Collaborative implementation of an evidence-based package of integrated primary mental healthcare using quality improvement within a learning health systems approach: Lessons from the Mental health INTegration programme in South Africa.

Introduction: The treatment gap for mental health disorders persists in low- and middle-income countries despite overwhelming evidence of the efficacy of task-sharing mental health interventions. Key barriers in the uptake of these innovations include the absence of policy to support implementation and diverting of staff from usual routines in health systems that are already overstretched. South Africa enjoys a conducive policy environment; however, strategies for operationalizing the policy ideals are lacking. This paper describes the Mental health INTegration Programme (MhINT), which adopted a health system strengthening approach to embed an evidence-based task-sharing care package for depression to integrate mental health care into chronic care at primary health care (PHC). Methods: The MhINT care package consisting of psycho-education talks, nurse-led mental health assessment, and a structured psychosocial counselling intervention provided by lay counsellors was implemented in Amajuba district in KwaZulu-Natal over a 2-year period. A learning health systems approach was adopted, using continuous quality improvement (CQI) strategies to facilitate embedding of the intervention.MhINT was implemented along five phases: the project phase wherein teams to drive implementation were formed; the diagnostic phase where routinely collected data were used to identify system barriers to integrated mental health care; the intervention phase consisting of capacity building and using Plan-Do-Study-Act cycles to address implementation barriers and the impact and sustaining improvement phases entailed assessing the impact of the program and initiation of system-level interventions to sustain and institutionalize successful change ideas. Results: Integrated planning and monitoring were enabled by including key mental health service indicators in weekly meetings designed to track the performance of noncommunicable diseases and human immunovirus clinical programmes. Lack of standardization in mental health screening prompted the validation of a mental health screening tool and testing feasibility of its use in centralized screening stations. A culture of collaborative problem-solving was promoted through CQI data-driven learning sessions. The province-level screening rate increased by 10%, whilst the district screening rate increased by 7% and new patients initiated to mental health treatment increased by 16%. Conclusions: The CQI approach holds promise in facilitating the attainment of integrated mental health care in resource-scarce contexts. A collaborative relationship between researchers and health system stakeholders is an important strategy for facilitating the uptake of evidence-based innovations. However, the lack of interventions to address healthcare workers' own mental health poses a threat to integrated mental health care at PHC.

Amigas Latinas Motivando el Alma: Participant Perspectives on an In-Person and Online Implementation of an Intervention to Promote Mental Health in Latina Immigrant Women.

Amigas Latinas Motivando el Alma is a community-based intervention designed to increase social support and coping strategies among Latina immigrant women at risk for depression and anxiety. To assess satisfaction and perceived efficacy of the intervention, we conducted interviews with 32 participants that received the intervention in-person and online. Participants across both modalities found the program supportive in maintaining their mental health. They learned stress management techniques and found the support from facilitators and other participants helpful. Those receiving the intervention in-person were able to connect with other participants more easily than those that received it online. Those receiving it online noted distractions at home that made it challenging to fully engage. Community-based interventions that promote coping strategies and social support are a promising strategy for addressing mental health disparities among Latina immigrant women.TRN: NCT03749278, date of registration: November 21, 2018.

Flexible B12 ecophysiology of Phaeocystis antarctica due to a fusion B12-independent methionine synthase with widespread homologues.

Coastal Antarctic marine ecosystems are significant in carbon cycling because of their intense seasonal phytoplankton blooms. Southern Ocean algae are primarily limited by light and iron (Fe) and can be co-limited by cobalamin (vitamin B12). Micronutrient limitation controls productivity and shapes the composition of blooms which are typically dominated by either diatoms or the haptophyte Phaeocystis antarctica. However, the vitamin requirements and ecophysiology of the keystone species P. antarctica remain poorly characterized. Using cultures, physiological analysis, and comparative omics, we examined the response of P. antarctica to a matrix of Fe-B12 conditions. We show that P. antarctica is not auxotrophic for B12, as previously suggested, and identify mechanisms underlying its B12 response in cultures of predominantly solitary and colonial cells. A combination of proteomics and proteogenomics reveals a B12-independent methionine synthase fusion protein (MetE-fusion) that is expressed under vitamin limitation and interreplaced with the B12-dependent isoform under replete conditions. Database searches return homologues of the MetE-fusion protein in multiple Phaeocystis species and in a wide range of marine microbes, including other photosynthetic eukaryotes with polymorphic life cycles as well as bacterioplankton. Furthermore, we find MetE-fusion homologues expressed in metaproteomic and metatranscriptomic field samples in polar and more geographically widespread regions. As climate change impacts micronutrient availability in the coastal Southern Ocean, our finding that P. antarctica has a flexible B12 metabolism has implications for its relative fitness compared to B12-auxotrophic diatoms and for the detection of B12-stress in a more diverse set of marine microbes.

The Impact of a Collaborative Care Model on Health Trajectories among Patients with Co-Morbid Depression and Diabetes: The INDEPENDENT Study.

Context: Collaborative care models for depression have been successful in a variety of settings, but their success may differ by patient engagement. We conducted a post-hoc analysis of the INDEPENDENT trial to investigate the role of differential engagement of participants on health outcomes over 3 years. Settings and Design: INDEPENDENT study was a parallel, single-blinded, randomised clinical trial conducted at four socio-economically diverse clinics in India. Participants were randomised to receive either active collaborative care or usual care for 12 months and followed up for 24 months. Method: We grouped intervention participants by engagement, defined as moderate (≤7 visits) or high, (8 or more visits) and compared them with usual care participants. Improvements in composite measure (depressive symptoms and at least one of three cardio-metabolic) were the primary outcome. Statistical Analysis: Mean levels of depression and cardio-metabolic measures were analysed over time using computer package IBM SPSS Statistics 25. Results: The composite outcome was sustained the highest in the moderate engagers [27.5%, 95% confidence interval (CI): 19.5, 36.7] and the lowest in high engagers (15.8%, 95% CI: 8.1, 26.8). This pattern was observed for individual parameters - depressive symptoms and glycosylated haemoglobin. Progressive reductions in mean depressive symptom scores were observed for moderate engagers and usual care group from baseline to 36 months. However, in high engagers of collaborative care, mean depressive symptoms were higher at 36 months compared to 12 months. Conclusion: Sustained benefits of collaborative care were larger in participants with moderate engagement compared with high engagement, although a majority of participants relapsed on one or more outcome measures by 36 months. High engagers of collaborative care for co-morbid depression and diabetes may need light touch interventions for longer periods to maintain health and reduce depressive symptoms.

Strengthening integrated depression services within routine primary health care using the RE-AIM framework in South Africa.

Integration of mental health into routine primary health care (PHC) services in low-and middle-income countries is globally accepted to improve health outcomes of other conditions and narrow the mental health treatment gap. Yet implementation remains a challenge. The aim of this study was to identify implementation strategies that improve implementation outcomes of an evidence-based depression care collaborative implementation model integrated with routine PHC clinic services in South Africa. An iterative, quasi-experimental, observational implementation research design, incorporating the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, was applied to evaluate implementation outcomes of a strengthened package of implementation strategies (stage two) compared with an initial evaluation of the model (stage one). The first stage package was implemented and evaluated in 10 PHC clinics and the second stage strengthened package in 19 PHC clinics (inclusive of the initial 10 clinics) in one resource-scarce district in the province of KwaZulu-Natal, South Africa. Diagnosed service users were more likely to be referred for counselling treatment in the second stage compared with stage one (OR 23.15, SE = 18.03, z = 4.04, 95%CI [5.03-106.49], p < .001). Training in and use of a validated, mandated mental health screening tool, including on-site educational outreach and technical support visits, was an important promoter of nurse-level diagnosis rates (OR 3.75, 95% CI [1.19, 11.80], p = 0.02). Nurses who perceived the integrated care model as acceptable were also more likely to successfully diagnose patients (OR 2.57, 95% CI [1.03-6.40], p = 0.043). Consistent availability of a clinic counsellor was associated with a greater probability of referral (OR 5.9, 95%CI [1.29-27.75], p = 0.022). Treatment uptake among referred service users remained a concern across both stages, with inconsistent co-located counselling services associated with poor uptake. The importance of implementation research for strengthening implementation strategies along the cascade of care for integrating depression care within routine PHC services is highlighted.

Zinc stimulation of coastal productivity in low carbon dioxide environments.

Zinc (Zn) is a key micronutrient used by phytoplankton for carbon (C) acquisition, yet there have been few observations of its influence on natural oceanic phytoplankton populations. In this study, we observed Zn limitation of growth in the natural phytoplankton community of Terra Nova Bay, Antarctica, due to low (~220 µatm) pCO2 conditions, in addition to primary iron (Fe) limitation. Shipboard incubation experiments amended with Zn and Fe resulted in significantly higher chlorophyll a content and dissolved inorganic carbon drawdown compared to Fe addition alone. Zn and Fe response proteins detected in incubation and environmental biomass provided independent verification of algal co-stress for these micronutrients. These observations of Zn limitation under low pCO2 conditions demonstrate Zn can influence coastal primary productivity. Yet, as surface ocean pCO2 rises with continued anthropogenic emissions, the occurrence of Zn/C co-limitation will become rarer, impacting the biogeochemical cycling of Zn and other trace metal micronutrients.

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic.

Background: The collaborative care management (CoCM) model is an evidence-based intervention for integrating behavioral health care into nonpsychiatric settings. CoCM has been extensively studied in primary care clinics, but implementation in nonconventional clinics, such as those tailored to provide care for high-need, complex patients, has not been well described. Method: We adapted CoCM for a low-barrier HIV clinic that provides walk-in medical care for a patient population with high levels of mental illness, substance use, and housing instability. The Exploration, Preparation, Implementation, and Sustainment model guided implementation activities and support through the phases of implementing CoCM. The Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions guided our documentation of adaptations to process-of-care elements and structural elements of CoCM. We used a multicomponent strategy to implement the adapted CoCM model. In this article, we describe our experience through the first 6 months of implementation. Results: The key contextual factors necessitating adaptation of the CoCM model were the clinic team structure, lack of scheduled appointments, high complexity of the patient population, and time constraints with competing priorities for patient care, all of which required substantial flexibility in the model. The process-of-care elements were adapted to improve the fit of the intervention with the context, but the core structural elements of CoCM were maintained. Conclusions: The CoCM model can be adapted for a setting that requires more flexibility than the usual primary care clinic while maintaining the core elements of the intervention.

What is already known about this topic? Collaborative care management is an evidence-based intervention to integrate behavioral health care into primary medical care. The model uses a task-sharing approach in which a behavioral health care manager who is supervised by a remote psychiatrist works with the primary medical team. What does this paper add? We describe adaptation of the collaborative care management model for a low-barrier HIV care clinic. Adaptation was necessary because the clinic provides all care on a walk-in basis, the team structure differs from usual primary care, and the patient population has complex medical and social needs. What are the implications for practice, research or policy? Our experience can inform implementation of collaborative care management into other medical settings that are designed to provide care for high-need, complex patient populations.

Nerve-Sparing Gynecologic Surgery Enabled by A Near-Infrared Nerve-Specific Fluorophore Using Existing Clinical Fluorescence Imaging Systems.

Patients undergoing gynecological procedures suffer from lasting side effects due to intraoperative nerve damage. Small, delicate nerves with complex and nonuniform branching patterns in the female pelvic neuroanatomy make nerve-sparing efforts during standard gynecological procedures such as hysterectomy, cystectomy, and colorectal cancer resection difficult, and thus many patients are left with incontinence and sexual dysfunction. Herein, a near-infrared (NIR) fluorescent nerve-specific contrast agent, LGW08-35, that is spectrally compatible with clinical fluorescence guided surgery (FGS) systems is formulated and characterized for rapid implementation for nerve-sparing gynecologic surgeries. The toxicology, pharmacokinetics (PK), and pharmacodynamics (PD) of micelle formulated LGW08-35 are examined, enabling the determination of the optimal imaging doses and time points, blood and tissue uptake parameters, and maximum tolerated dose (MTD). Application of the formulated fluorophore to imaging of female rat and swine pelvic neuroanatomy validates the continued clinical translation and use for real-time identification of important nerves such as the femoral, sciatic, lumbar, iliac, and hypogastric nerves. Further development of LGW08-35 for clinical use will unlock a valuable tool for surgeons in direct visualization of important nerves and contribute to the ongoing characterization of the female pelvic neuroanatomy to eliminate the debilitating side effects of nerve damage during gynecological procedures.

Management of Depression in Chronic Care Patients Using a Task-Sharing Approach in a Real-World Primary Health Care Setting in South Africa: Outcomes of a Cohort Study.

Depressive symptoms are common in South African primary care patients with chronic medical conditions, but are usually unrecognised and untreated. This study evaluated an integrated, task-sharing collaborative approach to management of depression comorbid with chronic diseases in primary health care (PHC) patients in a real-world setting. Existing HIV clinic counsellors provided a manualised depression counselling intervention with stepped-up referral pathways to PHC doctors for initiation of anti-depressant medication and/ or referral to specialist mental health services. Using a comparative group cohort design, adult PHC patients in 10 PHC facilities were screened with the Patient Health Questionnaire-9 with those scoring above the validated cut-off enrolled. PHC nurses independently assessed, diagnosed and referred patients. Referral for treatment was independently associated with substantial improvements in depression symptoms three months later. The study confirms the viability of task-shared stepped-up collaborative care for depression treatment using co-located counselling in underserved real-world PHC settings.

Promoting mental health in Latina immigrant women: Results from the Amigas Latinas Motivando el Alma intervention trial.

INTRODUCTION: Latina immigrants are at increased risk of depression and anxiety and limited access to mental health care. This study evaluated the effectiveness of Amigas Latinas Motivando el Alma (ALMA), a community-based intervention to reduce stress and promote mental health among Latina immigrants. METHODS: ALMA was evaluated using a delayed intervention comparison group study design. Latina immigrants (N = 226) were recruited from community organizations in King County, Washington from 2018 to 2021. Although originally developed to be delivered in-person, due to the COVID-19 pandemic the intervention was adapted mid-study to be delivered online. Participants completed surveys to assess changes in depression and anxiety post-intervention and at a two-month follow-up. We estimated generalized estimating equation models to assess differences in outcomes across groups, including stratified models for those receiving the intervention in-person or online. RESULTS: In adjusted models, participants in the intervention group had lower levels of depressive symptoms than the comparison group post-intervention (ß = -1.82, p = 0.01) and at two-month follow-up (ß = -1.52, p = 0.01). Anxiety scores decreased for both groups, and there were no significant differences post-intervention or at follow-up. In stratified models, participants in the online intervention group had lower levels of depressive (ß = -2.50, p = 0.007) and anxiety (ß = -1.86, p = 0.02) symptoms than those in the comparison group, but there were no significant differences among those that received the intervention in-person. CONCLUSIONS: Community-based interventions can be effective in preventing and reducing depressive symptoms among Latina immigrant women, even when delivered online. Further research should evaluate the ALMA intervention among larger more diverse Latina immigrant populations.

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention.

BACKGROUND: Collaborative care (CC) is a multicomponent team-based approach to providing mental health care with systematic integration into outpatient medical settings. The 12-month INDEPENDENT CC intervention improved joint disease control measures in patients with both depression and diabetes at 12 and 24 months following randomization. OBJECTIVE: This study investigated the durability of intervention effects on patient outcomes at 36 months following randomization. PARTICIPANTS: Adult patients with poorly controlled T2D and depression in India randomized to CC or usual care. DESIGN: Post hoc analyses of between-group differences in patient outcomes at 36 months post-randomization (N = 331) and maintenance of outcomes from 12 to 36 months (N = 314). MAIN MEASURES: We evaluated combined risk factor improvement since baseline, defined as ≥ 50.0% reduction in Symptom Checklist Depression Scale (SCL-20) scores along with reduction of at least 0.5 percentage point hemoglobin A1C, 5 mmHg systolic blood pressure, or 10 mg/dL low-density lipoprotein cholesterol. Improvements in single risk factors were also examined. KEY RESULTS: There were no between-group differences in improvements since baseline in multiple or single risk factors at 36 months. Patients in the CC group with improved outcomes at 12 months were more likely to maintain a ≥ 50.0% reduction since baseline in SCL-20 scores (CC [54.9%] vs. UC [40.9%]; RR: 1.27 [95% CI: 1.04, 1.56]) and 0.5 percentage point reduction since baseline in hemoglobin A1C (CC [31.9%] vs. UC [19.5%]; RR: 1.64 [95% CI: 1.11, 2.41]) at 36 months. CONCLUSIONS: While improvements since baseline in patient outcomes did not differ between the collaborative care and usual care groups at 36 months, patients who received CC were more likely to maintain improvements in depressive symptoms and glucose levels at 36 months if they had achieved these improvements at the end of active intervention. TRIAL REGISTRATION NUMBER: NCT02022111.

Perinatal Depressive Symptoms and Viral Non-suppression Among a Prospective Cohort of Pregnant Women Living with HIV in Nigeria, Kenya, Uganda, and Tanzania.

Depression is common during pregnancy and is associated with reduced adherence to HIV-related care, though little is known about perinatal trajectories of depression and viral suppression among women living with HIV (WLHV) in sub-Saharan Africa. We sought to assess any association between perinatal depressive symptoms and viral non-suppression among WLWH. Depressive symptomatology and viral load data were collected every 6 months from WLWH enrolled in the African Cohort Study (AFRICOS; January 2013-February 2020). Generalized estimating equations modeled associations between depressive symptoms [Center for Epidemiological Studies Depression (CES-D) ≥ 16] and viral non-suppression. Of 1722 WLWH, 248 (14.4%) had at least one pregnancy (291 total) and for 61 pregnancies (21.0%), women reported depressive symptoms (13.4% pre-conception, 7.6% pregnancy, 5.5% one-year postpartum). Depressive symptomatology was associated with increased odds of viral non-suppression (aOR 2.2; 95% CI 1.2-4.0, p = 0.011). Identification and treatment of depression among women with HIV may improve HIV outcomes for mothers.

Understanding the Relationship Between Social Stressors, Trauma, and Somatic Symptoms Among Latina Immigrant Women.

BACKGROUND: Latina immigrant women are at increased risk for poor mental health. Little is known about factors associated with somatic symptoms, the physical manifestation of distress, in this population. This study examined associations between social stressors, trauma, and somatic symptoms. METHODS: This study used survey data from a community-based sample of Latina immigrant women (n = 154). We determined the frequency of somatic symptoms and used linear regressions to estimate associations of stressors and trauma with physical symptoms. RESULTS: Most participants reported mild or moderate levels of somatic symptom severity. In univariate models, all social stressors and trauma types were significantly associated with higher levels of somatic symptoms. A multivariate model suggested perceived stress was associated with increased somatic symptoms after accounting for other stressors and trauma. DISCUSSION: Future research should examine whether stress and trauma lead to higher levels of somatic symptoms among Latina immigrants.

Feasibility and Acceptability of a School-Based Emotion Regulation Prevention Intervention (READY-Nepal) for Secondary School Students in Post-Earthquake Nepal.

BACKGROUND: Child and adolescent mental health problems are major contributors to the global burden of disease in low- and middle-income country (LMIC) settings. To advance the evidence base for adolescent mental health interventions in LMICs, we evaluated the feasibility and acceptability of a school-based emotion regulation prevention intervention (READY-Nepal) for adolescents who had a recent exposure to a humanitarian disaster. METHODS: A mixed-method, non-randomized controlled trial was conducted with Nepali secondary school students in one heavily affected post-earthquake district. Students (N = 102; aged 13 to 17 years) were enrolled in the intervention (n = 42) and waitlist control (n = 60) conditions. Feasibility and acceptability were examined via attendance, and by qualitative interviews with a subset of students (n = 15), teachers (n = 2), and caregivers (n = 3). Preliminary efficacy was examined on primary outcome (emotion regulation) and secondary outcomes (anxiety symptoms, posttraumatic stress symptoms, functional impairment, resilience, coping skills), which were measured at baseline and post-intervention (four weeks). RESULTS: Delivering the intervention was feasible and acceptable, as demonstrated by low dropout (8%) and high program attendance (6.7 of 8 sessions). Qualitative data suggested high uptake of anger regulation skills, but lower uptake of mindfulness skills. Despite this, there were no significant differences by condition on primary or secondary outcomes at four-week follow-up. Students provided suggestions for improvement of the program. CONCLUSION: Further research on longitudinal outcome measurement, use of alternatives to retrospective self-report data, and rigorous development of culturally grounded models of emotion regulation is necessary to explore the utility of school-based emotion regulation interventions in Nepal and other LMICs.

Amigas Latinas Motivando el Alma: In-Person and Online Delivery of an Intervention to Promote Mental Health Among Latina Immigrant Women.

Objective: A few mindfulness-based interventions have been developed for Latina immigrant populations. We describe the feasibility and acceptability of Amigas Latinas Motivando el Alma (ALMA), a culturally grounded intervention developed to prevent and reduce depression and anxiety among Latina immigrants. We also compare participation in the intervention in-person with an online adaptation developed in response to the COVID-19 pandemic. Methods: ALMA was developed through several years of formative research in collaboration with community organizations serving Latino immigrants. The curriculum integrates mindfulness-based approaches with Latino cultural strengths to reduce stress, enhance coping strategies, and increase social support. Latina immigrant women who spoke Spanish were recruited from Latino serving organizations to participate in an intervention trial. The program consisted of eight sessions offered weekly in person to groups of ∼20 Latina immigrants. After the onset of the pandemic, the program was adapted to be delivered online via zoom. Attendance and fidelity were monitored by intervention staff, and a satisfaction survey was given to participants post-intervention. Results: We enrolled 226 Latina immigrant women with an average age of 40 years and an average of 15.0 years living in the United States. The majority of participants were monolingual Spanish speakers (59%) with a high school degree (66%), although almost half were living on less than $2,200 per month (48%). One hundred and seven (47%) attended the program in-person, and 119 (53%) participated online. Program attendance was similar across modalities, with an average of 58% sessions completed among in-person and 60% among online participants. Participant satisfaction and perceived efficacy of the intervention were high in both in-person and online groups. Discussion: Our findings indicate that the ALMA intervention is acceptable and feasible in this population. Future research should assess the efficacy of mindfulness-based interventions in Latina immigrant populations, including both in-person and online modalities. CTR# NCT03749278.

A Technical Guide to Sampling the Beagle Dog Nervous System for General Toxicity and Neurotoxicity Studies.

Beagle dogs are a key nonrodent species in nonclinical safety evaluation of new biomedical products. The Society of Toxicologic Pathology (STP) has published "best practices" recommendations for nervous system sampling in nonrodents during general toxicity studies (Toxicol Pathol 41[7]: 1028-1048, 2013), but their adaptation to the Beagle dog has not been defined specifically. Here we provide 2 trimming schemes suitable for evaluating the unique neuroanatomic features of the dog brain in nonclinical toxicity studies. The first scheme is intended for general toxicity studies (Tier 1) to screen test articles with unknown or no anticipated neurotoxic potential; this plan using at least 7 coronal hemisections matches the STP "best practices" recommendations. The second trimming scheme for neurotoxicity studies (Tier 2) uses up to 14 coronal levels to investigate test articles where the brain is a suspected or known target organ. Collection of spinal cord, ganglia (somatic and autonomic), and nerves for dogs during nonclinical studies should follow published STP "best practices" recommendations for sampling the central (Toxicol Pathol 41[7]: 1028-1048, 2013) and peripheral (Toxicol Pathol 46[4]: 372-402, 2018) nervous systems. This technical guide also demonstrates the locations and approaches to collecting uncommonly sampled peripheral nervous system sites.

Provider perspectives on the use of motivational interviewing and problem-solving counseling paired with the point-of-care nucleic acid test for HIV care.

AIMS: To evaluate provider perspectives on the use of a point-of-care nucleic acid test (POC NAT) and preferential opinions for motivational interviewing (MI) or problem-solving counseling (PSC) as an ultra-brief intervention for patients experiencing challenges to antiretroviral therapy (ART) adherence. METHODS: A qualitative study was conducted among providers at an HIV care clinic in Seattle, Washington. Ten in-depth interviews with HIV care providers were completed, which explored determinants of acceptability, feasibility and preferences for a combined adherence counseling and POC NAT intervention for patients living with HIV. Interviews were analyzed through consensus coding and the Five A's Framework to inform thematic analysis. RESULTS: Providers favored the use of a combined adherence counseling technique and POC NAT for their non-adherent patients living with HIV. Providers believed the intervention was an improvement on current assessment and advising practices. However, concerns about extended wait times for the POC NAT results influenced perceptions about feasibility around clinic flow and incorporation into clinic practice. Providers believed that acceptability of POC NAT implementation would be enhanced by including a subset of patient populations whom tend to be in the clinic for longer periods, and in tandem face greater ART adherence challenges. CONCLUSION: The GAIN Study will be the first project to evaluate the implementation of POC NAT in the U.S. Continued formative work is ongoing and may illustrate how best to address feasibility and concern around the two-hour time to result. The planned GAIN study will incorporate some of the findings found in this qualitative study and pilot this intervention, including a time-in-motion analyses of clinic flow, which may help reduce perceived wide-scale adaptation of POC NAT and ART adherence counselling among PLHW. Future work, including a shorter time to results and/or lower limit detection could make a significant improvement in the provision of HIV care.

A clinically relevant formulation for direct administration of nerve specific fluorophores to mitigate iatrogenic nerve injury.

Iatrogenic nerve injury significantly affects surgical outcomes. Although intraoperative neuromonitoring is utilized, nerve identification remains challenging and the success of nerve sparing is strongly correlated with surgeon experience levels. Fluorescence guided surgery (FGS) offers a potential solution for improved nerve sparing by providing direct visualization of nerve tissue intraoperatively. However, novel probes for FGS face a long regulatory pathway to achieve clinical translation. Herein, we report on the development of a clinically-viable, gel-based formulation that enables direct administration of nerve-specific probes for nerve sparing FGS applications, facilitating clinical translation via the exploratory investigational new drug (eIND) guidance. The developed formulation possesses unique gelling characteristics, allowing it to be easily spread as a liquid followed by rapid gelling for subsequent tissue hold. Optimization of the direct administration protocol with our gel-based formulation enabled a total staining time of 1-2 min for compatibility with surgical procedures and successful clinical translation.

Mechanistic Basis for the Role of Phytochemicals in Inflammation-Associated Chronic Diseases.

Chronic inflammatory diseases occur in a large portion of the population and are associated with a poor diet. Key natural products found in fruits and vegetables may assist in lowering inflammation associated with chronic diseases such as obesity, diabetes, cardiovascular diseases, and cancer. This review seeks to examine the roles of several natural products, resveratrol (RES), quercetin (QUE), curcumin (CUR), piperine (PIP), epigallocatechin gallate (EGCG), and gingerol (GIN), in their ability to attenuate inflammatory markers in specific diseases states. Additionally, we will discuss findings in past and ongoing clinical trials, detail possible phytochemical-drug interactions, and provide a brief resource for researchers and healthcare professionals on natural product and supplement regulation as well as names of databases with information on efficacy, indications, and natural product-drug interactions. As diet and over-the-counter supplement use are modifiable factors and patients are interested in using complementary and alternative therapies, understanding the mechanisms by which natural products have demonstrated efficacy and the types of drugs they interact with and knowing where to find information on herbs and supplements is important for practicing healthcare providers and researchers interested in this field.