男性安全性行为试验：一项关于交互式数字干预措施以增加男性避孕套使用的可行性随机对照试验。

The Men's Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

作者信息

Bailey Julia V, Webster Rosie, Griffin Mark, Freemantle Nick, Hunter Rachael, Rait Greta, Estcourt Claudia, Anderson Jane, Gerressu Makeda, Stephenson Judith, Michie Susan, Murray Elizabeth

机构信息

eHealth 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.

出版信息

Digit Health. 2016 Nov 22;2:2055207616679002. doi: 10.1177/2055207616679002. eCollection 2016 Jan-Dec.

DOI:10.1177/2055207616679002

PMID:29942575

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6003442/

Abstract

OBJECTIVES

We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men's Safer Sex website, measuring condom use and sexually transmitted infection (STI).

METHODS

For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care ( = 84), or usual clinic care only ( = 75). Online outcome data were solicited at 3, 6, and 12 months.

RESULTS

Men were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website ( = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90).

CONCLUSION

It is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings.Trial registration number: ISRCTN18649610.

摘要

目的

我们旨在确定针对男性安全性行为网站开展在线随机对照试验（RCT）的可行性，该试验用于衡量避孕套的使用情况和性传播感染（STI）。

方法

在本研究中，从英国的三家性健康诊所招募了159名年龄≥16岁、有女性性伴侣且近期有无保护性行为或疑似性传播感染的男性。参与者被随机分为接受干预网站加常规诊所护理组（n = 84）或仅接受常规诊所护理组（n = 75）。在3个月、6个月和12个月时收集在线结局数据。

结果

男性在诊所候诊室通过平板电脑登记入组。软件错误和诊所无线网络接入带来了重大挑战，在线问卷回复率较低（3个月时，有10英镑代金券的情况下为36%；12个月时，有30英镑的情况下为50%）。94%的参与者的临床记录（用于性传播感染诊断）可获取。约37%的干预组参与者未访问干预网站（n = 31/84），并且（正如预期的那样）与女性伴侣发生无保护性行为方面没有可检测到的差异（发病率比[IRR]=1.01，95%置信区间[CI]为0.52至1.96）。在12个月期间，干预组有8.8%（7/80）的参与者被记录有新的急性性传播感染诊断，对照组为13.0%（9/69）（IRR = 0.75，95% CI为0.29至1.90）。