A protocol for a cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls

Background Uptake of the human papillomavirus (HPV) vaccine in the UK is good, but there are pockets of the community who remain unprotected. Immunisation teams usually require written parental consent for a girl to receive the vaccine. Evidence suggests that uptake of the vaccine might be improved by promoting consent form return (if returned, forms are likely to grant consent). Incentivising girls to return consent forms is a promising approach to promoting consent form return. Before testing the efficacy of an incentive intervention in a randomised controlled trial (RCT), we must first establish whether the RCT is feasible. In this randomised feasibility study, we aim to establish the feasibility of conducting a cluster RCT of an adolescent incentive intervention to increase uptake of HPV vaccination. Methods At least six schools will be randomised to either an incentive intervention arm or a standard invitation arm. Girls in standard invitation arm schools will receive the usual HPV vaccine programme invitation materials. Girls attending schools in the incentive intervention arm will receive the standard invitation and will also be told that they will receive an incentive if they return their consent form (regardless of whether consent is granted or denied). The incentive is being entered into a prize draw to win a retail voucher. Feasibility objectives include estimating the schools’ and parents’ willingness to participate in the study and be randomised; response rates to questionnaires; the extent of missing data; the girls’ and parents’ attitudes towards the incentive offered; school staff experiences of participating, fidelity to the trial procedures, data on any unintended consequences and the possible mechanisms of action, and proof-of-concept evidence of the effect of the intervention on consent form return rates and uptake of the vaccine. Analysis of feasibility outcomes will primarily be descriptive. Consent form return rates and uptake of the vaccine will be presented by trial arm without comparison. Discussion Incentivising HPV vaccine consent form return may promote HPV vaccine uptake. This study will provide the evidence needed to establish whether testing this incentive intervention using a RCT design in the future is feasible

Role of ethnicity in human papillomavirus vaccination uptake: a cross-sectional study of girls from ethnic minority groups attending London schools

OBJECTIVE: Research suggests that girls from ethnic minority groups are less likely to receive the human papillomavirus (HPV) vaccination than white British girls; however, the specific ethnic minority groups that have lower uptake have not been identified. This study aimed to examine the relationship between school-level uptake and ethnicity as well as uptake and other ethnicity-related factors, to understand which specific groups are less likely to receive the vaccination. METHODS: Aggregated uptake rates from 195 schools were obtained for each of the three recommended vaccine doses from 2008 to 2010. Census data at the lower super output area (LSOA) level for the postcode of each school were also obtained, describing the ethnic breakdown of the resident population (ethnicity, language spoken, religion, proficiency in English and duration of residency in the UK). These were used as proxy measures of the ethnic make-up of the schools. The most prevalent non-majority group for each ethnicity and ethnicity-related factor was assigned to each school. Analyses explored differences in uptake by ethnicity and ethnicity-related factors. RESULTS: No significant differences in vaccination uptake were found by ethnicity or ethnicity-related factors, although descriptive differences were apparent. Schools in areas where black ethnicities were the most prevalent non-white British ethnicities had consistently low rates of uptake for all doses. Schools in areas where some Asian ethnicities were the most prevalent non-white British ethnicities had consistently high rates of uptake for all doses. There was evidence of variability in mean uptake rates for ethnicities within ‘black’ and ‘Asian’ ethnic groups. CONCLUSIONS: Future research would benefit from focusing on specific ethnicities rather than broad ethnic categories. Replication of this study with a larger sample and using complete individual-level data, collected on a national level, would provide a clearer indication of where ethnic differences in HPV vaccination uptake exist

Information needs among women taking part in primary HPV screening in England: a content analysis

Objectives: Introducing primary human papillomavirus (HPV) testing to cervical screening programmes means changes to the results women receive. We explored additional information needs among women undergoing HPV primary screening. / Design: Women were sent a postal questionnaire shortly after receiving their results and 6 and 12 months later. Each questionnaire asked if women had any unanswered questions about cervical screening or HPV testing. Free-text responses constituted the data. Themes were identified using content analysis. / Setting: National Health Service (NHS) Cervical Screening Programme, England. / Participants: 381 women who recorded one or more free-text responses. / Results: The most common theme represented women’s emotional responses and attempts to understand their results. This theme was raised by 45% of women overall, but was as high as 59% in the HPV cleared group. General questions about the cause and epidemiology of HPV were raised by 38% of women and were more common among those testing HPV positive with normal cytology (52%). Questions about the purpose and procedure for HPV testing were most common among HPV-negative women (40%, compared with 16%–24% of the other results groups). Questions about future implications of test results were raised by 19% of women, and this theme was most common among those with persistent HPV. / Conclusions: Despite provision of information alongside screening invitations, women can still have unanswered questions following receipt of their results. Details about the epidemiology of HPV and why cervical screening procedures are changing should be included with screening invitations. Some results groups may benefit from additional tailored information with their results letter

Exploring Human Papillomavirus Vaccination Refusal Among Ethnic Minorities in England: A Comparative Qualitative Study.

OBJECTIVES: In England, uptake of human papillomavirus (HPV) vaccination to prevent HPV-related cancer is lower among girls from ethnic minority backgrounds. We aimed to explore the factors that prevented ethnic minority parents from vaccinating, compared to White British non-vaccinating parents and vaccinating ethnic minority parents. METHODS: Interviews with 33 parents (n = 14 ethnic minority non-vaccinating, n = 10 White British non-vaccinating, n = 9 ethnic minority vaccinating) explored parents' reasons for giving or withholding consent for HPV vaccination. Data were analysed using Framework Analysis. RESULTS: Concerns about the vaccine were raised by all non-vaccinating ethnic minority parents, and they wanted information to address these concerns. External and internal influences affected parents' decisions, as well as parents' perceptions that HPV could be prevented using means other than vaccination. Reasons were not always exclusive to non-vaccinating ethnic minority parents, although some were, including a preference for abstinence from sex before marriage. Only ethnic minority parents wanted information provided via workshops. CONCLUSIONS: Ethnic differences in HPV vaccination uptake may be partly explained by concerns that were only reported by parents from some ethnic groups. Interventions to improve uptake may need to tackle difficult topics like abstinence from sex before marriage, and use a targeted format

It’s hard to reach the "hard-to-reach": the challenges of recruiting people who do not access preventative healthcare services into interview studies

In this article, we discuss the challenges faced in recruiting “hard-to-reach” groups for interview studies, specifically those who do not access preventative healthcare services. We do this by reflecting on the varying success of different recruitment methods we have used in two recent studies; one investigating ethnic disparities in human papillomavirus vaccination uptake and another exploring difference in cervical screening non-participation. Engaging new community groups to help with recruitment proved particularly difficult, as did recruiting online. Our most successful recruitment methods included recruiting through community groups with whom we had previously established relationships, recruiting through schools and re-contacting participants who previously completed a related survey. We conclude that successful recruitment is dependent on study awareness and engagement. We urge others to be transparent in reporting recruitment methods in order to benefit the qualitative research community and suggest that details are published as supplementary material alongside qualitative articles in future

Memory and mood changes in pregnancy: a qualitative content analysis of women’s first-hand accounts

Objective: This qualitative study aimed to explore how pregnant women and new mothers self-report changes to their mood and memory during pregnancy. Background: Researchers have investigated the various changes that women report throughout their pregnancy. Despite this evidence base, there is a notable lack of studies that take a qualitative approach to understanding how pregnant women and women in the postpartum period experience memory and mood changes through their pregnancy. Method: The present study involved a qualitative content analysis of women’s first-hand accounts. Of the 423 participants who responded, 118 participants provided textual responses to questions about their memory and 288 participants provided textual responses to questions about their mood. Data were collected online via a free-text survey and analysed using both deductive inductive open coding. Results: A qualitative content analysis generated four overall categories: two typologies of self-reported memory changes in pregnancy (‘short-term memory lapses’ and ‘chronic memory fog’) and two typologies of self-reported mood changes (‘mood instability and constant change’ and ‘low mood and parenting anxiety’). Conclusion: These typologies represent unique profiles of the memory and mood changes that women experience during pregnancy and serve to accompany and expand the quantitative literature, which documents the changes women experience during pregnancy

Cognitive behavioural therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Dissociative seizures are paroxysmal events resembling epilepsy or syncope with characteristic features that allow them to be distinguished from other medical conditions. We aimed to compare the effectiveness of cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone for the reduction of dissociative seizure frequency. METHODS: In this pragmatic, parallel-arm, multicentre randomised controlled trial, we initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales. Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months were subsequently randomly assigned (1:1) from 17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system. Randomisation was stratified by neuropsychiatry or liaison psychiatry recruitment site. The trial manager, chief investigator, all treating clinicians, and patients were aware of treatment allocation, but outcome data collectors and trial statisticians were unaware of treatment allocation. Patients were followed up 6 months and 12 months after randomisation. The primary outcome was monthly dissociative seizure frequency (ie, frequency in the previous 4 weeks) assessed at 12 months. Secondary outcomes assessed at 12 months were: seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom in the previous 3 months; a greater than 50% reduction in seizure frequency relative to baseline; changes in dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction. p values and statistical significance for outcomes were reported without correction for multiple comparisons as per our protocol. Primary and secondary outcomes were assessed in the intention-to-treat population with multiple imputation for missing observations. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN05681227, and ClinicalTrials.gov, NCT02325544. FINDINGS: Between Jan 16, 2015, and May 31, 2017, we randomly assigned 368 patients to receive CBT plus standardised medical care (n=186) or standardised medical care alone (n=182); of whom 313 had primary outcome data at 12 months (156 [84%] of 186 patients in the CBT plus standardised medical care group and 157 [86%] of 182 patients in the standardised medical care group). At 12 months, no significant difference in monthly dissociative seizure frequency was identified between the groups (median 4 seizures [IQR 0-20] in the CBT plus standardised medical care group vs 7 seizures [1-35] in the standardised medical care group; estimated incidence rate ratio [IRR] 0·78 [95% CI 0·56-1·09]; p=0·144). Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53 [95% CI -0·97 to -0·08]; p=0·020). The CBT plus standardised medical care group had a longer period of dissociative seizure freedom in the previous 6 months (estimated IRR 1·64 [95% CI 1·22 to 2·20]; p=0·001), reported better health-related quality of life on the EuroQoL-5 Dimensions-5 Level Health Today visual analogue scale (estimated mean difference 6·16 [95% CI 1·48 to 10·84]; p=0·010), less impairment in psychosocial functioning on the Work and Social Adjustment Scale (estimated mean difference -4·12 [95% CI -6·35 to -1·89]; p<0·001), less overall psychological distress than the standardised medical care group on the Clinical Outcomes in Routine Evaluation-10 scale (estimated mean difference -1·65 [95% CI -2·96 to -0·35]; p=0·013), and fewer somatic symptoms on the modified Patient Health Questionnaire-15 scale (estimated mean difference -1·67 [95% CI -2·90 to -0·44]; p=0·008). Clinical improvement at 12 months was greater in the CBT plus standardised medical care group than the standardised medical care alone group as reported by patients (estimated mean difference 0·66 [95% CI 0·26 to 1·04]; p=0·001) and by clinicians (estimated mean difference 0·47 [95% CI 0·21 to 0·73]; p<0·001), and the CBT plus standardised medical care group had greater satisfaction with treatment than did the standardised medical care group (estimated mean difference 0·90 [95% CI 0·48 to 1·31]; p<0·001). No significant differences in patient-reported seizure severity (estimated mean difference -0·11 [95% CI -0·50 to 0·29]; p=0·593) or seizure freedom in the last 3 months of the study (estimated odds ratio [OR] 1·77 [95% CI 0·93 to 3·37]; p=0·083) were identified between the groups. Furthermore, no significant differences were identified in the proportion of patients who had a more than 50% reduction in dissociative seizure frequency compared with baseline (OR 1·27 [95% CI 0·80 to 2·02]; p=0·313). Additionally, the 12-item Short Form survey-version 2 scores (estimated mean difference for the Physical Component Summary score 1·78 [95% CI -0·37 to 3·92]; p=0·105; estimated mean difference for the Mental Component Summary score 2·22 [95% CI -0·30 to 4·75]; p=0·084), the Generalised Anxiety Disorder-7 scale score (estimated mean difference -1·09 [95% CI -2·27 to 0·09]; p=0·069), and the Patient Health Questionnaire-9 scale depression score (estimated mean difference -1·10 [95% CI -2·41 to 0·21]; p=0·099) did not differ significantly between groups. Changes in dissociative seizures (rated by others) could not be assessed due to insufficient data. During the 12-month period, the number of adverse events was similar between the groups: 57 (31%) of 186 participants in the CBT plus standardised medical care group reported 97 adverse events and 53 (29%) of 182 participants in the standardised medical care group reported 79 adverse events. INTERPRETATION: CBT plus standardised medical care had no statistically significant advantage compared with standardised medical care alone for the reduction of monthly seizures. However, improvements were observed in a number of clinically relevant secondary outcomes following CBT plus standardised medical care when compared with standardised medical care alone. Thus, adults with dissociative seizures might benefit from the addition of dissociative seizure-specific CBT to specialist care from neurologists and psychiatrists. Future work is needed to identify patients who would benefit most from a dissociative seizure-specific CBT approach. FUNDING: National Institute for Health Research, Health Technology Assessment programme

A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination.

BACKGROUND: Uptake of human papillomavirus (HPV) vaccination is suboptimal among some groups. We aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) of incentives to improve HPV vaccination uptake by increasing consent form return. METHODS: An equal-allocation, two-arm cluster RCT design was used. We invited 60 London schools to participate. Those agreeing were randomised to either a standard invitation or incentive intervention arm, in which Year 8 girls had the chance to win a £50 shopping voucher if they returned a vaccination consent form, regardless of whether consent was provided. We collected data on school and parent participation rates and questionnaire response rates. Analyses were descriptive. RESULTS: Six schools completed the trial and only 3% of parents opted out. The response rate was 70% for the girls' questionnaire and 17% for the parents'. In the intervention arm, 87% of girls returned a consent form compared with 67% in the standard invitation arm. The proportion of girls whose parents gave consent for vaccination was higher in the intervention arm (76%) than the standard invitation arm (61%). CONCLUSIONS: An RCT of an incentive intervention is feasible. The intervention may improve vaccination uptake but a fully powered RCT is needed.British Journal of Cancer advance online publication: 22 August 2017; doi:10.1038/bjc.2017.284 www.bjcancer.com