Zambart, University of Zambia, Lusaka, Zambia.
Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
Lancet HIV. 2019 Feb;6(2):e81-e92. doi: 10.1016/S2352-3018(18)30258-3. Epub 2018 Dec 21.
BACKGROUND: The HPTN 071 (PopART) cluster-randomised trial provided door-to-door HIV testing services to a large proportion of individuals residing in 21 intervention communities in Zambia and South Africa from 2014 to 2017 and reached the UNAIDS first 90 target among women in Zambia, yet gaps remained among men and young adults. This cluster-randomised study nested in the HPTN 071 (PopART) trial sought to increase knowledge of HIV status across all groups by offering the choice of oral HIV self-testing in addition to routine door-to-door HIV testing services. METHODS: We nested this cluster-randomised trial in four HTPN 071 (PopART) intervention communities in northern Zambia. 66 zones (clusters) in these communities were randomly allocated (1:1) to either oral HIV self-testing plus routine door-to-door HIV testing services (HIV self-testing group) or the PopART standard of care of door-to-door HIV testing services alone (non- HIV self-testing group) over a 3-month period. All individuals aged 16 years or older were eligible for HIV testing. Randomisation was achieved by randomly selecting one allocation from a list of 10 000 possible allocations during a public ceremony. In HIV self-testing zones, trained lay-counsellors (known as community HIV care providers) visited households and offered eligible individuals the choice of HIV testing using HIV self-testing or routine door-to-door HIV testing services. For individuals aged 18 years or older whose partner was absent during the household visit, an HIV self-test kit could be left for secondary distribution to the absent partner. The primary outcome was knowledge of HIV status (defined as self-reporting HIV positive to the community HIV care providers or accepting an offer of HIV testing services). Outcomes were measured among households that were first visited, and individuals first enumerated as a household member during the HIV self-testing intervention period. We analysed data at the individual level using population-average logistic regression models, accounting for clustering of outcomes by zone, to estimate the effect of the intervention. This trial is registered with ClinicalTrials.gov, number NCT02994329. FINDINGS: Between Feb 1, and April 30, 2017, the community HIV care providers enumerated 13 267 eligible individuals in the HIV self-testing group and 13 706 in the non-HIV self-testing group. After intervention implementation, 9027 (68%) of 13 267 in the HIV self-testing group had knowledge of HIV status compared with 8952 (65%) of 13 706 in the non-HIV self-testing group (adjusted odds ratio 1·30, 95% CI 1·03-1·65; p=0·03). The effect differed by sex (p=0·01). Among men, knowledge of HIV status was higher in the HIV self-testing group than in the non-HIV self-testing group (3843 [60%] of 6368 vs 3571 [55%] of 6486; adjusted odds ratio 1·31, 95% CI 1·07-1·60; p=0·01). There was no evidence of a between-group difference among female participants. INTERPRETATION: Providing a choice of HIV self-testing during delivery of door-to-door HIV testing services increased knowledge of HIV status, driven by an effect among men. Lay counsellors have a vital role to play in adapting HIV self-testing interventions to local context. FUNDING: The International Initiative for Impact Evaluation (3ie), the Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and the President's Emergency Plan for AIDS Relief.
背景:HPTN 071(PopART)集群随机试验于 2014 年至 2017 年向赞比亚和南非的 21 个干预社区的大部分居民提供了上门艾滋病毒检测服务,并在赞比亚实现了艾滋病规划署首次 90 目标,即 90%的艾滋病毒感染者知晓其艾滋病毒感染状况,但男性和青年成年人仍存在差距。这项在 HPTN 071(PopART)试验中嵌套的集群随机研究旨在通过提供口服艾滋病毒自我检测服务,除了常规的上门艾滋病毒检测服务之外,增加所有人群对艾滋病毒状况的了解。
方法:我们将这项集群随机试验嵌套在赞比亚北部的四个 HPTN 071(PopART)干预社区中。这些社区的 66 个区(集群)被随机分配(1:1)接受口服艾滋病毒自我检测加常规上门艾滋病毒检测服务(艾滋病毒自我检测组)或 PopART 标准的仅上门艾滋病毒检测服务(非艾滋病毒自我检测组),为期 3 个月。所有年龄在 16 岁或以上的人都有资格接受艾滋病毒检测。随机化是通过在一次公开仪式上从 10000 个可能的分配中随机选择一个分配来实现的。在艾滋病毒自我检测区,经过培训的准专业人员(称为社区艾滋病毒护理提供者)访问家庭,并为符合条件的个人提供选择艾滋病毒检测的机会,使用艾滋病毒自我检测或常规上门艾滋病毒检测服务。对于在家庭访问期间其伴侣不在的 18 岁或以上的个人,可以留下一份艾滋病毒自我检测试剂盒,以便向不在的伴侣进行二次分发。主要结局是艾滋病毒状况的知识(定义为向社区艾滋病毒护理提供者自我报告艾滋病毒阳性或接受艾滋病毒检测服务的提供)。在第一次访问的家庭和在艾滋病毒自我检测干预期间首次被列为家庭成员的个人中测量结果。我们使用人群平均逻辑回归模型在个体水平上分析数据,通过区的结果聚类来估计干预的效果。这项试验在 ClinicalTrials.gov 上注册,编号为 NCT02994329。
结果:在 2017 年 2 月 1 日至 4 月 30 日期间,艾滋病毒自我检测组的社区艾滋病毒护理提供者共登记了 13267 名符合条件的个人,非艾滋病毒自我检测组登记了 13706 名符合条件的个人。在干预措施实施后,与非艾滋病毒自我检测组(65%,13706 名中有 8952 名)相比,艾滋病毒自我检测组中 9027 名(68%)的人了解艾滋病毒状况(调整后的优势比 1.30,95%CI 1.03-1.65;p=0.03)。这种效果因性别而异(p=0.01)。在男性中,艾滋病毒自我检测组中了解艾滋病毒状况的人数高于非艾滋病毒自我检测组(6368 名中的 3843 名[60%],6486 名中的 3571 名[55%];调整后的优势比 1.31,95%CI 1.07-1.60;p=0.01)。在女性参与者中没有证据表明两组之间存在差异。
解释:在提供上门艾滋病毒检测服务的同时提供艾滋病毒自我检测服务的选择,增加了艾滋病毒状况的了解,这主要是由于男性的影响。准专业人员在适应艾滋病毒自我检测干预措施以适应当地情况方面发挥着重要作用。
资金:国际影响评估倡议(3ie)、比尔和梅琳达盖茨基金会、国家过敏和传染病研究所、国家药物滥用研究所、国家心理健康研究所和总统艾滋病紧急救援计划。
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