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: 8261540
• 负责人: Philippa Musoke
• 金额: $ 49.99万
• 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 2014-10-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8261540
• 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.

抽象的 在乌干达，就像其他撒哈拉以南非洲国家一样，卫生部正在 采用和实施新的WHO 2010 PMTCT指南。这些准则 建议对感染的HIV感染的孕妇使用两种ARV预防选择之一 为了自己的健康，不需要抗逆转录病毒疗法（ART）。选项A由母亲组成 在整个怀孕和分娩过程中，AZT预防，每日奈韦拉平的补充 婴儿从出生到一周后，彻底停止母乳喂养。选项B包括 从第14周到完全停止后一周，母亲的三重艺术 每天的奈韦拉平的母乳喂养六个星期。这两个选项 显着降低了艾滋病毒的母亲到儿童艾滋病毒传播（MTCT）的风险 在运营可行性，安全性和可接受性方面的优势和缺点 由于尚未评估成本。世界卫生组织指南指出“首选的选择 考虑到这些优势之后，应在一个国家 /地区做出选择 缺点”。目前缺乏支持此决定所需的证据 像乌干达这样的国家需要做出明智的选择，需要哪种选择 全国推出。 该运营研究建议的总体目标是比较提供的可行性 谁在两家Urban Kampala医院和两家农村医院中的PMTCT选择A和B 乌干达。我们将招募600名合格（CD4> 350）HIV感染的孕妇 选项A或B总共有1,200个母亲对，并进行研究。在每个城市或农村地区， 一家医院将被分配给期权A，另一个医院将一家医院分配给期权B。在每家医院，300个研究 参与者将被招收，并随后在产后12个月。主要目的 该研究将是将选项A和B实施与以下方面进行比较：AIM 1） 和婴儿PMTCT药物依从性通过自报告，药丸计数和ARV药物检测 在血液中；目的2）母亲与药物相关的严重不良事件和妊娠结局；和 婴儿安全；目标3）任何一种选项的成本效益。 该研究将有动力检测药物依从性的差异10％或更高 PMTCT服务级联的累积和四个关键时间点，包括第三个 妊娠中期和三次与免疫和婴儿艾滋病毒相对应的产后访问 诊断时间表：分娩后6周，6个月和12个月或 母乳喂养。次要终点将包括垂直艾滋病毒传播率 基于婴儿血液中的HIV DNA在出生时，6周龄，6个月和12个 几个月；艾滋病毒暴露婴儿的12个月无艾滋病毒生存率和总体存活率； 并且，在12个月后的随访期间，随后的妊娠发生率。我们 将使用焦点小组讨论和关键的线人访谈来评估 艾滋病毒感染的母亲，服务提供者和社区卫生中的PMTCT选择 领导者。这项研究的结果将提供关键的证据，以告知运营决策 关于在 资源有限的设置。