The SaFE intervention was implemented and well received by students, staff and nurses in further education settings, and if strategies to boost student recruitment to the survey can be identified, progression to a phase III effectiveness trial of SaFE is warranted.
Key Findings
Results
Three of the four pre-specified progression criteria were met in the pilot cluster randomised controlled trial of SaFE.
The four progression criteria related to: (a) FE setting and student recruitment; (b) acceptability of the intervention; and (c) qualitative data and documentary evidence on acceptability, fidelity of implementation and receipt.
Eight FE settings were successfully recruited, randomised and retained, meeting the setting recruitment criterion.
Student questionnaire completion was 60.7% (1124/1852) at baseline and 51.9% (1139/2193) at 12-month follow-up, with the target being 60%; the follow-up rate did not meet the target.
Over 80% of onsite sexual health service sessions were attended by a nurse, and onsite publicity about sexual health services was observed at all intervention settings.
Results
Eight further education settings in South Wales and the West of England were recruited, randomised and retained throughout the trial.
The trial was a two-arm repeated cross-sectional pilot cluster randomised controlled trial (cRCT).
Settings were located in South Wales and the West of England, UK.
All eight settings were retained through to the 12-month follow-up, indicating high setting-level retention.
The trial was registered under ISRCTN54793810.
Results
Student questionnaire completion rates met the 60% target at baseline but fell short at 12-month follow-up.
At baseline, 60.7% of approached students completed the questionnaire (1124 of 1852 students).
At 12-month follow-up, 51.9% of approached students completed the questionnaire (1139 of 2193 students), below the 60% target.
The authors note that strategies to boost student recruitment to the survey need to be identified before progression to a phase III trial.
Results
SaFE was viewed positively by further education students, staff and sexual health nurses, though it was noted to need more time to embed.
Qualitative and documentary evidence from students, staff and sexual health nurses was collected as part of the process evaluation.
137 staff members were trained on how to promote sexual health and recognise, prevent and respond to dating and relationship violence (DRV) and sexual harassment.
Stakeholders across all groups viewed the intervention positively but indicated it needed more time to embed in the college environment.
Onsite publicity about sexual health services was observed at all intervention settings.
Results
The prevalence of self-reported unprotected sex at last intercourse was 15.5% at baseline and 18.7% at 12-month follow-up.
Unprotected sex at last intercourse was assessed as a secondary/intermediate outcome measure.
Baseline prevalence was 15.5% and follow-up prevalence was 18.7% across the sample.
The pilot was not powered to detect intervention effects; these figures provide baseline estimates for future trial planning.
Low rates of missing data were found for almost all variables with no discernible differences across trial arms.
Results
There was evidence of floor effects in the measure of dating and relationship violence (DRV) victimisation in the last 12 months.
DRV victimisation was assessed as a primary or intermediate outcome measure in the trial.
Floor effects indicate that the majority of respondents reported no or very low levels of DRV victimisation, limiting variability and the measure's sensitivity to detect change.
This finding has implications for outcome measure selection in any future phase III effectiveness trial.
Results
The estimated cost of implementing the SaFE intervention was £38,363.09 per further education setting.
This cost estimate was generated as part of an economic assessment component of the pilot trial.
The three components of SaFE included: onsite sexual health and relationship services (nurse-led, 2 hours on 2 days per week); publicity about onsite services; and staff training.
Cost data will inform resource planning and cost-effectiveness analysis in any future definitive trial.
Methods
The SaFE intervention comprised three components targeting sexual health service access, publicity, and staff training in further education settings.
Component 1: onsite access to sexual health and relationship services provided by sexual health nurses available for 2 hours on 2 days per week.
Component 2: publicity about onsite sexual health and relationship services displayed throughout intervention settings.
Component 3: further education staff training on how to promote sexual health and recognise, prevent and respond to dating and relationship violence (DRV) and sexual harassment.
The comparator was usual practice in further education settings.
Results
Missing data rates were low for almost all variables with no discernible differences across trial arms.
Completeness of primary, secondary and intermediate outcome measures was assessed as part of the pilot objectives.
Low missing data rates across arms suggest the outcome measures and data collection procedures are feasible for use in a larger trial.
This finding supports the viability of the questionnaire measures used in a future phase III trial.
What This Means
This study tested whether a sexual health programme called SaFE (Sexual health and healthy relationships for Further Education) could be feasibly delivered and trialled in colleges in South Wales and the West of England. The programme had three parts: bringing sexual health nurses into colleges for regular drop-in sessions, putting up information about these services around the college, and training college staff to support students around sexual health and to recognise and respond to relationship violence and sexual harassment. Eight colleges took part, with half receiving SaFE and half continuing with their usual approach. The study found that the programme was successfully set up and was well-liked by students, college staff, and nurses, though it was noted that it needed more time to become fully embedded in college life. Over 80% of scheduled nurse sessions were covered, and 137 staff members received training.
The study also looked at whether it would be practical to run a larger, full-scale trial in the future. Three out of four key targets were met: all eight colleges were recruited and stayed in the study, the intervention was well received, and data was mostly complete with very little missing information across both groups. However, the student survey response rate fell slightly short of the 60% target at the 12-month follow-up (achieving 51.9%), which is the main hurdle to address before a larger trial can go ahead. The researchers also found that the measure used to capture experiences of dating and relationship violence showed a 'floor effect', meaning most students reported no such experiences, which makes it harder to detect any changes over time — suggesting this measure may need to be reconsidered.
This research suggests that the SaFE programme is feasible to deliver in further education colleges and is acceptable to the people it involves. The estimated cost was around £38,000 per college. If ways can be found to increase the number of students completing the survey, the authors conclude that moving forward to a larger trial to properly test whether SaFE improves student sexual health and reduces relationship violence would be justified.
Williams-Thomas R, Townson J, Lewis R, Copeland L, Madan J, Melendez-Torres G, et al.. (2025). Sexual health and healthy relationships for Further Education (SaFE) in Wales and England: results from a pilot cluster randomised controlled trial.. BMJ open. https://doi.org/10.1136/bmjopen-2024-091355