Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi

撒哈拉以南非洲的孕产妇和围产期死亡率是世界上最高的，占世界人口的三分之二。 新的艾滋病毒感染和1/4的早产。产前护理是进入卫生系统的切入点 为许多妇女提供了一个独特的机会来提供救生监测。然而，供应商 短缺、护理质量低以及未能参加所有建议的访问意味着， 产前保健没有实现。迫切需要测试新的干预措施，以减少健康风险， 母亲和孩子小组产前护理是一种变革性的护理模式，提供积极的怀孕 经验，有效利用提供者的时间，并改善围产期和艾滋病毒相关的结果。团体中的妇女 产前保健由同一个提供者在一组8-12名妇女中进行2小时的访问， 怀孕妇女进行自我评估，简短地咨询助产士，并进行80-90分钟的 以游戏及角色扮演为主题的互动式健康推广活动。妇女与助产士建立关系， 对方.在美国的一项随机临床试验（RCT）中，小组护理改善了早产率， 出勤率，对护理的满意度，母乳喂养的做法，安全性行为和计划生育的吸收。 我们在马拉维和坦桑尼亚的随机试验取得了可喜的成果。接受集体护理的妇女比 常规护理完成≥4次产前访视（94% vs 58%）。他们的伴侣更有可能接受艾滋病毒检测 怀孕期间（51%对27%）。我们建立了一个严格的随机对照试验， 尽管供应商短缺，但仍具有高保真度。下一步是充分把握的有效性试验。 马拉维是一个特别合适的地点，因为它有世界上最高的早产率（18%）和高艾滋病毒 患病率（全国10%，研究中心16%）。我们使用混合设计同时进行 有效性随机对照试验，采用个体水平随机化，并检查6家诊所的实施过程， 马拉维布兰太尔区。目的1.通过6个月的产前集体保健效果评价 产后我们假设，与常规护理相比，集体护理中的妇女及其婴儿的 发病率和死亡率以及艾滋病毒预防的积极成果。我们测试目标1假设使用多- 使用重复调查和健康记录的数据建立层次模型。目标2是确定临床水平 实施成功的程度以及与每个诊所和整个诊所的成功相关的背景因素 诊所。分析使用病例内和病例间矩阵。这项高影响力的研究涉及三个全球健康 这是一个优先事项，包括孕产妇和婴儿死亡率以及艾滋病毒预防，影响到马拉维所有育龄妇女。 卫生部大力支持这一项目;结果将有助于他们决定是否扩大这一项目 集体护理创新模式。负面结果将避免在无效护理上的支出。积极的结果将 提供在全国和其他资源匮乏国家采用集体产前护理所需的证据。

Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for 2/3 of new HIV infections and 1/4 of preterm births. Antenatal (prenatal) care is the entry point into the health system for many women and offers a unique opportunity to provide life-saving monitoring. However, provider shortages, low quality of care and failure to attend all recommended visits mean that the potential benefits of antenatal care are not realized. There is an urgent need to test novel interventions to reduce health risks for mother and child. Group antenatal care is a transformative model of care that provides a positive pregnancy experience, uses provider time efficiently, and improves perinatal and HIV-related outcomes. Women in group antenatal care have 2-hour visits with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women conduct self-assessments, briefly consult the midwife, and meet for 80-90 minutes of interactive health promotion enlivened by games and role-plays. Women form relationships with midwives and each other. In a US randomized clinical trial (RCT), group care improved prematurity rates, antenatal care attendance, satisfaction with care, breastfeeding practices, safer sex behaviors, and uptake of family planning. Our randomized pilot in Malawi and Tanzania had promising outcomes. More women in group care than in usual care completed ≥4 antenatal visits (94% vs 58%). Their partners were more likely to be tested for HIV during pregnancy (51% vs. 27%). We established that group antenatal care can be offered in a rigorous RCT with high fidelity despite provider shortages. The next step is an adequately powered effectiveness trial. Malawi is an especially appropriate site because it has the world's highest prematurity rate (18%) and high HIV prevalence (10% nationally, 16% at the study site). We use a hybrid design to simultaneously conduct an effectiveness RCT with individual-level randomization and examine implementation processes at 6 clinics in Blantyre District, Malawi. Aim 1 is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that compared to usual care, women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We test Aim 1 hypotheses using multi- level hierarchical models using data from repeated surveys and health records. Aim 2 is to identify clinic-level degree of implementation success and contextual factors associated with success for each clinic and across clinics. Analyses use within and across-case matrices. This high-impact study addresses three global health priorities, maternal and infant mortality and HIV prevention, that affect all women of childbearing age in Malawi. The Ministry of Health strongly supports this project; results will help them decide whether to scale-up this innovative model of group care. Negative results will avoid spending on ineffective care. Positive results will provide evidence needed to adopt group antenatal care nationally and in other low-resource countries.