Cowan James F, Micek Mark, Cowan Jessica F Greenberg, Napúa Manuel, Hoek Roxanne, Gimbel Sarah, Gloyd Stephen, Sherr Kenneth, Pfeiffer James T, Chapman Rachel R
Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St.,, Seattle, WA, 98195, USA.
Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA.
Implement Sci. 2015 Apr 30;10:61. doi: 10.1186/s13012-015-0249-6.
Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended "Option B+" strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy.
This study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care.
This pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa.
ClinicalTrials.gov: NCT02371265.
尽管有有效的预防策略且对全球卫生的投入不断增加，但艾滋病毒母婴传播（MTCT）在全球仍是一个重大问题，尤其是在撒哈拉以南非洲地区。2012年，莫桑比克有9.4万名艾滋病毒呈阳性的孕妇。这些孕妇中约15%将艾滋病毒传染给了她们的新生儿，导致当年近1.4万名儿童感染新的艾滋病毒。为解决这一问题，2013年，莫桑比克卫生部实施了世界卫生组织推荐的“B+方案”策略，即所有新诊断出的艾滋病毒呈阳性的孕妇在确诊后无论CD4细胞计数多少均被建议立即开始联合抗逆转录病毒疗法（ART），并终身持续治疗。鉴于在撒哈拉以南非洲地区对“B+方案”的经验有限，很少有严格的实用试验研究这种新的治疗策略。
本研究采用了初步的形成性研究过程，包括患者和医疗服务提供者访谈、焦点小组讨论、劳动力评估、价值流映射以及商品使用评估，以了解当前“B+方案”护理流程的优势和劣势。形成性研究旨在指导确定关键工作流程改进的优先级并制定强化的依从性和保留方案。这两个部分被整合到一个明确的干预措施中，利用阶梯楔形随机对照试验研究设计在六个卫生设施中实施和评估。该试验的总体目标是在莫桑比克中部开发并测试一种试点干预措施，以高保真度实施新的“B+方案”指南，并提高目标产前诊所（ANC）中在分娩前开始接受抗逆转录病毒治疗并持续接受护理的艾滋病毒呈阳性孕妇的比例。
这项实用研究采用的研究策略有可能切实改善莫桑比克中部的 “B+方案” 护理流程，并减少艾滋病毒母婴传播。该试验旨在确定可整合到明确干预措施中的关键低成本改进策略。如果这种干预措施有可衡量的影响，它可以迅速推广到莫桑比克和撒哈拉以南非洲的其他产前诊所。
ClinicalTrials.gov：NCT02371265。
