School of Healthcare, Faculty of Medicine and Health, University of Leeds, Leeds, UK.
Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, England.
BMC Public Health. 2020 Nov 17;20(1):1736. doi: 10.1186/s12889-020-09661-x.
People with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK.
The RESPECT study was a two-armed randomised controlled, open feasibility trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers.
Of a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it. At three months, 81.9% (30 I; 29 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22).
The target of 100 participants was not achieved within the study's timescale. However, effective strategies were identified that improved recruitment in the final few months. Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex.
ISRCTN Registry ISRCTN15747739 prospectively registered 5th July 2016.
患有严重精神疾病 (SMI) 的人有性健康需求，但几乎没有证据表明有效的干预措施可以满足这些需求。事实上，在美国和巴西以外，很少有研究针对患有 SMI 的人解决这个问题。因此，本研究的目的是确定在英国为患有 SMI 的人提供性健康促进干预措施的试验的可接受性和可行性。
RESPECT 研究是一项为期两年的双臂随机对照、开放性可行性试验 (RCT)，比较了性健康促进干预措施（3 次 1 小时的个体干预）（I）或常规治疗（TAU），针对的是英国四个城市社区心理健康服务机构中年龄在 18 岁或以上的患有 SMI 的成年人。主要观察结果是参与者同意参与的百分比，以及在试验的每个臂中保留、保留干预措施以及数据收集的完整性。一项嵌套定性研究通过由具有实际经验的研究人员进行的个人电话访谈，获得了参与者对研究可接受性的看法。
在目标样本为 100 人的情况下，在 12 个月内共有 72 人参加了试验。在最初的几个月中，招募人数较低，因此获得了延期。然而，这一延期意味着后来招募的参与者只能在 3 个月时进行随访。干预和整个研究的保留率都很好；分配到干预组的 77.8%（n=28）接受了干预。在 3 个月时，81.9%（30 个 I；29 个 TAU）和 6 个月时，76.3%（13 个 I 和 16 个 TAU）完成了随访数据收集。没有报告不良事件。数据完整性良好。干预组的性健康结果有利于干预。基于对定性访谈的分析，招募方法、参与者信息的质量、数据收集和干预措施被认为是可以接受的（n=22）。
在研究的时间范围内，没有达到 100 名参与者的目标。然而，已经确定了有效的策略，这些策略在最后几个月提高了招募率。两组的保留率和数据完整性表明，为患有 SMI 的人促进性健康是可以接受和可行的。需要一项完全有效的 RCT 来确定该干预措施在采用更安全的性行为方面的有效性。
ISRCTN 注册处于 2016 年 7 月 5 日前瞻性注册 ISRCTN84634364。
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