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Sexual health
Original research
Sexual health and healthy relationships for Further Education (SaFE) in Wales and England: results from a pilot cluster randomised controlled trial
  1. Rhys Williams-Thomas1,
  2. Julia Townson1,
  3. Ruth Lewis2,
  4. Lauren Copeland3,
  5. Jason Madan4,
  6. G J Melendez-Torres5,
  7. Fiona V Lugg-Widger1,
  8. Philip Pallmann1,
  9. Muhammad Riaz1,
  10. Rachel Brown6,
  11. Chris Bonell7,
  12. Gemma S Morgan8,
  13. James White1,6,
  14. Honor Young6
  1. 1 Centre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UK
  2. 2 Institute of Health and Wellbeing, MRC Social and Public Health Sciences Unit, Glasgow, UK
  3. 3 Cardiff Metropolitan University, Cardiff, UK
  4. 4 University of Warwick, Warwick Medical School, Coventry, Warwick, UK
  5. 5 Faculty of Health and Life Sciences, University of Exeter, Exeter, UK
  6. 6 Centre for the Development, Evaluation, Complexity and Implementation in Public Health Improvement, Cardiff University School of Social Sciences, Cardiff, UK
  7. 7 Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, UK
  8. 8 Public Health and Wellbeing Division, South Gloucestershire Council, Yate, UK
  1. Correspondence to Dr Honor Young; youngh6{at}cardiff.ac.uk

Abstract

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.

  • Health
  • Nurses
  • SEXUAL MEDICINE
  • Schools
  • Sexually Transmitted Disease

Data availability statement

Data are available upon reasonable request. The data will be openly available from the Cardiff University repository or Honor Young (youngh6@cardiff.ac.uk).

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2024-091355

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    Data availability statement

    Data are available upon reasonable request. The data will be openly available from the Cardiff University repository or Honor Young (youngh6@cardiff.ac.uk).

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    Footnotes

    • X @fionalugg

    • Contributors HY was the chief investigator and acted as guarantor. HY, JW, CB, JT, RL, GSM, FVL-W and PP designed the study. JW created the first draft of this manuscript. All authors made substantive contributions to the development of the manuscript, critically reviewed and gave final approval to the manuscript. LC, RW-T and HY conducted the process evaluation. RW-T and JT were responsible for the management of the trial. PP and MR conducted the statistical analysis. JM developed and conducted the economic evaluation.

    • Funding This research was supported by the National Institute for Health and Care Research (NIHR) Public Health Research programme, grant number NIHR PHR 17/149/12. HY and JW are supported by the Centre for Development, Evaluation, Complexity and Implementation in Public Health Improvement (DECIPHer), which is funded by Welsh Government through Health and Care Research Wales. The Centre for Trials Research, Cardiff University receives infrastructure funding from Health and Care Research Wales. RL is supported by the Medical Research Council (MC_UU_12017/11 and MC_UU_00022/3) and the Scottish Government Chief Scientist Office (SPHSU11 and SPHSU18).This research was supported by the National Institute for Health and Care Research (NIHR) Public Health Research programme, grant number NIHR PHR 17/149/12. HY and JW are supported by the Centre for Development, Evaluation, Complexity and Implementation in Public Health Improvement (DECIPHer), which is funded by Welsh Government through Health and Care Research Wales. The Centre for Trials Research, Cardiff University receives infrastructure funding from Health and Care Research Wales. RL is supported by the Medical Research Council (MC_UU_12017/11 and MC_UU_00022/3) and the Scottish Government Chief Scientist Office (SPHSU11 and SPHSU18). GJMT is an NIHR Senior Investigator.

    • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.