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在马拉维的 B+方案中招募男性伴侣参与夫妇 HIV 检测和咨询:一项非盲随机对照试验。

Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial.

机构信息

UNC Project, University of North Carolina at Chapel Hill, Lilongwe, Malawi; School of Medicine, University of North Carolina at Chapel Hill, NC, USA.

UNC Project, University of North Carolina at Chapel Hill, Lilongwe, Malawi.

出版信息

Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.

DOI:10.1016/S2352-3018(15)00182-4
PMID:26520928
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4656790/
Abstract

BACKGROUND

Couples HIV testing and counselling (CHTC) is encouraged but is not widely done in sub-Saharan Africa. We aimed to compare two strategies for recruiting male partners for CHTC in Malawi's option B+ prevention of mother-to-child transmission programme: invitation only versus invitation plus tracing and postulated that invitation plus tracing would be more effective.

METHODS

We did an unblinded, randomised, controlled trial assessing uptake of CHTC in the antenatal unit at Bwaila District Hospital, a maternity hospital in Lilongwe, Malawi. Women were eligible if they were pregnant, had just tested HIV-positive and therefore could initiate antiretroviral therapy, had not yet had CHTC, were older than 18 years or 16-17 years and married, reported a male sex partner in Lilongwe, and intended to remain in Lilongwe for at least 1 month. Women were randomly assigned (1:1) to either the invitation only group or the invitation plus tracing group with block randomisation (block size=4). In the invitation only group, women were provided with an invitation for male partners to present to the antenatal clinic. In the invitation plus tracing group, women were provided with the same invitation, and partners were traced if they did not present. When couples presented they were offered pregnancy information and CHTC. Women were asked to attend a follow-up visit 1 month after enrolment to assess social harms and sexual behaviour. The primary outcome was the proportion of couples who presented to the clinic together and received CHTC during the study period and was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, number NCT02139176.

FINDINGS

Between March 4, 2014, and Oct 3, 2014, 200 HIV-positive pregnant women were enrolled and randomly assigned to either the invitation only group (n=100) or the invitation plus tracing group (n=100). 74 couples in the invitation plus tracing group and 52 in the invitation only group presented to the clinic and had CHTC (risk difference 22%, 95% CI 9-35; p=0.001) during the 10 month study period. Of 181 women with follow-up data, two reported union dissolution, one reported emotional distress, and none reported intimate partner violence. One male partner, when traced, was confused about which of his sex partners was enrolled in the study. No other adverse events were reported.

INTERPRETATION

An invitation plus tracing strategy was highly effective at increasing CHTC uptake. Invitation plus tracing with CHTC could have many substantial benefits if brought to scale.

FUNDING

National Institutes of Health.

摘要

背景

在撒哈拉以南非洲地区,鼓励夫妻双方进行艾滋病毒检测和咨询(CHTC),但并未广泛实施。我们旨在比较两种在马拉维的 B+预防母婴传播方案中招募男性伴侣进行 CHTC 的策略:仅邀请与邀请加追踪,并假设邀请加追踪会更有效。

方法

我们进行了一项非盲、随机、对照试验,评估了在马拉维利隆圭的 Bwaila 区医院产前病房中,对 CHTC 的接受情况。如果女性怀孕、刚刚检测出 HIV 阳性且因此可以开始接受抗逆转录病毒治疗、尚未接受 CHTC、年龄在 18 岁以上或 16-17 岁且已婚、报告在利隆圭有男性性伴侣,并且打算在利隆圭至少停留 1 个月,则符合条件。女性以 1:1 的比例随机分配(随机分组大小=4)至仅邀请组或邀请加追踪组。在仅邀请组中,女性会收到一份邀请男性伴侣到产前诊所就诊的邀请函。在邀请加追踪组中,女性会收到相同的邀请函,如果伴侣未出现,则会对其进行追踪。当夫妻双方出现时,他们会获得怀孕信息和 CHTC。女性会被要求在入组后 1 个月进行随访,以评估社会危害和性行为。主要结局是在研究期间共同到诊所就诊并接受 CHTC 的夫妇比例,并在所有随机分配的参与者中进行评估。这项研究在 ClinicalTrials.gov 注册,编号为 NCT02139176。

结果

2014 年 3 月 4 日至 2014 年 10 月 3 日期间,共有 200 名 HIV 阳性孕妇入组并随机分配至仅邀请组(n=100)或邀请加追踪组(n=100)。在 10 个月的研究期间,邀请加追踪组中有 74 对夫妇和仅邀请组中有 52 对夫妇到诊所就诊并接受了 CHTC(风险差异 22%,95%CI 9-35;p=0.001)。在有随访数据的 181 名女性中,有 2 人报告离婚,1 人报告情绪困扰,无人报告亲密伴侣暴力。一名被追踪的男性伴侣对哪个性伴侣参加了研究感到困惑。没有其他不良事件报告。

解释

邀请加追踪策略在提高 CHTC 接受度方面非常有效。如果将其推广到更大的规模,邀请加追踪和 CHTC 可能会带来许多实质性的好处。

资金来源

美国国立卫生研究院。

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