Protocol, rationale and design of SELPHI: a randomised controlled trial assessing whether offering free HIV self-testing kits via the internet increases the rate of HIV diagnosis.
Protocol, rationale and design of SELPHI: a randomised controlled trial assessing whether offering free HIV self-testing kits via the internet increases the rate of HIV diagnosis.
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DOI：
10.1186/s12879-018-3433-x
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发表时间：
2018-10-23
影响因子：
3.7
通讯作者：
Rodger AJ
中科院分区：
文献类型：
--
作者：
Gabriel MM;Dunn DT;Speakman A;McCabe L;Ward D;Witzel TC;Harbottle J;Collins S;Gafos M;Burns FM;Lampe FC;Weatherburn P;Phillips A;McCormack S;Rodger AJ
在英国的男男性行为者（MSM）中，估计有28%的人从未接受过艾滋病毒检测，只有27%的高危人群至少每6个月进行一次检测。艾滋病毒自我检测（HIVST），即个人采取自己的血液/唾液样本并自行处理，提供了消除许多结构性和社会障碍的机会。尽管一些随机对照试验正在评估提供HIVST对艾滋病毒检测率的影响，但没有一项研究涉及这是否会导致与临床护理相关的艾滋病毒诊断率增加。与护理挂钩是关键成果，因为这是获得抗逆转录病毒治疗的唯一途径。我们在这里描述了一个大型的，基于互联网的随机对照试验的艾滋病毒，称为SELPHI，旨在告知这个关键问题的设计。正在进行的SELPHI研究通过社交网站和应用程序广告进行推广，旨在招募居住在英格兰和威尔士的16岁以上的艾滋病毒阴性男性，跨性别男性和跨性别女性。除了实际交付检测包外，所有审判过程，包括征聘，都在网上进行。在两阶段随机化中，参与者首先随机（3：2）接受免费基线HIVST或无免费基线HIVST。在3个月时，被分配接受基线HIVST（并符合进一步的资格标准）的参与者随后被随机（1：1）接受定期（每3个月）免费HIVST的提议，并提醒测试，而没有这样的提议。两次随机化的主要结果是实验室确认的HIV诊断，通过与国家HIV监测数据库的链接确定。SELPHI将提供第一个可靠的证据，证明通过互联网提供免费的HIVST是否会增加艾滋病毒确诊率和与临床护理的联系。这两种随机化反映了检测流行感染（可能是长期存在的）和更迅速地诊断艾滋病毒感染事件的双重目标。预计SELPHI的结果将为联合王国今后获得艾滋病毒自我检测提供信息。DOI 10.1186/ISRCTN 20312003于2016年10月24日注册。
Among men who have sex with men (MSM) in the UK, an estimated 28% have never tested for HIV and only 27% of those at higher risk test at least every 6 months. HIV self-testing (HIVST), where the person takes their own blood/saliva sample and processes it themselves, offers the opportunity to remove many structural and social barriers to testing. Although several randomised controlled trials are assessing the impact of providing HIVST on rates of HIV testing, none are addressing whether this results in increased rates of HIV diagnoses that link to clinical care. Linking to care is the critical outcome because it is the only way to access antiretroviral treatment (ART). We describe here the design of a large, internet-based randomised controlled trial of HIVST, called SELPHI, which aims to inform this key question. The SELPHI study, which is ongoing is promoted via social networking website and app advertising, and aims to enroll HIV negative men, trans men and trans women, aged over 16 years, who are living in England and Wales. Apart from the physical delivery of the test kits, all trial processes, including recruitment, take place online. In a two-stage randomisation, participants are first randomised (3:2) to receive a free baseline HIVST or no free baseline HIVST. At 3 months, participants allocated to receive a baseline HIVST (and meeting further eligibility criteria) are subsequently randomised (1:1) to receive the offer of regular (every 3 months) free HIVST, with testing reminders, versus no such offer. The primary outcome from both randomisations is a laboratory-confirmed HIV diagnosis, ascertained via linkage to a national HIV surveillance database. SELPHI will provide the first reliable evidence on whether offering free HIVST via the internet increases rates of confirmed HIV diagnoses and linkage to clinical care. The two randomisations reflect the dual objectives of detecting prevalent infections (possibly long-standing) and the more rapid diagnosis of incident HIV infections. It is anticipated that the results of SELPHI will inform future access to HIV self-testing provision in the UK. DOI 10.1186/ISRCTN20312003 registered 24/10/2016.
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影响因子：
3.8
作者：
Williamson, Lisa M.;Dodds, Julie P.;Johnson, Anne M.
通讯作者：
Johnson, Anne M.
DOI：
10.1080/09540121.2013.824543
发表时间：
2014-03-04
影响因子：
1.7
作者：
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通讯作者：
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作者：
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通讯作者：
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影响因子：
1.4
作者：
Clutterbuck, D. J.;Flowers, P.;Sullivan, A. K.
通讯作者：
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影响因子：
3.6
作者：
Hickson, Ford;Melendez-Torres, G. J.;Weatherburn, Peter
通讯作者：
Weatherburn, Peter