Jamil Muhammad S, Prestage Garrett, Fairley Christopher K, Smith Kirsty S, Kaldor John M, Grulich Andrew E, McNulty Anna M, Chen Marcus, Holt Martin, Conway Damian P, Wand Handan, Keen Phillip, Batrouney Colin, Bradley Jack, Bavinton Benjamin R, Ryan Dermot, Russell Darren, Guy Rebecca J
The Kirby Institute, UNSW Australia, Sydney, NSW, Australia.
Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, VIC, Australia.
BMC Infect Dis. 2015 Dec 10;15:561. doi: 10.1186/s12879-015-1300-6.
Gay and bisexual men (GBM) are a major risk group for HIV acquisition, yet the majority of higher-risk GBM test for HIV less often than recommended (3-6 monthly). HIV self-testing has the potential to increase testing frequency and improve awareness of personal HIV status. HIV self-tests have been approved in some countries, however there are concerns whether self-testing would increase HIV testing frequency enough to compensate for the reduced sensitivity of self-tests in early infection. We describe here a randomised controlled trial to assess the effectiveness of self-testing in increasing HIV testing frequency among higher-risk GBM, and its acceptability.
METHODS/DESIGN: Participants are higher-risk HIV negative GBM (>5 partners or condomless anal intercourse in previous 3 months; n = 350), including 50 GBM who tested for HIV over two years ago or never tested before ('infrequent-testers'). Participants are recruited from sexual health clinics and community-based organisations, and randomised 1:1 to either self-testing or standard-care (routine clinic-based testing) arms. The trial employs a wait-list control design: participants in the standard-care arm switch to self-testing arm in the second year, and gain access to self-test kits. Participants in the self-testing arm receive four oral-fluid self-test kits at enrolment, with additional kits provided on request. Demographics, sexual behaviour and HIV testing preferences are collected at baseline, and the frequency and pattern of HIV and sexually transmissible infection (STI) testing is collected via online 3-monthly questionnaires. The acceptability of self-testing is assessed at 12 months via an online questionnaire and in-depth interviews. A 24-h telephone support is provided, with expedited follow-up of those with reactive self-test results. The primary outcome is HIV testing frequency (mean number of HIV tests per person) over 12 months, and the secondary outcomes are: mean number of STI tests (chlamydia, gonorrhoea, syphilis) per person; reasons for HIV testing; and acceptability of HIV self-testing.
This is the first trial to evaluate the use of self-testing among GBM in Australia, and the first internationally among infrequent testers. The study will provide evidence on whether self-testing increases HIV testing frequency, and its acceptability among GBM. The findings will improve our understanding of self-testing patterns, and whether GBM supplement or replace their existing testing routine.
Australian and New Zealand Clinical Trial Registration number: ACTRN12613001236785 , registered on November 12, 2013.
男同性恋者和双性恋男性（GBM）是感染艾滋病毒的主要风险群体，但大多数高危GBM进行艾滋病毒检测的频率低于推荐频率（每3 - 6个月一次）。艾滋病毒自我检测有可能提高检测频率并增强对个人艾滋病毒感染状况的认知。艾滋病毒自我检测已在一些国家获得批准，然而，人们担心自我检测是否能充分提高艾滋病毒检测频率，以弥补早期感染时自我检测灵敏度较低的问题。我们在此描述一项随机对照试验，以评估自我检测在提高高危GBM艾滋病毒检测频率方面的有效性及其可接受性。
方法/设计：参与者为高危艾滋病毒阴性GBM（过去3个月内有超过5个性伴侣或有无保护肛交行为；n = 350），其中包括50名在两年多以前进行过艾滋病毒检测或从未检测过的GBM（“不常检测者”）。参与者从性健康诊所和社区组织招募，并按1:1随机分为自我检测组或标准护理组（基于诊所的常规检测）。该试验采用等待名单对照设计：标准护理组的参与者在第二年转至自我检测组，并可获得自我检测试剂盒。自我检测组的参与者在入组时会收到四个口腔液自我检测试剂盒，如有需要可额外提供。在基线时收集人口统计学、性行为和艾滋病毒检测偏好信息，并通过每3个月一次的在线问卷收集艾滋病毒和性传播感染（STI）检测的频率和模式。通过在线问卷和深入访谈在12个月时评估自我检测的可接受性。提供24小时电话支持，对自我检测结果呈阳性的参与者进行快速随访。主要结局是12个月内的艾滋病毒检测频率（每人的艾滋病毒检测平均次数），次要结局包括：每人的性传播感染检测（衣原体、淋病、梅毒）平均次数；艾滋病毒检测的原因；以及艾滋病毒自我检测的可接受性。
这是澳大利亚首次评估GBM中自我检测使用情况的试验，也是国际上首次针对不常检测者进行的此类试验。该研究将提供证据，证明自我检测是否能提高艾滋病毒检测频率及其在GBM中的可接受性。研究结果将增进我们对自我检测模式的理解，以及GBM是否补充或取代其现有的检测常规。
澳大利亚和新西兰临床试验注册号：ACTRN12613001236785，于2013年11月12日注册。
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