scholarly journals A Program Evaluation of the Engagement of Participants in the AstraZeneca COVID-19 Vaccine Clinical Trial at Indiana University School of Medicine

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Cynthia Ziwawo ◽  
Sylk Sotto-Santiago

Background/Objective: Since the emergence of various COVID-19 vaccines, there have been a significant amount of members of historically marginalized populations that remain unvaccinated. Specifically, Black and Latino/x populations vaccine rates are consistently lower than their white counterparts not just in Indiana, but across the country. The recruitment of the AstraZeneca clinical trial for the COVID-19 vaccine that was hosted by Indiana University School of Medicine underscored this disparity. The drop off rates for Black and Latino/x participants between being screened for the study to ultimately being enrolled into the study became a cause for concern. The concept of vaccine hesitancy in these communities is a concept worth further exploration in order to determine the best strategies to improve health outcomes as we continue to mitigate the current pandemic. Methods: Interviews with the research assistants of the AstraZeneca clinical trial were conducted in order to identify the major causes of hesitancy and acceptance amongst the individuals that were screened and enrolled into the study. The questions explored the interactions with the participants, specifically for anecdotal evidence of the screened participants that ultimately did and did not participate in the study. Results: Despite the outpouring of Indiana residents that enrolled in the study, many chose not to participate due to unknown potential side effects of the vaccine, access to provider advise, trust, among others. Furthermore, the timeframe of the study was heavily impacted by the availability of the FDA approval of Pfizer’s vaccine, in which many participants chose to drop out for a guaranteed vaccine. Conclusion and Potential Impact: Identifying barriers to vaccine acceptance in marginalized communities will provide vital information for advancing public health efforts to increase vaccination rates. Additionally, implementing these strategies into vaccine clinical trials will allow for more equitable representation, and culturally competent scientific evidence.

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
S D'Amato ◽  
G F Pellicanò ◽  
C Genovese ◽  
F Mazzitelli ◽  
G Nunnari ◽  
...  

Abstract Background At the end of 2018 across the globe there are ∼37.9 million people with HIV/AIDS also thanks to the use of HAART which led to an increase in life expectancy. The Italy Immunization Plan 2017-19 recommend vaccines to these patients but a protocol still isn't present. Moreover, despite the availability of effective vaccines, coverage remained very low for many reasons including problems with privacy. The objectives of this study were a) the appliance of a shared clinical pathway between the “Immunization Center of Hospital Hygiene Operating Unit” and the “HIV/AIDS Disease Prevention, Diagnosis and Treatment Center of Infectious Diseases Operating Unit” b) the increase in vaccination coverage and the evaluation of side effects. Methods A prospective study was conducted from Oct 2019 to Feb 2020 at the G. Martino University Hospital of Messina. In particular, of the 138 patients followed by the Infectious Diseases OU, after evaluation of their immune status, 62% were enrolled in this study. Following the acquisition of informed consent, we collected socio-anagraphical data and we started the free administration of vaccines by providing an hoc calendar in the Immunization Center. Statistical analysis was performed with R software. Results The sample was represented by 86 patients (74% males and 26% females, 21% foreigners and 79% Italian, mean age=40±13.6 SD). We didn't observe drop out and no differences were observed for local/systemic AEs generally reported. We obtained an increase of vaccination coverage with a total of 74 doses administered for flu (+164%) and 240 for other vaccines (+172%). In particular, we immunized a total of 74% of patients for HPV (2% in 2018), 42% for HAV (28% in 2018), 37% for HBV (28% in 2018), 58% for pneumococcal (21% in 2018), 54% for meningococcal ACWY and B (0% in 2018). Conclusions The undertook clinical pathway showed the relevance of specific management of these patients and the need to increase the vaccination offer. Key messages The immunization in people living with HIV is priority to reduce the risk of infectious disease. It’s important to implement a shared clinical pathway to increase vaccination rates of these patients. The application of the protocol had an high impact in patients' adhesion to vaccination also thanks to the chance of accessing to the service in a comfortable setting and suitable to protect privacy.


2021 ◽  
pp. 030802262110002
Author(s):  
Joanne Inman ◽  
Katrina Bannigan ◽  
Jacqueline Akhurst

Introduction The dearth of clinical trials of individualised occupational therapy with people with a diagnosis of psychosis limits the evidence base globally for occupational therapy practice. This study evaluated the feasibility of conducting a pragmatic clinical trial. Method Mixed methods design using a pragmatic perspective; two-centre, one-group pretest-posttest study, at six months. POINTER Occupational Intervention Specification captured routine individualised occupational therapy. Process evaluation included recruitment, retention, intervention delivery, fidelity, adherence and outcome measurement. The primary outcome was participation in activities of everyday life, measured by Time Use Survey, Participation Scale and Utrecht Scale for Evaluation of Rehabilitation-Participation. The Canadian Occupational Performance Measure measured self-reported experience of and satisfaction with occupational performance. The Short Form-36v2 Health Survey measured health-related quality of life, a secondary outcome. Participants’ experiences were explored using a questionnaire. Intervention providers’ perspectives were investigated via the POINTER occupational intervention log and focus groups. Results Recruitment was (20/36) and drop-out 20% (4/20). Fidelity was 77%, and adherence was good; POINTER had validity and utility. Outcome measurement was acceptable to participants, indicating increased participation in activities of everyday life. Conclusion A larger clinical trial is merited; recruitment processes need further exploration, and outcome measurement needs refining.


2014 ◽  
Vol 72 (2) ◽  
pp. 152-156 ◽  
Author(s):  
Doralina Guimarães Brum ◽  
Elizabeth Regina Comini-Frota ◽  
Claúdia Cristina F. Vasconcelos ◽  
Elza Dias-Tosta

Multiple sclerosis (MS) is an inflammatory, autoimmune, demyelinating, and degenerative central nervous system disease. Even though the etiology of MS has not yet been fully elucidated, there is evidence that genetic and environmental factors interact to cause the disease. Among the main environmental factors studied, those more likely associated with MS include certain viruses, smoking, and hypovitaminosis D. This review aimed to determine whether there is evidence to recommend the use of vitamin D as monotherapy or as adjunct therapy in patients with MS. We searched PUBMED, EMBASE, COCHRANNE, and LILACS databases for studies published until September 9 th , 2013, using the keywords “multiple sclerosis”, “vitamin D”, and “clinical trial”. There is no scientific evidence up to the production of this consensus for the use of vitamin D as monotherapy for MS in clinical practice.


2021 ◽  
Vol 12 ◽  
Author(s):  
Daniel S. Courtney ◽  
Ana-Maria Bliuc

Following decreasing vaccination rates over the last two decades, understanding the roots of vaccine hesitancy has become a public health priority. Vaccine hesitancy is linked to scientifically unfounded fears around the MMR vaccine and autism which are often fuelled by misinformation spread on social media. To counteract the effects of misinformation about vaccines and in particular the falling vaccination rates, much research has focused on identifying the antecedents of vaccine hesitancy. As antecedents of vaccine hesitancy are contextually dependent, a one-size-fits-all approach is unlikely to be successful in non-WEIRD (Western, Educated, Industrialised, Rich, and Democratic) populations, and even in certain (non-typical) WEIRD sub-populations. Successful interventions to reduce vaccine hesitancy must be based on understanding of the specific context. To identify potential contextual differences in the antecedents of vaccine hesitancy, we review research from three non-WEIRD populations in East Asia, and three WEIRD sub-populations. We find that regardless of the context, mistrust seems to be the key factor leading to vaccine hesitancy. However, the object of mistrust varies across WEIRD and non-WEIRD populations, and across WEIRD subgroups suggesting that effective science communication must be mindful of these differences.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Kayleigh Beaveridge

Introduction: The anti-vaccination movement has led to decreased vaccination rates and increased vulnerability to vaccine-preventable diseases in the general population. In order to better understand the anti-vaccination movement of today, the anti-vaccination movement that emerged in the 19th century is examined and measured against the one observed in the 20th century. Discussion: Though the population of the 19th and 20th centuries differ in many regards and our knowledge of vaccine and immune mechanisms are far greater; the anti-vaccination movement seen today stands on the same pillars as that of the 1800s with the sentiment of fear at its core. Though the façade of these pillars has been altered to suit the world today, both movements exploited the influence of prominent public figures, maintained false associations with dire vaccine consequences and emphasized these through the use of visual media, repetition and personal narratives. The persistence of the anti-vaccination movement lies largely in the use of personal stories which are more impactful and memorable then the statistical characteristics of scientific study. Conclusion: The pro-vaccination movement must respond to the tactics used by the anti-vaccination movement and create accessible, understandable and equally impactful communication strategies in order to prevent the spread of misinformation and counter the efforts of the current anti-vaccination movement. Relevance: Vaccine hesitancy was listed amongst the top 10 global health threats in 2019 by the World Health Organization. In order to shift the negative rhetoric surrounding vaccines, the anti-vaccination movement of today and its historic roots need to be understood.


2021 ◽  
Author(s):  
Silvia Stringhini ◽  
María-Eugenia Zaballa ◽  
Nick Pullen ◽  
Javier Perez-Saez ◽  
Carlos de Mestral ◽  
...  

Background: Up-to-date seroprevalence estimates are critical to describe the SARS-CoV-2 immune landscape in the population and guide public health measures. We aimed to estimate the seroprevalence of anti-SARS-CoV-2 antibodies 15 months into the COVID-19 pandemic and six months into the vaccination campaign. Methods: We conducted a population-based cross-sectional serosurvey between June 1 and July 7, 2021, recruiting participants from age- and sex-stratified random samples of the general population. We tested participants for anti-SARS-CoV-2 antibodies targeting the spike (S) or nucleocapsid (N) proteins (Roche Elecsys immunoassays). We estimated the anti-SARS-CoV-2 antibodies seroprevalence following vaccination and/or infection (anti-S antibodies), or infection only (anti-N antibodies). Results: We included 3355 individuals, of which 1814 (54.1%) were women, 697 (20.8%) were aged <18 years and 449 (13.4%) were aged ≥65 years, 2161 (64.4%) tested positive for anti-S antibodies, and 906 (27.0%) tested positive for anti-N antibodies. The total seroprevalence of anti-SARS-CoV-2 antibodies was 66.1% (95% credible interval, 64.1-68.0). Considering the presence of anti-N antibodies, we estimated that 29.9% (28.0-31.9) of the population developed antibodies after infection; the rest having developed antibodies only via vaccination. Seroprevalence estimates were similar across sexes, but differed markedly across age groups, being lowest among children aged 0-5 years (20.8% [15.5-26.7]) and highest among older adults aged ≥75 years (93.1% [89.6-96.0]). Seroprevalence of antibodies developed via infection and/or vaccination was higher among participants with a higher educational level. Conclusions: Most adults have developed anti-SARS-CoV-2 antibodies, while most teenagers and children remain vulnerable to infection. As the SARS-CoV-2 Delta variant spreads and vaccination rates stagnate, efforts are needed to address vaccine hesitancy, particularly among younger individuals and socioeconomically disadvantaged groups, and to minimize spread among children.


2020 ◽  
Vol 95 (9S) ◽  
pp. S175-S179
Author(s):  
Bradley L. Allen ◽  
Maureen A. Harrington ◽  
Jennifer Schwartz ◽  
Paul Ko ◽  
Paul Wallach

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