Integration of postpartum healthcare services for HIV-infected women and their infants in South Africa: A randomised controlled trial.
Integration of postpartum healthcare services for HIV-infected women and their infants in South Africa: A randomised controlled trial.
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DOI：
10.1371/journal.pmed.1002547
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发表时间：
2018-03
期刊：
影响因子：
15.8
通讯作者：
Abrams EJ
中科院分区：
文献类型：
--
作者：
Myer L;Phillips TK;Zerbe A;Brittain K;Lesosky M;Hsiao NY;Remien RH;Mellins CA;McIntyre JA;Abrams EJ
随着全球感染艾滋病毒的妇女在怀孕期间开始终身抗逆转录病毒治疗的人数增加，人们对艾滋病毒服务的保留率低和产后期间坚持抗逆转录病毒治疗的情况不佳表示关切。我们研究了在南非开普敦将产后抗逆转录病毒治疗与母婴健康（MCH）服务中的婴儿随访相结合的影响。我们在年龄≥18岁的HIV阳性产后妇女中进行了一项随机试验，这些妇女在妊娠期间在当地产前保健诊所开始ART，并在产后6周前进行筛查时进行母乳喂养。我们比较了母亲及其婴儿的综合产后服务（MCH-ART干预）与当地标准护理（对照）-接受ART治疗的HIV阳性妇女产后立即转诊至一般成人ART服务，其婴儿接受单独的常规婴儿随访。通过医疗记录和试验测量访视收集评估数据，这些访视与两组中涉及的医疗服务分开安排和定位。主要试验结局是女性保留ART护理和病毒抑制（VS）的复合终点。（病毒载量< 50拷贝/ml）;次要结果包括任何母乳喂养和纯母乳喂养的持续时间、母婴艾滋病毒传播和婴儿死亡率。在2013年6月5日至2014年12月10日期间，共招募并随机分配了471对母婴（平均年龄：28.6岁; 18%为未经产; 57%为妊娠期新诊断为HIV;随机分配时ART使用的中位持续时间：18周）。在411名有主要终点数据的妇女（87%）中，77%的随机分配到MCH-ART干预组的妇女（n = 155）在产后12个月时实现了保留ART服务伴VS的主要复合结局，而56%的随机分配到对照组的妇女（n = 117）（绝对风险差异，0.21; 95% CI：0.12-0.30; p < 0.001）。根据人口统计学和临床特征，MCH-ART干预组中女性的护理保留率和VS改善的结果在参与者亚组中一致。随机分配到干预组的女性的任何母乳喂养和纯母乳喂养的中位持续时间长于对照组（分别为6.9个月与3.0个月，p = 0.006，3.0个月与1.4个月，p < 0.001）。对于婴儿，12个月大的总无艾滋病毒存活率为97%：艾滋病毒母婴传播率为1.2%（干预组和对照组分别有n = 4和n = 1例传播），婴儿死亡率为1.9%（干预组和对照组分别有6例和3例死亡），这些结果在试验组之间是相似的。对这些结果的解释应该由本研究在单个城市地区的位置以及自我-报告母乳喂养结果的性质。在这项研究中，我们发现，在产后期间将ART服务纳入妇幼保健平台是一种简单有效的干预措施，这应该被考虑用于改善艾滋病毒背景下的孕产妇和儿童结局。ClinicalTrials.gov NCT01933477.在一项随机对照试验中，Landon Myer及其同事研究了综合母婴健康干预对提供艾滋病毒护理的影响。全球每年有100多万感染艾滋病毒的育龄妇女怀孕，世界卫生组织的政策呼吁对所有感染艾滋病毒的孕妇和哺乳期妇女开始终身抗逆转录病毒治疗。然而，让感染艾滋病毒的妇女继续接受护理，坚持抗逆转录病毒疗法，并进行艾滋病毒抑制，是一项重大的公共卫生挑战，特别是在产后。将抗逆转录病毒治疗服务纳入现有的妇幼保健方案是一种干预办法，已被广泛讨论，以应对这一挑战，但这种办法尚未得到严格的评价。我们在南非开普敦工作，招募了471名产后立即感染艾滋病毒的哺乳期妇女，她们在怀孕期间开始接受抗逆转录病毒治疗。我们将母婴配对随机分配到普通成人ART诊所，他们的孩子被转介到儿童保健诊所（当地标准护理，作为对照条件），或在以妇幼保健为重点的ART服务中将母亲和婴儿一起护理（干预）。我们随访母婴对产后12个月，定期进行研究访视，这些访视的安排和进行独立于干预组或对照组的常规服务;在这些研究访视时进行批量病毒载量检测，与常规护理分开。我们发现，随机分配到综合护理干预的妇女在产后12个月内保持了更高水平的护理和病毒抑制。这种差异在所有妇女亚组中都观察到，包括年轻和老年妇女、新诊断为艾滋病毒的妇女、CD 4细胞计数较低的妇女以及分娩前使用抗逆转录病毒治疗时间较长的妇女。参与综合护理干预措施的妇女还报告说，母乳喂养婴儿的时间更长。婴儿死亡率和母婴艾滋病毒传播水平较低，干预组和对照组之间相似。将妇幼保健和抗逆转录病毒治疗服务结合起来，似乎能有效地使感染艾滋病毒的母亲继续得到护理和病毒得到抑制。综合服务还可能有助于延长母乳喂养时间，从而有助于儿童健康。这些数据应仔细解释，因为它们来自南非的一个地区，需要进一步研究，以检查调查结果对其他环境的普遍性。
As the number of HIV-infected women initiating lifelong antiretroviral therapy (ART) during pregnancy increases globally, concerns have emerged regarding low levels of retention in HIV services and suboptimal adherence to ART during the postpartum period. We examined the impact of integrating postpartum ART for HIV+ mothers alongside infant follow-up within maternal and child health (MCH) services in Cape Town, South Africa. We conducted a randomised trial among HIV+ postpartum women aged ≥18 years who initiated ART during pregnancy in the local antenatal care clinic and were breastfeeding when screened before 6 weeks postpartum. We compared an integrated postnatal service among mothers and their infants (the MCH-ART intervention) to the local standard of care (control)—immediate postnatal referral of HIV+ women on ART to general adult ART services and their infants to separate routine infant follow-up. Evaluation data were collected through medical records and trial measurement visits scheduled and located separately from healthcare services involved in either arm. The primary trial outcome was a composite endpoint of women’s retention in ART care and viral suppression (VS) (viral load < 50 copies/ml) at 12 months postpartum; secondary outcomes included duration of any and exclusive breastfeeding, mother-to-child HIV transmission, and infant mortality. Between 5 June 2013 and 10 December 2014, a total of 471 mother–infant pairs were enrolled and randomised (mean age, 28.6 years; 18% nulliparous; 57% newly diagnosed with HIV in pregnancy; median duration of ART use at randomisation, 18 weeks). Among 411 women (87%) with primary endpoint data available, 77% of women (n = 155) randomised to the MCH-ART intervention achieved the primary composite outcome of retention in ART services with VS at 12 months postpartum, compared to 56% of women (n = 117) randomised to the control arm (absolute risk difference, 0.21; 95% CI: 0.12–0.30; p < 0.001). The findings for improved retention in care and VS among women in the MCH-ART intervention arm were consistent across subgroups of participants according to demographic and clinical characteristics. The median durations of any breastfeeding and exclusive breastfeeding were longer in women randomised to the intervention versus control arm (6.9 versus 3.0 months, p = 0.006, and 3.0 versus 1.4 months, p < 0.001, respectively). For the infants, overall HIV-free survival through 12 months of age was 97%: mother-to-child HIV transmission was 1.2% overall (n = 4 and n = 1 transmissions in the intervention and control arms, respectively), and infant mortality was 1.9% (n = 6 and n = 3 deaths in the intervention and control arms, respectively), and these outcomes were similar by trial arm. Interpretation of these findings should be qualified by the location of this study in a single urban area as well as the self-reported nature of breastfeeding outcomes. In this study, we found that integrating ART services into the MCH platform during the postnatal period was a simple and effective intervention, and this should be considered for improving maternal and child outcomes in the context of HIV. ClinicalTrials.gov NCT01933477. In a randomised controlled trial, Landon Myer and colleagues study the effect of an integrated maternal and child health intervention on provision of HIV care. More than 1 million HIV-infected women of reproductive age become pregnant globally each year, and World Health Organization policies call for initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant and breastfeeding women. However, keeping HIV-infected women retained in care, adherent to ART, and with HIV viral suppression is a major public health challenge, particularly postpartum. Integration of ART services into existing maternal and child health (MCH) programmes is one intervention approach that has been widely discussed to address this challenge, but this approach has not been rigorously evaluated. Working in Cape Town, South Africa, we recruited immediately postpartum 471 HIV-infected, breastfeeding women who had initiated ART during pregnancy. We randomised mother–infant pairs to either referral to general adult ART clinics, with their children referred to child health clinics (the local standard of care, which acted as a control condition), or keeping mothers and infants in care together in an MCH-focused ART service (the intervention). We followed mother–infant pairs through 12 months postpartum with regular study visits that were scheduled and conducted independent of routine services in either the intervention or control arms; batched viral load testing was conducted at these study visits, separate from routine care. We found that women randomised to the integrated care intervention had higher levels of retention in care and viral suppression through 12 months postpartum. This difference was observed in all subgroups of women, including younger and older women, those newly diagnosed with HIV, those with lower CD4 cell counts, and those with longer durations of ART use before delivery. Women in the integrated care intervention also reported breastfeeding their infants for longer periods. Levels of infant mortality and mother-to-child HIV transmission were low and similar between the intervention and control arms. Integrating MCH and ART services appears effective in keeping HIV-infected mothers retained in care and virally suppressed. Integrated services may also contribute to longer durations of breastfeeding, and thus contribute to child health. These data should be interpreted carefully, as they come from a single part of South Africa, and further research is needed to examine the generalisability of the findings to other settings.
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DOI：
10.1097/qai.0000000000000771
发表时间：
2015-11-01
影响因子：
3.6
作者：
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10.1097/qai.0000000000001319
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