A Sexual health and healthy relationships intervention for Further Education (SaFE): a synopsis of results from a pilot cluster randomised controlled trial including an assessment of the feasibility of record linkage and a health economic analysis

Poor sexual health, dating and relationship violence and sexual harassment pose significant public health concerns, especially for young people. There is potential for short- and long-term adverse medical, social, educational and economic outcomes. To optimise the intervention materials and examine the acceptability of implementing, trialling and estimating the cost of the Sexual health and healthy relationships for Further Education (SaFE) intervention, including an assessment of the feasibility of record linkage and a health economic analysis. Optimisation of intervention materials followed by two-arm repeated cross-sectional pilot cluster randomised controlled trial of the SaFE intervention compared to usual practice, including a process evaluation and a health economic assessment. Optimisation took place using an iterative process with a series of key stakeholders. The pilot cluster randomised controlled trial took place in eight Further Education settings in South Wales and the West of England, United Kingdom. Participants included Further Education students and staff, and sexual health nurses. The SaFE intervention had three components: (1) onsite access to sexual health and relationship services provided by sexual health nurses available for 2 hours, 2 days per week; (2) publicity about these services; and (3) Further Education staff training on how to promote sexual health, and recognise, prevent and respond to dating and relationship violence and sexual harassment. The primary outcome was feasibility, assessing whether the study met progression criteria relating to: (1) Further Education setting and student recruitment; (2) the acceptability of the intervention; and (3) qualitative data and documentary evidence from students, staff and sexual health nurses on acceptability, fidelity of implementation and receipt. We also assessed the completeness of primary, secondary and intermediate outcome measures and estimated cost of the intervention. Three of the four progression criteria were met. Eight Further Education settings were recruited, randomised and retained. Of students approached, 60.7% (1124/1852) at baseline and 51.9% (1139/2193) at 12-month follow-up completed the questionnaire (target 60%). Over 80% of onsite sexual health services were attended by a nurse; onsite publicity about sexual health services was observed at all intervention settings; and 137 staff were trained. The SaFE intervention was viewed positively by students, staff and nurses but needed more time to embed. The prevalence of self-reported unprotected sex at last intercourse was 15.5% at baseline and 18.7% at follow-up. There was evidence of floor effects in the measure of dating and relationship violence victimisation in the last 12 months. We found low rates of missing data for almost all variables with no discernible differences across arms. Around a quarter of participants at baseline and follow-up said they were not at all, or not very comfortable providing consent to link to their routine health records. The estimated cost per Further Education setting was £38,363.09. Coronavirus disease discovered in 2019 pandemic restrictions at Further Education settings meant the intervention was not implemented for as long as planned (up to 23 weeks vs. 39 weeks). Overall the SaFE intervention was implemented and well received by students, staff and nurses. If strategies to boost student recruitment to the survey can be identified and implemented, progression to a Phase III effectiveness trial of the SaFE intervention is warranted. This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number 17/149/12.