Title: Phase-III RCT of Positive Choices: a whole-school social-marketing intervention to promote sexual health and reduce health inequalities
Funder: Department of Health and Social Care

Abstract: Many young people experience poor sexual health. Most report a lack of ‘competence’ at first sex defining in terms of not using contraception, feeling pressure to have sex, partners not being equally willing to have sex and not feeling it is the right time to have sex. _x000D_ _x000D_ Relationships and sex education in school classrooms can contribute to promoting sexual competence and health. But in general its impact on students' sexual health are small, inconsistent and not sustained. Education in classrooms needs to be supplemented by ‘whole-school’ work such as student campaigns or sexual health services. Such work can be informed by ‘social marketing’ techniques which harness commercial marketing to social ends. There is good evidence from other countries that such interventions work but not from the UK. _x000D_ _x000D_ Positive Choices is a whole-school social marketing intervention for secondary schools aiming to promote sexual health and comprising: a school health promotion council which involves staff and students working together to coordinate intervention delivery; student surveys informing local decisions about how to deliver the intervention; classroom lessons; student-run campaigns; parent information; and review of sexual health services to inform improvements._x000D_ _x000D_ We will assess if the Positive Choices intervention is effective in ensuring young people are competent at first sex, alongside other benefits. _x000D_ _x000D_ Our evaluation proposal builds on an earlier NIHR-funded pilot study which met all the targets set for it in terms of the research and intervention. It is also informed by findings from another NIHR-funded pilot of the Project Respect school based intervention to prevent dating violence which concluded such work should be integrated within Positive Choices._x000D_ _x000D_ Involvement from policy, practice and youth groups recommended a change to the Positive Choices primary outcome from pregnancy to lack of sexual competence. This was for several reasons. While teenage pregnancy rates are falling, other risks such as sexually transmitted infections and dating violence are increasing. Those who report lack of sexual competence at first sex are more likely to experience later problems such as sexually transmitted infections, unplanned pregnancy, forced sex and sexual dysfunction. Furthermore, sexual competence is relevant for young people regardless of gender and sexual orientation._x000D_ _x000D_ We aim to conduct a randomised controlled trial of the Positive Choices intervention. This will recruit 50 schools, half of whom will be randomly chosen to deliver the intervention with the others acting as comparisons. The trial will include involvement from the public and professionals. We will assess impacts by surveying students with questionnaires at the beginning of the trial and then 33 months later. Surveys will ask students about sexual knowledge and experiences. We will also evaluate whether the intervention is worth the money and whether it is delivered well. _x000D_ _x000D_ The key scientific learning from the study will concern the effectiveness, costs and feasibility of delivery of Positive Choices. If effective, the intervention would be scaled up across secondary schools.

Lay abstract: Research question_x000D_ _x000D_ What is the effect of the Positive Choices intervention on student-reported non-competent first sex (primary outcome - absence of: contraception, autonomy of decision, equal partner willingness, judgement of being the right time) and secondary outcomes?_x000D_ _x000D_ Background_x000D_ _x000D_ Positive Choices is a whole-school social-marketing intervention to promote sexual health among secondary school students. Intervention comprises: school health promotion council involving staff and students coordinating delivery; student survey to inform local tailoring; teacher-delivered classroom curriculum; student-run campaigns; parent information; and review of sexual/reproductive health services to inform improvements. _x000D_ _x000D_ This RCT proposal builds on an NIHR-funded optimisation/pilot-RCT study which met progression criteria, plus findings from another NIHR-funded pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence (both too large to upload as part of proposal but available on request) which concluded such work should be integrated within Positive Choices. PPI with policy, practice and youth stakeholders recommended a change to the Positive Choices primary outcome from pregnancy to lack of sexual competence because: while teenage pregnancy rates are declining, other risks such as STIs and DRV are increasing; lack of sexual competence at first sex predicts subsequent risk of STI, unplanned pregnancy, non-volitional sex and sexual dysfunction; and this measure is relevant regardless of young people’s gender and sexual orientation._x000D_ _x000D_ Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by ‘whole-school’ (e.g. student campaigns, sexual health services) and ‘social marketing’ (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK. Positive Choices is informed by such interventions with the strongest evidence of effectiveness: the Safer Choices, CAS Carrera and Gatehouse interventions. _x000D_ _x000D_ Aim_x000D_ _x000D_ To conduct an RCT of Positive Choices with public and policy involvement and economic and process evaluation._x000D_ _x000D_ Methods_x000D_ _x000D_ We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. _x000D_ _x000D_ Timelines for delivery_x000D_ _x000D_ To recruit 50 school and undertake baseline surveys by month 6._x000D_ To implement the intervention over the 2022-24 school years and conduct the economic and process evaluations by month 34._x000D_ To undertake follow-up surveys by month 39._x000D_ To complete analyses, all patient and policy involvement and draft the study report by month 42, and engage in knowledge exchange from month 39._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ _x000D_ The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices. If effective, this would be scaled up across secondary schools. Findings will be communicated to multiple audience via diverse outputs.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: INFECTION;REPRODUCTIVE HEALTH AND CHILDBIRTH