McCarthy Ona L, French Rebecca S, Baraitser Paula, Roberts Ian, Rathod Sujit D, Devries Karen, Bailey Julia V, Edwards Phil, Wellings Kaye, Michie Susan, Free Caroline
The London School of Hygiene and Tropical Medicine, London, UK.
Kings College London, London, UK.
BMJ Open. 2016 Dec 23;6(12):e013045. doi: 10.1136/bmjopen-2016-013045.
OBJECTIVE: To test the procedures proposed for a main trial of a safer sex intervention for young people delivered by mobile phone text message ('safetxt'). DESIGN AND SETTING: Pilot randomised controlled trial. Participants were recruited through sexual health services in the UK. An independent online randomisation system allocated participants to receive the safetxt intervention or to receive the control text messages (monthly messages about participation in the study). Texting software delivered the messages in accordance with a predetermined schedule. PARTICIPANTS: Residents of England aged 16-24 who had received either a positive chlamydia test result or reported unsafe sex in the last year (defined as more than 1 partner and at least 1 occasion of sex without a condom). INTERVENTION: The safetxt intervention is designed to reduce sexually transmitted infection in young people by supporting them in using condoms, telling a partner about an infection and testing before unprotected sex with a new partner. Safetxt was developed drawing on: behavioural science; face-to-face interventions; the factors known to influence safer sex behaviours and the views of young people. OUTCOMES: The coprimary outcomes of the pilot trial were the recruitment rate and completeness of follow-up. RESULTS: We recruited 200 participants within our target of 3 months and we achieved 81% (162/200) follow-up response for the proposed primary outcome of the main trial, cumulative incidence of chlamydia at 12 months. CONCLUSIONS: Recruitment, randomisation, intervention delivery and follow-up were successful and a randomised controlled trial of the safetxt intervention is feasible. TRIAL REGISTRATION NUMBER: ISRCTN02304709; Results.
目的:对通过手机短信(“安全短信”)为年轻人提供的安全性行为干预主要试验所提议的程序进行测试。 设计与背景:试点随机对照试验。通过英国的性健康服务机构招募参与者。一个独立的在线随机系统将参与者分配为接受“安全短信”干预或接受对照短信(关于参与研究的月度短信)。短信软件按照预定时间表发送短信。 参与者:年龄在16 - 24岁之间、去年衣原体检测结果呈阳性或报告有不安全性行为(定义为有多个性伴侣且至少有一次无保护性行为)的英格兰居民。 干预措施:“安全短信”干预旨在通过支持年轻人使用避孕套、告知伴侣感染情况以及在与新伴侣进行无保护性行为前进行检测,来减少年轻人的性传播感染。“安全短信”的开发借鉴了:行为科学;面对面干预;已知影响安全性行为的因素以及年轻人的观点。 结果:试点试验的共同主要结果是招募率和随访完整性。 结果:我们在3个月的目标时间内招募了200名参与者,对于主要试验提议的主要结果,即12个月时衣原体的累积发病率,我们实现了81%(162/200)的随访回复率。 结论:招募、随机分组、干预实施和随访均取得成功,“安全短信”干预的随机对照试验是可行的。 试验注册号:ISRCTN02304709;结果。
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