Trial reportBMJ open2024
Sexual health and healthy relationships for Further Education (SaFE) in Wales and England: results from a pilot cluster randomised controlled trial.
Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
objectivesTo examine the acceptability of implementing, trialling and estimating the cost of the Sexual health and healthy relationships for Further Education (SaFE) intervention.
designTwo-arm repeated cross-sectional pilot cluster randomised controlled trial (cRCT) of SaFE compared with usual practice, including a process evaluation and an economic assessment.
settingEight further education (FE) settings in South Wales and the West of England, UK.
participantsFE students, staff and sexual health nurses.
interventionSaFE 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.
resultsThree 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.
conclusionsSaFE 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.
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