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A school-based social-marketing intervention to promote sexual health in English secondary schools: the Positive Choices pilot cluster RCTPonsford, Ruth; Bragg, Sara; Allen, Elizabeth; Tilouche, Nerissa; Meiksin, Rebecca; Emmerson, Lucy; Van Dyck, Laura; Opondo, Charles; Morris, Steve; Sturgess, Joanna; et al. (NIHR Journals Library, 2021-01-31)The UK still has the highest rate of teenage births in western Europe. Teenagers are also the age group most likely to experience unplanned pregnancy, with around half of conceptions in those aged < 18 years ending in abortion. After controlling for prior disadvantage, teenage parenthood is associated with adverse medical and social outcomes for mothers and children, and increases health inequalities. This study evaluates Positive Choices (a new intervention for secondary schools in England) and study methods to assess the value of a Phase III trial. To optimise and feasibility-test Positive Choices and then conduct a pilot trial in the south of England assessing whether or not progression to Phase III would be justified in terms of prespecified criteria. Intervention optimisation and feasibility testing; pilot randomised controlled trial. The south of England: optimisation and feasibility-testing in one secondary school; pilot cluster trial in six other secondary schools (four intervention, two control) varying by local deprivation and educational attainment. School students in year 8 at baseline, and school staff. Schools were randomised (1 : 2) to control or intervention. The intervention comprised staff training, needs survey, school health promotion council, year 9 curriculum, student-led social marketing, parent information and review of school/local sexual health services. The prespecified criteria for progression to Phase III concerned intervention fidelity of delivery and acceptability; successful randomisation and school retention; survey response rates; and feasible linkage to routine administrative data on pregnancies. The primary health outcome of births was assessed using routine data on births and abortions, and various self-reported secondary sexual health outcomes. The data sources were routine data on births and abortions, baseline and follow-up student surveys, interviews, audio-recordings, observations and logbooks. The intervention was optimised and feasible in the first secondary school, meeting the fidelity targets other than those for curriculum delivery and criteria for progress to the pilot trial. In the pilot trial, randomisation and school retention were successful. Student response rates in the intervention group and control group were 868 (89.4%) and 298 (84.2%), respectively, at baseline, and 863 (89.0%) and 296 (82.0%), respectively, at follow-up. The target of achieving ≥ 70% fidelity of implementation of essential elements in three schools was achieved. Coverage of relationships and sex education topics was much higher in intervention schools than in control schools. The intervention was acceptable to 80% of students. Interviews with staff indicated strong acceptability. Data linkage was feasible, but there were no exact matches for births or abortions in our cohort. Measures performed well. Poor test–retest reliability on some sexual behaviour measures reflected that this was a cohort of developing adolescents. Qualitative research confirmed the appropriateness of the intervention and theory of change, but suggested some refinements. The optimisation school underwent repeated changes in leadership, which undermined its participation. Moderator analyses were not conducted as these would be very underpowered. Our findings suggest that this intervention has met prespecified criteria for progression to a Phase III trial. Declining prevalence of teenage pregnancy suggests that the primary outcome in a full trial could be replaced by a more comprehensive measure of sexual health. Any future Phase III trial should have a longer lead-in from randomisation to intervention commencement. Current Controlled Trials ISRCTN12524938. ; Vol. 9, No. 1. See the NIHR Journals Library website for further project information.
Study protocol for the optimisation, feasibility testing and pilot cluster randomised trial of Positive Choices: a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in EnglandPonsford, Ruth; Allen, Elizabeth; Campbell, Rona; Elbourne, Diana; Hadley, Alison; Lohan, Maria; Melendez-Torres, G. J.; Mercer, Catherine H.; Morris, Steve; Young, Honor; et al. (BMC (part of Springer Nature), 2018-05-23)Background: Since the introduction of the Teenage Pregnancy Strategy (TPS), England's under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that schoolbased social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices. Methods: Design: Optimisation, feasibility testing and pilot cluster randomised trial. Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services. Systematic optimisation of Positive Choices will be carried out with the National Children's Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders. Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT. Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial. The following outcome measures will be trialled as part of the pilot: 1. Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections, 2. Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sex 3. Educational attainment The feasibility of linking administrative data on births and termination to self-report survey data to measure our primary outcome (unintended teenage pregnancy) will also be tested. Discussion: This will be the first UK-based pilot trial of a school-wide social marketing intervention to reduce unintended teenage pregnancy and improve sexual health. If this study indicates feasibility and acceptability of the optimised Positive Choices intervention in English secondary schools, plans will be initiated for a phase III trial and economic evaluation of the intervention. Trial registration: ISRCTN registry (ISCTN12524938. Registered 03/07/2017).