Sexual minority men experience intimate partner violence (IPV) at rates similar to those reported by heterosexual women in the United States. Previous studies linked both IPV victimization and perpetration to HIV risk and seroconversion; however, less is known about the impact of IPV on HIV testing, sexually transmitted infection (STI) testing, pre-exposure prophylaxis (PrEP) uptake, and the persistence of PrEP use among sexual minority men experiencing IPV. Although prior work suggests that IPV may influence HIV prevention behavior, experiences of IPV are so highly varied among sexual minority men  that additional research is needed to better understand the impact that IPV has on HIV risk and protective behaviors to develop more effective interventions for sexual minority men.This study aims to contribute to our understanding of the antecedents of IPV and the direct and indirect pathways between perpetration and receipt of IPV and HIV or STI risk behavior, STIs, and use of PrEP among sexual minority men experiencing IPV.This mixed methods study has 2 phases: phase 1 involved formative qualitative interviews with 23 sexual minority men experiencing IPV and 10 key stakeholders or providers of services to sexual minority men experiencing IPV to inform the content of a subsequent web-based cohort study, and phase 2 involves the recruitment of a web-based cohort study of 500 currently partnered HIV-negative sexual minority men who reside in Centers for Disease Control and Prevention–identified Ending the HIV Epidemic priority jurisdictions across the United States. Participants will be followed for 24 months. They will be assessed through a full survey and asked to self-collect and return biospecimen kits assessing HIV, STIs, and PrEP use at 0, 6, 12, 18, and 24 months. They will also be asked to complete abbreviated surveys to assess for self-reported changes in key study variables at 3, 9, 15, and 21 months.Phase 1 was launched in May 2021, and the phase 1 qualitative interviews began in December 2021 and were concluded in March 2022 after a diversity of experiences and perceptions were gathered and no new ideas emerged in the interviews. Rapid analysis of the qualitative interviews took place between March 2022 and June 2022. Phase 2 recruitment of the full cohort began in August 2022 and is planned to continue through February 2024.This mixed methods study will contribute valuable insights into the association that IPV has with HIV risk and protective behaviors among sexual minority men. The findings from this study will be used to inform the development or adaptation of HIV and IPV prevention interventions for sexual minority men experiencing IPV.DERR1-10.2196/41453 Sexual minority cisgender men experience alarming rates of intimate partner violence (IPV). Rates of IPV victimization or perpetration range from 1 in 4 to 1 in 2 sexual minority men . These rThe overarching goal of the proposed study is to examine how IPV influences HIV risk behavior and contributes to gaps in engagement in the HIV prevention continuum at 3 specific points: HIV testing (awareness), pre-exposure prophylaxis (PrEP) uptake (uptake), and PrEP persistence (adherence or retention ). A receResearch has linked both IPV victimization and perpetration to HIV risk and seroconversion. A large longitudinal study of Latinx sexual minority men in Los Angeles, California, United States, found that any lifetime experience of IPV (perpetration or victimization) doubled the odds of HIV seroconversion during the study period . In a meMinority stress theory ,37 and sAlthough recent literature reveals IPV to be common and to have grave implications for sexual minority men’s health, there are critical methodological limitations and gaps in knowledge. Of the limited studies of IPV among sexual minority men, heterogeneous definitions and measures of IPV have led to unreliable and widely varied prevalence estimates ,57. Few Very few studies have examined IPV perpetration among sexual minority men; most have focused on the receipt of IPV . Little These shortcomings have hampered the field’s basic understanding of the etiology, chronicity, severity, and escalation of IPV among sexual minority men, with consideration of the multiple forms of violence that exist . Together, this presents a knowledge gap regarding the 3 multidimensional aspects of IPV among sexual minority men  and longitudinal trends among individuals or dyads. These 3 aspects are critical to intervention development.Little is known about the mechanisms underlying the associations between IPV and the HIV prevention continuum, which undermines our ability to develop evidence-based interventions. Few studies have delved into the experiences and correlates of IPV for male-male couples. Previous, limited research suggests that stressors and triggers commonly acknowledged in the literature regarding heterosexual couples and IPV are also relevant to male-male couples  ,61,62. IThe overall aim of the proposed study is to provide new knowledge of how perpetration and receipt of various forms of IPV  contribute to HIV risk, sexually transmitted infections (STIs), and HIV PrEP use among sexual minority men in the United States. Longitudinal research must unpack the global negative association of IPV with HIV risk, as well as how specific types of IPV may be associated with HIV risk and HIV prevention continuum engagement. This research is critical to the development of appropriate and effective HIV and IPV interventions for sexual minority men.This study represents a collaboration between researchers and staff at the San Diego State University, the University of Michigan, and the RAND Corporation. All survey assessments will be programmed and administered by the RAND Survey Research Group (SRG). Phase 1 research activities involved formative qualitative interviews with 23 sexual minority men who reported experienced or perpetrated IPV during the 12 months before the interviews and an additional 10 interviews with key stakeholders and providers of IPV-related services to sexual minority men to inform the subsequent cohort study to be completed in phase 2.In phase 1, we conducted formative, in-depth interviews with 23 racially and ethnically diverse sexual minority men experiencing or perpetrating IPV in the past 12 months and 10 key stakeholders with experience providing services to sexual minority men experiencing or perpetrating IPV. The general purpose of these interviews was to inform the selection of measures and the development of additional questions for the phase 2 surveys and also inform methods and materials to be used for participant recruitment. To recruit a diverse sample of sexual minority men in terms of age and racial or ethnic identity, we used a combination of recruitment sources. We received direct referrals for participation from clinicians working directly with sexual minority men as part of an IPV prevention program for sexual and gender minorities. We also advertised the study through the social media page of a large urban lesbian, gay, bisexual, transgender, and queer service provider and by passing out flyers for the study in community spaces that sexual minority men were known to frequently visit . All phase 1 study activities took place in Los Angeles.Data Analysis Plan section.Interviews were conducted via video teleconference  with sexual minority men and focused on examining how participants’ lived experiences of IPV, both victimization and perpetration, may have directly or indirectly influenced their risk for HIV and STIs, their engagement in HIV testing, and their use of PrEP among other sexual health behaviors. For the stakeholder interviews, we purposely recruited participants from a wide range of professional roles interacting with and serving sexual minority men experiencing or perpetrating IPV, including counselors and program directors from an IPV-focused program, as well as additional mental and sexual health providers who work with sexual and gender minorities who have experienced IPV. Interviews with key stakeholders focused on the experiences of IPV victimization and perpetration that may be unique to sexual minority men, as well as any ways that they have noticed IPV affecting the sexual health of the sexual minority men they were working with. Interview probes specifically assessed for any relationships noticed between IPV and HIV and STI risks or engagement in prevention behaviors, including HIV and STI testing, PrEP uptake, and PrEP persistence, and elicited suggestions for what may be beneficial for future IPV and HIV prevention interventions focused on sexual minority men. Providers were also asked to provide feedback on the proposed recruitment methods and materials to be used in the recruitment of sexual minority men in the cohort study. All interviews were audio recorded and transcribed verbatim with identifying information removed to prepare for analysis. The phase 1 qualitative data analysis plan and how the data are being used to inform phase 2 study activities are described in the Each of the 500 participants who enroll in the prospective cohort study will be followed for 24 months. Each laboratory-confirmed HIV-negative cisgender sexual minority men participant will need to report being in a relationship with another cisgender sexual minority man for a minimum of 3 months at baseline and will also need to report residing in one of the Centers for Disease Control and Prevention (CDC)–identified Ending the HIV Epidemic (EHE) jurisdictions across the United States to be eligible for participation. Participants will be recruited through web-based advertising from across all the CDC-identified EHE jurisdictions. Participants will be followed for 24 months, with full study assessments at 0, 6, 12, 18, and 24 months and mini “check-in” assessments at 3, 9, 15, and 21 months to assess for changes in key study outcomes (IPV and engagement in HIV prevention). Participants will also submit self-collected dried blood spot (DBS) samples at 0, 6, 12, 18, and 24 months to test for the use of PrEP and for HIV seroconversion through mailed home test kits. Participants will also submit self-collected urine samples and self-collected rectal and pharyngeal swabs for the culture of gonorrhea and chlamydia at 0, 12, and 24 months through the same mailed home test kits. At each assessment, participants will receive up to 3 reminders based on their preference  containing a link to the baseline survey at regular  intervals during the survey window period. We currently plan to use a 28-day window but may expand or contract this window based on real-world completion rates.This is a nonintervention cohort study. We will enroll 500 sexual minority men, allowing for 20% attrition, for a final sample of 400 sexual minority men at month 24. The eligibility criteria are listed in Inclusion criteriaAssigned male sex at birth and currently identifying as man Aged 18 to 45 yearsReporting currently being in a relationship with a cisgender man lasting at least 3 months; a relationship is defined as “Do you have a primary male partner, that is, someone you feel emotionally, romantically committed to above others?”Residing in one of the Centers for Disease Control and Prevention Ending the Epidemic priority jurisdictionsAble to provide at least two means of contact for follow-upNot currently enrolled in an HIV prevention studyHaving self-reported HIV-negative serostatus at baseline (status confirmed via home test kit mailed to laboratory)We may stratify eligibility as needed to ensure that at least 60% of participants report past-year intimate partner violence at baselineWe will stratify as needed to ensure at least 35% of the sample identifies as Black or African American and at least 35% identifies as Hispanic or LatinxExclusion criteriaNot assigned male sex at birthAged <18 years or >45 years at enrollmentPartnered <3 months or currently unpartneredLiving outside of the Centers for Disease Control and Prevention Ending the Epidemic priority jurisdictionsSelf-reporting HIV-positive status or is laboratory determined to be HIV positive at baselineExpressing unwillingness to complete regular surveys during informed consentExpressing unwillingness to provide biospecimens with home testing kits during informed consentExpressing unwillingness to provide partner contact information Individual’s romantic partner is already enrolled in the study (we will not enroll dyads)Investigators and research staff from San Diego State University and the University of Michigan will be responsible for all recruitment activities. The study will enroll participants who reside in one of the CDC-defined EHE priority jurisdictions. The “Ending the HIV Epidemic: A Plan for America” was launched by the US Department of Health and Human Services to reduce new HIV infections by 90% by 2030 by leveraging critical scientific prevention strategies in specified high-incident geographic locations . The proAdvertisements will be targeted at adult (aged 18-45 years) sexual minority men in the EHE jurisdictions. We will be using the social media platforms Facebook and Instagram, as well as the sexual networking apps mentioned above. Men with partners may have relationship agreements that allow for outside sex partners, hence, the decision to enroll through sex-seeking apps.Men who click on the web-based or app-based advertisements will be shown a brief introduction script that describes the study. They will then be directed to a consent form (to be screened for eligibility) and complete a short demographic and behavioral eligibility survey form. Screening data will be accessible to study staff only.Participants who are eligible based on the screener survey will be contacted by a study research coordinator to schedule their 30-minute virtual onboarding orientation session, during which the research coordinator will provide a thorough overview of all research activities and timelines, go over the biological specimen collection instructions, review an informed consent form, and collect the participant’s consent (through electronic signature) to participate in the cohort study.StatesAlabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South CarolinaCounties[Arizona] Maricopa; [California] Alameda, Los Angeles, Orange, Riverside, Sacramento, San Bernardino, San Diego, and San Francisco; [Florida] Broward, Duval, Hillsborough, Miami-Dade, Orange, Palm Beach, and Pinellas; [Georgia] Cobb, DeKalb, Fulton, and Gwinnett; [Illinois] Cook; [Indiana] Marion; [Louisiana] East Baton Rouge Parish and Orleans Parish; [Maryland] Baltimore City, Montgomery, and Prince George’s; [Massachusetts] Suffolk; [Michigan] Wayne; [Nevada] Clark; [New Jersey] Essex and Hudson; [New York] the Bronx, Kings, New York, and Queens; [North Carolina] Mecklenburg; [Ohio] Cuyahoga, Franklin, and Hamilton; [Pennsylvania] Philadelphia; [Tennessee] Shelby; [Texas] Bexar, Dallas, Harris, Tarrant, and Travis; and [Washington] KingTerritoriesPuerto Rico’s San Juan Municipio and Washington DCphysical, sexual, emotional, financial, monitoring, stalking, and HIV prevention–specific forms of IPV; mental health; relationship and partner; sexual behavior and agreements; experiences of stigma and discrimination; structural vulnerabilities; social support; spirituality and religiosity; HIV testing; PrEP uptake; PrEP persistence; STIs; and sexual risk behavior. Baseline measures are presented in Once a participant has completed the onboarding interview and consented to participate in the cohort study, the research coordinator will complete a study enrollment form to import the participant’s contact information and key data elements into the RAND SRG–developed Record Management System, which will then trigger a unique link to the baseline survey (programmed in Forsta) to be sent to the participant’s email address. The baseline survey has been informed by the phase 1 qualitative interview data and will include questions from the following domains: demographic characteristics; IPV, including Participants who do not complete the baseline survey during the survey open window will be removed from the study unless they contact the study team to request more time.Intimate partner violence (IPV)Modified IPV–Gay and Bisexual Men scale   and adapDisclosure of IPV experiences to or by others -68 IPV victimization stigma and shame IPV perpetration stigma and shame Perceived prevalence of IPV -68 HIV status Pre-exposure prophylaxis (PrEP) uptake and PrEP persistence (self-report and biomarker)Perceived PrEP adherence (self-report)Reasons for not using PrEP or stopping PrEP -68 Employment status Employment precarity Financial well-being Educational attainment Food insecurity Sexual orientation Housing status and housing instability Recent homelessness Housing precarity Gender identity  Partner and relationship characteristics (reported by index participant)Relationship statusRelationship characteristics Marital statusCohabitationPartner demographics Financial reliancePartner PrEP use or HIV treatment status or viral suppressionPrEP conversations -68 Relationship power balance and decision-making Communication patterns Social support from partner Relationship role models (regardless of relationship status)Early-life and childhood experiencesChildhood violence and abuse and mistreatment by adults   Experienced discrimination  Perceived neighborhood safety Recent exchange or transactional sex Mental healthDepressive symptoms Loneliness     Coping self-efficacy Global self-esteem   through MTL’s application programming interface. The RAND SRG will assign a unique order ID to each specimen collection kit to inform MTL to mail the participant the specimen collection kit through US Postal Service Priority Mail. The collection kit will contain instructions and materials for collecting and returning the biospecimen samples. Packaging will be plain and discreet. After the participant has received their kit and collected their sample, they will return the samples using a prepaid mailer. Participants will be given 2 weeks from the date of kit delivery to collect their samples and return them in the mail for processing. They will receive up to 6 reminders through SMS text messages or email. After 4 weeks, participants who have not returned their baseline samples will be designated as having decided to not collect their samples and will be stopped from further study participation. In addition, those who screen HIV positive (at baseline) will not be enrolled in the full cohort study.DBS specimens will be collected to detect the presence of HIV at baseline and 12- and 24-month assessments. DBS specimens will also be used to confirm reported use of PrEP at 0-, 6-, 12-, 18-, and 24-month assessment points when participants self-report taking PrEP (survey). The DBS procedure involves using a lancet to prick one’s fingertip, and 3 to 6 drops of blood are applied to each of the 5 circles on a DBS collection paper card. We will also collect self-administered urethral gonorrhea and chlamydia testing at baseline and 12- and 24-month assessment visits through the nucleic acid probe of urine specimens. Participants will provide a urine sample of 30 mL to 50 mL from the initial urine stream in a collection cup.To complement the urine-based urethral samples, we will also collect self-administered rectal and pharyngeal swabs for gonorrhea and chlamydia testing at baseline and 12- and 24-month assessment visits. Briefly, participants will swab each site using provided collection swabs and place the swabs into transport tubes for processing. All survey and biospecimen procedures will take place according to the schedule presented in Samples will be tested by MTL for HIV, PrEP, and STIs (gonorrhea and chlamydia). In the event that MTL finds the quality of the sample to be insufficient, participants will be contacted by their preferred method of communication (either email or SMS text message) by the study team to request a second sample collection. MTL will mail a second kit, and the participant will re-collect the sample and mail it back to MTL.Participants who have a reactive HIV or STI test will be contacted by study staff to let them know that they have received a preliminary positive test result and will be told that they need to schedule a visit with a local provider to confirm the result and be linked to care for treatment. Participants will be instructed that the laboratory test is for research purposes and that they should seek confirmation from their physician. Study staff will offer to help participants locate a local provider or clinic should they request assistance.The study will use multiple platforms to maintain the participant database, program the web surveys, and circulate email and SMS text message communications. Participant information, survey response data, test results, and other administrative data are maintained in a secure, encrypted database. Most email-based and SMS text message–based study communications  are automated, using scheduling criteria and prewritten templates that use a conversational tone and accessible reading level. For participants in danger of missing a study task , study staff will contact participants individually by telephone, email, or SMS text message.Participants will have the potential to earn up to US $340 as remuneration (in the form of e-gift certificates) for participation in this study. Each survey time point includes US $25 as remuneration, each returned biospecimen kit includes US $25 as remuneration, and check-in surveys include US $10 as remuneration. Participants who complete all primary study tasks (full survey time points and biospecimen kits) will also receive a US $50 bonus at the conclusion of their follow-up.The analyses described in the following sections describe the analyses for phase 1 and our preliminary analysis plan for phase 2, specified in advance. Although the focal outcomes will remain the same, the specific analytic methods may change based on data , evolution of the research questions , and statistician input. We may also pursue additional analyses on secondary outcomes of interest.To inform the selection of measures, development of any additional items, and inform the development of recruitment materials and methods for phase 2 of the study, members of the study team reviewed and discussed analytic memos written by interviewers after each interview and memos written by coders upon reading the verbatim transcripts ,110. ThiIn June 2022, we began the process of rigorously confirming the preliminary findings that informed the baseline survey using an applied thematic analysis approach to identify all key patterns across our 2 sources of qualitative data . This prOnce all qualitative data have been coded, we will develop code summaries , which will be reviewed and discussed by members of the research team with attention to repetition, frequency, salience of ideas, and meaning within context across interviews. Multiple rounds of group-level discussion, rereading of code summaries and specific coded excerpts, visually mapping relationships between key themes and subthemes, and triangulation across the sexual minority men and key stakeholder interviews  will infsbart), which is nonparametric and avoids assuming that covariates are related [Phase 2 analyses will examine the robustness of our measures and our sample. First, we will assess the psychometric properties of all measures. Second, Wilcoxon rank sum and chi-square tests will be performed on baseline and follow-up variables to test for differences between dropouts and completers. Statistical adjustments will be used to correct for effects of attrition . Standar related . Before f). With 5 waves of data, the repeated measures of the same latent variable are represented by f1 to f5 in the LCM. The developmental trajectory of HIV prevention continuum engagement will then be based on the latent variables f1 to f5. In a similar fashion, we can model the relationship between the predictor trajectory and the trajectory for STI diagnoses (primary outcome) and condomless anal sex and seroconversion (secondary outcomes).In phase 2, we will model multiple developmental trajectories of 5 waves of data using LCMs. We will examine three developmental trajectories: (1) the trajectory of the predictor, IPV; (2) the trajectory of the primary outcomes, HIV prevention continuum engagement and STI diagnoses; and (3) the trajectory of the secondary outcomes, risky sexual behavior  and seroconversion. The predictor trajectory is defined by repeated measures of IPV. As LCM allows for the estimation of multiple trajectories at the same time, we are also modeling a parallel process of HIV prevention continuum engagement. These primary outcomes are based on repeated measures of 3 binary indicators: HIV testing, PrEP uptake, and PrEP persistence. Although engagement in these HIV prevention continuum indicators has been described as discrete steps , the appWe will explore trajectory patterns to assess whether growth is linear or nonlinear. If it is nonlinear, we will explore quadratic effects or piecewise developmental patterns. To our knowledge, modeling the developmental trajectory of a latent HIV prevention continuum factor using multiple indicators is novel. Furthermore, we have multiple parallel developmental processes  in the same growth model.We hypothesize that resilience factors  will mediate (or moderate) the relationship between IPV and HIV risk and strengthen the association between IPV and HIV prevention continuum outcomes. We also hypothesize mediating effects of potential risk factors . Such potential mediating effects can easily be incorporated into SEMs. Given the complicated LCM setup with multiple developmental trajectories, we anticipate challenges in adding moderators directly into the growth model.A way of overcoming these challenges is to use multiple group analysis. By comparing relationships between the predictor trajectory and the outcomes trajectories across different groups, multiple group analysis allows us to (1) test different assumptions about group equality  and (2) All study protocols and procedures have been approved by the San Diego State University Institutional Review Board (phase 1 protocol number HS-2021-0054 and phase 2 protocol number HS-2022-0094). All procedures are in accordance with the ethical standards of the institutional and national research committees and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was or will be obtained from all participants included in the study.This project does not exceed the US $500,000 cap set by the National Institutes of Health in any project year. However, based on the importance of the data, we encourage collaborations with interested investigators. Data will be made publicly available through publication in peer-reviewed journals, public seminars, and invited lectures and conference presentations. After 2 years of publication of the main findings of the study, we will consult with the San Diego State University’s Human Research Protection Program about how to securely make data available in the form of an electronic database for researchers who successfully complete a registration process. Any shared data will be deidentified and will not contain any direct or indirect identifiers. As part of the registration process, users must complete a data sharing agreement that outlines the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgment of the data resource. The data sharing agreement will include a commitment to using the data only for research purposes, a commitment to securing the data using appropriate computer technology, and a commitment to destroying or returning the data after analyses are completed. Users must submit brief proposals regarding the intended use of the data; the study team will determine the scientific soundness of the proposal as part of the decision to allow the researchers to access the public use data set. Users must be monitored by an approved human subjects board.This study was funded in March 2021 by the National Institute of Mental Health (R01MH126762). The study was launched in May 2021, and phase 1 interviews began in December 2021 and concluded in March 2022. Rapid analysis of the qualitative interviews took place between March 2022 and June 2022. Phase 2 recruitment of the full cohort began in August 2022 and is planned to continue through February 2024.This study seeks to conduct a multidimensional, longitudinal assessment of IPV and HIV prevention continuum outcomes among sexual minority men. Unlike most studies that have only focused on physical contact forms of abuse, we will also assess forms of IPV that involve coercive control and psychological abuse. We hypothesize that IPV will have a deleterious overall impact on HIV prevention continuum engagement and that the pathways between IPV and HIV prevention continuum engagement will be mediated by individual , interpersonal , and structural-level  factors. Our measurement of IPV will include measurement of both the receipt and perpetration of IPV among sexual minority men, unlike prior research that has largely neglected IPV perpetration. Our assessment of the chronicity of IPV is also novel, as is the type of relationships in which it occurs. Most of the research has assessed either lifetime or recent  experiences of IPV, which precludes analysis of chronicity, spacing of episodes, or escalation or waning of IPV.We will use a longitudinal design for temporality to better understand the potential mechanisms between IPV and HIV risk and protective factors. We will use SEM to assess the intersectionality of multiple syndemic factors made possible with methods that we have refined over several previous studies of sexual minority men. This will allow us to explore the unique and common effects of different kinds of stigmas and supportive factors on HIV risk and HIV prevention outcomes. A longitudinal approach allows us to assess temporality with regard to associations between IPV and HIV prevention continuum engagement and heterogeneous phenotypes therein; for example, we will be able to differentiate sexual minority men who experience simultaneous IPV and poor HIV prevention continuum engagement from men whose IPV experiences precede worsening HIV prevention continuum engagement or HIV risk behaviors. We will also be able to assess whether HIV prevention continuum engagement is associated with waning IPV over time, perhaps as sexual minority men avail themselves of wraparound services linked to HIV prevention continuum services. Longitudinal assessment also allows us to assess how mediators and moderators such as mental health problems, psychosocial factors, and resiliency factors change over time in this context. Although a longitudinal design is critical, it is also necessary to have a large enough sample  and a long enough follow-up period to adequately examine the complexity of the dynamics in play with IPV and HIV risk among sexual minority men in multiple types of relationships, all of which necessitates and is accomplished by the proposed research.In addition, we will examine resiliencies and risk factors to better understand underlying mechanisms and identify modifiable intervention targets. Most studies have focused on risk factors. Much less is known regarding the vitality of protective factors in the health of sexual minority men. To design IPV and HIV prevention interventions for sexual minority men, it is vital that we also examine protective factors. Our study may be the first to elucidate the potential effects of resiliencies such as coping skills, social support, and sexual minority pride in the constellation of risk factors between IPV and poor HIV prevention continuum engagement. Understanding the important role of these protective factors is vital to the development of innovative strengths-based interventions.A handful of limitations could affect this study and are important to acknowledge. First, documentation of IPV, both in terms of victimization and perpetration, will rely on self-report. As such, there may be underreporting of perpetration because of fear of possible legal consequences. There may also be underreporting of victimization because of potentially socially desirable responding and social norms that shame male survivors of IPV. To minimize these concerns, in-depth interviews will provide insights into how best to assess both victimization and perpetration in the context of same-sex male relationships. In addition, by conducting a prospective investigation, we will be uniquely positioned to examine how current experiences of IPV influence gaps in HIV prevention continuum outcomes prospectively. Second, the measurement of perceived social support, a potential buffer between IPV and IPV-associated HIV prevention continuum gaps, is based on the egocentric assessment of the degree to which individuals perceive receiving social support from a range of social network members . However, obtaining egocentric-level data on multiple forms of perceived social support using a validated measure is a common and widely accepted approach.The proposed study will be designed and implemented with a high degree of scientific rigor and has the potential for significant public health impact. First, we have a core team with expertise in the design and conduct of prospective cohort studies in IPV, HIV risk, and HIV prevention continuum outcomes among sexual minority men, as well as in advanced statistical analyses. Second, we will measure exposures, moderators, and outcomes at multiple time points in this prospective cohort study. Third, we will be conducting this study in the EHE-identified HIV high-incidence jurisdictions.The research team will collaborate with key community stakeholders to review and validate the data and findings and make recommendations for intervention development or adaptation. We will also review interventions from the CDC compendium of evidence-based interventions to examine where content that addresses IPV may be integrated. The aim is not necessarily to develop an intervention in the time frame of this study but rather to use the data to provide strong evidence for the forms, types, and content of new interventions or adaptations to existing interventions. It is likely that this planning phase will lead to the development of an intervention that we will test in the next phase of our ongoing research program. Dissemination of findings will take place primarily through the publication of scientific manuscripts and stakeholder-oriented research briefs; professional conference presentations; and community-focused meetings and presentations with stakeholder groups at local, regional, state, and national levels. We will maximize the impact of our dissemination efforts through best-practice approaches such as framing the presentation of results in ways that highlight the relevance to various stakeholder audiences and by working with trusted intermediary organizations.This longitudinal cohort study will provide the data needed to better understand the direct and indirect ways in which IPV affects HIV risk and prevention behaviors. With the goal of providing concrete recommendations for intervention development, we believe that this is the first study to provide the needed science to develop and promote interventions to reduce the harms associated with both IPV and HIV risk or HIV prevention continuum outcomes. These findings will fill a critical gap in our efforts to reduce HIV-related disparities as part of the National Institutes of Health Strategic Plan for HIV and HIV-Related Research.


Interventions that modify the built environment can increase population physical activity levels and prevent chronic disease. The national Cooperative Extension System is poised to implement built environment approaches , but implementation strategies  are needed to improve uptake. Effective implementation strategies address relevant barriers and capitalize on facilitators. The purpose of this study was to understand 1) barriers and facilitators to implementing built environment approaches in two state Extension systems, 2) preferences for built environment approaches, and 3) preferences for implementation strategies.n = 42) in two states. Quantitative data analysis consisted of numbers/proportions and Friedman tests. Qualitative analysis was completed through a rapid deductive approach to quickly produce actionable results.A cross-sectional online survey was used to understand Extension personnel's preferences for and barriers and facilitators to built environment approaches through a mixed-methods study design. This work was informed by anthropological inquiry as the overall research philosophy, and by the Health Impact Pyramid, Leeman et al.'s classification of implementation strategies, and the Consolidated Framework for Implementation Research as the theoretical frameworks. The survey was distributed to eligible Extension personnel (Fourteen respondents (33%) completed the survey. Most had not implemented physical activity interventions in their communities or had implemented only individual-level interventions, though were interested in implementing built environment approaches. Benches, playground improvements, and crosswalks were the most desired approaches, while facilitation, assessing community strengths and needs, and technical assistance were desired implementation strategies. The most common barriers were relative priority and available resources; facilitators were external policy and incentives and implementation climate.Extension personnel are receptive to built environment approaches and engaged with community coalitions. Yet, invested parties prefer individual-level interventions, and agents perceive a lack of resources for implementation. Implementation strategies that build capacity in both the Extension system and community coalitions may address these barriers through increasing relative priority and sharing existing resources. This work is a first step toward compiling implementation strategies to address relevant barriers to built environment approaches in community settings. Physical inactivity is a modifiable risk factor for multiple chronic diseases  –3. HowevInterventions that modify the built environment are an evidence-based approach to increasing physical activity levels. Organizations including the American Academy of Pediatrics, American Heart Association, and Institute of Medicine now recommend interventions at the organizational, community, and policy levels . The ComBuilt environment approaches include evidence-based interventions at both the micro and macro level. While both are effective, micro-level interventions can be implemented more rapidly and typically require less money . Rather With their strong local ties and commitment to improving health –18, the Implementation strategies  are recommended to improve the adoption, implementation, and maintenance of evidence-based interventions . For exaFirst, for implementation strategies to be effective, they needed to address relevant barriers and capitalize on facilitators. However, the status quo in supporting community settings to implementing built environment approaches is providing top-down or “push” implementation strategies  such as Related, for implementation strategies to succeed, they need to fit the unique needs and resources of their intended settings and be considered feasible and important by the personnel and settings they affect . ExtensiTaken together, little is known about Extension personnel's barriers and facilitators to implementing built environment approaches, preferences for implementation strategies, or preferences for the built environment approaches these strategies would support. The purpose of this study was to understand 1) barriers and facilitators to implementing built environment approaches in two state Extension systems, 2) preferences for potential implementation strategies, and 3) preferences for micro-level built environment approaches. A secondary purpose was to assess Extension personnel's interest in joining an integrated research-practice partnership , 42 to cA mixed-methods study design was used to understand Extension personnel's preferences for and barriers and facilitators to built environment approaches through a cross-sectional online survey. This study deemed exempt by the Pacific Institute for Research and Evaluation Institutional Review Board.This work was informed by anthropological inquiry , 44 as tThe Health Impact Pyramid describes the population health impact vs. individual effort needed to benefit at multiple intervention levels . It was n = 35 in Montana, n = 4 in Wyoming). The survey was distributed through saturation sampling  (n = 3) also be included in the sample, for a total of 42 surveys distributed across both states. Eligible personnel were sent an email inviting them to participate in the survey, with a follow-up email sent 1 week later. The survey was open for 2 weeks. Compensation for completing the survey was not provided. The recruitment email text encouraged agents to provide input and lead to future collaborative projects.The research team distributed the survey within Montana State University Extension (MSUE) and University of Wyoming Extension (UWE). County-based Extension personnel  who could potentially implement built environment approaches were eligible to complete the survey (icipate) . In UWE,The survey was designed to query aspects of the implementation context that may facilitate or impede implementation of built environment approaches and provide insight into which types of built environment approaches are desired to implement in local communities. Respondents were asked about 1) their current practices and interest in implementing physical activity interventions (multiple response options), 2) interest in implementing specific micro-level built environment approaches (ranked choice item) –14, 47, Statistical analysis was conducted using SPSS . Quantitative data analysis consisted of numbers/proportions for the current practices and interest items, and Friedman tests to obtain the mean rankings for the rank choice items. For qualitative analysis, the open-ended barriers and facilitators questions were analyzed through a rapid deductive approach selected to quickly produce actionable results . First, n = 6, 43%) or had implemented only individual-level interventions . Fewer reported having implemented both individual-level and environment-level interventions  or only environment-level . The majority of respondents were somewhat or extremely interested in implementing more built environment approaches in their communities  and implementing more individual-level physical activity programming .Fourteen respondents (33% of those eligible) completed the survey. Eight were employed within MSUE, two within UWE, and four declined to provide this information. Most reported that they had not implemented physical activity interventions in their communities (n = 2), path maintenance (n = 1), and curb extensions (n = 1).Results from the built environment approach ranking question indicate that benches , playground improvements  and crosswalks or mid-block crossings  were the most desired micro-level approaches see . Park imRegarding desired implementation strategies, agents were most interested in facilitation , assessing community strengths and needs , and technical assistance . They were least interested in new funding  see . Lastly,n = 10, 71%) and facilitators  to implementing built environment approaches. Each response was coded as one or more CFIR constructs, yielding a total of 21 unique barriers and 21 unique facilitators. The most common barriers were CFIR constructs of relative priority (n = 3), available resources (n = 3), cost (n = 2), and knowledge and beliefs about the intervention (n = 2). The most common facilitators were external policy and incentives (n = 6) and implementation climate (n = 3).Survey participants provided responses to their barriers  and access to places for physical activity (playground improvements and shared use agreements). This is an important finding, considering implementing a combination of these types of interventions is recommended , 47. ImpThe most prevalent barriers were relative priority and available resources, while the most prevalent facilitators were external policy and incentives  and implementation climate. Taken together, Extension agents are receptive to built environment approaches and most are already engaged with community coalitions. Yet, invested parties prefer individual-level approaches to physical activity promotion, and agents perceive a lack of resources (time and personnel) to implement built environment approaches. Thus, implementation strategies that build capacity in both Extension personnel and community coalitions have the potential to overcome these barriers through increasing relative priority and sharing resources that exist within community coalitions.The primary implementation strategies preferred by agents  may be effective in meeting these goals. Providing guidance on community assessments could increase priority through demonstrating needs  . Needs aTechnical assistance is commonly used to support the implementation of environment-level physical activity interventions in community settings, including Extension –55. HoweThere is less research on the use of facilitation—defined as interactive problem solving and support —to assisFinally, while there is little similar research to compare this study to, it is interesting to note the differences in barriers and preferred implementation strategies in other states. In two investigations in Louisiana, relative priority, available resources and knowledge of the intervention were also perceived as barriers to environmental change approaches  , 36. In N = 4). The remaining ERIC implementation strategies (N = 6), in order of highest cumulative percentage of endorsement, are detailed in One recommended approach to selecting implementation strategies to address identified contextual factors is mapping barriers to implementation strategies, as defined by the Expert Recommendations for Implementing Change (ERIC) project  through Only one of these strategies, conduct local needs assessment was included in the survey (revised to read “assessing community strengths and needs”). The remaining strategies may also be useful in addressing the identified barriers. For example, increasing demand could be used to inform coalition members and the public about built environment approaches to overcome the barrier of low relative priority. Only one strategy, build a coalition, was less applicable to addressing the identified barriers. Overall, our approach of assessing interest in potential implementation strategies before linking contextual factors to strategies may speed the process of selecting and tailoring relevant strategies. Future work is needed to select and tailor these implementation strategies with Extension professionals  and determining which are ranked as both feasible and important  to move A typical process for identifying implementation strategies includes assessing barriers and facilitators, mapping them to implementation strategies, and then following up with delivery agents/implementers to query the feasibility and importance of the strategies , 40. InsAs well, the sample size was small. While all Extension personnel recruited for the survey are eligible to deliver health promotion programming, for many, it is not their primary role. In MSUE, only seven agents have a primary role of delivering health promotion programming. The other 28 eligible agents are the only agents in their counties, meaning their job duties include all disciplines of Extension programming . In UWE, the seven agents and specialists recruited to complete the survey serve on the Community Vitality and Health initiative team, a merger of one previous team focused on health promotion programming and another on community development. Thus, we may have captured the perceptions of most of the health promotion-focused personnel as well as those focused on other disciplines  who could collaborate on built environment work.Literature on effective implementation strategies for built environment approaches is limited, and little is known about barriers, facilitators, or perceptions crucial to informing this work. The results described here indicate that barriers and facilitators to built environment approaches differ by region. In Montana and Wyoming, are interested in integrating both activity-friendly routes to everyday destinations  and access to places for physical activity (playground improvements and shared use agreements). Barriers to these efforts include relative priority and available resources, while facilitators include the presence of community coalitions and a supportive implementation climate. Potential implementation strategies to address these barriers include facilitation, assessing community strengths and needs, and technical assistance. This work is a significant first step to begin compiling collaborator-informed, community-appropriate implementation strategies to address relevant barriers to built environment approaches in community settings. Ultimately, increasing the uptake of built environment approaches can improve the proportion of community members who meet physical activity guidelines and decrease the burden of chronic disease.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by Pacific Institute for Research and Evaluation IRB. Written informed consent for participation was not required for this study in accordance with the National Legislation and the Institutional Requirements.LB conceived of the study, contributed to its design, and coordination. MG-D contributed to study design, coordination, and manuscript preparation. All authors contributed to the article and approved the submitted version.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.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Older adults are often underrepresented in clinical research, even though older adults are major consumers of novel therapies. We present major themes and recommendations from the 2021 "Inclusion of Older Adults in Clinical Research" Workshop, convened by the Clinical and Translational Science Award (CTSA) Inclusion of Older Adults as a Model for Special Populations Workgroup and the Research Centers Collaborative Network (RCCN). The goal of this workshop was to develop strategies to assist the research community in increasing the inclusion of older adults in clinical research. Major identified barriers include historical lack of federal guidelines, ageist biases and stereotypes, and lack of recruitment and retention techniques or infrastructure focused on older adults. Three key recommendations emerged: 1) engaging with the policymaking process to further promote inclusion; 2) using the CTSA Workgroup Presentation Materials Library and other resources to overcome ageism, and 3) building institutional capacity to support age inclusion. Over the last century, there has been great progress in life expectancy in the USA. However, this change in longevity is accompanied by increases in the burden of multimorbidity, polypharmacy, and frailty. Despite the growth in the number of medically complex older adults, many clinical trials exclude such individuals, and as a result, older adults are underrepresented in clinical research ,2.S1 lists all workshop speakers). This manuscript presents summaries of discussion from the Workshop to inform the inclusion of older adults in clinical research.Recognition of the need to address underrepresentation of older adults in clinical research has grown in recent years ,4. The CThe National Institutes of Health (NIH) is the largest funder of research in the US; therefore, NIH policies have significant impact on research practices. The NIH began setting policies to stimulate broader inclusion in 1986, with the policy encouraging researchers to include women in studies. In 2017, the NIH “Inclusion Across the Lifespan” Workshop hosted a meeting to discuss the representation of older adults (65 years and older) in research ,7.Furthermore, in 2015 the CTSA Program established the Hub Research Capacity Cores and instituted the LIFESPAN Domain Task Force as one of five major platforms for network-wide communication and collaboration dedicated to promoting age inclusivity in research. This led to the development of an “Inclusion of Older Adults as a Model for Special Populations” working group  in 2019 with the mission of increasing inclusion of older adults in research.In 2020, the NIH convened a second workshop “Inclusion Across the Lifespan” that examined the representation of racial/ethnic minority and other marginalized older populations in clinical studies . This woThe Workshop was organized to discuss the current state of older adult inclusion, overall and among older adults of color with panelists featuring oncology, cardiology, Alzheimer’s Disease and Related Dementias (ADRD) as examples. In cancer research, clinical trials often do not include older adults, which limits data on tolerability, leaving clinicians to improvise dose adjustments in older adults. Researchers in geriatric oncology are focused on increasing the inclusion of older adults in clinical trials and optimizing the screening and management of older adults with cancer. When examining data on 224,766 older adults with cancer supporting 105 Federal Drug Administration (FDA) drug applications according to age distributions of <65, 65–69, 70–74, 75–79, and ≥80, the participation rates of older adults with cancer in clinical trials were significantly lower compared to corresponding participation rates in the US cancer population. For example, 4% of all clinical trial participants enrolled between 2005 and 2015 were over the age of 80, whereas approximately 16% of older adults age 80+ in 2013 were diagnosed with cancer [Similarly, older adults with cardiovascular disease are frequently excluded from cardiovascular clinical trials, despite the growing number of older adults with these diseases ,12. MoreOlder adults with ADRD continue to be frequently excluded from clinical research. In a 2012 review, 16% of studies applied recruitment methods that were likely to reduce participation of older adults living with ADRD and only 6% of studies provided justification for exclusion . A recenLastly, health disparities cut across all chronic diseases and contribute to ageism. Ageism is defined as “negative or positive stereotypes, prejudice and/or discrimination against (or to advantage of) elderly people on the basis of their chronological age…” . PotentiWorkshop panelists identified three main barriers to the inclusion of older adults in clinical trials: 1) historical lack of federal guidelines; 2) ageism; and 3) lack of recruitment and retention techniques/infrastructure focused on older adults.The recent changes to NIH’s inclusion policy may have a substantial impact on the inclusion of older adults with researchers having to justify age limits for inclusion criteria in grant applications. However, disease-based exclusions will still differentially impact older adults. In 2020, the FDA published guidance to broaden the eligibility criteria to increase the diversity of study participants with comorbidities  . This guAgeism can play out through the entire human research subject protections process: study design, institutional review board (IRB) evaluation, and conduct of research. Contributing to implicit bias, benevolent prejudice refers to a “superficially positive type of prejudice… expressed in terms of positive beliefs and emotional responses, which results in keeping the group of members experiencing prejudice in inferior positions in society” . Older aSuccessful recruitment strategies used in population-based survey research may provide useful techniques to increase representation of older adults in clinical research outside of a traditional clinical setting. Examples of survey research include surveys supported by the NIH , Census Bureau , and National Center for Health Statistics . Surveys can provide nuanced, longitudinal information on the national trends in health and social determinants of health in representative samples of older adults. Lessons on inclusion of older adults in population-based surveys include using multi-pronged recruitment models, building relationships and trust with older adults by engaging with them outside of clinic visits, using financial incentives, and engaging with care partners. In addition, some older adults may need assistance in getting transportation to research sites or may need help navigating complicated medical facilities. Centralized infrastructure support would make it easier for investigators to access the resources required to promote inclusion.In order to make the case to include older adults in research, schema such as the 5Ts framework  can guide researchers to support inclusion of older adults in studies . Below wFirst, inclusion of older adults is consistent with the ethical value and principle of justice, which is defined by The Belmont Report as risk and benefits of research that are equally shared amongst each person . Second,Concerns about selective participation and study dropout leading to decreased sample size and bias related to misrepresentation of the target population may contribute to the exclusion of older adults. As a result, study treatments generalize to younger, healthier participants as opposed to the intended target. However, in the experience of the Workshop participants, retention of older adults is usually excellent. Nevertheless, at the design stage, sample sizes can be calculated to account for incomplete retention, and collection of auxiliary data related to dropout can mitigate biases. If researchers are concerned about missed measures, prioritizing key measures early in the assessment can help protect the validity of data. Stereotypes related to the cognitive capacity of older adults may engender concerns about measurement accuracy. Design choices can mitigate these concerns. For example, wearable sensors can collect data on exposures and outcomes and can overcome concerns about the ability of older adults with cognitive and physical impairments. In longer-term studies, competing risks, such as death prior to achieving a study outcome, can be managed and even leveraged to additional insight using appropriate statistical methods.Lastly, researchers may have concerns about treatment heterogeneity across age groups as well as heterogeneity in older adult health. In some cases, these can be leveraged for increased power in estimating the relationships between independent and dependent variables . Both dehttps://clic-ctsa.org/education/kits/presentation-materials-library-inclusion-older-adults-clinical-and-translational) and other resources to overcome ageism; and 3) building institutional capacity to support age inclusion  engaging with the policymaking process to further promote inclusion; 2) using the CTSA Presentation Materials Library on Inclusion of Older Adults in Clinical and Translational Research . In addition, slide set modules provide examples of successful recruitment approaches, methods to address typical reasons older adults are excluded from research, ways to adapt studies, and ethical considerations regarding consent of older adults with limited decision-making capacity.The CTSA Inclusion Workgroup under the NIH National Center for Advancing Translational Sciences (NCATS) is a recent effort aimed at equipping research teams with tools to facilitate successful inclusion of diverse older adults in clinical research. It has provided a slide set repository focused on ways to improve recruitment, enrollment, and retention of older adults, particularly from marginalized backgrounds and underresourced settings , peer-to-peer conversations, and continuing education opportunities that keep researchers up to date with federal policies on inclusion. Other educational topics may include ways to combat ageism, how to actively engage and build trust with diverse older adult populations, how to address IRB-related challenges related to including older adults in research, approaches to developing and implementing age-friendly initiatives in recruitment and retention. At a minimum, institutions could launch pilot grants focused on research on older adult populations to support a pipeline of aging-related research among scientists.The aim of the Workshop, a collaboration between the CTSA Inclusion Workgroup and RCCN, was to develop and disseminate strategies to assist the research community with improving the inclusion of older adults in clinical research. Researchers should engage with the policymaking process to further promote inclusion, include the voice of older participants in every stage of research, and promote age-friendly initiatives in their institutions to make a significant impact on the health of older adults, who are one of the fastest-growing populations in the U.S.


According to the concept of “flexible surge capacity,” hospitals may need to be evacuated on two occasions: (1) when they are exposed to danger, such as in war; and (2) when they are contaminated, such as during the Covid-19 pandemic. In the former, the entire hospital must be evacuated, while in the latter, the hospital becomes a pandemic center necessitating the transfer of its non-contaminated staff, patients, and routine activities to other facilities. Such occasions involve several degrees of evacuation—partial or total—yet all require deliberate surge planning and collaboration with diverse authorities. This study aimed to investigate the extent of hospital evacuation preparedness in Thailand, using the main elements of the flexible surge capacity concept. A mixed method cross-sectional study was conducted using a hospital evacuation questionnaire from a previously published multinational hospital evacuation study. The tool contained questions regarding evacuation preparedness encompassing surge capacity and collaborative elements and an open-ended inquiry to grasp potential perspectives. All 143 secondary care, tertiary care, and university hospitals received the questionnaire; 43 hospitals provided responses. The findings indicate glitches in evacuation protocols, particularly triage systems, the inadequacies of surge planning and multiagency collaboration, and knowledge limitations in community capabilities. In conclusion, the applications of the essential components of flexible surge capacity allow the assessment of hospital preparedness and facilitate the evaluation of guidelines and instructions through scenario-based training exercises. Hospitals play a crucial role in disasters caused by natural hazards, manmade threats, and public health emergencies (DPHE), aiming to optimize the outcomes of medical management of injuries and to reduce the suffering of victims under limited access to resources  as a process of “Moving people and assets temporarily to safer places before, during or after the occurrence of a hazardous event to protect them” UNDRR . The UNDIrrespective of definitions, evacuation inherently increases the risks for patients, staff, and other people nearby when transferred due to a variety of internal and external factors that may impact them  concept, in which the collaboration is extended further to embrace communities’ potential resources and facilities , tertiary care (500 beds capacity), and university hospital (400−2265 beds capacity) levels because these levels of hospital serve complex conditions and comprise specialized healthcare staff, modern medical devices, procedures, prompted areas for treatments, and up-to-date guidelines and protocols  and between having prepared systems and shared stuff (p < 0.05).Command and control All hospitals claimed to have an incident command system (ICS). Most operated independently except for one hospital that declared a mutual ICS with the local health authorities as a network  triage during evacuation. Although 28 facilities commented on their familiarity with the reverse triage system, only 6 out of 28 correctly elaborated. Many of them still lacked the necessary knowledge.Training Most hospitals answered that they annually practiced their mass casualty responses or fire evacuation protocols  and reported annual training. Although the study’s sample size is too small to infer the association between hospital bed capacity and surge planning and collaboration, all hospitals, regardless of bed capacity, exhibited ICS. The results contradicted a study of 1100 US hospitals in 2008 that indicated a correlation between larger bed capacity and safety cooperation and drills (Niska Regarding evacuation, our findings demonstrated that hospitals adopted the ICS protocols for evacuation management in some areas, including personnel surges and medicine and device stockpiling, which is consistent with previous studies (Khorram-Manesh et al. The surveyed facilities indicated under-developed surge planning and incomplete preparedness, consistent with disaster resilience reports from other countries (King et al. Most hospitals presented plans and protocols for primary and secondary staff and stuff surges. However, similar to other countries, these capacities were circulated within the healthcare system and were underserved during DPHE (Rojek and Little Although most hospitals would prefer to transfer their patients to other healthcare facilities, some emergency scenarios still require field hospitals, shelter-in-place, or other local facilities because of damaged infrastructures (King et al. Most hospitals reported minimal concern about ethical and legal issues during disasters, and some did not address these issues. One reason for such unawareness could be a lack of previous lawsuits against healthcare providers for legal and ethical violations during disasters and emergencies. Another reason might be the lack of discussion and awareness of such issues among the authorities and populations in society. Nevertheless, the participants expected local health authorities to consider and enact legislation regulating patients’ treatment during crises, mainly when the only option during an evacuation is to leave someone behind with or without knowledge and perception of reverse triage. Currently, there are neither laws nor rules in Thailand to protect healthcare personnel in charge of tactical and strategic medical decision making during crises. However, the United States National Academy of Medicine has suggested striking a balance between the standard of care and the requirements of the larger community (Hick et al. The reverse triage system has been introduced for decades (Kelen et al. With limited logistical resources, some hospitals expressed their concerns about disproportionate resource consumption in critical care transportation (Einav et al. The results showed a certain degree of collaboration between hospitals and other organizations, such as task coordination to refer patients and sharing information through communication with the local health authority. Moreover, the statistically significant associations between the available system that participating facilities claimed to have in surge capacity and police or fire departments and between the available system and shared stuff indicate the directions that hospitals with established systems would have organized collaboration, including shared stuff, and with police or fire departments. However, collaboration requires cooperation, coordination, and communication, and no hospitals showed complete collaboration, which also emphasized the need for preparedness and training Gajda , 2022b.In summary, the findings of this study accentuated the shortcomings of hospital evacuation preparedness in terms of comprehensive surge planning including staff, stuff, and structure capacities and capabilities to create effective systems, seamless multiagency collaboration, and opportunities for community engagement. Previous studies have demonstrated the value of realistic and practical exercises and training in improving disaster responses (Sammut et al. Although the survey with an online approach was considered the most suitable method during the current pandemic due to the in-person contact limitation policy, a face-to-face interview could be a more straightforward way to achieve the highest degree of responses. The low response rate in this study may reflect the negligence of the evacuation preparedness. However, a nationally issued and supported survey may increase the response rate in future studies. Additionally, selection bias might have occurred in this study, as in all survey studies since the facilities that were more interested or prepared were more likely to participate. However, this study’s response rate met the expectation given by past research in a similar design (Aerny-Perreten et al. Hospitals are vulnerable to internal and external hazards, which may result in an evacuation. Such evacuation needs internal and external resources to assure the safety of affected patients. This study, to the best of our knowledge, is the first study assessing hospital evacuation preparedness in Thailand and elsewhere using the theoretical and conceptual frameworks for the FSC. Focusing on surge capacity’s four vital elements and collaborative factors encompassing CSCATTT, the study’s findings indicate a gap in hospital evacuation procedures, particularly triage and logistics, and inadequacies in surge planning and multiagency collaboration, in which the FSC implementation is plausible. Although using community resources may be beneficial during a disaster, the measures for concept integration into hospital evacuation are still challenging.Nevertheless, pragmatic research exploring planning for community engagement according to the flexible surge capacity to build a concrete hospital evacuation plan would enhance hospital readiness and its generalizations. The latter needs to be tested in simulation exercises. In conclusion, the concept of FSC and its collaborative tool seem valuable for evaluating hospital evacuation preparedness and creating educational initiatives to enhance such preparedness.


Sedimentsare sources and sinks of contaminants and play an important role in mediating pollutants across environmental compartments of terrestrial and aquatic ecosystems. In surface waters , organic and inorganic contaminants are either dissolved or sorbed to suspended matter and sediment particles according to their chemical properties. In the case of strong sorption, settling of suspended particles and sediment formation scavenge contaminants out of the water phase, resulting in the accumulation of contaminants in the beds of rivers and lakes.Under anoxic conditions, contaminants are less biodegradable; therefore, preservation of pollutants in anaerobic sediments  create a long-lasting potential source as has recently been demonstrated in streams, lake, and marine sediments , physicochemical processes , and microbial transformations. Therefore, a correct evaluation of these processes is of fundamental importance for environmental risk assessment and the prediction of the long-term fate of chemical pollution in sediments. Chronic contaminant inputs to sediments at trace levels occur very widely from regional to global scales by means of riverine, run-off, industrial activities, and atmospheric input pathways. Additionally, sediments can also be severely contaminated either continuously  or by accidents . Compared to established standards for water, air and to some extent soil quality, the ecotoxicological thresholds for polluted sediments are less well defined in national and international legislation. Therefore, advancing the interdisciplinary science of contaminated sediments with chemicals released into the environment directly  or indirectly  is of high societal relevance.Currently available methods for the determination of chemicals at trace levels provide very valuable information with results useful for pollutant source identification and apportionment recognition and historic pollution reconstruction. For example, gas chromatography or liquid chromatography–mass spectrometry (GC/LC–MS), using single- or triple-quadrupole instrumentation has been shown to be selective, very sensitive, and fast. Moreover, advances in analytical techniques such as high-resolution mass spectrometry (HRMS) have led to new opportunities in environmental trace analysis  can be used as markers of atmospheric deposition in sediments from remote water bodies ,  provide a comprehensive view of known and unknown contamination since the onset of industrialization, (ii) systematically document the time when contaminants appear and disappear, and (iii) explore their changes over time as a response to different management practices and regulatory interventions or environmental changes. In addition, spatial analysis of sediments can give insights on the transport and deposition of contaminants.Environmental risk assessments of contaminants in sediments are performed for supporting decision-making in very different contexts and situations. These include prospective and generic risk assessments conducted for (pre)marketing authorizations of chemicals, pesticides, pharmaceuticals, etc. as well as retrospective assessments, e.g., as diagnosis tools in the identification of ecological effects and the responsible stressors at contaminated areas, or to monitor effectiveness of remediation. In pre-marketing authorizations, risk assessment for the sediment compartment is mainly triggered by the results of partitioning and persistence assessments, which are performed according to standard protocols to estimate the partitioning coefficient n-octanol/water, and targeting transformation in aquatic sediment systems for persistence assessment OECD , b, 2004Overall, the refinement and update of existing protocols and regulatory guidelines triggering risk assessment for the sediment compartment are warranted. Recently, bioavailability has been started to be considered within risk assessment for a more realistic assessment rather than relying on the traditional approach of using total-extractable concentrations  earth scientists (sedimentologists) who play a pivotal role for identifying ideal sampling sites, analyzing sedimentation regimes, and dating of the sediment layers; (ii) analytical chemists who provide qualitative and quantitative determinations at trace to ultra-trace concentrations (10–6 to 10–9 g per kg sediment); (iii) microbiologists who evaluate the impact of aerobic and anaerobic biotransformation processes occurring in the sediments; and (iv) ecotoxicologists who assess the potential impact of contaminated sediment on aquatic ecosystems and associated risks for human exposure. Merging recent scientific advances in these different disciplines is required to achieve significant progress and overcome current challenges in environmental risk assessments of contaminated sediments.In 2015, the first International Conference of Contaminated Sediments, ContaSed 2015, was held at the Swiss Federal Institutes of Technology (ETH) Conference Center Stefano Franscini, Monte Verita, Ascona, Switzerland (Bogdal et al. This special issue contains a collection of different articles, in which the authors present diverse work in sediment research from heavy metals to legacy and perfluorinated compounds. We hope that by getting out some of the latest sediment research, we can raise awareness of this very important matrix within the environmental science community and the broader scientific community interested in environmental issues.


Integrated community healthcare Hubs may offer a ‘one stop shop’ for service users with complex health and social needs, and more efficiently use service resources. Various policy imperatives exist to implement Hub models of care, however, there is a dearth of research specifically evaluating Hubs targeted at families experiencing adversity. To contribute to building this evidence, we propose to co-design, test and evaluate integrated Hub models of care in two Australian community health services in low socioeconomic areas that serve families experiencing adversity: Wyndham Vale in Victoria and Marrickville in New South Wales.This multisite convergent mixed-methods study will run over three phases to (1) develop the initial Hub programme theory through formative research; (2) test and, then, (3) refine the Hub theory using empirical data. Phase 1 involves co-design of each Hub with caregivers, community members and practitioners. Phase 2 uses caregiver and Hub practitioner surveys at baseline, and 6 and 12 months after Hub implementation, and in-depth interviews at 12 months. Two stakeholder groups will be recruited: caregivers (n=100–200 per site) and Hub practitioners (n=20–30 per site). The intervention is a co-located Hub providing health, social, legal and community services with no comparator. The primary outcomes are caregiver-reported: (i) identification of, (ii) interventions received and/or (iii) referrals received for adversity from Hub practitioners. The study also assesses child, caregiver, practitioner and system outcomes including mental health, parenting, quality of life, care experience and service linkages. Primary and secondary outcomes will be assessed by examining change in proportions/means from baseline to 6 months, from 6 to 12 months and from baseline to 12 months. Service linkages will be analysed using social network analysis. Costs of Hub implementation and a health economics analysis of unmet need will be conducted. Thematic analysis will be employed to analyse qualitative data.Royal Children’s Hospital and Sydney Local Health District ethics committees have approved the study (HREC/62866/RCHM-2020). Participants and stakeholders will receive results through meetings, presentations and publications.ISRCTN55495932. The ‘Child and Family Hub’ study is the first to our knowledge to co-design, test and evaluate two integrated Hub models of care for improving the detection of and response to family adversity for children aged 0–8 years.Implementation and evaluation in two community health services across two Australian states will maximise the generalisability of findings for different community and service contexts.The interdisciplinary conceptual framework underpinning this study strengthens its empirical robustness through synthesis of approaches from many disciplines to capture the complexity of the Hub models.The study has no comparison group which means that any observed changes for primary and secondary outcomes cannot be directly attributed to the Hub models of care.The English language inclusion criterion for participants limits our ability to engage culturally and linguistically diverse caregiver and practitioners.Interventions aimed at reducing or preventing the impact of adversity on children could avert a substantial proportion of the population burden of mental illness, and build on evidence demonstrating the health and economic benefits of investing early in life.11As part of an Australian Centre of Research Excellence in Childhood Adversity and Mental Health, we will develop, test and evaluate an approach to improving the detection of and response to adversity in children aged 0–8 years and their families. Effective detection of adversity is crucial to the provision of appropriate, timely and evidence-based responses to the effects of adversity. However, major service barriers exist to the detection of, and responses to, adversity, including service time pressures, a lack of practitioner time, training and confidence in how to effectively discuss adversities, and practitioners’ concerns about causing harm.Integrated care has the potential to overcome service fragmentation and respond to a range of holistic health and social needs for families and their children experiencing adversity. Integration is defined as care that: ‘connect[s] the healthcare system  with other human service systems  to improve outcomes ’.29 30Various policy imperatives have been established to implement and evaluate Hub models of care for child and family mental health in Australia. These include the 2021 Royal Commission into Victoria’s Mental Health System  identification of, (ii) interventions received and/or (iii) referrals received for adversity from Hub practitioners.1.2. Hub practitioner-reported (i) identification of, (ii) interventions delivered and/or (iii) referrals provided for adversity,1.3. Caregiver-reported uptake of referrals,1.4. Child and caregiver mental health,1.5. Infant temperament,1.6. Child and caregiver global health,1.7. Caregiver parenting,1.8. Caregiver quality of life,1.9. Caregiver personal well-being outcomes,1.10. Caregiver experience of care,1.11. Practitioner experience including confidence and competence in detecting and responding to adversity,1.12. Linkages between intersectoral Hub practitioners, and2. To determine the costs of implementing the Hub models, and3. To determine the extent that the Hub models are providing the intended service option .Reporting in this protocol is based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement.35This study is a multisite implementation and evaluation project that employs a convergent mixed-methods design conducted over three research phases displayed in 36The study is underpinned by an interdisciplinary conceptual framework drawn from implementation science, critical realism, improvement science and collaborative co-design paradigms.Implementation science: Given the focus of our inquiry on complex Hub interventions, key implementation science frameworks form the basis of our process and outcomes evaluation, including our framing and synthesis of context using the Consolidated Framework for Implementation Research (CFIR).42Critical realism and realist evaluation: We draw on elements of critical realism and realist evaluation, a form of theory-driven evaluation, to theorise and examine ‘what works, for whom, under what circumstances and how’.54 55Improvement science: We use improvement science methods to implement agile learning and testing cycles that will iterate the Hub models and embed learning systems into practice.43Collaborative co-design: We use these principles and methods to co-design the Hub models and promote stakeholder engagement throughout the research process.The initial Hub programme theory was developed through an intensive formative research phase during which we collected contextual information and co-designed the Hub models with intersectoral  practitioners and caregivers from each local community. This phase occurred from October 2020 to June 2021 in Victoria and January to August 2021 in NSW. First, a historical and current needs assessment of the health, social, legal and community contexts of each site was conducted using qualitative data from online group discussions, individual interviews and meetings with key stakeholders including intersectoral practitioners  and caregivers. We used CFIRSecond, we reviewed the HHAN programme theories and other relevant realist literature focused on integrated care for children and families experiencing adversityThird, the Hub models were then developed and refined through a collaborative co-design process with intersectoral practitioners, caregivers and children at each site. The co-design process focused on the client journey through each proposed Hub and the workforce capacities and infrastructure needed to support implementation of the Hub. In Wyndham Vale, the Hub model was co-designed through an intensive 10-week series of co-design workshops and consultations with local caregivers and practitioners using human-centred design processes.The theorised Hub models comprise:Family and community partnerships: intentional creation and strengthening of connections between the Hub and caregivers, community groups and individuals. These partnerships also involve Hub practitioners working in partnership with families during clinical practice.Entry to the Hub: a ‘no wrong door’ approach in which caregivers are safely engaged in a conversation about adversity and provided with any necessary support and/or referrals regardless of how they enter the Hub.Workforce development: workforce capacity building and training of Hub practitioners to engage families in a safe and respectful conversation to identify adversities and connect families to relevant support.Case-based discussions: monthly professional development with intersectoral Hub practitioners to embed training learnings into practice and facilitate between-practitioner referrals .Referral pathways into and out of the Hub: systematic mapping of available health, community and social sector supports and services in the local area, linked to training of Hub practitioners to use this information in their practice.Care navigation: In Wyndham Vale, a Well-being Coordinator will support caregivers to identify the holistic needs of their child and/or family and assist them to navigate relevant services and supports in the community, social and health sectors. In Marrickville, care navigation is likely to include a Well-being Coordinator or a virtual application for caregivers that provides a risk stratification and recommendations of relevant services.We will empirically test the initial programme theory for the Hubs through a mixed-methods process with 6 and 12 months outcomes evaluation. The evaluation aims to assess for whom, how and why the Hub models had an impact (if any) in the two different contexts of Wyndham Vale and Marrickville across the child, caregiver, practitioner and system level outcomes specified in The study is a mixed-methods repeated measures evaluation that uses caregiver and Hub practitioner surveys at baseline, 6 and 12 months after Hub implementation begins and in-depth interviews at 12 months.=100–200 per site) and Hub practitioners (n=20–30 per site).We aim to recruit two stakeholder groups: caregivers  care for a child aged 0–8 years, including women who are pregnant, (ii) access any of the universal or specialist services provided in the Hub, such as general practitioners (GPs), paediatricians, lawyers and (iii) can understand written or spoken English language. The English language criterion is a limitation of our study; however, funding is not available to provide interpreters. Furthermore, culturally and linguistically diverse persons participated in an informed and meaningful way in phone-based or in-person surveys for HHAN .Given the preventative focus of this study, caregivers will not be screened for adverse experiences as an inclusion criterion. Instead, caregivers will report the frequency of 15 adversity types in the baseline survey. These adversity types are derived from the Parent Engagement ResourcePotential practitioner participants are those who: (i) work in any of the intersectoral services provided as part of each Hub, including GPs, maternal and child health nurses, paediatricians, allied health professionals, social workers, lawyers, and (ii) can understand written or spoken English language.As this study is testing the Hub models using a non-experimental design, we have not conducted a formal sample size calculation. However, the sample size of 200–400 caregivers is likely to provide rich data on the primary and secondary outcomes.The study is designed to accommodate a range of participants, many of whom may have complex life circumstances.We will invite practitioners working in each Hub who have been identified and recruited by the study team or health centre managers. We will send an invitation email to potential practitioner participants with the Practitioner PICF attached before they attend the workforce training. Practitioner participants will provide written (online or hard copy) informed consent prior to completing the baseline survey.The study will assess the child, caregiver, practitioner and systems outcomes summarised in The Caregiver and Hub practitioner baseline and outcome surveys consisting of the measures outlined in 10.1136/bmjopen-2021-055431.supp1Supplementary dataTwelve months after Hub implementation begins, we will conduct realist-informed semi-structured interviews with 18–24 caregivers and 5–10 Hub practitioners per site.Statistical analyses will be conducted using Stata or R statistical software packages.Quantitative measures of the strength and structure of service linkages between Hub practitioners will be analysed using social network analysis (SNA) software package UCINET.68–71Costs of the Hubs will be identified, including practitioner training, administration for referrals, personnel to oversee clinical implementation and other relevant costs. Downstream costs of services and potential cost-offsets will be collected and analysed to obtain the cost per additional child/or caregiver attending the Hub. Quality of life will be measured using the carer-specific measure EQ-HWB-S. An analIndividual interviews will be transcribed verbatim by a transcription service and imported into NVivo Release 1.0We will conduct a process evaluation using multiple data sources, including routinely collected data  and observation field notes of Hub practitioner clinical practice, the training sessions and the case-based discussions. The process evaluation examines the acceptability, feasibility and fidelity of implementation for each Hub component shown in the initial Hub programme theory in We will also conduct improvement cycles guided by the Model for Improvement.75We will use the process and outcome evaluation data to refine the initial Hub programme theory. Further testing will be undertaken by explicitly seeking to confirm or contradict theories throughout the PDSA cycles, in-depth interviews and knowledge translation activities . A key strength of our study is the assessment of outcomes across multiple levels of the Hub intervention . The triangulation of multiple data sources to evaluate the implementation of the Hub model serves to maximise the study’s rigour and confidence in our findings.75 76Caregivers and practitioners were actively involved in the co-design of the Hub models and are members of local advisory groups at each site which oversee the study design, recruitment, piloting of instruments, interpretation and dissemination of findings. Their engagement is aimed at ensuring the research is responsive to each context and to facilitate the translation of findings into practice.77The study protocol has been approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC/62866/RCHM-2020) and Sydney Local Health District (HREC/62866/RCHM-2020). All participants will be asked to provide written or verbal informed consent prior to completing the surveys and interviews. Each participant will be allocated a participant identification number that is kept securely under password protection accessible only to the research team.Participant confidentiality is strictly held in trust by the participating investigators, research staff and the sponsoring institution and their agents. The study protocol, documentation, data and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorised third party other than Murdoch Children’s Research Institute, without prior approval by the participant.All investigators will be able to access cleaned study data for analysis. Data will be housed on Murdoch Children’s Research Institute’s secure network or via file transfer, and all data sets will be password protected. To ensure confidentiality, dispersed data files will not include identifying participant information.While we do not anticipate any major risks to participants, the surveys and individual interviews may raise issues that are uncomfortable, upsetting or frustrating for some participants. To reduce the potential for distress to participants, the study team will provide clear explanations about why the study is being conducted, how the information will be used and the kinds of questions that will be asked. If the participant becomes distressed at any point, the researchers will empathise with the participant, stop the survey or interview if requested and discuss ways in which they might get support from family, friends or formal support services.We will publish study findings in international peer-reviewed journals and present papers at national and international conferences. At a local level in Wyndham Vale and Marrickville, we will communicate project learnings to local stakeholders via presentations, community social media and research summaries. We will provide research summaries to local and state-wide media and in social media posts. A knowledge translation strategy will disseminate findings using a range of mediums including state-wide and national Hub networks, communities of practice and regular engagements with relevant government departments. The strategy is intended to support the scale up of effective components to other community health services in Victoria, NSW and across Australia.


Obesity is the most prevalent nutrition-related disorder among the pediatric population. The World Health Organization (WHO) estimated that about 41 million children aged < 5 years and 340 million subjects aged 5–19 years are affected by overweight or obesity . AlthougChildhood obesity is a multisystem condition that has potentially harmful consequences and various comorbidities, thereby contributing to premature mortality in adulthood . In addiAdipose tissue (AT) immunomodulation is a crucial pathogenetic factor of all obesity comorbidities. Adipocyte hypertrophia and/or hyperplasia can promote local hypoxia, mechanical stress, and death of the adipocytes inducing the secretion of pro-inflammatory molecules and chemokines by adipocytes, endothelial cells, and resident macrophages, thus initiating an inflammatory process and transition of this local inflammation to SLGCI . SLCGI iSedentary children and adolescents are at higher risk for cardio-metabolic diseases than subjects who engage in regular physical exercise (PE) . Less thPE is a non-pharmacological intervention that can delay obesity-related comorbidities, improving cardiovascular fitness and attenuating SLGCI.Several beneficial PE effects have been described ,10,11,12PE may represent a tool to mitigate the global problems of overweight and obesity, as well as related comorbidities. Regular PE must be considered to be a natural part of a healthy lifestyle starting from childhood. Public health campaigns that promote the role of PE are crucial to support the care and wellbeing of pediatric population. Promoting PA is also needed to limit the negative effects of obesity on health economics. To consider the potential effects of PA and PE and the pathogenic mechanisms by which PA impacts the resolution of comorbidities must be explored to propose and adopt a new preventive perspective in children and adolescents. The role of PE as a non-pharmacological intervention for attenuating obesity-related complications should be considered and supported by healthcare providers, teachers, parents and guardians to ameliorate the future burden of pediatric obesity comorbidities.