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首页> 外文期刊>Trials >Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial
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Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial

机译：为南非夫妇实施母婴传播的全面预防和艾滋病毒预防：一项随机对照试验的研究方案

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Background In rural South Africa, only two-thirds of HIV-positive pregnant women seeking antenatal care at community health centers took full advantage of ‘prevention of mother-to-child transmission’ (PMTCT) services in 2010. Studies generally support male involvement to promote PMTCT, but the nature and impact of that involvement is unclear and untested. Additionally, stigma, disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care, suggesting that male involvement may be ‘necessary, but not sufficient’ to reduce infant HIV incidence. This study expands on a successful United States President's Emergency Plan for AIDS Relief (PEPFAR)-supported PMTCT couples intervention pilot study conducted in the Mpumalanga province, targeting HIV-positive pregnant women and their partners, the primary objective being to determine whether male partner involvement plus a behavioral intervention will significantly reduce infant HIV incidence. Methods/design The study follows a cluster randomized controlled design enrolling two cohorts of HIV-positive pregnant women recruited from 12 randomly assigned Community Health Centers (CHC) (six experimental, six control). The two cohorts will consist of women attending without their male partners (n = 720) and women attending with their male partners (n = 720 couples), in order to determine whether the influence of male participation itself, or combined with a behavioral PMTCT intervention, can significantly reduce infant HIV infection ante-, peri- and postnatally. Discussion It is our intention to significantly increase PMTCT participation from current levels (69%) in the Mpumalanga province to between 90 and 95% through engaging women and couples in a controlled, six session ante- and postnatal risk-reducing and PMTCT promotion intervention addressing barriers to PMTCT (such as stigma, disclosure, intimate partner violence, communication, infant feeding practices and safer conception) that prevent women and men from utilizing treatment opportunities available to them and their infants. Based upon the encouraging preliminary results from our pilot study, successful CHC adoption of the program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa: HIV-positive pregnant women and their infants. Trial registration ClinicalTrials.gov NCT02085356 (registration date: 10 March 2014).
机译：背景资料在南非农村地区，2010年只有三分之二的在社区卫生中心寻求产前保健的HIV阳性孕妇充分利用了“预防母婴传播”（PMTCT）服务。研究普遍支持男性参与促进PMTCT，但这种参与的性质和影响尚不清楚，也未经检验。此外，污名，披露和亲密伴侣的暴力行为严重阻碍了PMTCT的使用和护理，这表明男性参与可能是“必要但不充分”以降低婴儿HIV发生率。这项研究是在成功的美国总统艾滋病紧急救援计划（PEPFAR）支持下在姆普马兰加省开展的PMTCT夫妇干预试验研究的基础上进行的，该研究针对艾滋病毒呈阳性的孕妇及其伴侣，主要目的是确定男性伴侣是否参与加上行为干预将大大降低婴儿艾滋病毒的发病率。方法/设计这项研究遵循一项随机分组对照设计，该设计招募了从12个随机分配的社区卫生中心（CHC）招募的两个队列中的HIV阳性孕妇（六个实验组，六个对照组）。这两个队列将由没有男性伴侣参加的妇女（n = 720）和有男性伴侣参加的妇女（n = 720对夫妇）组成，以确定男性参与本身的影响，还是与行为PMTCT干预相结合可以大大减少婴儿在出生前，围产期和产后的HIV感染。讨论我们打算通过让妇女和夫妇参与有控制的，六次产前和产后降低风险和PMTCT促进干预措施，将姆普马兰加省的PMTCT参与率从目前的水平（69％）大幅提高到90％至95％预防PMTCT的障碍（例如污名，公开，伴侣之间的亲密暴力，沟通，婴儿喂养方式和更安全的受孕）阻碍了男女利用其及其婴儿可获得的治疗机会。根据我们的先导研究令人鼓舞的初步结果，成功实施CHC计划可能对遏制南非农村地区最脆弱人群（艾滋病毒呈阳性的孕妇及其婴儿）中的流行病具有重大的公共卫生政策影响。试用注册ClinicalTrials.gov NCT02085356（注册日期：2014年3月10日）。

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