Bailey Julia V, Webster Rosie, Hunter Rachael, Griffin Mark, Freemantle Nicholas, Rait Greta, Estcourt Claudia, Michie Susan, Anderson Jane, Stephenson Judith, Gerressu Makeda, Ang Chee Siang, Murray Elizabeth
E-Health unit, Research Department of Primary Care and Population Health, University College London, London, UK.
PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
Health Technol Assess. 2016 Dec;20(91):1-124. doi: 10.3310/hta20910.
This report details the development of the Men's Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation.
(1) Develop the Men's Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men's views of online research methodology.
(1) Website development: we combined evidence from research literature and the views of experts ( = 18) and male clinic users ( = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men's Safer Sex website plus usual care ( = 84) or usual clinic care only ( = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires.
(1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men's Safer Sex website and technical problems were frustrating. Men's views of the Men's Safer Sex website and research procedures were largely positive.
It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS.
Current Controlled Trials ISRCTN18649610.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.
本报告详细介绍了男性安全性行为网站的开发情况以及一项可行性随机对照试验（RCT）的结果、健康经济评估和定性评估。
（1）开发男性安全性行为网站以解决使用避孕套的障碍；（2）确定在线随机对照试验的最佳设计；（3）为收集和分析健康经济数据的方法提供信息；（4）评估性生活质量（SQoL）问卷和欧洲五维度健康量表三级版本（EQ-5D-3L）以计算质量调整生命年（QALYs）；（5）探讨诊所工作人员和男性对在线研究方法的看法。
（1）网站开发：我们结合了研究文献中的证据以及专家（n = 18）和男性诊所使用者（n = 43）的意见；（2）可行性随机对照试验：从三家性健康诊所招募了159名异性性行为活跃的男性，并通过计算机随机分为男性安全性行为网站加常规护理组（n = 84）或仅常规诊所护理组（n = 75）。邀请男性在3、6、9和12个月时完成在线问卷，并在12个月时从诊所记录中记录性传播感染（STI）诊断情况；（3）健康经济评估：我们研究了使用不同问卷计算效用和QALYs（EQ-5D-3L和SQoL问卷）的影响，并比较了收集资源使用情况的不同方法；（4）定性评估：对11名男性试验参与者和9名诊所工作人员的访谈进行主题分析，以及对在线结果问卷的自由文本评论。
（1）软件错误和诊所无线网络接入带来了重大挑战。在线问卷的回复率较低，但较大的代金券可提高回复率（从10英镑时的36%提高到30英镑时的50%）。94%的参与者找到了用于STI诊断的临床记录。与女性伴侣进行无保护性行为方面无组间差异[发病率比（IRR）1.01，95%置信区间（CI）0.52至1.96]。干预组有8.8%（7/80）记录了新的STI诊断，对照组为13.0%（9/69）（IRR 0.75，95%CI 0.29至1.89）。（2）使用患者档案比问卷收集的医疗保健资源数据更完整。干预具有成本效益的概率对所使用的数据来源以及是否包括预期妊娠数据敏感。（3）试点随机对照试验与临床活动配合良好，但37%的干预组未查看男性安全性行为网站，技术问题令人沮丧。男性对男性安全性行为网站和研究程序的看法总体上是积极的。
以诊所STI诊断作为主要结局进行大规模随机对照试验是可行的；然而，技术错误和低回复率限制了在线自我报告结局的收集。下一步是（1）优化在线试验软件；（2）找到将数字健康促进与临床服务整合的最佳方法；（3）开发更精确的收集资源使用数据的方法；（4）研究如何克服国民保健服务体系（NHS）中数字干预测试和实施的障碍。
当前受控试验ISRCTN18649610。
本项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，将在《》第20卷第91期全文发表。有关更多项目信息，请访问NIHR期刊图书馆网站。
