Development of a sexual consent intervention for adolescents with intellectual and developmental disabilities.

BACKGROUND: Tailored sexuality education for adolescents with intellectual and developmental disabilities is a crucial, yet unmet, need as this population is particularly at risk for sexual abuse and victimisation. However, there are no evidence-based interventions to specifically address this need. This paper presents the development of an intervention framework to address equity in sexuality education and support adolescents with intellectual and developmental disabilities to understand and provide sexual consent, a foundational aspect of sexuality education and sexual health. METHODS: The Sexual Health Equity Project team used a Community-Based Participatory Research approach to develop a four-module sexual consent intervention for adolescents with intellectual and developmental disabilities. We leveraged a diverse, interdisciplinary team in a suburban Midwestern school district, and used Backward Design to create objectives and assessments which were rooted in findings from qualitative data by special education teachers. RESULTS: The resulting sexual consent intervention, Ask Me First-Choices, is comprised of four modules covering topics including definition of sexual consent; decision-making strategies and practice; communicating consent and refusal, identifying situations of consent and non-consent; and legal issues surrounding consent. Each module is divided into five components for content delivery: (1) introduction, (2) lecture, (3) supplemental activity, (4) assessment, and (5) conclusion. We detail the intervention's unique aspects, emphasising areas where we used Universal Design for Learning principles to support teachers' instruction and students' learning. CONCLUSION: Our efforts to create a sexual consent intervention directly address sexuality education equity issues. We offer commentary on our design process and decisions, as well as recommendations for future groups who want to develop sexual health interventions in similar contexts for students with intellectual and developmental disabilities. Next steps include further testing and validation of the sexual consent intervention to build the evidence-base of sexuality education for adolescents with intellectual and developmental disabilities.

A qualitative analysis of vaccine decision makers' conceptualization and fostering of 'community engagement' in India.

BACKGROUND: Globally, and in India, research has highlighted the importance of community engagement in achieving national vaccination goals and in promoting health equity. However, community engagement is not well-defined and remains an underutilized approach. There is also paucity of literature on community engagement's effectiveness in achieving vaccination outcomes. To address that gap, this study interviewed Indian vaccination decision makers to derive a shared understanding of the evolving conceptualization of community engagement, and how it has been fostered during India's Decade of Vaccines (2010-2020). METHODS: Semi-structured interviews were conducted with 25 purposefully sampled national-level vaccine decision makers in India, including policymakers, immunization program heads, and vaccine technical committee leads. Participants were identified by their 'elite' status among decisionmakers in the Indian vaccination space. Schutz' Social Phenomenological Theory guided development of an a priori framework derived from the Social Ecological Model. The framework helped organize participants' conceptualizations of communities, community engagement, and related themes. Inter-rater reliability was computed for a subsample of coded interviews, and findings were validated in a one-day member check-in meeting with study participants and teams. RESULTS: The interviews successfully elucidated participants' understanding of key terminology ("community") and approaches to community engagement propagated by the vaccine decision makers. Participants conceptualized 'communities' as vaccine-eligible children, their parents, frontline healthcare workers, and vaccination influencers. Engagement with those communities was understood to mean vaccine outreach, capacity-building of healthcare workers, and information dissemination. However, participants indicated that there were neither explicit policy guidelines defining community engagement nor pertinent evaluation metrics, despite awareness that community engagement is complex and under-researched. Examples of different approaches to community engagement ranged from vaccine imposition to empowered community vaccination decision-making. Finally, participants proposed an operational definition of community engagement and discussed concerns related to implementing it. CONCLUSIONS: Although decision makers had different perceptions about what constitutes a community, and how community engagement should optimally function, the combined group articulated its importance to ensure vaccination equity and reiterated the need for concerted political will to build trust with communities. At the same time, work remains to be done both in terms of research on community engagement as well as development of appropriate implementation and outcome metrics.

Development of standard clinical endpoints for use in dengue interventional trials: introduction and methodology.

BACKGROUND: As increasing numbers of dengue vaccines and therapeutics are in clinical development, standardized consensus clinical endpoint definitions are urgently needed to assess the efficacy of different interventions with respect to disease severity. We aimed to convene dengue experts representing various sectors and dengue endemic areas to review the literature and propose clinical endpoint definitions for moderate and severe disease based on the framework provided by the WHO 2009 classification. METHODS: The endpoints were first proposed and discussed in a structured expert consultation. After that, the Delphi method was carried out to assess the usefulness, validity and feasibility of the standardized clinical disease endpoints for interventional dengue research. RESULTS: Most respondents (> 80%) agreed there is a need for both standardized clinical endpoints and operationalization of severe endpoints. Most respondents (67%) felt there is utility for moderate severity endpoints, but cited challenges in their development. Hospitalization as a moderate endpoint of disease severity or measure of public health impact was deemed to be useful by only 47% of respondents, but 89% felt it could bring about supplemental information if carefully contextualized according to data collection setting. Over half of the respondents favored alignment of the standard endpoints with the WHO guidelines (58%), but cautioned that the endpoints could have ramifications for public health practice. In terms of data granularity of the endpoints, there was a slight preference for a categorical vs numeric system (e.g. 1-10) (47% vs 34%), and 74% of respondents suggested validating the endpoints using large prospective data sets. CONCLUSION: The structured consensus-building process was successful taking into account the history of the debate around potential endpoints for severe dengue. There is clear support for the development of standardized endpoints for interventional clinical research and the need for subsequent validation with prospective data sets. Challenges include the complexity of developing moderate disease research endpoints for dengue.

Exploring Proxy Measures of Mutuality for Strategic Partnership Development: A Case Study.

Partnerships between academic and clinical-based health organizations are becoming increasingly important in improving health outcomes. Mutuality is recognized as a vital component of these partnerships. If partnerships are to achieve mutuality, there is a need to define what it means to partnering organizations. Few studies have described the elements contributing to mutuality, particularly in new relationships between academic and clinical partners. This study seeks to identify how mutuality is expressed and to explore potential proxy measures of mutuality for an alliance consisting of a hospital system and a School of Public Health. Key informant interviews were conducted with faculty and hospital representatives serving on the partnership steering committee. Key informants were asked about perceived events that led to the development of the Alliance; perceived goals, expectations, and outcomes; and current/future roles with the Alliance. Four proxy measures of mutuality for an academic-clinical partnership were identified: policy directives, community beneficence, procurement of human capital, and partnership longevity. Findings can inform the development of tools for assisting in strengthening relationships and ensuring stakeholders' interests align with the mission and goal of the partnership by operationalizing elements necessary to evaluate the progress of the partnership.

Dengue research opportunities in the Americas.

Dengue is a systemic arthropod-borne viral disease of major global public health importance. At least 2.5 billion people who live in areas of the world where dengue occurs are at risk of developing dengue fever (DF) and its severe complications, dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS). Repeated reemergences of dengue in sudden explosive epidemics often cause public alarm and seriously stress healthcare systems. The control of dengue is further challenged by the lack of effective therapies, vaccines, and point-of-care diagnostics. Despite years of study, even its pathogenic mechanisms are poorly understood. This article discusses recent advances in dengue research and identifies challenging gaps in research on dengue clinical evaluation, diagnostics, epidemiology, immunology, therapeutics, vaccinology/clinical trials research, vector biology, and vector ecology. Although dengue is a major global tropical pathogen, epidemiologic and disease control considerations in this article emphasize dengue in the Americas.

The role of community-based organizations in adolescent sexual health promotion.

Many scholars and practitioners have advocated for a more ecological approach to sexual health promotion for adolescents, such as one that includes involvement from schools, parents, and community organizations. Although extensive research has been conducted with schools and parents, little is known about the roles community-based organizations (CBOs) may play in the education and promotion of sexual health to young people. This study aimed to (a) identify the types of sexual health and sexuality-related questions asked by youth and programming/services, resources, and referrals currently being provided by CBOs; (b) explore the approaches used by CBOs when developing and implementing sexual health promotion programs; and (c) compare these findings with those from a similar study on school teachers, counselors, and nurses within the same state. Data collected from 169 people working in CBOs indicate that a wide variety of topics were covered by CBOs through programming and services, resources, and/or referral protocols. Topics covered varied in frequency. Overall, participants indicated a relatively comprehensive and accessible approach to providing sexuality information to youth. The results of this study suggest that CBOs should be included in the range of sources to be used for comprehensive sexual health promotion. If such organizations are supported with information, training, and resources, they could play a valuable role in the promotion of sexual health for adolescents.

"It Was Just Really Hard to Be Pregnant in a Smaller Town ": Pregnant and Parenting Teenagers' Perspectives of Social Support in Their Rural Communities.

Teenage pregnancy has a history of being a "social problem" in the United States, with there being higher rates in rural communities. Social support, a contributor to improving mental health outcomes, can significantly impact a teenager's pregnancy and parenting experience. Using House's (1981) social support framework, this study explores the teenagers' perceptions of how their rural community reacted and responded to them as pregnant and parenting teenagers. The results were formulated through the thematic analysis of semi-structured interviews (n = 26) with current and former pregnant and/or parenting teenagers. The participants reported experiencing both positive and negative social support. There were more reports of emotional support and instrumental support among the forms of positive support than there were in the other categories. Informational support was lacking. The appraisal support from community members was negative. There is a need for rural communities to develop effective social support strategies to provide positive support for pregnant and parenting teenagers.

Perceived enablers and barriers of community engagement for vaccination in India: Using socioecological analysis.

BACKGROUND: There is high level policy consensus in India that community engagement (CE) improves vaccination uptake and reduces burden of vaccine preventable diseases. However, to date, vaccination studies in the country have not explicitly focused on CE as an outcome in and of itself. Therefore, this study sought to examine the barriers and enablers of community engagement for vaccination in India. METHODS: Employing qualitative methods, twenty-five semi-structured elite interviews among vaccine decisionmakers' were triangulated with twenty-four national-level vaccine policy documents and researcher field notes (December 2017 to February 2018). Data collected for this study included perceptions and examples of enablers of and barriers to CE for vaccination uptake. Concepts, such as the absence of formal procedures or data collection approaches related to CE, were confirmed during document review, and a final convening to review study results was conducted with study respondents in December 2018 and January 2019 to affirm the general set of findings from this study. The Social Ecological Model (SEM) was used to organize and interpret the study findings. RESULTS: Although decisionmakers and policy documents generally supported CE, there were more CE barriers than facilitators in the context of vaccination, which were identified at all social-ecological levels. Interviews with vaccine decisionmakers in India revealed complex systemic and structural factors which affect CE for vaccination and are present across each of the SEM levels, from individual to policy. Policy-level enablers included decisionmakers' political will for CE and policy documents and interviews highlighted social mobilization, whereas barriers were lack of a CE strategy document and a broad understanding of CE by decisionmakers. At the community level, dissemination of Social-behavioral Change Communication (SBCC) materials from the national-level to the states was considered a CE facilitator, while class, and caste-based power relations in the community, lack of family-centric CE strategies, and paternalistic attitude of decisionmakers toward communities (the latter reported by some NGO heads) were considered CE barriers. At the organizational level, partnerships with local organizations were considered CE enablers, while lack of institutionalized support to formalize and incentivize these partnerships highlighted by several decisionmakers, were barriers. At the interpersonal level, SBCC training for healthcare workers, sensitive messaging to communities with low vaccine confidence, and social media messaging were considered CE facilitators. The lack of strategies to manage vaccine related rumors or replicate successful CE interventions during the during the introduction and rollout of new vaccines were perceived as CE barriers by several decisionmakers. CONCLUSION: Data obtained for this study highlighted national-level perceptions of the complexities and challenges of CE across the entire SEM, from individual to systemic levels. Future studies should attempt to associate these enablers and barriers with actual CE outcomes, such as participation or community support in vaccine policy-making, CE implementation for specific vaccines and situations (such as disease outbreaks), or frequency of sub-population-based incidents of community resistance and community facilitation to vaccination uptake. There would likely be value in developing a population-based operational definition of CE, with a step-by-step manual on 'how to do CE.' The data from this study also indicate the importance of including CE indicators in national datasets and developing a compendium documenting CE best-practices. Doing so would allow more rigorous analysis of the evidence-base for CE for vaccination in India and other countries with similar immunization programs.

Elementary School Personnel and Cultural Factors Affecting Health Education Implementation in the High-Stakes Testing Era.

BACKGROUND: Despite proven health and learning benefits, health education implementation in elementary schools is not optimal. This study investigated learning environment, leadership, and training factors that may influence elementary-level health education implementation in the current standardized testing-saturated environment. METHODS: Survey data were collected from principals of 8 Michigan elementary schools and, via focus groups, 30 teachers in their schools. Teacher groups were separated into 2 categories based on principals' understanding of state health education policies. Grounded theory analysis was used. RESULTS: Despite all 30 teachers' positive attitudes toward health education, numerous consistent implementation barriers were identified; competition for instructional time with tested subjects was most critical. Teachers with principals who indicated a greater understanding of state policies reported more: consistent instruction; availability of resources, and encouragement to teach select topics, especially mental health. CONCLUSION: That these findings were produced in a state with strong CSHE polices, proven curricula, and expansive support systems are disheartening and accentuate the profound impact of standardized testing on elementary-level health education implementation. More promising, principals' understanding of applicable state-level policies appeared to generate stronger health education implementation. Future research should focus on the possible impact of time devoted to health instruction on standardized test scores.

Self-Reported Sexual Behavioral Similarities and Differences Among Young Men Who Have Sex With Men With Childhood Sexual Abuse Histories: A Qualitative Exploratory Study.

Young men who have sex with men (YMSM) have the highest burden of sexually transmitted infections (STIs), including HIV. Childhood sexual abuse (CSA) is a risk factor for high-risk sexual behavior and STI acquisition. Studies that have explored sexual behavior based on the type of reported sexual abuse are limited. This study aimed to further understand current sexual behaviors and perceptions among YMSM that have experienced different types of CSA. Sixteen YMSM who were survivors of CSA were interviewed utilizing a phenomenological conceptual framework and methodology. Thematic findings were divided into two parts. Part I gave an overview of the entire sample, and themes were as follows: unprotected oral sex used to evaluate penile abnormalities, trust promoting unprotected sex, and alcohol and other drugs not cited as the reason for casual sex. Part II demonstrated the differences among those with a history of CSA involving non-penile-anal intercourse and those with a history of CSA involving penile-anal intercourse. The major themes in Part II were that victims of CSA involving penile-anal intercourse reported the following: a hypersexual self-definition, an STI diagnosis and noncondom use history, and a third sexual partner during sexual activity. Based on the findings, early life experiences such as CSA should be considered when developing preventative sexual health strategies and individuals who experienced penetrative sexual abuse may have different needs which should be further explored.

Development of a 10-Item Tool to Identify Advanced Practice Nurse Readiness to Prescribe Pre-exposure Prophylaxis.

Pre-exposure prophylaxis (PrEP), a biomedical tool to prevent the acquisition of HIV, reduces the risk of HIV in high-risk individuals by more than 90%. An online questionnaire was fielded from March 2017 to May 2017 to a random sample of licensed advanced practice nurses (APNs) from the U.S. state of Indiana. Discriminant function analysis was performed to reveal willingness to prescribe PrEP. Two discriminant functions were identified: Sexual Risk Assessment (r = .686), PrEP Barriers (r = .587), Evidence-Based Practice Implementation (r = .545), Community Awareness (r = .446), Perceived Risk (r = .356), and Organizational Climate (r = .346) were loaded on the first function, whereas PrEP Skills (r = .837) was loaded on the second function. The results suggest APN's willingness to learn and knowledge about PrEP-influenced implementation. Findings demonstrated that readiness to prescribe PrEP by APNs in Indiana could be predicted with a high level of certainty using identified variables.

NIAID resources for developing new therapies for severe viral infections.

Severe viral infections, including hemorrhagic fever and encephalitis, occur throughout the world, but are most prevalent in developing areas that are most vulnerable to infectious diseases. Some of these can also infect related species as illustrated by the threatened extinction of gorillas by Ebola infection in west and central Africa. There are no safe and effective treatments available for these serious infections. In addition to the logistical difficulties inherent in developing a drug for infections that are sporadic and occur mainly in the third world, there is the overwhelming barrier of no hope for return on investment to encourage the pharmaceutical industry to address these unmet medical needs. Therefore, the National Institute of Allergy and infectious Disease (NIAID) has developed and supported a variety of programs and resources to provide assistance and lower the barrier for those who undertake these difficult challenges. The primary programs relevant to the development of therapies for severe viral infections are described and three case studies illustrate how they have been used. In addition, contact information for accessing these resources is supplied.

Dengue illness index-A tool to characterize the subjective dengue illness experience.

Dengue virus infections are a major cause of febrile illness that significantly affects individual and societal productivity and drives up health care costs principally in the developing world. Two dengue vaccine candidates are in advanced clinical efficacy trials in Latin America and Asia, and another has been licensed in more than fifteen countries but its uptake has been limited. Despite these advances, standardized metrics for comparability of protective efficacy between dengue vaccines remain poorly defined. The Dengue Illness Index (DII) is a tool that we developed thru refinement of previous similar iterations in an attempt to improve and standardize the measurement of vaccine and drug efficacy in reducing moderate dengue illness. The tool is designed to capture an individual's overall disease experience based on how the totality of their symptoms impacts their general wellness and daily functionality. We applied the DII to a diary card, the Dengue Illness Card (DIC), which was examined and further developed by a working group. The card was then refined with feedback garnered from a Delphi methodology-based query that addressed the adequacy and applicability of the tool in clinical dengue research. There was overall agreement that the tool would generate useful data and provide an alternative perspective to the assessment of drug or vaccine candidates, which in the case of vaccines, are assessed by their reduction in any virologically confirmed dengue of any severity with a focus on the more severe. The DIC needs to be evaluated in the field in the context of vaccine or drug trials, prospective cohort studies, or during experimental human infection studies. Here, we present the final DIC resulting from the Delphi process and offer its further development or use to the dengue research community.

Addressing viral resistance through vaccines.

Antimicrobial resistance is a serious healthcare concern affecting millions of people around the world. Antiviral resistance has been viewed as a lesser threat than antibiotic resistance, but it is important to consider approaches to address this growing issue. While vaccination is a logical strategy, and has been shown to be successful many times over, next generation viral vaccines with a specific goal of curbing antiviral resistance will need to clear several hurdles including vaccine design, evaluation and implementation. This article suggests that a new model of vaccination may need to be considered: rather than focusing on public health, this model would primarily target sectors of the population who are at high risk for complications from certain infections.

Coping and survival skills: the role school personnel play regarding support for bullied sexual minority-oriented youth.

BACKGROUND: Research has shown that bullying has serious health consequences, and sexual minority-oriented youth are disproportionately affected. Sexual minority-oriented youth include lesbian, gay, bisexual, transgender, queer, or questioning (LGBTQ) individuals. This study examined the bullying experiences of sexual minority-oriented youth in a predominantly rural area of a Midwestern state. The purpose of this study was to have bullied youth describe their experiences and to present their perspectives. METHODS: Using critical qualitative inquiry, 16 in-depth interviews were conducted in-person or online with youth, ages 15-20, who self-identified as having been bullied based on their perceived minority sexual orientation status. RESULTS: The role of supportive school personnel was found to be meaningful, and supportive school personnel were mentioned as assisting with the coping and survival among this group of bullied sexual minority youth. CONCLUSIONS: Supportive school personnel are crucial to the coping and survival of these youth. All school personnel need to be aware of the anti-bullying policies in their school corporations. They may then work to strengthen and enforce their policies for the protection of bullied youth.

Priorities for CMV vaccine development.

A multidisciplinary meeting addressed priorities related to development of vaccines against cytomegalovirus (CMV), the cause of congenital CMV (cCMV) disease and of serious disease in the immunocompromised. Participants discussed optimal uses of a CMV vaccine, aspects of clinical study design, and the value of additional research. A universal childhood CMV vaccine could potentially rapidly reduce cCMV disease, as infected children are sources of viral transmission to seronegative and seropositive mothers. A vaccine administered to adolescents or adult women could also reduce cCMV disease by making them immune prior to pregnancy. Clinical trials of CMV vaccines in women should evaluate protection against cCMV infection, an essential precursor of cCMV disease, which is a more practical and acceptable endpoint for assessing vaccine effects on maternal-fetal transmission. Clinical trials of vaccines to evaluate prevention of CMV disease in stem cell transplant recipients could use CMV viremia at a level triggering pre-emptive antiviral therapy as an endpoint, because widespread use of pre-emptive and prophylactic antivirals has rendered CMV-induced disease too rare to be a practical endpoint for clinical trials. In solid organ transplant patients, CMV-associated disease is sufficiently common for use as a primary endpoint. Additional research to advance CMV vaccine development should include identifying factors that predict fetal loss due to CMV, determining age-specific incidence and transmission rates, defining the mechanism and relative contributions of maternal reactivation and re-infection to cCMV disease, developing assays that can distinguish between reactivation and re-infection in seropositive vaccinees, further defining predictors of sequelae from cCMV infection, and identifying clinically relevant immune response parameters to CMV (including developing validated assays that could assess CMV antibody avidity) that could lead to the establishment of immune correlates of protection.

Report of an NIAID workshop on dengue animal models.

Dengue is a mosquito-borne viral disease of humans that has re-emerged in many parts of the world and has become an important international public health threat. Dengue incidence and geographical spread has dramatically increased in the last few decades and is now affecting most tropical and sub-tropical regions of the world. Despite extensive research efforts for several decades, no vaccines or therapeutics are currently available to prevent and treat dengue infections. One of the main obstacles to the development of countermeasures has been the lack of good animal models that recapitulate dengue pathogenesis in humans and reliably predict the safety and efficacy of countermeasures against dengue. In September 2008, the National Institute of Allergy and Infectious Diseases (NIAID) held a workshop to consider the current state-of-the-art developments in animal models for dengue and discuss strategies to accelerate progress in this field. This report summarizes the main discussions and recommendations that resulted from the meeting.

Cross-species virus transmission and the emergence of new epidemic diseases.

Host range is a viral property reflecting natural hosts that are infected either as part of a principal transmission cycle or, less commonly, as "spillover" infections into alternative hosts. Rarely, viruses gain the ability to spread efficiently within a new host that was not previously exposed or susceptible. These transfers involve either increased exposure or the acquisition of variations that allow them to overcome barriers to infection of the new hosts. In these cases, devastating outbreaks can result. Steps involved in transfers of viruses to new hosts include contact between the virus and the host, infection of an initial individual leading to amplification and an outbreak, and the generation within the original or new host of viral variants that have the ability to spread efficiently between individuals in populations of the new host. Here we review what is known about host switching leading to viral emergence from known examples, considering the evolutionary mechanisms, virus-host interactions, host range barriers to infection, and processes that allow efficient host-to-host transmission in the new host population.