Jones Deborah, Peltzer Karl, Weiss Stephen M, Sifunda Sibusiso, Dwane Ntabozuko, Ramlagan Shandir, Cook Ryan, Matseke Gladys, Maduna Vincent, Spence Andrew
HIV/AIDS, STIs and TB (HAST) Research Programme, Human Sciences Research Council (HSRC), Private Bag X41, Pretoria 0001, South Africa.
Trials. 2014 Oct 27;15:417. doi: 10.1186/1745-6215-15-417.
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.
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.
ClinicalTrials.gov NCT02085356 (registration date: 10 March 2014).
2010年在南非农村地区，在社区卫生中心寻求产前护理的HIV阳性孕妇中，只有三分之二充分利用了“预防母婴传播”（PMTCT）服务。研究普遍支持男性参与以促进PMTCT，但这种参与的性质和影响尚不清楚且未经检验。此外，耻辱感、信息披露和亲密伴侣暴力对PMTCT服务的接受和持续护理构成了重大障碍，这表明男性参与可能是降低婴儿HIV感染率“必要但不充分”的条件。本研究是在南非姆普马兰加省开展的一项成功的由美国总统艾滋病紧急救援计划（PEPFAR）支持的PMTCT夫妇干预试点研究的基础上进行扩展，目标是HIV阳性孕妇及其伴侣，主要目的是确定男性伴侣的参与加上行为干预是否会显著降低婴儿HIV感染率。
方法/设计：该研究采用整群随机对照设计，招募了两组HIV阳性孕妇，她们来自12个随机分配的社区卫生中心（CHC）（6个实验组，6个对照组）。这两组将包括未带男性伴侣前来就诊的女性（n = 720）和带男性伴侣前来就诊的女性（n = 720对夫妇），以便确定男性参与本身的影响，或与行为PMTCT干预相结合，是否能在产前、产时和产后显著降低婴儿HIV感染率。
我们的目标是通过让女性和夫妇参与一项为期六节的、有对照的产前和产后降低风险及促进PMTCT的干预措施，解决阻碍PMTCT的因素（如耻辱感、信息披露、亲密伴侣暴力、沟通、婴儿喂养方式和更安全的受孕），从而将姆普马兰加省目前的PMTCT参与率（69%）显著提高到90%至95%，这些阻碍因素使女性和男性无法利用为他们及其婴儿提供的治疗机会。基于我们试点研究令人鼓舞的初步结果，CHC成功采用该项目可能对控制南非农村最脆弱人群（HIV阳性孕妇及其婴儿）中的疫情产生重大公共卫生政策影响。
ClinicalTrials.gov NCT02085356（注册日期：2014年3月10日）。
