Improving prevention of mother-to-child HIV transmission outcomes in Malawi

改善马拉维艾滋病毒母婴传播的预防

• 批准号: 8739567
• 负责人: Maria Hyoun Kim
• 金额: $ 13.26万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-10 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8739567
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Africa South of the Sahara; Age-Months; Anti-Retroviral Agents; Biometry; Biostatistical Methods; Breast Feeding; Caring; Cessation of life; Child; Clinical; Clinical Trials; Cohort Studies; Coin; Collaborations; Communication; Communities; Community Health; Complement; Country; Data; Data Aggregation; Data Reporting; Disease; Ensure; Environment; Evaluation; Evidence based intervention; Funding; Goals; Government; HIV; HIV Infections; Health; Health Services Research; Improve Access; Infant; Infection; International; Intervention; Interview; Knowledge; Language; Learning; Life; Malaria; Malawi; Maps; Measures; Medical; Medicine; Mentors; Mentorship; Methods; Mothers; North Carolina; Outcome; Patients; Pharmaceutical Preparations; Pregnancy; Preparation; Prevention; Prevention Measures; Published Comment; Publishing; Qualitative Research; Reporting; Research; Research Design; Research Personnel; Resources; Retrovirology; Science; Scientist; Services; Site; Staging; Structure; Testing; Training Programs; Universities; Vertical Disease Transmission; Woman; Women' s Health; World Health; Writing; antiretroviral therapy; authority; base; career development; cohort; college; cost; design; experience; follow-up; global health; implementation research; implementation trial; improved; informant; novel; novel strategies; pediatric human immunodeficiency virus; pediatrician; pregnant; prevent; professor; programs; prospective; public health relevance; randomized trial; research and development; scale up; skills; therapy design; transmission process; uptake

DESCRIPTION (provided by applicant): In 2010, there were an estimated 250,000 AIDS related child deaths, and over 330,000 children newly infected with HIV in 2011, the majority in sub-Saharan Africa. With current, efficacious, low-cost medical interventions to prevent mother-to-child transmission of HIV (PMTCT), most of these infections were preventable. The continuing high rates of AIDS related child deaths demonstrate that scientifically rigorous implementation research is needed to successfully implement evidence-based interventions, like PMTCT, in resource-limited settings. Dr. Maria Kim, Assistant Professor in the Section of Retrovirology and Global Health at Baylor College of Medicine (BCM), is focused on closing this gap between knowledge and action by learning how to identify, research, and address implementation problems and thereby improve access to and use of interventions by women and children in need. Dr. Kim's research will evaluate how to optimize the implementation of Malawi's novel national PMTCT program Option B+ (B+). Other PMTCT approaches require HIV disease staging by clinical or lab criterion to distinguish between women who need life-long treatment for their own health versus those who only require short-term medication for PMTCT. In contrast, B+ offers all HIV-infected pregnant and breastfeeding women life-long antiretroviral treatment. Therefore, B+ theoretically provides a simplified approach, which may improve uptake, retention and transmission outcomes. However, there are no published studies evaluating its efficacy. A recent commentary in the Lancet highlighted the urgent need for more data about B+, before widely implementing in other countries. As a pediatrician in Malawi, Dr. Kim participated in a study that suggested inadequate coordination of maternal and infant HIV services was significantly contributing to >70% loss-to-follow-up in PMTCT care. Based on this data, she began a prospective open cohort study to examine the impact of a strategy called Tingathe, which utilizes community health workers (CHW) to help women navigate PMTCT care. In 2011, Dr. Kim analyzed 2 years of data on >1600 women-infant pairs which demonstrated improved retention to PMTCT care from <30% to ~75%, but still did not reach the target >90%. In September 2011, B+ was implemented in the context of this ongoing evaluation. Recent aggregate and field data from Malawi government and Tingathe program reports suggest that although uptake and retention has improved post B+, levels are still suboptimal. Additional patient level data are needed to build upon these reports. B+ has already been implemented widely throughout Malawi; thus, a randomized trial utilizing a control (non B+ sites) cannot be performed. However, Dr. Kim's cohort study provides a unique opportunity to evaluate B+ using patient level data, and Tingathe forms an implementation platform that can be modified to improve B+. In this IRSDA application, Dr. Kim proposes a three-prong study to both evaluate and optimize the implementation of B+. First, in Years 1 and 2 she will conduct a quasi-experimental pre/post study utilizing the prospectively collected longitudinal patient level data from the Tingathe program. Second, to better understand both implementation barriers and facilitators to optimizing PMTCT outcomes of B+ and the Tingathe strategy she will conduct a qualitative study using semi-structured 1:1 interviews of patients, health workers, and key informants engaging in PMTCT service uptake and delivery. Finally, starting in Year 3, she will design a modified CHW intervention informed by her previous studies, utilizing a community participatory approach and intervention mapping and design skills. The modified intervention will be tested for acceptability and feasibility in Years 4 and 5 using both qualitative and quantitativ methods, in preparation for a proposed R01 funded randomized trial. Dr. Kim has assembled an outstanding mentorship team to help guide her research and career development. Dr. Peter Kazembe, the primary Malawi mentor, has over 30 years experience in child survival, malaria, and HIV research. He will be supported by Dr. Mina Hosseinipour, a former IRSDA recipient, Clinical Director of the University of North Carolina Malawi Project, and an expert in clinical and implementation trials in sub-Saharan Africa. Dr. Thomas Giordano, the primary US mentor, is an expert in health services research and will be supported by Drs. Christine Markham (mixed methods, intervention mapping and evaluation), Wenyaw Chan (biostatistics), Elizabeth Chiao (women's health, health services research), and Mary Paul (pediatric HIV). Co-mentor Dr Elaine Abrams, Senior Research Director of ICAP, and one of the foremost international authorities on PMTCT rounds out the mentorship team. With IRSDA support, Dr. Kim seeks to gain expertise in: 1) implementation research in resource- limited settings; 2) advanced study design and biostatistical methods; 3) qualitative research; 4) intervention design and evaluation; and 5) scientific writing and communication skills. To accomplish this she will complement her proposed research with structured tutorials and coursework and complete a Masters in Clinical Investigation through the Clinical Scientist Training Program at BCM. The unique Malawi research environment, supportive Malawi-US mentorship collaboration, and multi- disciplinary coursework will prepare Dr. Kim for independence as an implementation researcher by providing the skills, experience, and preliminary data to develop a R01 supported randomized trial evaluating the impact of a novel strategy to optimize the implementation of PMTCT.

描述（由申请人提供）：2010 年，估计有 250,000 名儿童因艾滋病死亡，2011 年有超过 330,000 名儿童新感染艾滋病毒，其中大多数发生在撒哈拉以南非洲地区。利用当前有效、低成本的预防艾滋病毒母婴传播 (PMTCT) 的医疗干预措施，大多数感染是可以预防的。与艾滋病相关的儿童死亡率持续居高不下，这表明需要进行科学严谨的实施研究，才能在资源有限的环境中成功实施预防母婴传播等循证干预措施。贝勒医学院 (BCM) 逆转录病毒学和全球健康系助理教授 Maria Kim 博士致力于通过学习如何识别、研究和解决实施问题来缩小知识与行动之间的差距，从而改善获取机会向有需要的妇女和儿童提供干预措施并采取干预措施。 Kim 博士的研究将评估如何优化马拉维新颖的国家 PMTCT 计划选项 B+ (B+) 的实施。其他 PMTCT 方法需要根据临床或实验室标准对 HIV 疾病进行分期，以区分需要为自身健康进行终身治疗的女性与仅需要短期药物治疗 PMTCT 的女性。相比之下，B+ 为所有感染艾滋病毒的孕妇和哺乳期妇女提供终身抗逆转录病毒治疗。因此，B+ 理论上提供了一种简化的方法，可以提高吸收、保留和传播结果。然而，尚无已发表的研究评估其功效。 《柳叶刀》最近的一篇评论强调，在其他国家广泛实施之前，迫切需要更多有关 B+ 的数据。 作为马拉维的一名儿科医生，Kim 博士参与了一项研究，该研究表明，孕产妇和婴儿艾滋病毒服务协调不足是导致 PMTCT 护理失访率超过 70% 的重要原因。基于这些数据，她开始了一项前瞻性开放队列研究，以检验名为 Tingathe 的策略的影响，该策略利用社区卫生工作者 (CHW) 帮助女性进行 PMTCT 护理。 2011 年，Kim 博士分析了超过 1600 对母婴的 2 年数据，结果表明 PMTCT 护理的保留率从 <30% 提高到约 75%，但仍未达到 >90% 的目标。 2011 年 9 月，B+ 在此持续评估的背景下实施。马拉维政府和 Tingathe 计划报告的最新汇总和现场数据表明，尽管 B+ 后的吸收率和保留率有所改善，但水平仍然不理想。需要额外的患者级别数据来构建这些报告。 B+ 已在马拉维全国广泛实施；因此，无法进行利用对照（非 B+ 位点）的随机试验。然而，Kim 博士的队列研究提供了使用患者水平数据评估 B+ 的独特机会，而 Tingathe 形成了一个可以修改以提高 B+ 的实施平台。 在此 IRSDA 申请中，Kim 博士提出了一项三管齐下的研究，以评估和优化 B+ 的实施。首先，在第一年和第二年，她将利用 Tingathe 项目前瞻性收集的纵向患者水平数据进行准实验性的前/后研究。其次，为了更好地了解优化 B+ 和 Tingathe 策略的 PMTCT 结果的实施障碍和促进因素，她将使用半结构化 1:1 访谈对参与 PMTCT 服务吸收和提供的患者、卫生工作者和关键信息提供者进行定性研究。最后，从第三年开始，她将根据之前的研究，利用社区参与方法以及干预绘图和设计技能，设计修改后的社区卫生工作者干预措施。修改后的干预措施将在第 4 年和第 5 年使用定性和定量方法进行可接受性和可行性测试，为拟议的 R01 资助的随机试验做准备。 金博士组建了一支优秀的导师团队来帮助指导她的研究和职业发展。 Peter Kazembe 博士是马拉维的首席导师，在儿童生存、疟疾和艾滋病毒研究方面拥有 30 多年的经验。他将得到 Mina Hosseinipour 博士的支持，Mina Hosseinipour 博士是前 IRSDA 获奖者、北卡罗莱纳大学马拉维项目临床主任，也是临床和医学领域的专家。 撒哈拉以南非洲地区的实施试验。美国首席导师 Thomas Giordano 博士是卫生服务研究领域的专家，并将得到 Drs. Thomas Giordano 的支持。 Christine Markham（混合方法、干预绘图和评估）、Wenyaw Chan（生物统计学）、Elizabeth Chiao（妇女健康、卫生服务研究）和 Mary Paul（儿童艾滋病毒）。联合导师伊莱恩·艾布拉姆斯 (Elaine Abrams) 博士是 ICAP 的高级研究总监，也是 PMTCT 领域最重要的国际权威之一，这使得导师团队更加完善。 在 IRSDA 的支持下，Kim 博士寻求获得以下方面的专业知识：1) 在资源有限的环境中进行实施研究； 2）先进的研究设计和生物统计方法； 3）定性研究； 4）干预设计与评估； 5) 科学写作和沟通技巧。为了实现这一目标，她将通过结构化教程和课程来补充她拟议的研究，并通过 BCM 的临床科学家培训计划完成临床研究硕士学位。 独特的马拉维研究环境、支持性的马拉维-美国指导合作以及多学科课程将为 Kim 博士提供技能、经验和初步数据，以开发 R01 支持的随机试验，评估优化 PMTCT 实施的新策略。