Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study.

BACKGROUND: The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry network provides access to vaccine trial sites across the European region and supports a sustainable volunteer platform for identifying potential participants for forthcoming vaccine clinical research. OBJECTIVE: The aim of this study was to approach members of patient advocacy groups (PAGs) across Europe to assess their willingness to register for the VACCELERATE Volunteer Registry and their perspectives related to participating in vaccine trials. METHODS: In an effort to understand how to increase recruitment for the VACCELERATE Volunteer Registry, a standardized survey was developed in English and translated into 8 different languages (Dutch, English, French, German, Greek, Italian, Spanish, and Swedish) by the respective National Coordinator team. The online, anonymous survey was circulated, from March 2022 to May 2022, to PAGs across 10 European countries (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) to share with their members. The questionnaire constituted of multiple choice and open-ended questions evaluating information regarding participants' perceptions on participating in vaccine trials and their willingness to become involved in the VACCELERATE Volunteer Registry. RESULTS: In total, 520 responses were collected and analyzed. The PAG members reported that the principal criteria influencing their decision to participate in clinical trials overall are (1) the risks involved, (2) the benefits that will be gained from their potential participation, and (3) the quality and quantity of information provided regarding the trial. The survey revealed that, out of the 520 respondents, 133 individuals across all age groups were "positive" toward registering in the VACCELERATE Volunteer Registry, with an additional 47 individuals reporting being "very positive." Respondents from Northern European countries were 1.725 (95% CI 1.206-2.468) times more likely to be willing to participate in the VACCELERATE Volunteer Registry than respondents from Southern European countries. CONCLUSIONS: Factors discouraging participants from joining vaccine trial registries or clinical trials primarily include concerns of the safety of novel vaccines and a lack of trust in those involved in vaccine development. These outcomes aid in identifying issues and setbacks in present registries, providing the VACCELERATE network with feedback on how to potentially increase participation and enrollment in trials across Europe. Development of European health communication strategies among diverse public communities, especially via PAGs, is the key for increasing patients' willingness to participate in clinical studies.

Impact of age and comorbidities on SARS-CoV-2 vaccine-induced T cell immunity.

BACKGROUND: Older age and chronic disease are important risk factors for developing severe COVID-19. At population level, vaccine-induced immunity substantially reduces the risk of severe COVID-19 disease and hospitalization. However, the relative impact of humoral and cellular immunity on protection from breakthrough infection and severe disease is not fully understood. METHODS: In a study cohort of 655 primarily older study participants (median of 63 years (IQR: 51-72)), we determined serum levels of Spike IgG antibodies using a Multiantigen Serological Assay and quantified the frequency of SARS-CoV-2 Spike-specific CD4 + and CD8 + T cells using activation induced marker assay. This enabled characterization of suboptimal vaccine-induced cellular immunity. The risk factors of being a cellular hypo responder were assessed using logistic regression. Further follow-up of study participants allowed for an evaluation of the impact of T cell immunity on breakthrough infections. RESULTS: We show reduced serological immunity and frequency of CD4 + Spike-specific T cells in the oldest age group (≥75 years) and higher Charlson Comorbidity Index (CCI) categories. Male sex, age group ≥75 years, and CCI > 0 is associated with an increased likelihood of being a cellular hypo-responder while vaccine type is a significant risk factor. Assessing breakthrough infections, no protective effect of T cell immunity is identified. CONCLUSIONS: SARS-CoV-2 Spike-specific immune responses in both the cellular and serological compartment of the adaptive immune system increase with each vaccine dose and are progressively lower with older age and higher prevalence of comorbidities. The findings contribute to the understanding of the vaccine response in individuals with increased risk of severe COVID-19 disease and hospitalization.

Vaccination has proven very effective in protecting against severe disease and hospitalization of people with COVID-19, the disease caused by SARS-CoV-2. It is still unclear, however, how the different components of the immune system respond to SARS-CoV-2 vaccination and protect from infection and severe disease. Two of the most predominant components of the immune system are specialized proteins and cells. The proteins circulate in the blood and help clear the virus by binding to it, while the cells either kill the virus or help other cells to produce more antibodies. Here, we examined the response of these two components to the SARS-CoV-2 vaccine in 655 Danish citizens. The response of both components was lower in people over 75 years old and with other diseases. These findings help in understanding the immune responses following SARS-CoV-2 vaccination in people at increased risk of severe symptoms of COVID-19.

National medical specialty guidelines of HIV indicator conditions in Europe lack adequate HIV testing recommendations: a systematic guideline review.

BackgroundAdequate identification and testing of people at risk for HIV is fundamental for the HIV care continuum. A key strategy to improve timely testing is HIV indicator condition (IC) guided testing.AimTo evaluate the uptake of HIV testing recommendations in HIV IC-specific guidelines in European countries.MethodsBetween 2019 and 2021, European HIV experts reviewed guideline databases to identify all national guidelines of 62 HIV ICs. The proportion of HIV IC guidelines recommending HIV testing was reported, stratified by subgroup (HIV IC, country, eastern/western Europe, achievement of 90-90-90 goals and medical specialty).ResultsOf 30 invited European countries, 15 participated. A total of 791 HIV IC guidelines were identified: median 47 (IQR: 38-68) per country. Association with HIV was reported in 69% (545/791) of the guidelines, and 46% (366/791) recommended HIV testing, while 42% (101/242) of the AIDS-defining conditions recommended HIV testing. HIV testing recommendations were observed more frequently in guidelines in eastern (53%) than western (42%) European countries and in countries yet to achieve the 90-90-90 goals (52%) compared to those that had (38%). The medical specialties internal medicine, neurology/neurosurgery, ophthalmology, pulmonology and gynaecology/obstetrics had an HIV testing recommendation uptake below the 46% average. None of the 62 HIV ICs, countries or medical specialties had 100% accurate testing recommendation coverage in all their available HIV IC guidelines.ConclusionFewer than half the HIV IC guidelines recommended HIV testing. This signals an insufficient adoption of this recommendation in non-HIV specialty guidelines across Europe.

HIV seroprevalence in five key populations in Europe: a systematic literature review, 2009 to 2019.

BackgroundIn Europe, HIV disproportionately affects men who have sex with men (MSM), people who inject drugs (PWID), prisoners, sex workers, and transgender people. Epidemiological data are primarily available from national HIV case surveillance systems that rarely capture information on sex work, gender identity or imprisonment. Surveillance of HIV prevalence in key populations often occurs as independent studies with no established mechanism for collating such information at the European level.AimWe assessed HIV prevalence in MSM, PWID, prisoners, sex workers, and transgender people in the 30 European Union/European Economic Area countries and the United Kingdom.MethodsWe conducted a systematic literature review of peer-reviewed studies published during 2009-19, by searching PubMed, Embase and the Cochrane Library. Data are presented in forest plots by country, as simple prevalence or pooled across multiple studies.ResultsEighty-seven country- and population-specific studies were identified from 23 countries. The highest number of studies, and the largest variation in HIV prevalence, were identified for MSM, ranging from 2.4-29.0% (19 countries) and PWID, from 0.0-59.5% (13 countries). Prevalence ranged from 0.0-15.6% in prisoners (nine countries), 1.1-8.5% in sex workers (five countries) and was 10.9% in transgender people (one country). Individuals belonging to several key population groups had higher prevalence.ConclusionThis review demonstrates that HIV prevalence is highly diverse across population groups and countries. People belonging to multiple key population groups are particularly vulnerable; however, more studies are needed, particularly for sex workers, transgender people and people with multiple risks.

HIV testing in Europe: Evaluating the impact, added value, relevance and usability of the European Centre for Disease Prevention and Control (ECDC)'s 2010 HIV testing guidance.

BACKGROUND: An evaluation of the 2010 ECDC guidance on HIV testing, conducted in October 2015-January 2016, assessed its impact, added value, relevance and usability and the need for updated guidance. METHODS: Data sources were two surveys: one for the primary target audience (health policymakers and decision makers, national programme managers and ECDC official contact points in the European Union/European Economic Area (EU/EEA) countries and one for a broader target audience (clinicians, civil society organisations and international public health agencies); two moderated focus group discussions (17 participants each); webpage access data; a literature citation review; and an expert consultation (18 participants) to discuss the evaluation findings. RESULTS: Twenty-three of 28 primary target audience and 31 of 51 broader target audience respondents indicated the guidance was the most relevant when compared with other international guidance. Primary target audience respondents in 11 of 23 countries reported that they had used the guidance in development, monitoring and/or evaluation of their national HIV testing policy, guidelines, programme and/or strategy, and 29 of 51 of the broader target audience respondents reported having used the guidance in their work. Both the primary and broader target audience considered it important or very important to have an EU/EEA-level HIV testing guidance (23/28 and 46/51, respectively). CONCLUSION: The guidance has been widely used to develop policies, guidelines, programmes and strategies in the EU/EEA and should be regularly updated due to continuous developments in the field in order to continue to serve as an important reference guidance in the region.

[Case managers experience improved trajectories for cancer patients after implementation of the case manager function]. / Koordinatorerne oplever bedre forløb for kræftpatienter efter indførelsen af forløbskoordinationsfunktionen.

Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the func­tion and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been nar­rowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.

[Case managers experience improved trajectories for cancer patients after implementation of the case manager function].

Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the function and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been narrowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.

[Case study shows that the case manager function for cancer patients is used unevenly across the different cancer forms]. / Casestudie viser, at patienter med kræft benytter forløbskoordinatorfunktionen forskelligt

This case study of the obligatory case manager function for cancer patients explores by whom and for what the function is used. It draws on quantitative data from a database, focus group interviews with case managers at Rigshospitalet and telephone interviews with patients and relatives. The conclusion is that across the different cancer forms patients are using the function unevenly. This can probably be explained by the varying organizational set-ups for patient trajectories across departments. The individual patients and relatives express satisfaction with the information and assistance received from the case managers.

HIV/AIDS treatment and care in Estonia: evaluation report June 2014

This WHO country mission was performed in May 2014 to assess the achievements, strengths and shortcomings in the implementation of the Estonian national programme on HIV/AIDS treatment and care, and to generate strategic recommendations for improving key outcomes and impacts. The mission focused specifically on providing recommendations on the response of the health system to the many new HIV infections, on organization of procurement and provision of ART, and on improvement of prevention interventions. The mission found that HIV will remain a public health problem in the coming years in Estonia. This was echoed by all involved national stakeholders in the field. The epidemic is concentrated among people who inject drugs (PWID), but there are signs that it is increasingly affecting the general population. A worrying observation is the tendency that people with HIV are diagnosed late, that a large share starts treatment late; and there are many examples of non‐adherence to treatment or long‐term treatment interruptions. The problem of linkage and retention in care, particularly for the PWID population, needs urgent attention. The current health care system is not functioning to an extent that provides the PWID community with adequate treatment options and support. This needs to be addressed as high a priority in order to halt the HIV epidemic.

HIVi/AIDSi ravi ja hooldus Eestis: Hindamisaruanne Juuni 2014

WHO hindamisrühm hindas Eestis 2014. aasta mais HIVi ja AIDSi riikliku strateegia rakendamise edusamme, tugevaid ja nõrku külgi ning koostas strateegilised soovitused peamiste tulemuste ja mõju parandamiseks. Hindamisrühma peaeesmärk oli anda soovitusi, milliseid meetmeid peaks tervisesüsteem võtma seoses uute HIVi juhtude suure arvuga, kuidas korraldada ARV-ravimite hankimist ja ARV-ravi ning tõhustada ennetustööd. Hindamisrühm leidis, et HIV on Eestis lähiaastatel jätkuv rahvatervise probleem. Seda kinnitasid kõik valdkonnaga seotud sidusrühmad riigis. Epideemia on koondunud peamiselt süstivate narkomaanide hulka, kuid on märke, et see puudutab järjest rohkem kogu elanikkonda. Muret tekitab suundumus, et HIV diagnoositakse sageli hilises staadiumis, suur osa nakatunutest alustab ravi hilja ning paljudel juhtudel ei peeta ravirežiimist kinni või tehakse pikaajalises ravis katkestusi. Kiiresti vajab tähelepanu eriarsti poole pöördumise ja jälgimisel püsimise probleem, eriti süstivate narkomaanide puhul. Praegune tervisesüsteem ei toimi määral, mis tagaks süstivatele narkomaanidele sobivad ravivõimalused ja toe. HIVi epideemia peatamiseks peaks selle puuduse kõrvaldamine olema prioriteet.