A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination.
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ABSTRACT:
SUBMITTER: Forster AS
PROVIDER: S-EPMC5674104 | biostudies-literature | 2017 Oct
REPOSITORIES: biostudies-literature
Publications
A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination.
Forster Alice S AS Cornelius Victoria V Rockliffe Lauren L Marlow Laura Av LA Bedford Helen H Waller Jo J
British journal of cancer 20170822 8
<h4>Background</h4>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.<h4>Methods</h4>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 whic ...[more]
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Project description:BackgroundMost adolescent girls in the UK do not meet government physical activity recommendations and effective interventions are needed. This study reports the results of a feasibility trial of PLAN-A, a novel school-based peer-led physical activity intervention for adolescent girls.MethodsA two-arm cluster randomised controlled feasibility study was conducted in six English secondary schools (4 intervention & 2 control). Year 8 (age 12-13) girls were eligible and randomisation was at school-level. The intervention involved training Year 8 girls (out of school for two consecutive days, plus one top-up day 5 weeks later), who were identified by their peers as influential, to provide informal support to their friends to increase their physical activity. Feasibility of the intervention and the research was examined, including: recruitment, training attendance and data provision rates, evidence of promise of the intervention to affect weekday moderate-to-vigorous physical activity (MVPA), intervention cost and estimation of the sample size for a definitive trial. Accelerometer and questionnaire data were collected at the beginning of Year 8 (Time 0), the end of Year 8 (10-weeks after peer-supporter training) and the beginning of Year 9 (Time 2).ResultsFour hundred twenty-seven girls were recruited (95% recruitment rate). 55 girls consented to be a peer-supporter and 53 peer-supporters were trained (97% of those invited). Accelerometer return rates exceeded 85% at each time point and wear time criteria was met by 83%, 71% and 62% participants at Time 0, 1 and 2 respectively. Questionnaire data were provided by >91% of participants at each time point. Complete-case adjusted linear regression analysis showed evidence of a 6.09 minute (95% CI = 1.43, 10.76) between-arms difference in weekday MVPA at Time 2 in favour of the intervention arm. On average PLAN-A cost £2685 per school to deliver (£37 per Year 8 girl). There were no adverse events. A trial involving 20 schools would be adequately powered to detect a between-arms difference in weekday MVPA of at least six minutes.ConclusionsThe PLAN-A intervention adopts a novel peer-led approach, is feasible, and shows evidence of promise to positively affect girls' physical activity levels. A definitive trial is warranted.Trial registrationISCTRN, ISRCTN12543546, Registered on 28/7/2015, URL of registry record: http://www.isrctn.com/ISRCTN12543546.
| S-EPMC5992776 | biostudies-literature
Project description:Background:In Great Britain, 19% of trips to primary school within 1 mile, and 62% within 1-2 miles, are by car. Active travel to school (ATS) offers a potential source of moderate-to-vigorous physical activity (MVPA). This study tested the feasibility of an intervention to promote ATS in 9-10 year olds and associated trial procedures. Methods:A parallel cluster randomised pilot trial was conducted over 9 weeks in two schools from a low-income area in northeast England. Measures included daily parental ATS reports (optionally by SMS) and child ATS reports, as well as accelerometry (ActiGraph GT3X+). At baseline, all children were asked to wear the accelerometer for the same week; in the post-randomisation phase, small subsamples were monitored each week. In the 2 weeks when a child wore the accelerometer, parents also reported the start and finish times of the journey to school. The intervention consisted of a lottery-based incentive scheme; every ATS day reported by the parent, whether by paper or SMS, corresponded to one ticket entered into a weekly £5 voucher draw. Before each draw session, the researcher prepared the tickets and placed them into an opaque bag, from which one was randomly picked by the teacher at the draw session. Results:Four schools replied positively (3.3%, N = 123) and 29 participants were recruited in the two schools selected (33.0%, N = 88). Participant retention was 93.1%. Most materials were returned on time: accelerometers (81.9%), parental reports (82.1%) and child reports (97.9%). Draw sessions lasted on average 15.9 min (IQR 10-20) and overall session attendance was 94.5%. Parent-child report agreement regarding ATS was moderate (k = 0.53, CI 95% 0.45; 0.60). Differences in minutes of accelerometer-assessed MVPA between parent-reported ATS and non-ATS trips were assessed during two timeframes: during the journey to school based on the times reported by the parent (U = 390.5, p < 0.05, 2.46 (n = 99) vs 0.76 (n = 13)) and in the hour before classes (U = 665.5, p < 0.05, 4.99 (n = 104) vs 2.55 (n = 19)). Differences in MVPA minutes between child-reported ATS and non-ATS trips were also significant for each of the timeframes considered (U = 596.5, p < 0.05, 2.40 (n = 128) vs 0.81 (n = 15) and U = 955.0, p < 0.05, 4.99 (n = 146) vs 2.59 (n = 20), respectively). Conclusions:Data suggest the feasibility of an ATS incentive scheme and of most trial procedures. School recruitment stood out as requiring further piloting. Trial registration:ClinicalTrials.gov: NCT02282631. Registered 5th September 2014.
| S-EPMC5686940 | biostudies-literature
Project description:Background:Diabetic retinopathy screening (DRS) leads to the earlier detection of retinopathy and treatment that can prevent or delay the development of diabetes-related blindness. However, uptake continues to be sub-optimal in many countries, including Ireland. Routine management of type 2 diabetes largely takes place in primary care. As such, there may be an opportunity in primary care to introduce interventions to improve DRS uptake. However, few studies test the feasibility of interventions to enhance DRS uptake in this context. Our aim is to investigate the feasibility of an implementation intervention (IDEAs (Improving Diabetes Eye screening Attendance)) delivered in general practice to improve the uptake of the national DRS programme, RetinaScreen. Methods:The IDEAs study is a cluster randomised pilot trial with an embedded process evaluation and economic evaluation. Following stratification by practice size, eight general practices (clusters) will be randomly allocated to intervention (n = 4) or wait-list control groups (n = 4). The intervention will be delivered for 6?months, after which, it will be administered to wait-list control practices. The intervention is multi-faceted and comprises provider-level components (training, audit and feedback, health care professional prompt, reimbursement) and patient-level components (GP-endorsed reminder with information leaflet delivered opportunistically face-to-face, and systematically by phone and letter). Patient inclusion criteria are type 1 or type 2 diabetes and DRS programme non-attendance. A multi-method approach will be used to determine screening uptake, evaluate the trial and study procedures and examine the acceptability and feasibility of the intervention from staff and patient perspectives. Quantitative and qualitative data will be collected on intervention uptake and delivery, research processes and outcomes. Data will be collected at the practice, health professional and patient level. A partial economic evaluation will be conducted to estimate the cost of delivering the implementation intervention in general practice. Formal continuation criteria will be used to determine whether IDEAs should progress to a definitive trial. Discussion:Findings will determine whether IDEAsis feasible and acceptable and will be used to refine the intervention and study procedures. A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness. Trial registration:ClinicalTrials.gov NCT03901898. Registered 3rd April 2019.
| S-EPMC7216495 | biostudies-literature
Project description:ObjectivesTo 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.DesignMixed-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 participantsThe 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.InterventionsAn 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 measuresComparison of consent form return rates and HPV vaccine uptake between intervention and matched schools.ResultsHPV 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.ConclusionsThe 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.
| S-EPMC7640514 | biostudies-literature
Project description:BackgroundCare home (CH) residents are mainly inactive, leading to increased dependency and low mood. Strategies to improve activity are required.Design and settingCluster randomised controlled feasibility trial with embedded process and health economic evaluations. Twelve residential CHs in Yorkshire, United Kingdom, were randomised to the MoveMore intervention plus usual care (UC) (n = 5) or UC only (n = 7).ParticipantsPermanent residents aged ≥65 years.InterventionMoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents.Objectives and measurementsFeasibility objectives relating to recruitment, intervention delivery, data collection and follow-up and safety concerns informed the feasibility of progression to a definitive trial. Data collection at baseline, 3, 6 and 9 months included: participants' physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation.Results300 residents were screened; 153 were registered (62 MoveMore; 91 UC). Average cluster size: MoveMore: 12.4 CHs; UC: 13.0 CHs. There were no CH/resident withdrawals. Forty (26.1%) participants were unavailable for follow-up: 28 died (12 MoveMore; 16 UC); 12 moved from the CH. Staff informant/proxy data collection for participants was >80%; data collection from participants was <75%; at 9 months, 65.6% of residents provided valid accelerometer data; two CHs fully, two partially and one failed to implement the intervention. There were no safety concerns.ConclusionsRecruiting CHs and residents was feasible. Intervention implementation and data collection methods need refinement before a definitive trial. There were no safety concerns.
| S-EPMC8581372 | biostudies-literature
Project description:ObjectivesChildren in China have low levels of physical activity. We developed a school-based behaviour change intervention to increase their physical activity levels. The study aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) in the future. This future cluster RCT will evaluate the effectiveness of the intervention.DesignFeasibility cluster non-RCT design.SettingTwo public schools (one intervention and one control) in Yangzhou, China.ParticipantsChildren aged 10-12 years and their parents.InterventionThe 16-week school-based behaviour change intervention to increase physical activity levels consisted of three components (a) health education (physical education), (b) family involvement and (c) school environment support.Outcomes measuresWe estimated important parameters that are needed to design the future cluster RCT, such as SD of the primary outcome (ie, 7-day steps in children), intracluster correlation coefficient (ICC), recruitment of child-parent dyads, follow-up of children, completion of and time needed for data collection among children and intervention attendance.ResultsSixty-four children and their parents participated in the study (32 per study group). The SD of the primary outcome was 34 519 steps. The ICC was 0.03. The recruitment and follow-up rates were 100%. The completion of data collection was 100% (except for the 7-day steps at baseline-one child lost the step log in the intervention group and two children lost their pedometer in the control group). The time needed to complete the self-reported questionnaire by children was around 15 min per study group, and the measurement of their anthropometric parameters took around 40 min per study group. The intervention attendance was 100%.ConclusionsBased on the promising recruitment, follow-up, completion of and time needed for data collection and intervention attendance, it would be feasible to undertake the future cluster RCT in China.Trial registration numberChiCTR1900026865.
| S-EPMC8557291 | biostudies-literature
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.
| S-EPMC5854366 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness and cost effectiveness of a complex intervention in primary care that aims to increase uptake of hepatitis C virus (HCV) case finding and treatment.DesignPragmatic, two armed, practice level, cluster randomised controlled trial and economic evaluation.Setting and participants45 general practices in South West England (22 randomised to intervention and 23 to control arm). Outcome data were collected from all intervention practices and 21/23 control practices. Total number of flagged patients was 24 473 (about 5% of practice list).InterventionElectronic algorithm and flag on practice systems identifying patients with HCV risk markers (such as history of opioid dependence or HCV tests with no evidence of referral to hepatology), staff educational training in HCV, and practice posters/leaflets to increase patients' awareness. Flagged patients were invited by letter for an HCV test (with one follow-up) and had on-screen pop-ups to encourage opportunistic testing. The intervention lasted one year, with practices recruited April to December 2016.Main outcome measuresPrimary outcome: uptake of HCV testing.Secondary outcomesnumber of positive HCV tests and yield (proportion HCV positive); HCV treatment assessment at hepatology; cost effectiveness.ResultsBaseline HCV testing of flagged patients (six months before study start) was 608/13 097 (4.6%) in intervention practices and 380/11 376 (3.3%) in control practices. During the study 2071 (16%) of flagged patients in the intervention practices and 1163 (10%) in control practices were tested for HCV: overall intervention effect as an adjusted rate ratio of 1.59 (95% confidence interval 1.21 to 2.08; P<0.001). HCV antibodies were detected in 129 patients from intervention practices and 51 patients from control practices (adjusted rate ratio 2.24, 1.47 to 3.42) with weak evidence of an increase in yield (6.2% v 4.4%; adjusted risk ratio 1.40, 0.99 to 1.95). Referral and assessment increased in intervention practices compared with control practices (adjusted rate ratio 5.78, 1.6 to 21.6) with a risk difference of 1.3 per 1000 and a "number needed to help" of one extra HCV diagnosis, referral, and assessment per 792 (95% confidence interval 558 to 1883) patients flagged. The average cost of HCV case finding was £4.03 (95% confidence interval £2.27 to £5.80) per at risk patient and £3165 per additional patient assessed at hepatology. The incremental cost effectiveness ratio was £6212 per quality adjusted life year (QALY), with 92.5% probability of being below £20 000 per QALY.ConclusionHepCATT had a modest impact but is a low cost intervention that merits optimisation and implementation as part of an NHS strategy to increase HCV testing and treatment.Trial registrationISRCTN61788850.
| S-EPMC7190058 | biostudies-literature
Project description:ObjectiveUptake of meningococcal vaccine (MCV) and tetanus, diphtheria and pertussis (Tdap) vaccine among adolescents has approached Healthy People 2020 goals, but human papillomavirus (HPV) vaccination has not. This study evaluated an intervention using the 4 Pillars™ Practice Transformation Program to increase HPV, MCV and Tdap uptake among adolescents in primary care practices.MethodsPractices with at least 50 patients 11-17years old with estimated vaccination rates less than national goals, were assigned to intervention (n=11) and control (n=11) groups in a randomized controlled cluster trial; 9 intervention and 11 control sites completed the study. The baseline and active study periods were 7/1/2013-6/30/2014 and 7/1/2014-3/31/2015, respectively. Vaccination and demographic data for patients who had a visit in both study periods were derived from de-identified EMR extractions. Primary outcomes were vaccination rates and percentage point (PP) changes. Data were analyzed in 2015-16.ResultsAmong the cohort of 10,861 adolescent patients, 38% were 11-13years old; 50% were female; 18% were non-white; and 64% were commercially insured. Average baseline HPV initiation rates were 52.5% for intervention and 61.8% for control groups. After 9months, the intervention sites increased HPV initiation 10.2PP compared with 7.3PP in control sites (P<0.001); HPV series completion rates did not differ between groups. Implementation of >10 strategies to improve rates significantly increased the likelihood of HPV series initiation (OR=2.06, 95% CI=1.43, 2.96).ConclusionsUsing >10 strategies from the 4 Pillars™ Practice Transformation Program is effective for increasing HPV series initiation among adolescents. Clinical trial registry number: NCT02165722.
| S-EPMC5836294 | biostudies-literature
Project description:BackgroundSecondary education and delayed marriage provide long-term socio-economic and health benefits to adolescent girls. We tested whether a structural and norms-based intervention, which worked with adolescent girls, their families, communities, and secondary schools to address poverty, schooling quality and gender norms, could reduce secondary school drop-out and child marriage among scheduled-caste/scheduled-tribe (SC/ST) adolescent girls in rural settings of southern India.Methods80 of 121 villages in Vijayapura and Bagalkote districts, Karnataka State, were randomly selected (control = 40; intervention = 40). All 12-13 year-old SC/ST girls in final year of primary school (standard 7th) were enrolled and followed for 3 years (2014-2017) until the end of secondary school (standard 10th). Primary trial outcomes were proportion of girls who completed secondary school and were married, by trial end-line (15-16 years). Analyses were intention-to-treat and used individual-level girl data.Results92.6% (2275/2457) girls at baseline and 72.8% (1788/2457) at end-line were interviewed. At end-line, one-fourth had not completed secondary school (control = 24.9%; intervention = 25.4%), and one in ten reported being married (control = 9.6%; intervention = 10.1%). These were lower than expected based on district-level data available before the trial, with no difference between these, or other schooling or sexual and reproductive outcomes, by trial arm. There was a small but significant increase in secondary school entry (adjusted odds ratio AOR = 3.58, 95% confidence interval CI = 1.36-9.44) and completion (AOR=1.54, 95%CI = 1.02-2.34) in Vijayapura district. The sensitivity and attrition analyses did not impact the overall result indicating that attrition of girls at end-line was random without much bearing on overall result.ConclusionsSamata intervention had no overall impact, however, it added value in one of the two implementation districts- increasing secondary school entry and completion. Lower than expected school drop-out and child marriage rates at end-line reflect strong secular changes, likely due to large-scale government initiatives to keep girls in school and delay marriage. Although government programmes may be sufficient to reach most girls in these settings, a substantial proportion of SC/ST girls remain at-risk of early marriage and school drop-out, and require targeted programming. Addressing multiple forms of clustered disadvantage among hardest to reach will be key to ensuring India "leaves no-one behind" and achieves its gender, health and education Sustainable Development Goal aspirations.Trial registrationClinicalTrials.gov registration number NCT01996241.
| S-EPMC6684866 | biostudies-literature