背景:HIV自我检测(HIVST)可能造成伤害的可能性是阻碍其广泛实施的一个问题。本文的目的是了解HIVST与SELPHI(HIV自检公共卫生干预)中危害之间的关系,迄今为止在高收入国家最大的HIVST随机试验.
方法:10111名与男性发生性关系的男性和跨性别男性(MSM)在线招募(地理位置社交/性网络应用,社交媒体),16岁以上,报告以前的肛交和居住在英格兰或威尔士的首次随机60/40到基线HIVST(基线测试,BT)或不(无基线测试,nBT)(随机化A)。BT参与者报告阴性基线测试,3个月时的性风险和对进一步HIVST的兴趣被随机分配到三个月的HIVST(重复测试,RT)或不(无重复测试,nRT)(随机化B)。所有人都收到了一项出口调查,收集有关危害(对人际关系,幸福,错误的结果或被压力/说服进行测试)。对9名报告伤害的参与者进行了深入访谈,了解他们在一项探索性子研究中的经历;对定性数据进行了叙述性分析。
结果:基线:主要是顺式MSM,90%白色,88%的同性恋47%的大学教育和7%的当前/以前的暴露前预防(PrEP)用户。最终调查回复率为:nBT=26%(1056/4062),BT=45%(1674/3741),nRT=41%(471/1147),RT=50%(581/1161)。伤害很少见,在出口调查中报告了4%(n=138/3691),在其他研究调查中发现了另外两个假阳性结果。1%的人报告对BT的人际关系和福祉造成伤害,nRT和RT相结合。在所有的武器组合中,有1%(n=54/3678)被压力或被说服进行检测,0.7%(n=34/4665)被报告假阳性结果.定性分析揭示了试剂盒本身的危害(技术危害),干预(干预危害)或来自参与者的社会背景(社会紧急危害)。干预和社会紧急危害并没有降低HIVST的可接受性,而技术危害确实如此。
结论:HIVST的危害很少见,但在HIVST扩大规模时,应考虑将遭受危害的个体与社会心理支持联系起来的策略。
背景:ISRCTN20312003。
The potential of HIV self-testing (HIVST) to cause harm is a concern hindering widespread implementation. The aim of this paper is to understand the relationship between HIVST and harm in SELPHI (An HIV Self-testing Public Health Intervention), the largest randomised trial of HIVST in a high-income country to date.
10 111 cis and trans men who have sex with men (MSM) recruited online (geolocation social/sexual networking apps, social media), aged 16+, reporting previous anal intercourse and resident in England or Wales were first randomised 60/40 to baseline HIVST (baseline testing, BT) or not (no baseline testing, nBT) (randomisation A). BT participants reporting negative baseline test, sexual risk at 3 months and interest in further HIVST were randomised to three-monthly HIVST (repeat testing, RT) or not (no repeat testing, nRT) (randomisation B). All received an exit survey collecting data on harms (to relationships, well-being, false results or being pressured/persuaded to test). Nine participants reporting harm were interviewed in-depth about their experiences in an exploratory substudy; qualitative data were analysed narratively.
Baseline: predominantly cis MSM, 90% white, 88% gay, 47% university educated and 7% current/former pre-exposure prophylaxis (PrEP) users. Final survey response rate was: nBT=26% (1056/4062), BT=45% (1674/3741), nRT=41% (471/1147), RT=50% (581/1161).Harms were rare and reported by 4% (n=138/3691) in exit surveys, with an additional two false positive results captured in other study surveys. 1% reported harm to relationships and to well-being in BT, nRT and RT combined. In all arms combined, being pressured or persuaded to test was reported by 1% (n=54/3678) and false positive results in 0.7% (n=34/4665).Qualitative analysis revealed harms arose from the kit itself (technological harms), the intervention (intervention harms) or from the social context of the participant (socially emergent harms). Intervention and socially emergent harms did not reduce HIVST acceptability, whereas technological harms did.
HIVST harms were rare but strategies to link individuals experiencing harms with psychosocial support should be considered for HIVST scale-up.
ISRCTN20312003.