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， 怀孕期间接受抗逆转录病毒疗法和母亲血清转化的人数增加， 母乳喂养对儿童艾滋病毒感染有显著影响。艾滋病毒综合预防 包括暴露前预防（PrEP）等生物医学干预在内的计划， 降低艾滋病毒高发地区孕妇和哺乳期妇女的艾滋病毒发病率， 艾滋病毒传播。本提案的总体目标是评估以下方面的可行性和可接受性： 将PrEP纳入产前和产后护理，以描述在这种情况下启动PrEP的妇女的级联反应。 设置，并评估磨损的原因沿着PrEP级联队列中的怀孕和 候选人：我是一名艾滋病流行病学家，有艾滋病研究和项目的背景 发展，在非洲实施。我正在申请为期五年的Fogarty IRSDA K 01奖， 培训，指导和研究经验，成为一个独立的调查员，能够获得 R 01融资指导：我组建了一个出色的多学科指导团队， 在南非开展艾滋病毒预防研究的经验，该研究将临床研究、流行病学、PrEP 和定性方法。托马斯科茨博士（加州大学洛杉矶分校）和Landon Myer博士（南开普敦大学 非洲）将担任共同初级导师，并带来行为科学和临床方面的补充专业知识 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， 方法论，总部设在美国和南非。我的共同导师团队包括： 戈尔巴赫（美国-行为流行病学家，在混合方法研究方面有着丰富的经验。 Linda-Gail Bekker（基于SA，临床试验，PrEP和年轻女性研究）。培训：具体培训 临床试验，先进的生物统计学，行为科学和混合方法分析，将实现 通过在南非的强化指导培训、课程、讲习班和初级研究。指导 通过我的导师团队，这些培训和研究经验将建立我的独立调查员 在资源匮乏的环境中，作为研究孕妇和哺乳期妇女的专家。研究：The 具体目标是：（1）评估将PrEP纳入产前和产后护理的可行性和可接受性， 产后/健康婴儿服务;（2）描述队列中PrEP的启动、保留和依从性级联 未感染艾滋病毒的孕妇和哺乳期妇女，（3）评估整个国家的自然减员和相关因素， PrEP级联反应。我们的研究结果将为实施世卫组织指导和扩大规模提供一个模式 为有艾滋病毒风险的孕妇和哺乳期妇女提供PrEP， 艾滋病毒传播。我们将利用形成性研究申请R 01赠款，以评估干预措施， 在更大的孕妇和哺乳期妇女队列中提高PrEP级联的保留率。

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.