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

Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial.
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DOI:
10.1016/s2352-3018(15)00182-4
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发表时间:
2015-11
期刊:
The lancet. HIV
影响因子:
--
通讯作者:
Hosseinipour M
Hosseinipour M
中科院分区:
其他
文献类型:
--
作者:
Rosenberg NE;Mtande TK;Saidi F;Stanley C;Jere E;Paile L;Kumwenda K;Mofolo I;Ng'ambi W;Miller WC;Hoffman I;Hosseinipour M

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夫妇艾滋病毒检测和咨询(CHTC)受到鼓励,但在撒哈拉以南非洲尚未广泛开展。我们的目的是比较在马拉维B+预防母婴传播方案中为CHTC招募男性伴侣的两种策略:仅邀请与邀请加追踪,并假设邀请加追踪更有效。我们进行了一项非盲、随机、对照试验,评估了马拉维利隆圭的一家妇产医院Bwaila地区医院产前部门对CHTC的使用情况。符合条件的妇女包括:怀孕、艾滋病毒检测呈阳性,因此可以开始抗逆转录病毒治疗、尚未患有CHTC、年龄大于18岁或16-17岁、已婚、在利隆圭报告有男性性伴侣,并打算在利隆圭停留至少1个月。女性被随机分配(1:1)到仅邀请组或邀请加追踪组,随机分组(分组大小=4)。在只接受邀请的小组中,向妇女提供了邀请男性伴侣前往产前诊所的邀请函。在邀请加跟踪组中,向女性提供了同样的邀请,如果伴侣没有出席,则对其进行跟踪。当夫妇们到场时,他们得到了怀孕信息和CHTC。妇女被要求在入组1个月后参加随访,以评估社会危害和性行为。主要结果是在研究期间一起到诊所就诊并接受CHTC治疗的夫妇的比例,并对所有随机分配的参与者进行评估。本研究已在ClinicalTrials.gov注册,注册号NCT02139176。在2014年3月4日至2014年10月3日期间,200名艾滋病毒阳性孕妇被招募,并随机分配到仅邀请组(n=100)或邀请加追踪组(n=100)。在10个月的研究期间,邀请加追踪组和仅邀请组分别有74对夫妇到诊所就诊并患有CHTC(风险差异为22%,95% CI 9-35; p= 0.001)。在181名有随访数据的妇女中,两人报告婚姻破裂,一人报告情绪困扰,没有人报告亲密伴侣暴力。一位男性伴侣在被追踪时,对他的性伴侣中哪一位参与了这项研究感到困惑。没有其他不良事件的报道。邀请加追踪策略在增加CHTC吸收方面非常有效。邀请加上与卫生与健康中心的追踪,如果规模扩大,可以带来许多实质性的好处。
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. 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. 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. 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.