity group demonstrated higher daily step counts compared with the usual care group. However, no significant differences were observed in post-concussion symptom severity or quality of life at 14 days between groups. The early activity group experienced higher daily post-concussion symptom severity during the first 7 days and took longer to recover compared with the usual care group. Behavioral management showed no effect on outcomes. CONCLUSIONS: Early prescribed physical activity and behavioral management did not improve post-concussion outcomes in the first two weeks following injury. Early prescribed activity despite symptoms was associated with delayed symptom resolution. Clinical trial registration ClinicalTrials.gov NCT03869970.

Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

IMPORTANCE: Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomized trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Herein, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. OBSERVATIONS: We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, nonpharmacological treatment), other related reporting guidelines (Template for Intervention Description and Replication [TIDieR]), and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, 3-round Delphi survey involving 317 participants and discussed at a 2-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added 7 new checklist items, revised 3 items, deleted 1 item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomized trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. CONCLUSIONS AND RELEVANCE: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.

BACKGROUND: Guidelines recommend tailored reproductive health counseling for women with congenital heart defects (CHDs) beginning in adolescence, yet provider adherence to recommendations remains understudied, particularly outside specialized cardiac care settings. STUDY DESIGN: We conducted a cross-sectional cohort study among women aged 19 to 38 with CHDs, identified from active population-based birth defects registries in three states. Participants completed surveys from 2016 to 2019, including questions about contraception, pregnancy counseling, concerns, and experiences. Multivariable Poisson regression, adjusted for sociodemographic and health characteristics, assessed associations between CHD severity, counseling, and reproductive health outcomes. RESULTS: Of 765 women, those with severe CHDs, compared with non-severe, were more likely to report receiving clinician counseling about safe contraceptive methods (44.0% and 13.7%; adjusted prevalence ratio [aPR] = 3.0; 95% confidence interval [95% CI] [2.2, 4.0]), pregnancy, (63.3% and 16.5%; aPR = 3.6; 95% CI [2.7, 4.6]), and pregnancy avoidance (32.0% and 6.4%; aPR = 4.3; 95% CI [2.9, 6.6]); be concerned about ability to have children (40.9% and 31.2%; aPR = 1.4; 95% CI [1.1, 1.8]), and delay/avoid pregnancy (26.6% and 10.7%; aPR = 2.2; 95% CI [1.5, 3.2]). No disparity was found in ever being pregnant (30.0% vs. 37.2%; aPR = 1.0; 95% CI [0.7, 1.2]). One-third of the respondents with any CHD reported concerns about their ability to have children (33.6%). CONCLUSION: We found that only a minority of women with CHDs reported receiving counseling on safe contraception and pregnancy, and about a third reported concerns about their ability to have children. These findings highlight a gap between guideline recommendations and clinical practice, underscoring the need for improved reproductive health discussions for women with CHDs.

Background: Guidelines recommend tailored reproductive health counseling for women with congenital heart defects (CHDs) beginning in adolescence, yet provider adherence to recommendations remains understudied, particularly outside specialized cardiac care settings. Study Design: We conducted a cross-sectional cohort study among women aged 19 to 38 with CHDs, identified from active population-based birth defects registries in three states. Participants completed surveys from 2016 to 2019, including questions about contraception, pregnancy counseling, concerns, and experiences. Multivariable Poisson regression, adjusted for sociodemographic and health characteristics, assessed associations between CHD severity, counseling, and reproductive health outcomes. Results: Of 765 women, those with severe CHDs, compared with non-severe, were more likely to report receiving clinician counseling about safe contraceptive methods (44.0% and 13.7%; adjusted prevalence ratio [aPR] = 3.0; 95% confidence interval [95% CI] [2.2, 4.0]), pregnancy, (63.3% and 16.5%; aPR = 3.6; 95% CI [2.7, 4.6]), and pregnancy avoidance (32.0% and 6.4%; aPR = 4.3; 95% CI [2.9, 6.6]); be concerned about ability to have children (40.9% and 31.2%; aPR = 1.4; 95% CI [1.1, 1.8]), and delay/avoid pregnancy (26.6% and 10.7%; aPR = 2.2; 95% CI [1.5, 3.2]). No disparity was found in ever being pregnant (30.0% vs. 37.2%; aPR = 1.0; 95% CI [0.7, 1.2]). One-third of the respondents with any CHD reported concerns about their ability to have children (33.6%). Conclusion: We found that only a minority of women with CHDs reported receiving counseling on safe contraception and pregnancy, and about a third reported concerns about their ability to have children. These findings highlight a gap between guideline recommendations and clinical practice, underscoring the need for improved reproductive health discussions for women with CHDs. © 2025 Jacobs Institute of Women's Health, George Washington University

BACKGROUND: This manuscript describes an updated spreadsheet tool that sexually transmitted infection (STI) prevention programs in the United States can use to estimate the health and economic benefits of their STI and HIV prevention activities. METHODS: The development of the updated tool, STIC (Sexually Transmitted Infection Costs) Figure 2.0, involved two main components. First, we revised the tool to be more useful and user-friendly based on feedback from focus groups and usability testing. Second, we updated the mathematical model behind the calculations by (1) revising the model to reflect current STI and HIV prevention activities in the United States, (2) updating the epidemiological and economic parameters in the model using the best available evidence, and (3) including ranges (not just point estimates) in the model output. To demonstrate the use of STIC Figure 2.0, we applied it to estimate the impact of a hypothetical prevention program, consistent with that of a health department or large STI clinic in a metropolitan area. RESULTS: STIC Figure 2.0 incorporated new features, including an interactive user interface to explore findings and create customized charts for use in reports and presentations. The hypothetical example we analyzed illustrated how providing STI treatment to 2,680 people and HIV prevention services to 325 people could avert 1,253 adverse outcomes and save over $2 million in medical costs and productivity costs. CONCLUSIONS: Although subject to important limitations, STIC Figure 2.0 allows state and local programs, including STI clinics, to calculate evidence-based estimates of the impact of their program activities.

BACKGROUND: Our objective was to characterize the education and employment history of young adults with congenital heart defects (CHD) living in the United States. METHODS: The 2016-2019 Congenital Heart Survey To Recognize Outcomes, Needs, and well-beinG collected data from young adults (ages 19-38) with CHD identified from active birth defect in Arkansas, Arizona, and Atlanta, Georgia. Educational attainment, employment history, and special education between kindergarten and 12th grade were self-/proxy-reported. Respondent percentages were standardized to the eligible population by CHD severity, birth year, site, sex, and maternal race/ethnicity and compared by CHD severity using p values from Z-scores. Log-binomial prevalence ratios (aPRs) assessed associations between respondent characteristics and outcomes, adjusting for CHD severity, age group, sex, race/ethnicity, and site. Employment models also adjusted for education. Point estimates were compared to the 2018 American Community Survey (ACS) 5-year general population estimates. RESULTS: Among 1438 respondents, 28.3% attained ≥ bachelor's degree and 22.1% were unemployed for ≥ 12 months. Estimates were comparable by CHD severity (aPRs ~1.0) and similar to general population estimates (in ACS, 21% attained ≥ bachelor's degree and 26% were unemployed). About 25.3% of adults with CHD received special education, more commonly adults with severe (32.9%) than nonsevere CHD (23.5%, p = 0.01). CONCLUSIONS: Among young adults with CHD, educational attainment and employment did not substantially differ by CHD severity or from general population rates. One in four used special education between kindergarten and 12th grade. Clinical guidelines recommend ongoing educational and vocational support to individuals with CHD as needed so this population continues to thrive.

INTRODUCTION: Fall injuries are the second leading cause of traumatic injury and death for all US workers and are a leading injury concern for the Department of the Air Force (DAF). Bundled interventions can improve the likelihood of injury reduction, especially in large, heterogeneous working populations. In 2013, the DAF implemented the "Air Force Fall Prevention Focus," a bundled intervention of prevention efforts designed to reduce occupational fall injury events among DAF members. The purpose of this study is to describe the burden and risk factors associated with fall injuries and evaluate the effectiveness of the Fall Prevention Focus in reducing the burden of fall injuries. METHODS: The National Institute for Occupational Safety and Health (NIOSH) partnered with the US Air Force Safety Center (AFSEC) to examine the impact of the Fall Prevention Focus as a bundled intervention. Injury events included a narrative description of the injury event, demographics, work environment, job tasks, and other structured details. Descriptive statistics and pre-post longitudinal modeling were used to evaluate changes in fall injury rates. RESULTS: The Fall Prevention Focus Implementation (2013-2018) resulted in an annual 10.4% (95% confidence interval [CI]: 8.5%, 12.2%) reduction, and a 6-year cumulative 48.3% (95% CI: 41.4%, 54.3%) reduction in fall injury event rates by 2018. DISCUSSION: Safety in the DAF involves a comprehensive approach. Documenting the impact of the Fall Prevention Focus may help translate these findings to improve fall prevention efforts in other sectors of the military and high fall-risk industries in the private sector, such as construction.

Cardiovascular disease (CVD) is the leading cause of illness and death in the US and is substantially affected by social determinants of health, such as social, economic, and environmental factors. CVD disproportionately affects groups that have been economically and socially marginalized, yet health care and public health professionals often lack tools for collecting and using data to understand and address CVD inequities among their populations of focus. The Health Equity Indicators for Cardiovascular Disease Toolkit (HEI for CVD Toolkit) seeks to address this gap by providing metrics, measurement guidance, and resources to support users collecting, measuring, and analyzing data relevant to their CVD work. The toolkit includes a conceptual framework (a visual model for understanding health inequities in CVD); a comprehensive list of health equity indicators (metrics of inequities that influence CVD prevention, care, and management); guidance in definitions, measures, and data sources; lessons learned and examples of HEI implementation; and other resources to support health equity measurement. To develop this toolkit, we performed literature scans to identify primary topics and themes relevant to addressing inequities in CVD, engaged with subject matter experts in health equity and CVD, and conducted pilot studies to understand the feasibility of gathering and analyzing data on the social determinants of health in various settings. This comprehensive development process resulted in a toolkit that can help users understand the drivers of inequities in their communities or patient populations, assess progress, evaluate intervention outcomes, and guide actions to address CVD disparities.

Ensuring good quality of life (QoL) among persons with diagnosed HIV (PWH) is a priority of the National HIV/AIDS Strategy (NHAS), which established 2025 goals for improving QoL. Goals are monitored through five indicators: self-rated health, unmet needs for mental health services, unemployment, hunger or food insecurity, and unstable housing or homelessness. Among the growing population of PWH aged ≥50 years, progress toward these goals has not been assessed. Data collected during the 2017-2022 cycles of the Medical Monitoring Project, an annual complex sample survey of U.S. adults with diagnosed HIV, assessed progress toward NHAS 2025 QoL goals among PWH aged ≥50 years, overall and by age group. The recent estimated annual percentage change from baseline (2017 or 2018) to 2022 was calculated for each indicator. Among PWH aged ≥50 years, the 2025 goal of 95% PWH with good or better self-rated health is 46.2% higher than the 2022 estimate. The 2025 goals of a 50% reduction in the other indicators range from 26.3% to 56.3% lower than the 2022 estimates. Decreasing hunger or food insecurity by 50% among PWH aged ≥65 was the only goal met by 2022. If recent trends continue, other NHAS QoL 2025 goals are unlikely to be met. Multisectoral strategies to improve access to housing, employment, food, and mental health will be needed to meet NHAS 2025 goals for QoL among older PWH.

Invasive Haemophilus influenzae type b (Hib) disease is a serious bacterial infection that disproportionally affects American Indian and Alaska Native (AI/AN) populations. Hib vaccination with a monovalent Hib conjugate vaccine consisting of Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) conjugated to outer membrane protein complex of Neisseria meningitidis serogroup B, PRP-OMP (PedvaxHIB, Merck and Co., Inc.) has historically been preferred for AI/AN infants, who are at increased risk for invasive Hib disease, because it provides substantial protection after the first dose. On June 26, 2024, CDC's Advisory Committee on Immunization Practices (ACIP) recommended that a hexavalent, combined diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus (IPV), Hib conjugate, and hepatitis B (HepB) vaccine, DTaP-IPV-Hib-HepB (Vaxelis, MSP Vaccine Company) should be included with monovalent PRP-OMP in the preferential recommendation for AI/AN infants because of the PRP-OMP Hib component. A primary Hib vaccination series consisting of either 1) monovalent PRP-OMP (2-dose series at ages 2 and 4 months) or 2) DTaP-IPV-Hib-HepB (3-dose series at ages 2, 4, and 6 months) is preferred for AI/AN infants. DTaP-IPV-Hib-HepB is only indicated for use in infants at ages 2, 4, and 6 months and should not be used for the booster doses of Hib, DTaP, or IPV vaccines. For the booster dose of Hib vaccine, no vaccine formulation is preferred for AI/AN children; any Hib vaccine (except DTaP-IPV-Hib-HepB) should be used. This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of Hib-containing vaccines among AI/AN infants and children.

Aedes mosquito-borne viruses (ABVs) place a substantial strain on public health resources in the Americas. Vector control of Aedes mosquitoes is an important public health strategy to decrease or prevent spread of ABVs. The ongoing Targeted Indoor Residual Spraying (TIRS) trial is an NIH-sponsored clinical trial to study the efficacy of a novel, proactive vector control technique to prevent dengue virus (DENV), Zika virus (ZIKV), and chikungunya virus (CHIKV) infections in the endemic city of Merida, Yucatan, Mexico. The primary outcome of the trial is laboratory-confirmed ABV infections in neighborhood clusters. Despite the difficulties caused by the COVID-19 pandemic, by early 2021 the TIRS trial completed enrollment of 4,792 children aged 2-15 years in 50 neighborhood clusters which were allocated to control or intervention arms via a covariate-constrained randomization algorithm. Here, we describe the makeup and ABV seroprevalence of participants and mosquito population characteristics in both arms before TIRS administration. Baseline surveys showed similar distribution of age, sex, and socio-economic factors between the arms. Serum samples from 1,399 children were tested by commercially available ELISAs for presence of anti-ABV antibodies. We found that 45.1% of children were seropositive for one or more flaviviruses and 24.0% were seropositive for CHIKV. Of the flavivirus-positive participants, most were positive for ZIKV-neutralizing antibodies by focus reduction neutralization testing which indicated a higher proportion of participants with previous ZIKV than DENV infections within the cohort. Both study arms had statistically similar seroprevalence for all viruses tested, similar socio-demographic compositions, similar levels of Ae. aegypti infestation, and similar observed mosquito susceptibility to insecticides. These findings describe a population with a high rate of previous exposure to ZIKV and lower titers of neutralizing antibodies against DENV serotypes, suggesting susceptibility to future outbreaks of flaviviruses is possible, but proactive vector control may mitigate these risks.

This systematic review synthesized published literature (2000 - 2023) to identify HIV interventions specifically designed for transgender persons in the United States (PROSPERO registration number: CRD42021256460). The review also summarized strategies for improving outcomes related to the four pillars of the Ending the HIV Epidemic (EHE) initiative in the United States: Diagnose, Treat, Prevent, and Respond. A comprehensive search was conducted using the Centers for Disease Control and Prevention's HIV Prevention Research Synthesis Project database, which included over 120,000 citations from routine systematic searches in CINAHL, EMBASE, Global Health, MEDLINE, PsycInfo, and Sociological Abstracts. Of 23 interventions that met inclusion criteria, 94% focused on transgender women of color and 22% focused on young transgender persons aged 15-29 years old. Most interventions focused on Treat or Prevent, few focused on Diagnosis, and none focused on Respond. Twenty interventions (87%) showed improvement in at least one EHE related outcome and a quarter of these effective interventions were tested with randomized controlled trials. Common strategies observed in effective interventions include the following: engaging the community in intervention development; pilot-testing with the focus population to ensure appropriateness and acceptability; addressing social determinants of health (e.g. stigma, discrimination, violence) through empowerment and gender-affirming approaches; increasing access to care, prevention, and services through co-location and one-stop shop models; and utilizing peer-led counseling, education, support, and navigation. Continuous effort is needed in addressing gaps, including more research for transgender men and rural settings and for how best to adopt and adapt best practices for subgroups of transgender population.

Given the high and growing prevalence of obesity among adults in the United States, obesity treatment and prevention are important topics in biomedical and public health research. Although researchers recognize the significance of this problem, much remains unknown about safe and effective prevention and treatment of obesity in adults. In response to the worsening obesity epidemic and the many unknowns regarding the disease, a group of key scientific and program staff members of the National Institutes of Health (NIH) and other federal and non-government agencies gathered virtually in September 2021 to discuss the current state of obesity research, research gaps, and opportunities for future research in adult obesity prevention and treatment. The current article synthesizes presentations given by attendees and shares their organizations' current initiatives and identified gaps and opportunities. By integrating the information discussed in the meeting and current initiatives, we identify potential targets and overlapping priorities for future research, including health equity and disparities in obesity, the heterogeneity of obesity, and the use of technological and innovative approaches in interventions.

BACKGROUND: Human adenoviruses (HAdVs) can cause outbreaks of flu-like illness in university settings. Most infections in healthy young adults are mild; severe illnesses rarely occur. In Fall 2022, an adenovirus outbreak was identified in university students. METHODS: HAdV cases were defined as university students 17-26 years old who presented to the University Health Service or nearby emergency department with flu-like symptoms (eg, fever, cough, headache, myalgia, nausea) and had confirmed adenovirus infections by polymerase chain reaction (PCR). Demographic and clinical characteristics were abstracted from electronic medical records; clinical severity was categorized as mild, moderate, severe, or critical. We performed contact investigations among critical cases. A subset of specimens was sequenced to confirm the HAdV type. RESULTS: From 28 September 2022 to 30 January 2023, 90 PCR-confirmed cases were identified (51% female; mean age, 19.6 years). Most cases (88.9%) had mild illness. Seven cases required hospitalization, including 2 critical cases that required intensive care. Contact investigation identified 44 close contacts; 6 (14%) were confirmed HAdV cases and 8 (18%) reported symptoms but never sought care. All typed HAdV-positive specimens (n = 36) were type 4. CONCLUSIONS: While most students with confirmed HAdV had mild illness, 7 otherwise healthy students had severe or critical illness. Between the relatively high number of hospitalizations and proportion of close contacts with symptoms who did not seek care, the true number of HAdV cases was likely higher. Our findings illustrate the need to consider a wide range of pathogens, even when other viruses are known to be circulating.

Meningococcal disease is a life-threatening invasive infection caused by Neisseria meningitidis. Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer Inc.]), are licensed and available in the United States and have been recommended by CDC's Advisory Committee on Immunization Practices (ACIP). On October 20, 2023, the Food and Drug Administration approved the use of a pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp [Penbraya, Pfizer Inc.]) for prevention of invasive disease caused by N. meningitidis serogroups A, B, C, W, and Y among persons aged 10-25 years. On October 25, 2023, ACIP recommended that MenACWY-TT/MenB-FHbp may be used when both MenACWY and MenB are indicated at the same visit for the following groups: 1) healthy persons aged 16-23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine, and 2) persons aged ≥10 years who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia). Different manufacturers' serogroup B-containing vaccines are not interchangeable; therefore, when MenACWY-TT/MenB-FHbp is used, subsequent doses of MenB should be from the same manufacturer (Pfizer Inc.). This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp.

Workplace and non-workplace homicides in the United States (U.S.) have declined for over 30 years until recently. This study was conducted to address the change in trends for both workplace and non-workplace homicides and to evaluate the homogeneity of the change in workplace homicides by specified categories. Joinpoint and autoregressive models were used to assess trends of U.S. workplace and non-workplace homicides utilizing surveillance data collected by the Bureau of Labor Statistics and the Federal Bureau of Investigation from 1994 through 2021. Both workplace and non-workplace homicides decreased significantly from 1994 through 2014. Workplace homicides showed no significant trend from 2014 through 2021 (p = 0.79), while non-workplace homicides showed a significant average annual increase of 4.1% from 2014 through 2020 (p = 0.0013). The large decreases in the trend of workplace homicides occurring during a criminal act, such as robbery, leveled off and started to increase by the end of the study period (p < 0.0001). Declines in workplace homicides due to shootings also leveled off and started to increase by the end of the study period (p < 0.0001). U.S. workplace and non-workplace homicide rates declined from the 1990s until around 2014. Trends in workplace homicides varied by the types of the homicide committed and by the type of employee that was the victim. Criminal-intent-related events, such as robbery, appear to be the largest contributor to changes in workplace homicides. Researchers and industry leaders could develop and evaluate interventions that further address criminal-intent-related workplace homicides.

Maternal Death Surveillance and Response (MDSR) systems generate information that may aid efforts to end preventable maternal deaths. Many countries report MDSR data, but comparability over time and across settings has not been studied. We reviewed MDSR reports from low-and-middle income countries (LMICs) to examine core content and identify how surveillance data and data dissemination could be improved to guide recommendations and actions. We conducted deductive content analysis of 56 MDSR reports from 32 LMICs. A codebook was developed assessing how reports captured: 1) MDSR system implementation, 2) monitoring of maternal death notifications and reviews, and 3) response formulation and implementation. Reports published before 2014 focused on maternal death reviews only. In September 2013, the World Health Organization and partners published the global MDSR guidance, which advised that country reports should also include identification, notification and response activities. Of the 56 reports, 33 (59%) described their data as incomplete, meaning that not all maternal deaths were captured. While 45 (80%) reports presented the total number of maternal deaths that had been notified (officially reported), only 16 (29%) calculated notification rates. Deaths were reported at both community and facility levels in 31 (55%) reports, but 25 (45%) reported facility deaths only. The number of maternal deaths reviewed was reported in 33 (59%) reports, and 17 (30%) calculated review completion rates. While 48 (86%) reports provided recommendations for improving MDSR, evidence of actions based on prior recommendations was absent from 40 (71%) of subsequent reports. MDSR reports currently vary in content and in how response efforts are documented. Comprehensive reports could improve accountability and effectiveness of the system by providing feedback to MDSR stakeholders and information for action. A standard reporting template may improve the quality and comparability of MDSR data and their use for preventing future maternal deaths.

To end the largest known outbreak of Ebola virus disease (EVD) in West Africa and to prevent new transmissions, rapid epidemiological tracing of cases and contacts was required. The ability to quickly identify unknown sources and chains of transmission is key to ending the EVD epidemic and of even greater importance in the context of recent reports of Ebola virus (EBOV) persistence in survivors. Phylogenetic analysis of complete EBOV genomes can provide important information on the source of any new infection. A local deep sequencing facility was established at the Mateneh Ebola Treatment Centre in central Sierra Leone. The facility included all wetlab and computational resources to rapidly process EBOV diagnostic samples into full genome sequences. We produced 554 EBOV genomes from EVD cases across Sierra Leone. These genomes provided a detailed description of EBOV evolution and facilitated phylogenetic tracking of new EVD cases. Importantly, we show that linked genomic and epidemiological data can not only support contact tracing but also identify unconventional transmission chains involving body fluids, including semen. Rapid EBOV genome sequencing, when linked to epidemiological information and a comprehensive database of virus sequences across the outbreak, provided a powerful tool for public health epidemic control efforts.

CONTEXT: Estimating the return on investment for public health services, tailored to the state level, is critical for demonstrating their value and making resource allocation decisions. However, many health departments have limited staff capacity and expertise to conduct economic analyses in-house. PROGRAM: We developed a user-friendly, interactive Excel-based spreadsheet model that health departments can use to estimate the impact of increases or decreases in sexually transmitted infection (STI) prevention funding on the incidence and direct medical costs of chlamydia, gonorrhea, syphilis, and STI-attributable HIV infections. Users tailor results to their jurisdictions by entering the size of their population served; the number of annual STI diagnoses; their prior annual funding amount; and their anticipated new funding amount. The interface was developed using human-centered design principles, including focus groups with 15 model users to collect feedback on an earlier model version and a usability study on the prototype with 6 model users to finalize the interface. IMPLEMENTATION: The STI Prevention Allocation Consequences Estimator ("SPACE Monkey 2.0") model will be publicly available as a free downloadable tool. EVALUATION: In the usability testing of the prototype, participants provided overall positive feedback. They appreciated the clear interpretations, outcomes expressed as direct medical costs, functionalities to interact with the output and copy charts into external applications, visualization designs, and accessible information about the model's assumptions and limitations. Participants provided positive responses to a 10-item usability evaluation survey regarding their experiences with the prototype. DISCUSSION: Modeling tools that synthesize literature-based estimates and are developed with human-centered design principles have the potential to make evidence-based estimates of budget changes widely accessible to health departments.

Coccidioides is the fungal causative agent of Valley fever, a primarily pulmonary disease caused by inhalation of fungal arthroconidia, or spores. Although Coccidioides has been an established pathogen for 120 years and is responsible for hundreds of thousands of infections per year, little is known about when and where infectious Coccidioides arthroconidia are present within the ambient air in endemic regions. Long-term air sampling programs provide a means to investigate these characteristics across space and time. Here we present data from > 18 months of collections from 11 air sampling sites across the Phoenix, Arizona, metropolitan area. Overall, prevalence was highly variable across space and time with no obvious spatial or temporal correlations. Several high prevalence periods were identified at select sites, with no obvious spatial or temporal associations. Comparing these data with weather and environmental factor data, wind gusts and temperature were positively associated with Coccidioides detection, while soil moisture was negatively associated with Coccidioides detection. These results provide critical insights into the frequency and distribution of airborne arthroconidia and the associated risk of inhalation and potential disease that is present across space and time in a highly endemic locale.

Farmed mink are one of few animals in which infection with SARS-CoV-2 has resulted in sustained transmission among a population and spillback from mink to people. In September 2020, mink on a Michigan farm exhibited increased morbidity and mortality rates due to confirmed SARS-CoV-2 infection. We conducted an epidemiologic investigation to identify the source of initial mink exposure, assess the degree of spread within the facility's overall mink population, and evaluate the risk of further viral spread on the farm and in surrounding wildlife habitats. Three farm employees reported symptoms consistent with COVID-19 the same day that increased mortality rates were observed among the mink herd. One of these individuals, and another asymptomatic employee, tested positive for SARS-CoV-2 by real-time reverse transcription PCR (RT-qPCR) 9 days later. All but one mink sampled on the farm were positive for SARS-CoV-2 based on nucleic acid detection from at least one oral, nasal, or rectal swab tested by RT-qPCR (99%). Sequence analysis showed high degrees of similarity between sequences from mink and the two positive farm employees. Epidemiologic and genomic data, including the presence of F486L and N501T mutations believed to arise through mink adaptation, support the hypothesis that the two employees with SARS-CoV-2 nucleic acid detection contracted COVID-19 from mink. However, the specific source of virus introduction onto the farm was not identified. Three companion animals living with mink farm employees and 31 wild animals of six species sampled in the surrounding area were negative for SARS-CoV-2 by RT-qPCR. Results from this investigation support the necessity of a One Health approach to manage the zoonotic spread of SARS-CoV-2 and underscores the critical need for multifaceted public health approaches to prevent the introduction and spread of respiratory viruses on mink farms.

Wastewater surveillance (WWS), the systematic detection of infectious agents in wastewater, provided a valuable tool for monitoring SARS-CoV-2 circulation during the COVID-19 pandemic; surveillance has expanded from 20 to 53 jurisdictions across the United States, with increasing capacity to test for more respiratory pathogens (1,2). This report highlights the use of wastewater data by the four National Wastewater Surveillance System’s (NWSS) Centers of Excellence (California; Colorado; Houston, Texas; and Wisconsin) to guide public health action during the 2022–23 respiratory disease season. This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.*

In 2021, we conducted a survey about an energy efficiency program sponsored by the city of Fort Collins. We implemented a novel, hybrid push-to-web door hanger method that we hoped would combine the attractive qualities of drop-off/pick-up and push-to-web. However, this strategy proved ineffective in survey recruitment.