Forsyth Ross, Purcell Carrie, Barry Sarah, Simpson Sharon, Hunter Rachael, McDaid Lisa, Elliot Lawrie, Bailey Julia, Wetherall Kirsty, McCann Mark, Broccatelli Chiara, Moore Laurence, Mitchell Kirstin
1MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Top Floor, 200 Renfield St, Glasgow, G2 3AX UK.
3Department of Mathematics and Statistics, Strathclyde University, Glasgow, UK.
Pilot Feasibility Stud. 2018 Nov 29;4:180. doi: 10.1186/s40814-018-0354-9. eCollection 2018.
Young people in the UK are at highest risk of sexually transmitted infections and report higher levels of unsafe sex than any other age group. Involving peer supporters in intervention delivery is acceptable to students and effective in reducing risk behaviours via 'diffusion of innovation', particularly where peer supporters are influential in their networks. Informal peer-led interventions offer a useful alternative to peer-led didactic teaching, which has shown limited effects. Building on the successful ASSIST anti-smoking intervention, the 'STis And Sexual Health' (STASH) intervention involves identification and recruitment of the most influential students as peer supporters, training and support to these students by specialist trainers, positive sex and relationships messages, spread by peer supporters to their friendship groups in person and via social media.
METHODS/DESIGN: This protocol describes a feasibility trial of the STASH intervention in six schools. It builds on an earlier study phase of intervention co-development using patient and public involvement (PPI) activities, followed by a pilot of intervention components and evaluation tools in one school. Participants are fourth year (S4) students (aged 14-16) in state-funded Scottish secondary schools who have received some level of teacher-led sex education. The previous cohort of S4 students (those completing S4 in the year prior to the intervention) will serve as controls. Data will be collected from controls (month 16), baseline (month 20-21) and follow-up (month 27-30) via a web-based questionnaire, which will measure (and test the reliability of) primary outcome measures for a phase III trial (delayed initiation of/abstinence from sex and consistent condom use), secondary outcomes and mediators of sexual behaviour (including school climate and social networks). The main feasibility outcome is whether the study meets pre-set progression criteria regarding feasibility and acceptability, measured largely via a process evaluation (basic measures in all 6 schools and in-depth in 2-4 schools). An economic evaluation reporting costs alongside consequences will be conducted.
This study will inform decisions on the feasibility, design and sample size for a phase III effectiveness trial to assess whether the STASH intervention is effective in reducing the risk of sexually transmitted infections in young people.
ISRCTN97369178.
英国的年轻人感染性传播感染的风险最高，且报告显示他们进行不安全性行为的比例高于其他任何年龄组。让同伴支持者参与干预措施的实施，学生们对此表示接受，并且通过“创新扩散”在降低风险行为方面很有效，特别是当同伴支持者在其社交网络中有影响力时。非正式的同伴主导干预为同伴主导的说教式教学提供了一种有用的替代方式，后者已显示效果有限。基于成功的ASSIST反吸烟干预措施，“性传播感染与性健康”（STASH）干预措施包括识别和招募最有影响力的学生作为同伴支持者，由专业培训师对这些学生进行培训和支持，通过同伴支持者亲自向其朋友圈以及通过社交媒体传播积极的性与关系信息。
方法/设计：本方案描述了在六所学校对STASH干预措施进行的可行性试验。它建立在早期使用患者和公众参与（PPI）活动进行干预共同开发的研究阶段基础上，随后在一所学校对干预组成部分和评估工具进行了试点。参与者是苏格兰公立中学的四年级（S4）学生（年龄在14 - 16岁），他们已经接受了一定程度的教师主导的性教育。前一批S4学生（在干预前一年完成S4课程的学生）将作为对照组。数据将通过基于网络的问卷从对照组（第16个月）、基线（第20 - 21个月）和随访（第27 - 30个月）收集，该问卷将测量（并测试可靠性）III期试验的主要结局指标（延迟开始性行为/禁欲和持续使用避孕套）、次要结局以及性行为的调节因素（包括学校氛围和社交网络）。主要的可行性结局是该研究是否符合关于可行性和可接受性的预设进展标准，这主要通过过程评估来衡量（在所有6所学校进行基本测量，并在2 - 4所学校进行深入测量）。将进行一项经济评估，报告成本及相应结果。
本研究将为关于III期有效性试验的可行性、设计和样本量的决策提供信息，以评估STASH干预措施是否能有效降低年轻人感染性传播感染的风险。
ISRCTN97369178
