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: 8626964
• 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/8626964
• 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

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 quantitative 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.

2010 年，估计有 250,000 名儿童因艾滋病死亡，超过 330,000 名儿童 2011年新感染艾滋病毒的人大多数出现在撒哈拉以南非洲地区。现有的、有效的、低成本的 预防艾滋病毒母婴传播 (PMTCT) 的医疗干预措施，其中大部分感染 是可以预防的。与艾滋病相关的儿童死亡率持续居高不下，科学证明 需要严格的实施研究才能成功实施循证干预措施，例如 在资源有限的环境中预防母婴传播。 Maria Kim 博士，逆转录病毒学部助理教授 贝勒医学院 (BCM) 的全球健康致力于缩小知识与知识之间的差距 通过学习如何识别、研究和解决实施问题来采取行动，从而改进 有需要的妇女和儿童获得和使用干预措施。 金博士的研究将评估如何优化马拉维新国家战略的实施 PMTCT 计划选项 B+ (B+)。其他 PMTCT 方法需要通过临床或实验室对 HIV 疾病进行分期 区分需要终生治疗的女性和那些需要终生治疗的女性的标准 仅需要短期药物治疗 PMTCT。相比之下，B+ 为所有感染 HIV 的孕妇和 母乳喂养的妇女终生接受抗逆转录病毒治疗。因此，B+理论上提供了一种简化的 方法，这可能会提高吸收、保留和传播结果。然而，没有 发表的研究评估其功效。 《柳叶刀》最近的一篇评论强调了迫切需要 在其他国家广泛实施之前，请提供有关 B+ 的更多数据。 作为马拉维的一名儿科医生，金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导致 PMTCT 护理中超过 70% 的失访率显着升高。 根据这些数据，她开始了一项前瞻性开放队列研究，以检验名为“ Tingathe，利用社区卫生工作者 (CHW) 帮助妇女应对 PMTCT 护理。 2011年， Kim 博士分析了 1600 多对母婴的 2 年数据，结果表明保留率有所提高 PMTCT护理从<30%到~75%，但仍然没有达到>90%的目标。 2011 年 9 月，B+ 在此持续评估的背景下实施。近期累计 马拉维政府和 Tingathe 计划报告的实地数据表明，尽管吸收和 B+ 后，保留率有所提高，但水平仍然不理想。需要额外的患者级别数据来构建 根据这些报告。 B+ 已在马拉维全国广泛实施；因此，一项随机试验 无法使用对照（非 B+ 位点）进行。然而，金博士的队列研究提供了一个独特的 使用患者水平数据评估 B+ 的机会，Tingathe 形成了一个实施平台，可以 进行修改以提高B+。 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 从 Tingathe 项目中前瞻性收集的纵向患者水平数据。二、为了更好 了解优化 B+ 和 PMTCT 结果的实施障碍和促进因素 Tingathe 策略她将使用半结构化的 1:1 患者访谈进行定性研究， 卫生工作者以及参与预防母婴传播服务获取和提供的关键信息提供者。最后，开始于 第三年，她将根据她之前的研究，利用 社区参与方法以及干预绘图和设计技能。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测试可接受性和可行性 方法，为拟议的 R01 资助的随机试验做准备。 Kim 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生涯 发展。 Peter Kazembe 博士是马拉维的首席导师，拥有 30 多年的儿童治疗经验 生存、疟疾和艾滋病毒研究。他将得到前 IRSDA 成员 Mina Hosseinipour 博士的支持 获奖者，北卡罗来纳大学马拉维项目临床主任，临床和医学专家 撒哈拉以南非洲地区的实施试验。美国首席导师 Thomas Giordano 博士是以下领域的专家 卫生服务研究将得到 Drs 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）和玛丽·保罗（儿童艾滋病毒）。联合导师 Elaine Abrams 博士，ICAP 高级研究总监， 指导团队还包括预防母婴传播领域最重要的国际权威之一。 在 IRSDA 的支持下，Kim 博士寻求获得以下方面的专业知识：1）资源方面的实施研究 有限的设置； 2）先进的研究设计和生物统计方法； 3）定性研究； 4） 干预设计和评估； 5) 科学写作和沟通技巧。为了实现这一点 她将通过结构化教程和课程来补充她提出的研究，并完成 通过 BCM 临床科学家培训计划获得临床研究硕士学位。 独特的马拉维研究环境、支持性的马拉维-美国导师合作以及多方合作 学科课程将使 Kim 博士为独立作为一名实施研究员做好准备 提供技能、经验和初步数据来开发 R01 支持的随机试验 评估优化 PMTCT 实施的新策略的影响。