Evaluation of pre-exposure prophylaxis cascade in pregnant and breastfeeding women in Cape Town, South Africa

项目摘要 南非未感染艾滋病毒的孕妇和哺乳期妇女感染艾滋病毒的风险很高，尽管 孕期和孕期增加抗逆转录病毒治疗(ART)和孕产妇血清转换 母乳喂养极大地增加了儿童感染艾滋病毒的风险。全面预防艾滋病毒 包括生物医学干预的计划，如暴露前预防(PrEP)，可能会显著 减少艾滋病毒高发区孕妇和哺乳妇女的艾滋病毒发病率，并减少垂直 艾滋病毒的传播。这项建议的首要目标是评估以下各项的可行性和可接受性 将PrEP整合到产前和产后护理中，以描述在此过程中启动PrEP的妇女的级联 环境，并评估沿PrEP级联的原因在一组孕妇和 母乳喂养女性候选人：我是一名艾滋病毒流行病学家，有艾滋病毒研究和项目背景 在非洲的发展和实施。我正在申请为期五年的Fogarty IRSDA K01奖项，以获得 培训、指导和研究经验，以成为一名能够获得 R01基金。指导：我组建了一支出色的多学科指导团队，拥有广泛的 在南非从事集临床研究、流行病学、PrEP于一体的艾滋病毒预防研究经验 和定性的方法。Thomas Coates博士(加州大学洛杉矶分校)和Landon Myer博士(南开普敦大学 非洲)将担任联合小学导师，并带来行为科学和临床方面的互补专业知识 审判。除了我的两位主要导师外，我的共同导师还提供特定内容领域的专业知识和 方法论，总部设在美国和南非。我的联合导师团队包括：帕米纳博士 Gorbach博士(美国)，行为流行病学家，在混合方法研究方面有丰富的经验。 Linda-Gail Bekker(基于SA的临床试验、PrEP和年轻女性研究)。培训：特定的培训 将实现临床试验、高级生物统计学、行为科学和混合方法分析 通过在南非的强化辅导培训、课程作业、讲习班和初级研究。引导式 通过我的指导团队，这些培训和研究经验将建立我的独立调查员 在低资源环境下研究怀孕和哺乳妇女方面的专家生涯。研究： 具体目标是：(1)评估将PrEP整合到产前和产后护理中的可行性和可接受性 产后/健康婴儿服务；(2)描述在队列中启动、保留和坚持的PrEP级联 未感染艾滋病毒的孕妇和哺乳期妇女，(3)评估整个 预备级联。我们的研究结果将为实施世卫组织的指导和扩大提供一个模式 有艾滋病毒风险的孕妇和哺乳期妇女的产前分娩有助于消除垂直感染 艾滋病毒的传播。我们将利用形成性研究申请R01拨款，以评估干预措施 在更大的孕妇和哺乳期妇女队列中改善PrEP级联中的保留率。

Project Summary HIV-uninfected pregnant and breastfeeding women in South Africa are at high risk of HIV acquisition despite increased uptake of antiretroviral therapy (ART) and maternal seroconversion during pregnancy and breastfeeding contributes significantly toward pediatric HIV infections. Comprehensive HIV prevention programs that include biomedical interventions, such as pre-exposure prophylaxis (PrEP), could dramatically reduce HIV incidence in pregnant and breastfeeding women in high HIV incidence areas and reduce vertical HIV transmission. The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women Candidate: I am an HIV epidemiologist with a background in HIV research and program development, implementation in Africa. I am applying for a five-year Fogarty IRSDA K01 award to obtain training, mentorship, and research experience to become an independent investigator capable of obtaining R01 funding. Mentoring: I have put together an exceptional multi-disciplinary mentoring team with extensive experience in HIV prevention research in South Africa that integrates clinical research, epidemiology, PrEP and qualitative methods. Drs. Thomas Coates (UCLA) and Landon Myer (University of Cape Town, South Africa) will serve as co-Primary mentors and bring complementary expertise in behavioral science and clinical trials. In addition to my two Primary mentors, my co-mentors provide expertise in specific content areas and methodologies and are based in both the U.S. and South Africa. My co-mentorship team includes: Dr. Pamina Gorbach (U.S.-based, behavioural epidemiologist with significant experience in mixed methods research, Dr. Linda-Gail Bekker (SA-based, clinical trials, PrEP and research in young women). Training: Specific training in clinical trials, advanced biostatistics, behavioural science and mixed methods analysis, will be achieved through intensive mentored training, coursework, workshops and and primary research in South Africa. Guided by my mentorship team, these training and research experiences will establish my independent investigator career as an expert in research in pregnant and breastfeeding women in low resource settings. Research: The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade. The results from our study will provide a model to implement WHO guidance and scale-up PrEP delivery in pregnant and breastfeeding women at risk of HIV and contribute to the elimination of vertical HIV transmission. We will use the formative research to apply for a R01 grant to evaluate interventions to improve retention in the PrEP cascade in a larger cohort of pregnant and breastfeeding women.