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.

内容摘要

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. Improving sexual health and reducing dating and relationship violence in young people is a public health priority. We wanted to find out if it was possible to deliver ‘the SaFE intervention’, which promotes sexual health and prevents dating and relationship violence in Further Education settings by: providing free onsite sexual health and relationship services; publicising these services and; training Further Education staff to promote sexual health, and recognise and respond to dating and relationship violence and sexual harassment. We refined and tested the Sexual health and healthy relationships for Further Education (SaFE) intervention to see whether the intervention and study methods were acceptable. We worked with Further Education students, Further Education staff, policy makers, academic subject experts and a youth advisory group to adapt existing publicity and staff training materials for Further Education. Then we conducted a pilot study of the Sexual health and healthy relationships for Further Education intervention: we surveyed students in eight Further Education settings and randomly allocated six settings to receive the Sexual health and healthy relationships for Further Education intervention and two to act as control settings. We interviewed staff, students and sexual health nurses and observed the intervention delivery. We surveyed students in all sites again 12 months later. All Further Education settings agreed to take part and stayed in the study. Overall, 60.7% of students at the first survey agreed to take part, and 51.9% at the 12-month survey (our target was 60% for both time points), and left very few survey questions blank. Publicity of the onsite sexual health service was seen at all settings, allocated nurses attended over 80% of the onsite sexual health services sessions, and 137 staff were trained. Around a quarter of students had concerns about providing permission to access and link to their health records. Overall, the Sexual health and healthy relationships for Further Education intervention was successfully implemented and well received by students, staff and nurses but needed longer to embed. If we can improve student completion of the survey, it is worthwhile doing a larger study to test if the Sexual health and healthy relationships for Further Education intervention improves sexual health and reduces dating and relationship violence.