Sexual health and healthy relationships for Further Education (SaFE) in Wales and England: Results from a pilot cluster randomised controlled trial

Objectives: To examine the acceptability of implementing, trialling and estimating the cost of the Sexual health and healthy relationships for Further Education (SaFE) intervention. Design: Two-arm repeated cross-sectional pilot cluster randomised controlled trial (cRCT) of SaFE compared with usual practice, including a process evaluation and an economic assessment. Setting: Eight further education (FE) settings in South Wales and the West of England, UK. Participants: FE students, staff and sexual health nurses. Intervention: SaFE had three components: (1) onsite access to sexual health and relationship services provided by sexual health nurses available for 2 hours on 2 days per week; (2) publicity about onsite sexual health and relationship services and (3) FE staff training on how to promote sexual health, and recognise, prevent and respond to dating and relationship violence (DRV) and sexual harassment. Primary and secondary outcome measures: The primary outcome was feasibility, assessing whether the study met progression criteria relating to: (a) FE setting and student recruitment; (b) the acceptability of the intervention and (c) 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. Results: Three of the four progression criteria were met. Eight FE settings were recruited, randomised and retained. Of the students approached, 60.7% (1124/1852 students) at baseline and 51.9% (1139/2193 students) 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. SaFE was viewed positively by FE students, FE 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 DRV victimisation in the last 12 months. We found low rates of missing data for almost all variables with no discernible differences across arms. The estimated cost per FE setting was £38,363.09. Conclusions: SaFE was implemented and well received by students, staff and nurses. If strategies to boost student recruitment to the survey can be identified, progression to a phase III effectiveness trial of SaFE is warranted. Trial registration number: ISRCTN54793810.