Title: Optimisation, feasibility testing and a pilot randomised trial of SaFE: a sexual health and healthy relationships intervention for Further Education
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background: Dating and relationship violence (DRV) is common among young people in the UK. DRV includes threats, emotional abuse, controlling behaviour, physical violence and forced sexual activity. About half of young people in Further Education (FE) report DRV. Young people in the UK have poor sexual health including the highest rates of teenage pregnancy in Western Europe and high rates of sexually transmitted infections (STIs). Improving sexual health and reducing DRV in young people is a UK public health priority. The FE sector (including colleges and 6th forms) is growing and most students are aged 16-24. It is suited for public health interventions to improve sexual health and reduce DRV, but few exist to date._x000D_ _x000D_ Aim: To refine and test ‘SaFE,’ an intervention for FE settings to improve sexual health and reduce DRV and sexual harassment among young people._x000D_ _x000D_ Method: This project builds on our previously funded study where FE students, FE staff and sexual health charity staff said that they want onsite sexual health services and staff safeguarding training about sexual health and relationships, but they are not currently available. The SaFE intervention addresses these gaps by: 1) offering free onsite sexual health (e.g. condoms, STI tests and pregnancy tests) and relationship services; 2) publicising these services and; 3) training FE staff how to promote sexual health and recognize and respond to DRV and sexual harassment. _x000D_ _x000D_ We plan to test whether SaFE improves sexual health and reduces DRV, but first we need to find out whether the intervention and research methods are practical. First, we will work with FE students, FE staff, parents, policy makers and a youth advisory group to adapt existing publicity and staff training materials for use in FE. Second, we will test and refine SaFE in two FE settings. Third, we will conduct a larger pilot of SaFE: we will survey students in six FE settings then randomly decide four settings to receive SaFE and two to act as comparisons. In sites delivering SaFE we will interview staff and students to find out what they think of it, and we will observe the delivery of the intervention. We will survey students in all sites again 12 months later. This will tell us whether a much larger study to test the effectiveness of SaFE is worthwhile. This is important as we do not want to waste public resources if such a study is not promising._x000D_ _x000D_ Patient and public involvement (PPI): This study builds on 15 months of work with over 2000 students and 200 staff from six FE settings, 12 sexual health staff and an advisory group of 16-21 year olds (ALPHA) to explore which components should be combined into an intervention. We discussed the findings, intervention and methods for this project with 30 stakeholders at a consultation event. ALPHA are also in support of this proposal. PPI will continue in the proposed study by asking FE staff, students, parents and stakeholders to help refine the intervention materials. The Study Steering Committee will include FE staff, students, a parent and independent sexual health specialists._x000D_ _x000D_ Dissemination: We will make our results available via: summary reports to participating FE settings; the NIHR Public Health Research journal; two academic papers; practitioner and policy conferences; two policy stakeholder meetings (one England, one Wales); an article for the Times Education Supplement; DECIPHer and Centre for Trials Research Twitter, blogs and infographics.

Lay abstract: Background: Dating and relationship violence (DRV) includes threats, emotional abuse, controlling behaviour, physical violence and forced sexual activity and is reported by over half of further education (FE) students. The median age for most recent occurrence of non-volitional sex (sex against one’s will) is 18 among men and 16 among women. The UK also has the highest rate of under-18 births in Western Europe, 21% of unplanned pregnancies occur among 16-18 year-olds and 16-24 year olds account for over half of chlamydia and gonorrhoea diagnoses. Improving sexual health and reducing DRV in young people is a UK public health priority. In England, there are 1.2 million 16-18 year olds studying in FE with participation across social groups. FE provides a scalable setting for intervention as most students are aged 16-24. However intervention in this setting is virtually non-existent._x000D_ _x000D_ Aim: To optimise, feasibility test and pilot ‘SaFE,’ a sexual health and DRV intervention for FE settings._x000D_ _x000D_ Objectives: 1) Convene a network of stakeholders to optimise the intervention materials. 2) Assess the feasibility and acceptability of implementing SaFE in two FE settings. 3) Conduct a pilot cluster randomised controlled trial (cRCT) in six FE settings to determine whether a Phase III cRCT assessing effectiveness and cost-effectiveness should be conducted._x000D_ _x000D_ Methods and timelines:_x000D_ Phase 1) Intervention optimisation (Jan–Apr20)_x000D_ Informed by existing literature and the MRC PHIND funded Phase I intervention development “SaFE Project” [MR/M026272/1], the intervention components are: 1) onsite access to sexual health and relationship services; 2) publicity of onsite services and signposting to educational resources; and 3) FE staff training to promote sexual health and recognize, prevent and respond to DRV and sexual harassment. Existing literature and materials will be reviewed, adapted and refined, and draft staff training and publicity materials will be produced. Stakeholders, FE students, staff and the ALPHA youth advisory group will be consulted and the intervention materials refined._x000D_ _x000D_ Phase 2) Intervention feasibility testing (Apr–Aug20)_x000D_ Intervention components will be tested for feasibility and acceptability in two FE settings; one 6th form and one college (one in England, one in Wales). Refinements will be made based on feedback._x000D_ _x000D_ Phase 3) Pilot cRCT (Aug20-Mar22)_x000D_ A pilot cRCT will be conducted (4 intervention, 2 control settings) with integrated process and economic evaluations. Following baseline surveys (Sep 2020), clusters (settings) will be randomly allocated to 2 arms: SaFE in 4 settings and usual practice in 2. Allocation will use a 2:1 ratio in favour of the intervention, stratified by country and setting. Follow up surveys will be 12 months post-baseline (Sep 2021). A process evaluation will explore intervention feasibility, acceptability, fidelity, sustainability, reach, mechansisms of action, contamination, and scalability. _x000D_ _x000D_ Impact and dissemination: As well as the NIHR monograph, we will submit two open access papers to high impact journals on the implementation of SaFE and the pilot trial results. Findings will be presented at academic conferences and two stakeholder meetings with practitioners and policy makers (one England, one Wales). We will disseminate our findings to participating FE settings, and use DECIPHer and Centre for Trials Research blogs, Twitter and infographics to maximise public awareness.

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