Barriers and facilitators to implementing a Pharmacist, Physician, and Patient Navigator-Collaborative Care Model (PPP-CCM) to treat hepatitis C among people who inject drugs.

BACKGROUND: Direct-acting antivirals (DAAs) offer an unprecedented opportunity to eliminate hepatitis C virus (HCV) infection, yet barriers among people who inject drugs (PWID) remain. Having pharmacists provide care through collaborative drug therapy agreements (CDTAs) offers a promising solution. We developed and piloted a Pharmacist, Physician, and Patient Navigator-Collaborative Care Model (PPP-CCM) which utilized pharmacists to directly deliver HCV care at community organizations serving PWID. We conducted formative evaluation of the PPP-CCM pilot to characterize implementation experiences. METHODS: The PPP-CCM was implemented from November of 2020 through July of 2022. Formative evaluation team members observed implementation-related meetings and conducted multiple site visits, taking detailed fieldnotes. Fieldnotes were iteratively reviewed to identify barriers and facilitators to implementation and used to inform 7 key informant interviews conducted with programmatic staff at the end of the pilot. All data were analyzed using a Rapid Assessment Process (RAP) guided by the Consolidated Framework for Implementation Research (CFIR). The formative evaluation team shared results with program stakeholders (pharmacists, physicians, and other site staff) to verify and expand on learnings. RESULTS: Evaluation of PPP-CCM revealed 5 themes, encompassing all CFIR domains: 1) PPP-CCM was feasible but challenging to deliver efficiently; 2) the pharmacist role and characteristics (e.g., being flexible, available, and patient-centered) were key to PPP-CCM successes; 3) the PPP-CCM team met challenges engaging patients over time, but some team-based strategies helped; 4) community site characteristics (e.g., existing trusting relationships with PWID and physical space that enabled program visibility) were important contributors; and 5) financial barriers may limit PPP-CCM scale-up and sustainability. CONCLUSION: PPP-CCM is a novel and promising approach to HCV care delivery for PWID who may previously lack engagement in traditional care models, but careful attention needs to be paid to financial barriers to ensure scalability and sustainability.

Photograph as Skin, Skin as Wax: Indexicality and the Visualisation of Syphilis in Fin-de-Siècle France The William Bynum Prize Essay.

In early twentieth-century France, syphilis and its controversial status as a hereditary disease reigned as a chief concern for physicians and public health officials. As syphilis primarily presented visually on the surface of the skin, its study fell within the realms of both dermatologists and venereologists, who relied heavily on visual evidence in their detection, diagnosis, and treatment of the disease. Thus, in educational textbooks, atlases, and medical models, accurately reproducing the visible signposts of syphilis - the colour, texture, and patterns of primary chancres or secondary rashes - was of preeminent importance. Photography, with its potential claims to mechanical objectivity, would seem to provide the logical tool for such representations. Yet photography's relationship to syphilographie warrants further unpacking. Despite the rise of a desire for mechanical objectivity charted in the late nineteenth century, artist-produced, three-dimensional, wax-cast moulages coexisted with photographs as significant educational tools for dermatologists; at times, these models were further mediated through photographic reproduction in texts. Additionally, the rise of phototherapy complicated this relationship by fostering the clinical equation of the light-sensitive photographic plate with the patient's skin, which became the photographic record of disease and successful treatment. This paper explores these complexities to delineate a more nuanced understanding of objectivity vis-à-vis photography and syphilis. Rather than a desire to produce an unbiased image, fin-de-siècle dermatologists marshalled the photographic to exploit the verbal and visual rhetoric of objectivity, authority, and persuasion inextricably linked to culturally constructed understandings of the photograph. This rhetoric was often couched in the Peircean concept of indexicality, which physicians formulated through the language of witness, testimony, and direct connection.

Augmentation of cellular and humoral immune responses to HPV16 and HPV18 E6 and E7 antigens by VGX-3100.

We have previously demonstrated the immunogenicity of VGX-3100, a multicomponent DNA immunotherapy for the treatment of Human Papillomavirus (HPV)16/18-positive CIN2/3 in a phase 1 clinical trial. Here, we report on the ability to boost immune responses with an additional dose of VGX-3100. Patients completing our initial phase 1 trial were offered enrollment into a follow on trial consisting of a single boost dose of VGX-3100. Data show both cellular and humoral immune responses could be augmented above pre-boost levels, including the induction of interferon (IFN)γ production, tumor necrosis factor (TNF)α production, CD8+ T cell activation and the synthesis of lytic proteins. Moreover, observation of antigen-specific regulation of immune-related gene transcripts suggests the induction of a proinflammatory response following the boost. Analysis of T cell receptor (TCR) sequencing suggests the localization of putative HPV-specific T cell clones to the cervical mucosa, which underscores the putative mechanism of action of lesion regression and HPV16/18 elimination noted in our double-blind placebo-controlled phase 2B trial. Taken together, these data indicate that VGX-3100 drives the induction of robust cellular and humoral immune responses that can be augmented by a fourth "booster" dose. These data could be important in the scope of increasing the clinical efficacy rate of VGX-3100.

Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial.

BACKGROUND: Despite preventive vaccines for oncogenic human papillomaviruses (HPVs), cervical intraepithelial neoplasia (CIN) is common, and current treatments are ablative and can lead to long-term reproductive morbidity. We assessed whether VGX-3100, synthetic plasmids targeting HPV-16 and HPV-18 E6 and E7 proteins, delivered by electroporation, would cause histopathological regression in women with CIN2/3. METHODS: Efficacy, safety, and immunogenicity of VGX-3100 were assessed in CIN2/3 associated with HPV-16 and HPV-18, in a randomised, double-blind, placebo-controlled phase 2b study. Patients from 36 academic and private gynaecology practices in seven countries were randomised (3:1) to receive 6 mg VGX-3100 or placebo (1 mL), given intramuscularly at 0, 4, and 12 weeks. Randomisation was stratified by age (<25 vs ≥25 years) and CIN2 versus CIN3 by computer-generated allocation sequence (block size 4). Funder and site personnel, participants, and pathologists were masked to treatment. The primary efficacy endpoint was regression to CIN1 or normal pathology 36 weeks after the first dose. Per-protocol and modified intention-to-treat analyses were based on patients receiving three doses without protocol violations, and on patients receiving at least one dose, respectively. The safety population included all patients who received at least one dose. The trial is registered at ClinicalTrials.gov (number NCT01304524) and EudraCT (number 2012-001334-33). FINDINGS: Between Oct 19, 2011, and July 30, 2013, 167 patients received either VGX-3100 (n=125) or placebo (n=42). In the per-protocol analysis 53 (49·5%) of 107 VGX-3100 recipients and 11 (30·6%) of 36 placebo recipients had histopathological regression (percentage point difference 19·0 [95% CI 1·4-36·6]; p=0·034). In the modified intention-to-treat analysis 55 (48·2%) of 114 VGX-3100 recipients and 12 (30·0%) of 40 placebo recipients had histopathological regression (percentage point difference 18·2 [95% CI 1·3-34·4]; p=0·034). Injection-site reactions occurred in most patients, but only erythema was significantly more common in the VGX-3100 group (98/125, 78·4%) than in the placebo group (24/42, 57·1%; percentage point difference 21·3 [95% CI 5·3-37·8]; p=0·007). INTERPRETATION: VGX-3100 is the first therapeutic vaccine to show efficacy against CIN2/3 associated with HPV-16 and HPV-18. VGX-3100 could present a non-surgical therapeutic option for CIN2/3, changing the treatment outlook for this common disease. FUNDING: Inovio Pharmaceuticals.

Strategy development to sustain and strengthen the Navy Nurse Corps.

This article demonstrates how the strategic planning process was utilized to determine organizational priorities for the Navy Nurse Corps amidst a time of ongoing conflicts in Iraq and professional duress resulting from the national nursing shortage. The authors denote how overarching organizational goals of the US Navy and Navy medicine are woven into the priorities that were established for Navy Nursing. The emerging 6 priorities are relevant and vital to the sustainment of Navy Nursing today and in the future. They reflect the challenges associated with the development of clinical proficiency, educational policies, force structure/recruitment and retention, mid-grade and senior leadership roles, productivity measurement, and organizational communication. Similarly, these priorities mirror those that confront and warrant the attention of chief nursing officers in the civilian sector as they lead and develop their workforce.

Social identity complexity and outgroup tolerance.

Social identity complexity refers to the way in which individuals subjectively represent the relationships among their multiple ingroup memberships. More specifically, individuals with low social identity complexity see their ingroups as highly overlapping and convergent, whereas those with high complexity see their different ingroups as distinct and cross-cutting membership groups. The present study tested the hypothesis that perceived overlap among ingroup memberships would be negatively related to ingroup inclusiveness and tolerance for outgroups, such that individuals with high overlap (low complexity) would be less tolerant and accepting of outgroups in general than those with low overlap (high complexity). Results from a telephone interview survey of adult residents of the state of Ohio supported this hypothesis. Individual differences in complexity of perception of their national, religious, occupational, political, and recreational social identities were systematically related to their attitudes toward ethnic outgroups and diversity.

Telemedicine and coping skills groups for Pacific Island veterans with post-traumatic stress disorder: a pilot study.

Patients with post-traumatic stress disorder (PTSD) were randomly assigned to either an eight-week videoconferencing PTSD coping skills group or a traditional face-to-face PTSD coping skills group. Levels of attrition and compliance, patient satisfaction, clinician satisfaction and patients' retention of information were compared between the two conditions. Of the 41 referred veterans, 20 were eligible and agreed to participate in the study. Three of these participants withdrew from the study before randomization. By the end of the study, 89% of the patients remained in the videoconferencing group, whereas only 50% remained in the face-to-face group. Patients in the face-to-face group attended an average of 4.9 sessions and patients in the videoconferencing group attended 6.3 sessions (this difference was not significant). There was no difference between levels of patient satisfaction or clinician satisfaction at weeks 4 or 8. Patients' retention of information was similar in the two groups. The results show that videoconferencing can be used to provide coping skills groups for veteran patients with PTSD who reside in remote rural locations.