Alaska pharmacists: First responders to the pandemic in the last frontier.

BACKGROUND: Pharmacists are among the nation's most accessible and underused health professionals. Within their scope of practice, pharmacists can prescribe and administer vaccines, conduct point-of-care testing, and address drug shortages through therapeutic substitutions. OBJECTIVES: To better use pharmacists as first responders to coronavirus disease 2019 (COVID-19), we conducted a needs and capacity assessment to (1) determine individual commitment to provide COVID-19 testing and management services, (2) identify resources required to provide these services, and (3) help prioritize unmet community needs that could be addressed by pharmacists. METHODS: In March 2020, pharmacists and student pharmacists within the Alaska Pharmacist Association worked to tailor, administer, and evaluate results from a 10-question survey, including demographics (respondent name, ZIP Code, cell phone, and alternate e-mail). The survey was developed on the basis of published COVID-19 guidelines, Centers for Disease Control and Prevention COVID-19 screening and management guidelines, National Association of Boards of Pharmacy guidance, and joint policy recommendation from pharmacy organizations. RESULTS: Pharmacies are located in the areas of greatest COVID-19 need in Alaska. Pharmacists are willing and interested in providing support. Approximately 63% of the pharmacists who completed the survey indicated that they were interested in providing COVID-19 nasal testing, 60% were interested in conducting COVID-19 antibody testing, and 93% were interested in prescribing and administering immunizations for COVID-19, as available. When asked about resources needed to enable pharmacists to prescribe antiviral therapy, 37% of the pharmacists indicated they needed additional education or training, and 39% required access to technology to bill and document provided services. CONCLUSION: The primary barrier to pharmacists augmenting the current COVID-19 response is an inability to cover the costs of providing these health services. Pharmacists in Alaska are ready to meet COVID-19-related clinical needs if public and private insurers and legislators can help address the barriers to service sustainability.

Pharmacist medical provider status in Alaska, the last frontier.

Alaska law and health care policies, incidentally, designate pharmacists as billable medical providers when providing health care services. However, state and commercial provider enrollment and claims processing systems are not configured to enroll and accept claims from pharmacists. Alaska law does not protect pharmacists from unfair discriminatory practices by payors despite such protections being afforded in federal regulation. Additional advocacy and legislation are needed to fully implement pharmacists as billing medical providers within traditional payor models. Health care services provided by pharmacists can help alleviate unmet patient health care needs in the community and primary care settings of Alaska. The identified barriers will continue to limit the ability of pharmacists in Alaska to sustainably provide lifesaving, scope-permitted, and otherwise covered services to those in greatest need.

Implementing post-trial access plans for HIV prevention research.

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA.

Perceived Facilitators and Barriers to Local Health Department Workers' Participation in Infectious Disease Emergency Responses.

CONTEXT: Local health departments play a key role in emergency preparedness and respond to a wide range of threats including infectious diseases such as seasonal influenza, tuberculosis, H1N1, Ebola virus disease, and Zika virus disease. To successfully respond to an infectious disease outbreak, local health departments depend upon the participation of their workforce; yet, studies indicate that sizable numbers of workers would not participate in such a response. The reasons why local health department workers participate, or fail to participate, in infectious disease responses are not well understood. OBJECTIVE: To understand why local health department workers are willing, or not willing, to report to work during an infectious disease response. DESIGN: From April 2015 to January 2016, we conducted 28 semistructured interviews with local health department directors, preparedness staff, and nonpreparedness staff. SETTING: Interviews were conducted with individuals throughout the United States. PARTICIPANTS: We interviewed 28 individuals across 3 groups: local health department directors (n = 8), preparedness staff (n = 10), and nonpreparedness staff (n = 10). MAIN OUTCOME MEASURES: Individuals' descriptions of why local health department workers are willing, or not willing, to report to work during an infectious disease response. RESULTS: Factors that facilitate willingness to respond to an infectious disease emergency included availability of vaccines and personal protective equipment; flexible work schedule and childcare arrangements; information sharing via local health department trainings; and perceived commitments to one's job and community. Factors that hinder willingness to respond to an infectious disease emergency included potential disease exposure for oneself and one's family; logistical considerations for care of children, the elderly, and pets; and perceptions about one's role during an infectious disease response. CONCLUSION: Our findings highlight opportunities for local health departments to revisit their internal policies and engage in strategies likely to promote willingness to respond among their staff. As LHDs face the persistent threat of infectious diseases, they must account for response willingness when planning for and fielding emergency responses. Our findings highlight opportunities for local health departments to revisit their internal policies and engage in strategies likely to promote response willingness to infectious disease emergencies among their staff.

"From me to HIV": a case study of the community experience of donor transition of health programs.

BACKGROUND: Avahan, a large-scale HIV prevention program in India, transitioned over 130 intervention sites from donor funding and management to government ownership in three rounds. This paper examines the transition experience from the perspective of the communities targeted by these interventions. METHODS: Fifteen qualitative longitudinal case studies were conducted across all three rounds of transition, including 83 in-depth interviews and 45 focus group discussions. Data collection took place between 2010 and 2013 in four states: Andhra Pradesh, Karnataka, Maharashtra and Tamil Nadu. RESULTS: We find that communication about transition was difficult at first but improved over time, while issues related to employment of peer educators were challenging throughout the transition. Clinical services were shifted to government providers resulting in mixed experiences depending on the population being targeted. Lastly, the loss of activities aimed at community ownership and mobilization negatively affected the beneficiaries' view of transition. CONCLUSIONS: While some programmatic changes resulted in improvements, additional opportunity costs for beneficiaries may pose barriers to accessing HIV prevention services. Communicating and engaging community stakeholders early on in future such transitions may mitigate negative feelings and lead to more constructive relationships and dialogue.

Ethics and obesity prevention: ethical considerations in 3 approaches to reducing consumption of sugar-sweetened beverages.

Obesity and overweight prevalence soared to unprecedented levels in the United States, with 1 in 3 adults and 1 in 6 children currently categorized as obese. Although many approaches have been taken to encourage individual behavior change, policies increasingly attempt to modify environments to have a more positive influence on individuals' food and drink choices. Several policy proposals target sugar-sweetened beverages (SSBs), consumption of which has become the largest contributor to Americans' caloric intake. Yet proposals have been criticized for unduly inhibiting choice, being overly paternalistic, and stigmatizing low-income populations. We explored the ethical acceptability of 3 approaches to reduce SSB consumption: restricting sale of SSBs in public schools, levying significant taxes on SSBs, and prohibiting the use of Supplemental Nutrition and Assistance Program (formerly food stamps) benefits for SSB purchases.

Food security and development in South Sudan: a call to action.

OBJECTIVE: To examine household food insecurity and coping mechanisms in two relatively politically stable states of South Sudan. DESIGN: Cross-sectional assessment including structured interviews and focus group discussions with food aid programme beneficiaries and staff. Structured interview findings were analysed with descriptive statistics using the statistical software package STATA version 11. SETTING: Rural households in four payams (sub-county administrative districts) benefiting from a multi-year assistance programme funded by the US Agency for International Development. The study was conducted in January 2012, six months after independence. SUBJECTS: Study subjects included eighty mothers of children aged 6­23 months in structured interviews and eight focus groups, each with six to ten participants, of mothers of children aged 6­23 months. RESULTS: Ninety-three per cent of households surveyed in Warrap and 100% of households in Northern Bahr el Ghazal states were severely food access insecure. Nearly all households (97?5%) surveyed in both states reported there were months in 2011 without enough food to eat. The majority of households (88%) reported sometimes or often going to bed hungry in the month preceding the study. A number of coping mechanisms were used when households did not have enough food, including reduced meal size, skipping meals, selling assets and engaging in some kind business in order to generate money to buy food. CONCLUSIONS: Given the highly volatile political, economic and humanitarian situation in South Sudan, the priorities of the international community are understandably focused on securing greater stability in South Sudan and preventing humanitarian needs from escalating significantly. There is a need, however, for simultaneous emphasis on food assistance and longer-term development strategies throughout South Sudan, particularly in areas of agriculture, livelihoods and food security.

Pediatric and emergency medicine resident comfort assessing and treating pediatric pain across pediatric age groups.

Aim: Assess pediatric and emergency medicine (EM) resident comfort treating and assessing pediatric pain. Materials & methods: Pediatric and EM residents at a single institution (SIUH Northwell Health in New York) completed an anonymous survey 6 months into the academic year regarding comfort assessing and treating pediatric pain. Results: A total of 40 (16/24 EM and 24/24 pediatric) residents completed this survey: 20% (8/24) pediatric first year residents, 40% (16/40) pediatric second year and above, 20% (8/40) EM first year and 20% (8/40) EM second year and above. A 46% (11/24) pediatric and 12% (2/16) EM residents were comfortable assessing neonatal pain (p < 0.05). A 38% (9/24) pediatric residents were comfortable treating neonatal pain compared with 12% (2/16) EM residents (p < 0.05). Both resident groups reported increasing comfort assessing and treating pain with increasing patient age. Conclusion: Both residents groups reported limitations in comfort assessing and treating pediatric pain, especially in younger patients. Education for both groups is important to optimize pediatric pain management.

Pediatric pain is common, and often underassessed and undertreated. Pediatric and emergency medicine (EM) residents care for pediatric patients with pain and must be able to appropriately assess and treat this pain. For this study, pediatric and EM residents at a single institution (SIUH Northwell Health in New York) completed an anonymous survey 6 months into the academic year regarding comfort assessing and treating pain and comfort prescribing pain medications across pediatric age ranges. In this study, 40 (16/24 EM and 24/24 pediatric) residents completed this anonymous survey. Of the 40 residents, 20% (8/24) were pediatric first year residents, 40% (16/40) were second or third year pediatric residents, 20% (8/40) were EM first year residents and 20% (8/40) were second, third or fourth year residents. About 46% (11/24) of pediatric residents and 12% (2/16) of EM residents were comfortable assessing neonatal pain. With increasing patient age, pediatric residents and EM residents comfort in assessing pediatric pain trended up (93.3% EM residents comfortable assessing pain in teenage patients). About 38% (9/24) of pediatric residents were comfortable treating neonatal pain as compared with 12% (2/16) of EM residents. While pediatric residents were significantly more comfortable treating pain in age categories from neonate to adolescents as compared with EM residents, both pediatric and EM residents reported increasing comfort in treating pediatric pain with increasing patient age. Limitations in comfort assessing and treating pediatric pain exist for both specialties. Education for both groups is important to optimize pediatric pain management.

Minimal Kidney Disease Phenotype in Shroom3 Heterozygous Null Mice.

Background: Shroom family member 3 (SHROOM3) encodes an actin-associated protein that regulates epithelial morphology during development. Several genome-wide association studies (GWAS) have identified genetic variances primarily in the 5' region of SHROOM3, associated with chronic kidney disease (CKD) and poor transplant outcomes. These genetic variants are associated with alterations in Shroom3 expression. Objective: Characterize the phenotypic abnormalities associated with reduced Shroom3 expression in postnatal day 3-, 1-month and 3-month-old mice. Methods: The Shroom3 protein expression pattern was determined by immunofluorescence. We generated Shroom3 heterozygous null mice (Shroom3Gt/+) and performed comparative analyses with wild type littermates based on somatic and kidney growth, gross renal anatomy, renal histology, renal function at postnatal day 3, 1 month, and 3 months. Results: The Shroom3 protein expression localized to the apical regions of medullary and cortical tubular epithelium in postnatal wild type kidneys. Co-immunofluorescence studies confirmed protein expression localized to the apical side of the tubular epithelium in proximal convoluted tubules, distal convoluted tubules, and collecting ducts. While Shroom3 heterozygous null mice exhibited reduced Shroom3 protein expression, no differences in somatic and kidney growth were observed when compared to wild type mice. Although, rare cases of unilateral hypoplasia of the right kidney were observed at postnatal 1 month in Shroom3 heterozygotes. Yet renal histological analysis did not reveal any overt abnormalities in overall kidney structure or in glomerular and tubular organization in Shroom3 heterozygous null mice when compared to wild type mice. Analysis of the apical-basolateral orientation of the tubule epithelium demonstrated alterations in the proximal convoluted tubules and modest disorganization in the distal convoluted tubules at 3 months in Shroom3 heterozygotes. Additionally, these modest abnormalities were not accompanied by tubular injury or physiological defects in renal and cardiovascular function. Conclusion: Taken together, our results describe a mild kidney disease phenotype in adult Shroom3 heterozygous null mice, suggesting that Shroom3 expression and function may be required for proper structure and maintenance of the various tubular epithelial parenchyma of the kidney.

Contexte: Le gène SHROOM3 (membre 3 de la famille Shroom) code pour une protéine associée à l'actine qui régule la morphologie épithéliale pendant le développement. Plusieurs études d'association à l'échelle du génome (GWAS ­ Genome-wide association studies) ont identifié des variations génétiques, principalement dans la région 5' du gène SHROOM3, associées à l'insuffisance rénale chronique (IRC) et à de mauvais résultats de transplantation. Ces variations génétiques sont associées à des altérations dans l'expression de (Shroom3). Objectif: Caractériser les anomalies phénotypiques associées à une diminution de l'expression de Shroom3 chez des souris à l'âge postnatal de 3 jours, 1 mois et 3 mois. Méthodologie: Le profil d'expression des protéines Shroom3 a été déterminé par immunofluorescence. Nous avons généré des souris hétérozygotes Shroom3 (Shroom3Gt/+) et procédé à des analyses comparatives avec des congénères de type sauvage en ce qui concerne la croissance somatique et rénale, l'anatomie rénale, l'histologie rénale et la fonction rénale à l'âge postnatal de 3 jours, 1 mois et 3 mois. Résultats: L'expression de la protéine Shroom3 est localisée dans les régions apicales de l'épithélium tubulaire médullaire et cortical des reins des souris de type sauvage après la naissance. Des études de co-immunofluorescence ont confirmé l'expression des protéines localisée sur le côté apical de l'épithélium tubulaire dans les tubules contournés proximaux, les tubules contournés distaux et les tubes collecteurs. Les souris hétérozygotes Shroom3 ont présenté une expression réduite de la protéine Shroom3, mais aucune différence dans la croissance somatique et rénale n'a été observée par rapport aux souris de type sauvage. Cependant, de rares cas d'hypoplasie unilatérale du rein droit ont été observés à l'âge postnatal de 1 mois chez les souris hétérozygotes Shroom3. L'analyze histologique rénale n'a révélé aucune anomalie manifeste dans la structure globale des reins ou dans l'organization des glomérules et des tubules chez les souris hétérozygotes Shroom3 par rapport aux souris de type sauvage. L'analyze de l'orientation apicale-basolatérale de l'épithélium tubulaire a montré des altérations dans les tubules contournés proximaux et une légère désorganisation dans les tubules contournés distaux à l'âge de 3 mois chez les souris hétérozygotes Shroom3. En outre, ces légères anomalies n'étaient pas accompagnées d'une lésion tubulaire ou d'anomalies physiologiques dans la fonction rénale et cardiovasculaire. Conclusion: Pris dans leur ensemble, nos résultats décrivent un phénotype d'insuffisance rénale légère chez les souris hétérozygotes Shroom3 adultes, ce qui suggère que l'expression et la fonction de la protéine Shroom3 peuvent être nécessaires pour la structure et le maintien appropriés des différents parenchymes épithéliaux tubulaires du rein.

The Good and the Bad of SHROOM3 in Kidney Development and Disease: A Narrative Review.

Purpose of review: Multiple large-scale genome-wide association meta-analyses studies have reliably identified an association between genetic variants within the SHROOM3 gene and chronic kidney disease. This association extends to alterations in known markers of kidney disease including baseline estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and blood urea nitrogen. Yet, an understanding of the molecular mechanisms behind the association of SHROOM3 and kidney disease remains poorly communicated. We conducted a narrative review to summarize the current state of literature regarding the genetic and molecular relationships between SHROOM3 and kidney development and disease. Sources of information: PubMed, PubMed Central, SCOPUS, and Web of Science databases, as well as review of references from relevant studies and independent Google Scholar searches to fill gaps in knowledge. Methods: A comprehensive narrative review was conducted to explore the molecular mechanisms underlying SHROOM3 and kidney development, function, and disease. Key findings: SHROOM3 is a unique protein, as it is the only member of the SHROOM group of proteins that regulates actin dynamics through apical constriction and apicobasal cell elongation. It holds a dichotomous role in the kidney, as subtle alterations in SHROOM3 expression and function can be both pathological and protective toward kidney disease. Genome-wide association studies have identified genetic variants near the transcription start site of the SHROOM3 gene associated with chronic kidney disease. SHROOM3 also appears to protect the glomerular structure and function in conditions such as focal segmental glomerulosclerosis. However, little is known about the exact mechanisms by which this protection occurs, which is why SHROOM3 binding partners remain an opportunity for further investigation. Limitations: Our search was limited to English articles. No structured assessment of study quality was performed, and selection bias of included articles may have occurred. As we discuss future directions and opportunities, this narrative review reflects the academic views of the authors.

Contexte motivant la revue: Plusieurs méta-analyses d'envergure portant sur des études d'association pangénomiques ont permis d'identifier de manière fiable une association entre des variants génétiques du gène SHROOM3 et l'insuffisance rénale chronique. Cette association s'étend aux altérations des marqueurs connus de l'insuffisance rénale, notamment le débit de filtration glomérulaire estimé initial, le rapport albumine/créatinine urinaire et le taux d'urée dans le sang. Pourtant, la compréhension des mécanismes moléculaires qui sous-tendent cette association entre SHROOM3 et l'insuffisance rénale reste mal communiquée. Nous avons procédé à une revue narrative afin de résumer l'état actuel de la littérature en ce qui concerne les relations génétiques et moléculaires entre SHROOM3 et le développement des reins et de l'insuffisance rénale. Sources: Les bases de données PubMed, PubMed Central, SCOPUS et Web of Science. L'examen des références des études pertinentes et des recherches indépendantes sur Google Scholar a également été réalisé pour combler les lacunes dans les connaissances. Méthodologie: Une revue narrative complète a été effectuée afin d'explorer les mécanismes moléculaires qui sous-tendent SHROOM3, le développement des reins, la fonction rénale et l'insuffisance rénale. Principaux résultats: SHROOM3 est une protéine unique puisqu'elle est la seule du groupe de protéines SHROOM à réguler la dynamique de l'actine par la constriction apicale et l'élongation des cellules apico-basales. SHROOM3 joue un rôle dichotomique dans le rein; de subtiles altérations de son expression et de sa fonction pouvant à la fois être pathologiques ou protectrices en contexte d'insuffisance rénale. Des études d'association pangénomiques ont permis d'identifier des variants génétiques associés à l'insuffisance rénale chronique près du site d'initiation de la transcription du gène SHROOM3. SHROOM3 semble également protéger la structure et la fonction des glomérules dans des contextes comme la glomérulosclérose segmentaire focale. On en sait toutefois peu sur les mécanismes précis qui entraînent cette protection; les partenaires de liaison de SHROOM3 demeurent par conséquent d'intéressantes avenues pour une étude plus approfondie. Limites: Notre recherche était limitée aux articles rédigés en anglais. Les études pertinentes n'ont pas fait l'objet d'une évaluation structurée de leur qualité. Un biais de sélection des articles inclus peut s'être produit. Bien que nous discutions des orientations et des possibilités futures, cette revue narrative reflète les points de vue académiques des auteurs.

Billing and Coding: Disparities in Healthcare Provider Training.

BACKGROUND: In the United States, healthcare providers document and code healthcare encounters and submit claims to insurers for reimbursement. Most providers eligible for individual-level insurer reimbursement do not receive coding/billing training. The purpose of this commentary is to provide an overview of training disparities. METHODS: The top 100 universities within five healthcare disciplines (dietetics, nursing, pharmacy, social work, medicine) were asked about available didactic curriculum and coding resources provided during training. Results were compared across disciplines, by geographic region, funding mechanism, and size. RESULTS: Twenty-seven percent of schools/universities contacted participated; the response was greater among public institutions (73%) and varied by discipline. Coverage of coding/billing in the didactic curriculum varied: it was covered in 40 dietetics programs (93%), 23 nursing programs (57%), and 14 pharmacy programs (28%). None of the 36 social work programs covered coding/billing, and only 5% of the 20 medical schools did. No statistically significant differences by region or funding were noted; however, coverage of coding/billing in the curriculum did differ by discipline (p<0.0001). DISCUSSION: Upon graduation, healthcare providers may be ill-prepared to code/bill for services. This knowledge is crucial for sustainable health service provision and does not appear to be consistently provided within curriculum to healthcare students. Further study is needed to understand and address this training gap.

Patient Satisfaction with Pharmacist-Provided Health-Related Services in a Primary Care Clinic.

(1) Background: Patient satisfaction plays an important role in the perceived value, sustained utilization, and coverage of healthcare services by payers and clinics. (2) Methods: A 33-question survey was designed to assess patient satisfaction and perceived value for healthcare services provided by a clinical pharmacist in a single primary care facility. It included general items from validated patient satisfaction surveys (i.e., PROMIS®, CAHPS) and pharmacist-specific items identified in selected literature. It was offered to all patients who were presenting for a new, unique visit with the clinical pharmacist at the medical clinic between May 2019 and April 2020. (3) Results: A total of 66 patients agreed to take the survey (RR = 100%), and the responses were overwhelmingly positive. However, men were more likely than women to report higher satisfaction (X2(1, n = 920) = 0.67, p = 0.027), and new patients reported higher satisfaction than existing patients (X2(1, n = 1211) = 1.698, p = 0.037). (4) Conclusions: The findings of this study indicate a high degree of patient satisfaction with pharmacist-provided healthcare services in the primary care setting.

Practice Transformation Driven through Academic Partnerships.

Evidence-based interventions have been shown to improve the quality of patient care, reduce costs, and improve overall health outcomes; however, adopting new published research and knowledge into practice has historically been slow, and requires an active, systematic approach to engage clinicians and healthcare administrators in the required change. Pharmacists have been identified as important agents of change and can enhance care delivery in primary care settings through evidence-based interventions. Utilizing the Consolidated Framework for Implementation Research (CFIR) we identify, assess, and share barriers and facilitators to program development, as well as growth and expansion efforts across five discrete, university-subsidized, embedded-pharmacy practices in primary care. We identified two overarching modifiable factors that influence current and future practice delivery and highlight the role of academia as an incubator for practice change and implementation: Data collection and information sharing. Conceptual frameworks such as CFIR help establish a common vernacular that can be used to facilitate systematic practice site implementation and dissemination of information required to support practice transformation.

Disseminated histoplasmosis in a patient with AIDS: case report and review of the literature.

Disseminated histoplasmosis was uncommon prior to the AIDS epidemic, and cutaneous eruption rarely was seen. Since the onset of the worldwide AIDS epidemic, histoplasmosis has become a more common opportunistic fungal infection and should be considered in the differential diagnosis of mucocutaneous lesions in patients with AIDS in endemic areas. We report a case of classic disseminated histoplasmosis in a patient with AIDS and discuss the epidemiology, clinical presentation, pathogenesis, laboratory and histopathologic findings, and treatment options for disseminated histoplasmosis.

Ethics of health policy and systems research: a scoping review of the literature.

Health policy and systems research (HPSR) is increasingly funded and undertaken as part of health system strengthening efforts worldwide. HPSR ethics is also a relatively new and emerging field, with numerous normative and descriptive questions that have largely not been considered. Normative questions include what ethical principles and values should guide HPSR. Descriptive questions include what ethical concerns arise when conducting HPSR. A small but growing body of scholarly work characterizes the various ethics issues inherent in HPSR. Towards informing the future development of ethics guidance for HPSR, a scoping review was undertaken to: (1) identify the range of ethics issues relevant to the conduct of HPSR-with a deliberate (though not exclusive) focus on low- and middle-income country settings and (2) describe existing guidance on key ethics issues relevant to HPSR. Using the Cochrane methods as a basis, the review identified formal and informal literature on HPSR ethics by searching the following databases: PubMed's Medline, Embase, Global Health, Scopus, WHO Global Health Regional Libraries, LILACs, OpenDOAR and Bielefeld Academic Search Engine. In total, 11 062 documents were identified from the formal (10 519) and informal (543) literature. One hundred and seven of these documents (formal 99 and informal 8) met at least one inclusion criterion and underwent thematic analysis. Ethical issues in four main categories were identified: upholding autonomy, identifying and balancing risks and benefits, justice and determination of ethical review requirements. The review indicated that the ethical values behind HPSR place an emphasis on its contributing to the reduction of health disparities. Unsurprisingly then, numerous ethical concerns relating to justice arise in HPSR. However, the majority of existing guidance focuses on obtaining or waiving informed consent and, thus, appears to be insufficient for HPSR. A list of priority ethics issues in HPSR in need of guidance development is provided.

Ethical Challenges of Randomized Violence Intervention Trials: Examining the SHARE intervention in Rakai, Uganda.

OBJECTIVE: We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda. METHODS: Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs. RESULTS: Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial. CONCLUSION: Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.