The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Central Clinical School, Monash University, Melbourne, VIC, Australia; Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.
Lancet HIV. 2017 Jun;4(6):e241-e250. doi: 10.1016/S2352-3018(17)30023-1. Epub 2017 Feb 17.
Frequent testing of individuals at high risk of HIV is central to current prevention strategies. We aimed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men, with a particular focus on men who delayed testing or had never been tested before.
In this randomised trial, HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia. Enrolled participants were randomly assigned (1:1) to the intervention (free HIV self-testing plus facility-based testing) or standard care (facility-based testing only). Participants completed a brief online questionnaire every 3 months, which collected the number of self-tests used and the number and location of facility-based tests, and HIV testing was subsequently sourced from clinical records. The primary outcome of number of HIV tests over 12 months was assessed overall and in two strata: recent (last test ≤2 years ago) and non-recent (>2 years ago or never tested) testers. A statistician who was masked to group allocation analysed the data; analyses included all participants who completed at least one follow-up questionnaire. After the 12 month follow-up, men in the standard care group were offered free self-testing kits for a year. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001236785.
Between Dec 1, 2013, and Feb 5, 2015, 182 men were randomly assigned to self-testing, and 180 to standard care. The analysis population included 178 (98%) men in the self-testing group (174 person-years) and 165 (92%) in the standard care group (162 person-years). Overall, men in the self-testing group had 701 HIV tests (410 self-tests; mean 4·0 tests per year), and men in the standard care group had 313 HIV tests (mean 1·9 tests per year); rate ratio (RR) 2·08 (95% CI 1·82-2·38; p<0·0001). Among recent testers, men in the self-testing group had 627 tests (356 self-tests; mean 4·2 per year), and men in the standard care group had 297 tests (mean 2·1 per year); RR 1·99 (1·73-2·29; p<0·0001). Among non-recent testers, men in the self-testing group had 74 tests (54 self-tests; mean 2·8 per year), and men in the standard care group had 16 tests (mean 0·7 per year); RR 3·95 (2·30-6·78; p<0·0001). The mean number of facility-based HIV tests per year was similar in the self-testing and standard care groups (mean 1·7 vs 1·9 per year, respectively; RR 0·86, 0·74-1·01; p=0·074). No serious adverse events were reported during follow-up.
HIV self-testing resulted in a two times increase in frequency of testing in gay and bisexual men at high risk of infection, and a nearly four times increase in non-recent testers, compared with standard care, without reducing the frequency of facility-based HIV testing. HIV self-testing should be made more widely available to help increase testing and earlier diagnosis.
The National Health and Medical Research Council, Australia.
对艾滋病毒高危个体进行频繁检测是当前预防策略的核心。我们旨在确定 HIV 自我检测是否会增加感染高风险的男同性恋和双性恋男性的检测频率，特别关注那些延迟检测或以前从未检测过的男性。
在这项随机试验中，我们在澳大利亚的三个临床和两个社区机构招募了报告过去 3 个月内无保护肛交或超过 5 名男性性伴侣的 HIV 阴性高危男同性恋和双性恋男性。入组的参与者被随机分配（1:1）至干预组（免费 HIV 自我检测加机构检测）或标准护理组（仅机构检测）。参与者每 3 个月完成一份简短的在线问卷，问卷收集了自我检测的使用次数以及机构检测的数量和地点，随后从临床记录中获取 HIV 检测信息。主要结局是在 12 个月内进行的 HIV 检测次数，总体和两个分层进行评估：最近（最后一次检测≤2 年前）和非最近（>2 年前或从未检测过）检测者。一位对分组分配不知情的统计学家分析了数据；分析包括至少完成一次随访问卷的所有参与者。在 12 个月的随访后，标准护理组的男性获得了为期一年的免费自我检测包。这项试验在澳大利亚和新西兰临床试验注册中心注册，编号为 ACTRN12613001236785。
在 2013 年 12 月 1 日至 2015 年 2 月 5 日期间，有 182 名男性被随机分配到自我检测组，180 名男性被分配到标准护理组。分析人群包括自我检测组的 178 名（98%）男性（174 人年）和标准护理组的 165 名（92%）男性（162 人年）。总体而言，自我检测组的男性进行了 701 次 HIV 检测（410 次自我检测；每年平均 4.0 次检测），标准护理组的男性进行了 313 次 HIV 检测（每年平均 1.9 次检测）；率比（RR）为 2.08（95%CI 1.82-2.38；p<0.0001）。在最近检测者中，自我检测组的男性进行了 627 次检测（356 次自我检测；每年平均 4.2 次检测），标准护理组的男性进行了 297 次检测（每年平均 2.1 次检测）；RR 为 1.99（1.73-2.29；p<0.0001）。在非最近检测者中，自我检测组的男性进行了 74 次检测（54 次自我检测；每年平均 2.8 次检测），标准护理组的男性进行了 16 次检测（每年平均 0.7 次检测）；RR 为 3.95（2.30-6.78；p<0.0001）。自我检测组和标准护理组每年平均机构 HIV 检测次数相似（分别为每年平均 1.7 次和 1.9 次；RR 0.86，0.74-1.01；p=0.074）。在随访期间，没有报告严重不良事件。
与标准护理相比，HIV 自我检测使高危感染男同性恋和双性恋男性的检测频率增加了两倍，使非最近检测者的检测频率增加了近四倍，而不会降低机构 HIV 检测的频率。应更广泛地提供 HIV 自我检测，以帮助增加检测和早期诊断。
澳大利亚国家卫生和医学研究委员会。
