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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: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: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.

Project description:BackgroundHuman papillomavirus (HPV) is the most widespread sexually transmitted infection worldwide. It causes several health consequences, in particular accounting for the majority of cervical cancer cases in women. In the United Kingdom, a vaccination campaign targeting 12-year-old girls started in 2008; this campaign has been successful, with high uptake and reduced HPV prevalence observed in vaccinated cohorts. Recently, attention has focused on vaccinating both sexes, due to HPV-related diseases in males (particularly for high-risk men who have sex with men) and an equity argument over equalising levels of protection.MethodsWe constructed an epidemiological model for HPV transmission in the UK, accounting for nine of the most common HPV strains. We complemented this with an economic model to determine the likely health outcomes (healthcare costs and quality-adjusted life years) for individuals from the epidemiological model. We then tested vaccination with the three HPV vaccines currently available, vaccinating either girls alone or both sexes. For each strategy we calculated the threshold price per vaccine dose, i.e. the maximum amount paid for the added health benefits of vaccination to be worth the cost of each vaccine dose. We calculated results at 3.5% discounting, and also 1.5%, to consider the long-term health effects of HPV infection.ResultsAt 3.5% discounting, continuing to vaccinate girls remains highly cost-effective compared to halting vaccination, with threshold dose prices of £56-£108. Vaccination of girls and boys is less cost-effective (£25-£53). Compared to vaccinating girls only, adding boys to the programme is not cost-effective, with negative threshold prices (-£6 to -£3) due to the costs of administration. All threshold prices increase when using 1.5% discounting, and adding boys becomes cost-effective (£36-£47). These results are contingent on the UK's high vaccine uptake; for lower uptake rates, adding boys (at the same uptake rate) becomes more cost effective.ConclusionsVaccinating girls is extremely cost-effective compared with no vaccination, vaccinating both sexes is less so. Adding boys to an already successful girls-only programme has a low cost-effectiveness, as males have high protection through herd immunity. If future health effects are weighted more heavily, threshold prices increase and vaccination becomes cost-effective.

Project description:The HPV vaccine was introduced to Malaysian national immunization programme in 2010. The current implementation age of HPV vaccination in Malaysian is at the age of 13 years school girls, given according to a 3 doses protocol which may complicate implementation and compliance. Aim of the study is to determine the cost-effectiveness of HPV vaccination regime comparing twice versus thrice HPV vaccinations dose regime among adolescent girls in Malaysia.A Markov cohort model reflecting the natural history of HPV infection accounting for oncogenic and low-risk HPV was adapted for 13 year old Malaysian girls cohort (n = 274,050). Transition probabilities, utilities values, epidemiological and cost data were sourced from published literature and local data. Vaccine effectiveness was based on overall efficacy reported from 3-doses clinical trials, with the assumption that the 2-doses is non-inferior to the 3-doses allowing overall efficacy to be inferred from the 3-doses immunogenicity data. Price parity and life-long protection were assumed. The payer perspective was adopted, with appropriate discounting for costs (3 %) and outcomes (3 %). One way sensitivity analysis was conducted. The sensitivity analysis on cost of vaccine, vaccine coverage and discount rate with a 2-doses protocol was performed.The 3-doses and 2-doses regimes showed same number of Cervical Cancers averted (361 cases); QALYs saved at 7,732,266. However, the lifetime protection under the 2-doses regime, showed a significant cost-savings of RM 36, 722,700 compared to the 3-doses scheme. The MOH Malaysia could vaccinate 137,025 more girls in this country using saving 2-doses regime vaccination programme. The model predicted that 2-doses HPV vaccination schemes can avoid additional 180 Cervical Cancers and 63 deaths compare to 3-doses.A 2-doses HPV vaccination scheme may enable Malaysian women to be protected at a lower cost than that achievable under a 3-doses scheme, while avoiding the same number of Cervical Cancer cases and deaths. Using the saving money with 2-doses, more Cervical Cancers and deaths can be avoided.

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.

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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