scholarly journals Characterization of Physicians That Might Be Reluctant to Propose HIV Cure-Related Clinical Trials with Treatment Interruption to Their Patients? The ANRS-APSEC Study

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 334
Author(s):  
Christel Protiere ◽  
Lisa Fressard ◽  
Marion Mora ◽  
Laurence Meyer ◽  
Marie Préau ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hiv Transmission ◽  
Negative Impact ◽  
Treatment Interruption ◽  
Department Head ◽  
Professional Activity ◽  
Hiv Cure ◽  
Continuous Training ◽  
Treatment Interruptions ◽  
The Impact

HIV cure-related clinical trials (HCRCT) with analytical antiretroviral treatment interruptions (ATIs) have become unavoidable. However, the limited benefits for participants and the risk of HIV transmission during ATI might negatively impact physicians’ motivations to propose HCRCT to patients. Between October 2016 and March 2017, 164 French HIV physicians were asked about their level of agreement with four viewpoints regarding HCRCT. A reluctance score was derived from their answers and factors associated with reluctance identified. Results showed the highest reluctance to propose HCRCT was among physicians with a less research-orientated professional activity, those not informing themselves about cure trials through scientific literature, and those who participated in trials because their department head asked them. Physicians’ perceptions of the impact of HIV on their patients’ lives were also associated with their motivation to propose HCRCT: those who considered that living with HIV means living with a secret were more motivated, while those worrying about the negative impact on person living with HIV’s professional lives were more reluctant. Our study highlighted the need to design a HCRCT that minimizes constraints for participants and for continuous training programs to help physicians keep up-to-date with recent advances in HIV cure research.

scholarly journals Preexposure Prophylaxis for Mitigating Risk of HIV Transmission During HIV Cure–Related Clinical Trials With a Treatment Interruption

2019 ◽  
Vol 220 (Supplement_1) ◽  
pp. S16-S18 ◽  
Author(s):  
Jean-Daniel Lelièvre
Keyword(s):  
Human Immunodeficiency Virus ◽  
Clinical Trials ◽  
Hiv Transmission ◽  
Treatment Interruption ◽  
Sex Partners ◽  
Hiv Cure ◽  
Analytical Treatment ◽  
Secondary Transmission ◽  
Preexposure Prophylaxis ◽  
Immunodeficiency Virus

AbstractAnalytical treatment interruption performed during human immunodeficiency virus (HIV) cure–related clinical trials exposes sex partners of participants in these trials to a risk of HIV transmission. Preexposure prophylaxis (PrEP), which emerged in recent years as a key strategy for preventing HIV transmission, is often considered a useful tool to prevent this risk. This article supports offering PrEP to the stable sex partners of participants in these trials but also notes limitations that must be addressed. It concludes that PrEP cannot on its own eliminate the risk of secondary transmission in this context.

Building capacity and ensuring equity in clinical trials during the COVID-19 pandemic.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13598-e13598
Author(s):  
Helen Winter ◽  
Joanna Willis ◽  
Stephen Lang ◽  
Kay Drury ◽  
Jonathan Heywood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practice ◽  
Treatment Interruptions ◽  
Clinical Ward ◽  
The Everyday ◽  
The Future ◽  
Ward Rounds ◽  
Equity Of Access ◽  
The Impact

e13598 Background: The impact on cancer outcomes from the Covid-19 pandemic has yet to be determined. Concerns persist on screening, delays in diagnosis, treatment interruptions and outcomes of infection in the immunosuppressed. The need for agile working has been exemplified by establishment of Nightingale Hospitals, staff redeployment and sudden integration of virtual consultations into clinical working. With most cancer clinical trials halted, recruitment into COVID-19 research became essential and embedded into the everyday. Here we present how rapid implementation of COVID-19 randomised clinical trials within an NHS organisation during the pandemic was achieved. Methods: A COVID-19 senior facilitation committee was set up to provide oversight, maximise staff capacity and resource and prioritise studies. Specific strategies to maximise access and clinical trials recruitment for patients including children and those with solid tumours were designed. These included presence of a research nurse at clinical ward rounds and team meetings, the promotion of protocol and informed consent training to all including doctors in the acute settings and weekly research meetings to share-best practice. Reflecting on learnings from this time provide an opportunity to consider how we adjust working for our patients in the future. Results: The integration of research into the everyday working of clinical teams looking after patients with COVID-19 has become the norm. The provision of protocol and informed consent training for all levels of staff and the consideration of all patients for trials during clinical ward rounds and multi-disciplinary meetings, have ensured access to trials has become embedded. The integration of research nurses working, upskilling and prompting clinical colleagues has ensured equity of access and provided a research presence and focus during the busy clinical day. The adoption of cross-disciplinary working, sharing best practice and a culture of commitment and support to the trials ensures no patient is denied the opportunity to participate. Three RTCs opened over 7 weeks. At one site 1904 patients were screened for one of the randomised-controlled trials and over 18% of these patients (351) were recruited and 175 patients declined. Conclusions: The pandemic has had a devastating impact across the UK. However, a coordinated and collaborative multi-disciplinary approach has supported high recruitment and equity of access for patients into COVID-19 trials. Learnings from this work may lead to embedding clinical trials and access to translational research for cancer patients in the future as we recover from the full impact of the pandemic. COVID-19 research has demonstrated how increased recruitment accelerates access and implementation of new innovations and novel drug combinations.The full impact of improved access to cancer research in the future during COVID recovery is worthy of more research.

scholarly journals Acceptability, motivation and the prospect of cure for people living with HIV and their healthcare providers in HIV cure-focused treatment interruption studies

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Jillian S. Y. Lau ◽  
Miranda Z. Smith ◽  
Brent Allan ◽  
Cipriano Martinez ◽  
Jennifer Power ◽  
...  
Keyword(s):  
Descriptive Analysis ◽  
Healthcare Providers ◽  
Treatment Interruption ◽  
People Living With Hiv ◽  
Hiv Cure ◽  
Educational Strategies ◽  
Analytical Treatment ◽  
Clinical Endpoints ◽  
Treatment Interruptions ◽  
Living With Hiv

Abstract Background Analytical treatment interruptions (ATI) are commonly used clinical endpoints to assess interventions aimed at curing HIV or achieving antiretroviral therapy (ART)-free HIV remission. Understanding the acceptability of ATI amongst people living with HIV (PLHIV) and their HIV healthcare providers (HHP) is limited. Methods Two online surveys for PLHIV and HHP assessed awareness and acceptability of ATI, and understanding of the prospect for HIV cure in the future. Responses were collected from July 2017–January 2018. A descriptive analysis was performed and similar questions across the two surveys were compared using χ squared test. Results 442 PLHIV and 144 HHP completed the survey. 105/400 (26%) PLHIV had ever interrupted ART, 8% of which were in a clinical trial. Altruistic motivations were drivers of participation of PLHIV in cure related research. 81/135 (60%) HHP would support their patients wishing to enrol in an HIV cure-focused trial, but fewer would promote and allow such participation (25% and 31% respectively). Compared to HHP, PLHIV were more likely to believe that an HIV cure would be achievable within 10 years (55% vs. 19%, p < 0.001), had less awareness of ATI (46% vs. 62%, p < 0.001) and were less likely to have had experience of either participation or enrolment in an ATI study (5% vs. 18%, p < 0.001) Conclusion PLHIV were more optimistic about the potential for HIV cure. HHP had more direct experience with HIV cure-focused studies. Educational strategies are required for both groups to increase understanding around ATIs in HIV cure research but should be tailored specifically to each group.

scholarly journals Kinetics of Plasma HIV Rebound in the Era of Modern Antiretroviral Therapy

2020 ◽  
Vol 222 (10) ◽  
pp. 1655-1659 ◽  
Author(s):  
Michael C Sneller ◽  
Erin D Huiting ◽  
Katherine E Clarridge ◽  
Catherine Seamon ◽  
Jana Blazkova ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Antiretroviral Therapy ◽  
Therapeutic Efficacy ◽  
Historical Data ◽  
Modern Art ◽  
Treatment Interruption ◽  
Viral Rebound ◽  
Hiv Cure ◽  
Analytical Treatment ◽  
Kinetics Of

Abstract Historical data regarding time to viral rebound following analytical treatment interruption (ATI) have been used to determine therapeutic efficacy in HIV cure trials; however, such data were collected from studies conducted a decade or more ago and included participants receiving older antiretroviral therapy (ART) regimens with infrequent virologic monitoring. We conducted a study of 22 HIV-infected participants receiving modern ART to determine the kinetics of plasma viral rebound following ATI. Our data suggest that modern ART does not alter kinetics of viral rebound when compared to previous regimens and that immunologic interventions may be necessary to achieve ART-free virologic remission. Clinical Trials Registration ClinicaTrials.gov identifier: NCT03225118.

How Do the Romanian Students Consider the Research Competencies Appropriate for Their Future Career?

2021 ◽  
Vol 13 (4) ◽  
pp. 162-179
Author(s):  
Roxana Constanţa Enache ◽  
Gabriel Gorghiu ◽  
Laura Monica Gorghiu ◽  
Ana-Maria Aurelia Petrescu ◽  
Camelia Stăiculescu
Keyword(s):  
Negative Impact ◽  
Well Being ◽  
Professional Activity ◽  
Educational Practices ◽  
Research Activity ◽  
Continuous Training ◽  
Research And Innovation ◽  
Research Activities ◽  
Research Competencies ◽  
The Individual

Students’ research competencies are seen today, for any specialist, as necessary, both in terms of their use in academic training but also for the future careers. The analysis of educational practices in various education systems shows that the development of those skills starts sooner or later along the educational paths. We consider that research competencies are necessary in more and more diverse contexts, together with the development of educational practices that should develop the research competences in the initial and continuous training processes. This study aims to capture the correlation between the perceptions of Romanian students concerning the need to develop research competencies, and the extent to which they are effectively formed in actual higher education programs. The steps made for the development of each career, but also the successful completion of the university studies imply the development and practice of research competencies. The research aims to identify how students from several Romanian universities perceive the need to gather research competencies, what is the meaning of those skills, in what situations are used, but also what barriers are encountered in the research activity. Seeking to minimize any negative impact of research on the well-being status, we believe that a key factor in facilitating well-being is related to responsible research and innovation. Another important aspect of this research is offered by the identification of the respondents’ perceptions considering the importance of research in the students’ future professional activity, which could implicitly determine the interest in ensuring the individual and organizational well-being. For the present research, we aim to find a correlation of research competencies with the well-being status, to identify the necessary research competencies among the objectives of training, to determine the structural elements of research competencies, to identify situations / contexts in which such skills may be useful, to identify aspects that alters the well-being status in research activities, as well as solutions for promoting the well-being status in research activities.

scholarly journals The impact of COVID-19 pandemic on the professional activities and health of ophthalmologists in the Russian Federation. Results of an online survey

2021 ◽  
pp. 66-78
Author(s):  
E.V. Kechin ◽  
◽  
A.V. Doga ◽  
N.S. Khodjaev ◽  
K.D. Tonaeva ◽  
...  
Keyword(s):  
Russian Federation ◽  
Online Survey ◽  
Negative Impact ◽  
Work Load ◽  
Professional Activity ◽  
Professional Literature ◽  
Professional Activities ◽  
Coronavirus Infection ◽  
The Russian Federation ◽  
The Impact

Purpose. To study the impact of the COVID-19 pandemic on the professional activities and health of ophthalmologists in the Russian Federation. Material and methods. The All-Russian online survey of ophthalmologists «Impact of the COVID-19 pandemic on the professional activity, lifestyle and health of ophthalmologists in the Russian Federation» was conducted. The results are presented in % of those respondents who are engaged in the relevant activity. Results. The survey involved 582 ophthalmologists from various regions of Russia. In April 2020 (in the first month of non-working days throughout the Russian Federation), the work load as a whole became less than usual for 54.8% of respondents. In addition, 18.4% of respondents stated that they did not work during the entire April 2020. The number of face-to-face consultations decreased in 74.3% of the surveyed ophthalmologists. The number of telemedicine consultations decreased in 27.0% of respondents, and increased in 34.1%. The number of emergency and urgent surgery decreased in 25.0% of respondents, and increased in 23.2%. The number of planned surgery decreased in 80.4% of respondents. 23.9% of respondents began to provide medical care in an additional and new profile of ophthalmological care (which they do not usually do). Salaries in April 2020 decreased for 66.7% of respondents, in August 2020 – in 41.4% of respondents. Ophthalmologists have become more engaged in the study of professional literature on ophthalmology and coronavirus, as well as writing scientific products (articles, patents, etc.), preparing reports and presenting them. In 57.8% of cases of infection of ophthalmologists with COVID-19 was associated with their professional activities and 37.3% of infection with an ophthalmic patient. In 83.3% of cases, ophthalmologists were treated for COVID-19 on an outpatient, in 16.7% of cases – in an inpatient. In 66.7% of cases the health status of ophthalmologists after the coronavirus infection COVID-19 was poor. Conclusion. The COVID-19 pandemic had negative impact on the professional activity and health of ophthalmologists in the Russian Federation. Key words: pandemic, COVID-19, new coronavirus infection, ophthalmologists.

scholarly journals Influence of stress factors on the personality of employees of the Russian penal system in the course of professional activity

2021 ◽  
Vol 228 (5) ◽  
pp. 35-46
Author(s):  
YULIYA A. SOKOLOVA ◽  
Keyword(s):  
Negative Impact ◽  
Emotional Health ◽  
The Body ◽  
Stress Factors ◽  
Professional Activity ◽  
Penal System ◽  
Structural Method ◽  
Factors Affecting ◽  
Professional Stress ◽  
The Impact

Abstract. The article examines the issues related to the influence of stress factors on the personality of penal system employees, analyzes the concept of stress, the symptoms of its manifestation, as well as the causes of stress. The article is devoted to the results of psycho-diagnostic research and scientific literature on the topic of the work. The research is aimed at studying stress factors affecting the personality of the penal system employees, confirming the statement that the professional activity of the penal system employees takes place in tense, conflict, extreme conditions, it is associated with the presence of permanent stress factors, which leads to the development of professional stress, has a negative impact on the mental and emotional state of the individual, affects the success of the performance of official duties. The methodological basis of the research includes methods of analysis and synthesis, statistical and system- structural method. As a result of this work, the concept of stress as a response of the body to the impact of the external environment has been studied, its symptoms have been identified. The stress factors of professional activity are analyzed, their negative impact on the personality of the penal system employees is investigated, professionally important qualities that prevent the negative impact of stress on the personality are highlighted. It has been established that the intensity of the stress factors’ impact on the personality of penal system employees depends on the length of service in the penal system, age, and the level of professionalism. Conclusions are drawn about the importance of preventing stressful conditions for maintaining and strengthening the mental and emotional health of employees, for reducing the risk of development of negative personality changes, for developing skills of overcoming and regulating stressful conditions, for the successful fulfillment of professional duties. Key words: professional stress, stress factors, professional activity, penal system employees, penal system.

REMOTE WORK MANAGEMENT DURING A PANDEMIC

2018 ◽  
Author(s):  
Valentyn Kovshyk ◽  
◽  
Olha Yatsenko ◽  
Mykola Horbunov ◽  
◽  
...  
Keyword(s):  
Negative Impact ◽  
Legal Regulation ◽  
Personal Contact ◽  
Remote Work ◽  
Continuous Training ◽  
Work From Home ◽  
Methodical Approach ◽  
Management Functions ◽  
Structural Blocks ◽  
The Impact

For almost two years, humankind has been living in a coronavirus pandemic. It has gone from a complete misunderstanding of what to do and how to live and work to a step where informed and thoughtful decisions are already being made, and crisis management programs are being developed. The challenge for many was a new format of remote work, for which neither managers nor their subordinates were ready. The article considers the meaning of the term “telework” (“remote work”), the number of remote workers in the world before the pandemic, the peculiarities of the legal regulation of telework in Ukraine, and the number of people who were able to work from home after the introduction of quarantine in the country. The problems in management that complicate the transition to the remote format of work are analyzed. Authors list industries with a high and medium ability to work remotely; describe psychological aspects of unpreparedness for the transition to remote employment of managers and subordinates. Emphasis is placed on the availability of certain technical capabilities, as well as special knowledge, skills, and abilities to master tools for remote work, which highlights the need for continuous training of staff. It is noted that the classic management functions have also transformed: they take into account the prevention and leveling of the impact of negative factors associated with the pandemic. The key directions of managerial and organizational work during the pandemic are substantiated: ensuring the safety of workers, providing staff training, providing technical capabilities for remote work, and implementation of management functions. The general methodical approach and recommendations concerning the system of organizational measures having three structural blocks are presented: the general organizational measures; ensuring the safety of participants in bureaucratic procedures that require personal contact; providing technical capabilities for remote work. It is assumed that if the proposed measures are applied, enterprises and organizations will be able to increase their efficiency, operate in a crisis, and reduce the negative impact of the pandemic on workers.

scholarly journals Risk to Nonparticipants in HIV Remission Studies With Treatment Interruption: A Symposium

2019 ◽  
Vol 220 (Supplement_1) ◽  
pp. S1-S4 ◽  
Author(s):  
Nir Eyal ◽  
Steven G Deeks
Keyword(s):  
Human Subjects ◽  
Treatment Interruption ◽  
Sex Partners ◽  
Hiv Cure ◽  
Ethical Guidelines ◽  
Treatment Interruptions ◽  
Immunodeficiency Virus ◽  
Practical Challenge ◽  
Guidelines And Recommendations ◽  
Study Participants

AbstractEthical guidelines and recommendations for human subjects research typically focus on protecting the individuals who directly participate in that research. However, additional people, including sex partners of research participants, can also face harms and burdens from medical studies. In human immunodeficiency virus (HIV) cure–related research, a persistent ethical and practical challenge surrounds the use of analytical antiretroviral treatment interruptions. The challenge is usually discussed in relation to risks to study participants, but serious dangers accrue to nonparticipants, including sex partners of study participants. This multidisciplinary supplement relays the risks for nonparticipating sex partners in HIV cure–related studies and addresses the ethical dilemmas raised by these studies, with recommendations for researchers, advocates, sponsors, and oversight bodies.

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