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Does electronic consent improve the logistics and uptake of HPV vaccination in adolescent girls? A mixed-methods theory informed evaluation of a pilot intervention.

ABSTRACT: OBJECTIVES:To evaluate the usability and acceptability of an electronic consent pilot intervention for school-based immunisations and assess its impact on consent form returns and human papilloma virus (HPV) vaccine uptake. DESIGN:Mixed-methods theory-informed study applying qualitative methods to examine the usability and acceptability of the intervention and quantitative methods to assess its impact. SETTING AND PARTICIPANTS:The intervention was piloted in 14 secondary schools in seven London boroughs in 2018. Intervention schools were matched with schools using paper consent based on the proportion of students with English as a second language and students receiving free school meals. Participants included nurses, data managers, school-link staff, parents and adolescents. INTERVENTIONS:An electronic consent portal where parents could record whether they agreed to or declined vaccination, and nurses could access data to help them manage the immunisation programme. PRIMARY AND SECONDARY OUTCOME MEASURES:Comparison of consent form return rates and HPV vaccine uptake between intervention and matched schools. RESULTS:HPV vaccination uptake did not differ between intervention and matched schools, but timely consent form return was significantly lower in intervention schools (73.3% vs 91.6%, p=0.008). The transition to using electronic consent was not straightforward, while schools and staff understood the potential benefits, they found it difficult to adapt to new ways of working which removed some level of control from schools. Reasons for lower consent form return in e-consent schools included difficulties encountered by some parents in accessing and using the intervention. Adolescents highlighted the potential for electronic consent to by-pass their information needs. CONCLUSIONS:The pilot intervention did not improve consent form return or vaccine uptake due to challenges encountered in transitioning to new working practice. New technologies require embedding before they become incorporated in everyday practice. A re-evaluation once stakeholders are accustomed with electronic consent may be required to understand its impact.

SUBMITTER: Chantler T

PROVIDER: S-EPMC7640514 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Does electronic consent improve the logistics and uptake of HPV vaccination in adolescent girls? A mixed-methods theory informed evaluation of a pilot intervention.

Chantler Tracey T Pringle Ellen E Bell Sadie S Cooper Rosie R Edmundson Emily E Nielsen Heidi H Roberts Sheila S Edelstein Michael M Mounier-Jack Sandra S

BMJ open 20201103 11

<h4>Objectives</h4>To evaluate the usability and acceptability of an electronic consent pilot intervention for school-based immunisations and assess its impact on consent form returns and human papilloma virus (HPV) vaccine uptake.<h4>Design</h4>Mixed-methods theory-informed study applying qualitative methods to examine the usability and acceptability of the intervention and quantitative methods to assess its impact.<h4>Setting and participants</h4>The intervention was piloted in 14 secondary sc ...[more]

PMID: 33148741

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Project description:BackgroundThe development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.MethodsUsing a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants' views and concerns were solicited. Thematic analysis was undertaken using NVivo.ResultsThe majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders' access to an eIC system, and thus, to participants' personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants' understanding before providing their eIC.ConclusionsFollowing a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants' motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.

Project description:The present study is aimed at assessing the feasibility of delivering the HPV (human papillomavirus) vaccine to girls through a school-based program in Hong Kong, as well as to examine the facilitators and barriers associated with their participation. We approached 1,229 eligible girls aged 9 to 14 at eight schools in Hong Kong to join the program and then delivered the bivalent HPV vaccine at 0 and 6 months over the course of one school year. The students and their parents completed separate questionnaires to indicate their decision on whether or not to participate, and to assess their knowledge of cervical cancer and the HPV vaccine. The overall vaccine uptake was 81.4% (1,000/1,229) for the first dose and 80.8% (993/1,229) for the second dose. Parents and students were given separate questionnaires and asked whether or not they would like to participate in the vaccination program. 87.1% (1,010/1,160) of parents and 84.9% (974/1,147) of students indicated that they would join the program. The reasons associated with parents' decision not to vaccinate their daughters primarily included concerns around side effects and safety. Multivariate regression analysis showed that parents who thought that the vaccine would protect their daughter from getting cervical cancer (OR = 3.16, 95% CI = 1.39-7.15, p < .01), and those who reported having a doctor's recommendation (OR = 4.54, 95% CI = 1.05-19.57, p < .05) were more likely to join the program. In contrast, parents who had never heard of the vaccine (OR = .15, 95% CI = .03-.71, p < .02), those who were willing to pay more than HK$2,000 for the vaccine (OR = .39, 95% CI = .19-.81, p < .05), or had a preference to access it through a private clinic (OR = .44, 95% CI = .26-.75, p < .01) were significantly less likely to allow their daughter to join the program. Delivery of the HPV vaccine with high uptake rate in a school setting is feasible in Hong Kong. Engaging key stakeholders including school administrators, teachers and community physicians, and providing relevant information on safety and vaccine effectiveness to parents were important to the success of the program.

Project description:BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

Project description:BackgroundHuman papillomavirus (HPV) vaccination targets high-risk HPV16/18 that cause 70% of all cancers of the cervix. In Australia there is a fully-funded, school-based National HPV Vaccination Program which has achieved vaccine initiation rate of 82% among age-eligible females. Improving HPV vaccination rates is important in the prevention of morbidity and mortality associated with HPV-related disease. This study aimed to identify factors and barriers associated with uptake of the HPV vaccine in the Australian Program.MethodsBetween 2011 and 2014, females aged 18-25 years, living in Victoria, Australia who were offered HPV vaccination between 2007 and 2009 as part of the National HPV Vaccination Program, living in Victoria, Australia were recruited into a a young women's study examining effectiveness of the Australian National HPV Vaccination Program. Overall, 668 participants completed the recruitment survey, which collected data of participants' demographics and HPV knowledge. In 2015 these participants were invited to complete an additional supplementary survey on parental demographics and attitudes towards vaccinations.ResultsIn 2015, 417 participants completed the supplementary survey (62% response rate). Overall, 19% of participants were unvaccinated. In multivariate analyses, HPV vaccination was significantly associated with their being born in Australia (p<0.001), having completed childhood vaccinations (p<0.001) and their parents being main decision-makers for participants' HPV vaccination (p<0.001). The main reason reported for HPV non-vaccination was parental concern about vaccine safety (43%). Compared with HPV-vaccinated participants, those unvaccinated were significantly more likely to be opposed to all vaccines, including HPV vaccines (p<0.001) and were less likely to consider vaccinating their own children with all vaccines (p = 0.033), including HPV vaccines (p<0.001). Overall, 61% of unvaccinated participants reported that a recommendation from GPs would increase HPV vaccine acceptance.ConclusionsAttitudes towards general health, vaccinations in general, as well as HPV vaccines are important in HPV vaccine uptake. Long-term monitoring of the knowledge, attitude and beliefs towards HPV vaccination in the community is critical to ensure a continued high uptake of the vaccine and success of the program.

Project description:BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.MethodsSemi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.ResultsInterviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.ConclusionsInterviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.

Project description:BackgroundInformed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.ObjectiveWe aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.MethodsWe conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.ResultsA total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.ConclusionsElectronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979.

Project description:IntroductionWHO recommends vaccination against HPV for girls before sexual debut. Uganda started HPV vaccination in 2008 as pilot programs in 2 districts, followed by national roll out in 2015. Despite the availability of vaccines against human papillomavirus (HPV) in Uganda in the period covered by the study, there was reported low HPV vaccine uptake and completion especially of the second dose in Uganda; with little information available on timely completion of HPV vaccine and the associated factors in Uganda. This study was therefore done to determine the HPV vaccine dose 2 completion and describe the possible factors associated with timely HPV vaccine completion and non-completion among girls of age 9-14 years attending the adolescent clinic at Mulago hospital.MethodsA retrospective mixed methods study was conducted in Mulago National Referral hospital adolescent clinic. Data were mainly collected through review of charts and folders for clinic attendance by eligible girls and focus group discussions with eligible girls that completed the 2 doses of HPV vaccine on recommended/scheduled time.ResultsOut of the 201 girls studied, 87 girls (43.3%) had timely completion of the HPV vaccination. Knowledge about HPV infection and HPV vaccine benefits, positive peer influence and healthcare worker recommendation to get vaccinated at health facility level positively influenced timely completion of HPV vaccine. Among barriers to completion of HPV vaccine identified were: inadequate information about HPV infection and HPV vaccine, concerns about HPV vaccine efficacy and safety, unclear communication with adolescents/caregivers from healthcare workers and -stock out of the HPV vaccine.ConclusionTimely completion of the second dose of HPV vaccine among girls attending the adolescent clinic of Mulago hospital was low (at 43.3%) but higher when compared to earlier published reports. Interventions around improved social mobilization, enhanced outreach and static vaccination approach and education of eligible girls on HPV vaccination can help increase vaccine uptake.

Dataset Information

Does electronic consent improve the logistics and uptake of HPV vaccination in adolescent girls? A mixed-methods theory informed evaluation of a pilot intervention.

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Does electronic consent improve the logistics and uptake of HPV vaccination in adolescent girls? A mixed-methods theory informed evaluation of a pilot intervention.

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