Feasibility and Cost of WHO PMTCT Option A vs. B in Rural and Urban Uganda

世卫组织预防母婴传播方案 A 与 B 在乌干达农村和城市的可行性和成本

• 批准号: 8579800
• 负责人: Philippa Musoke
• 金额: $ 0.5万
• 依托单位: MU-JHU CARE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-10-15 至 2016-10-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8579800
• 关键词: Feasibility; Cost; WHO; PMTCT; Option

ABSTRACT In Uganda as in other sub-Saharan African countries, the Ministry of Health is in the process of adopting and implementing the new WHO 2010 PMTCT Guidelines. These Guidelines recommend using one of two ARV prophylaxis options for HIV-infected pregnant women who do not need antiretroviral therapy (ART) for their own health. Option A consists of maternal AZT prophylaxis throughout pregnancy and delivery, complemented by daily nevirapine for the infant from birth until one week after complete cessation of breastfeeding. Option B consists of triple ART for the mother from the 14th gestational week until one week after complete cessation of breastfeeding complemented by daily nevirapine for the infant for six weeks. Both options significantly reduce the risk of mother-to-child HIV transmission (MTCT) of HIV but their advantages and disadvantages in terms of operational feasibility, safety and acceptability as well as costs have not been evaluated. The WHO guidelines state that "the choice for a preferred option should be made at a country level, after considering these advantages and disadvantages". The evidence needed to support such decision is presently lacking and critically needed for countries like Uganda that are trying to make informed choices about which option to roll out nationally. The overall goal of this operational research proposal is to compare the feasibility of delivering WHO PMTCT Options A and B in two urban Kampala hospitals and two rural hospitals in Uganda. We will enroll 600 eligible (CD4 >350) HIV- infected pregnant women into either option A or B for a total of 1,200 mother-infant pairs into the study. In each urban or rural area, one hospital will be assigned to option A and the other to Option B. In each hospital, 300 study participants will be enrolled and followed-up for 12 months post-partum. The primary aims of the study will be to compare options A and B implementation with regards to: Aim 1) maternal and infant PMTCT drug adherence measured by self report, pill counts and ARV drug detection in blood; Aim 2) maternal drug-associated severe adverse events and pregnancy outcomes; and infant safety; Aim 3) the cost-effectiveness of either option. The study will be powered to detect a difference of 10% or greater in drug adherence cumulatively and at four key time points in the cascade of PMTCT services, including the third trimester and three post-natal visits corresponding to the immunization and early infant HIV diagnosis schedules: 6 weeks post delivery, 6 months, and 12 months or at the time of breastfeeding cessation. Secondary endpoints will be to include vertical HIV transmission rates based on the presence of HIV DNA in infant blood at birth, 6 weeks of age, 6 months and 12 months of age; 12-month HIV-free survival and overall survival rates of HIV-exposed infants; and, incidence of subsequent pregnancies in the 12-month post-partum follow-up period. We will use focus group discussions and key informant interviews to assess the acceptability of either PMTCT option among HIV-infected mothers, service providers and community health leaders. The results of this study will provide critical evidence to inform operational decisions regarding the feasibility of the current WHO PMTCT recommendations in the context of resource-limited settings.

摘要 在乌干达和其他撒哈拉以南非洲国家一样，卫生部正在 通过并实施新的世卫组织2010年预防母婴传播准则。这些准则 建议对感染艾滋病毒的孕妇使用两种抗逆转录病毒药物预防方案之一， 不需要抗逆转录病毒疗法（ART）来保护自己的健康。选项A包括产妇 在整个妊娠和分娩期间预防AZT，并补充每日奈韦拉平， 婴儿从出生到完全停止母乳喂养后一周。选项B包括 母亲从妊娠第14周至完全停止后一周接受三次ART 母乳喂养的婴儿补充每日奈韦拉平六周。两个选项 显著降低艾滋病毒母婴传播的风险，但 在操作可行性、安全性和可接受性方面的利弊 因为费用尚未评估。世界卫生组织的指导方针指出，“选择首选的 应在考虑到这些优势后，在国家一级作出选择， 缺点”。支持这一决定所需的证据目前缺乏， 对于像乌干达这样的国家来说，他们需要做出明智的选择， 在全国推广 这项业务研究提案的总体目标是比较交付的可行性 世卫组织在坎帕拉两所城市医院和坎帕拉两所农村医院实施预防母婴传播备选方案A和B。 乌干达我们将招募600名符合条件（CD 4>350）的HIV感染孕妇， 选择A或B，共1,200对母婴进入研究。在每个城市或农村地区， 一家医院将被指定为选项A，另一家医院将被指定为选项B。在每家医院，300项研究 参与者将被招募并在产后随访12个月。的主要目标 这项研究将比较方案A和B在以下方面执行情况：目标1）产妇 通过自我报告、药丸计数和抗逆转录病毒药物检测测量婴儿预防母婴传播药物依从性 目的2）母体药物相关的严重不良事件和妊娠结局;以及 婴儿安全;目标3）任何一种选择的成本效益。 本研究将有把握度检测药物依从性差异为10%或更大 在预防母婴传播服务级联的四个关键时间点， 妊娠期和产后三次访视对应的免疫接种和早期婴儿艾滋病毒 诊断时间表：分娩后6周、6个月和12个月或在 停止母乳喂养。次要终点将包括艾滋病毒垂直传播率 根据出生时、6周龄、6个月和12岁时婴儿血液中存在艾滋病毒DNA， 12个月无艾滋病毒存活率和艾滋病毒暴露婴儿的总存活率; 以及产后12个月随访期内再次怀孕的发生率。我们 将使用焦点小组讨论和关键线人访谈来评估 在感染艾滋病毒的母亲、服务提供者和社区保健中， 领导人的人选信号这项研究的结果将提供关键的证据，告知业务决策 关于世卫组织目前预防母婴传播建议在以下方面的可行性： 资源有限的环境。