Evaluation of an intravaginal ring for HIV and pregnancy prevention with scientific partnerships and robust systems to strengthen HIV research in Western Kenya

摘要 该项目将促进新的生物医学艾滋病毒预防工具的科学研究，并增进对 已证实的艾滋病毒生物医学预防工具的交付模式，重点是西部地区的年轻女性 肯尼亚。这些进展将通过加强肯尼亚科学家与 国际公认的设计和实施艾滋病毒预防临床试验的专家，地方和国家 肯尼亚卫生部和肯尼亚主要利益攸关方的代表并建立一个严格的 数据管理支持和实验室伙伴关系的骨干，以支持临床试验和公共卫生 艾滋病毒预防干预措施的评价。以推进产品开发流水线和交付 描述了生物医学艾滋病毒预防战略的六个目标，包括：(1)在2a阶段随机试验中， 评估多用途抗HIV和HSV-2的安全性、可接受性、依从性和初步疗效 替诺福韦联合左炔诺孕酮预防阴道基质环6个月 (2)在IIIb/IV期研究中，评估妇女对口服PrEP或阴道内PrEP的选择和依从性 达匹韦林环，两种不同的，经过验证的艾滋病毒预防产品，使用面向患者的决策支持工具来告知 偏好和产品选择；(3)在实施科学试点试验中，评估艾滋病毒自我检测的使用 通过男性伴侣检测和预防母婴传播(PMTCT)结果 与孕妇伴侣的艾滋病毒护理和治疗挂钩；(4)发展实验室能力和 合作，包括生物标志物分析，以评估对口腔和阴道内环的依从性，艾滋病毒抵抗力 在突破性感染方面；(5)加强现有的数据管理系统和 建立能够收集符合CDISC的数据和分析数据集的系统和协作；(6) 建立和维护强有力的科学、政策制定者和社区伙伴关系，以促进实施 以及在整个五年期间在肯尼亚西部采用优先的艾滋病毒研究。

ABSTRACT The project will advance the science on novel biomedical HIV prevention tools and advance understanding of delivery models for proven biomedical HIV prevention tools with a specific focus on young women in Western Kenya. These advances will be made by strengthening existing partnerships between Kenyan scientists with internationally recognized experts in the design and conduct of HIV prevention clinical trials, local and national representatives of the Kenyan Ministry of Health and key Kenyan stakeholders and establishing a rigorous backbone of data management support and laboratory partnerships to support clinical trials and public health evaluations of HIV prevention interventions. To advance the product development pipeline and the delivery of biomedical HIV prevention strategies, six objectives are described including: (1) In a phase 2a randomized trial, assess the safety, acceptability, adherence, and preliminary efficacy against HIV and HSV-2 of a multipurpose prevention vaginal matrix ring containing tenofovir in combination with levonorgestrel (TFV-LNG) with 6 months of use; (2) In a phase IIIb/IV study, evaluate women’s choice of and adherence to oral PrEP or the intravaginal dapivirine ring, two distinct, proven HIV prevention products, using a patient-facing decision support tool to inform preferences and product choice; (3) In an implementation science pilot trial, assess the use of HIV-self testing to improve prevention of mother-to-child transmission (PMTCT) outcomes through male partner testing and linkage to HIV care and treatment among partners of pregnant women; (4) Develop laboratory capacity and collaborations, including for biomarker assays to assess adherence to oral and intravaginal ring, HIV resistance in breakthrough infections, and the vaginal microbiome; (5) Strengthen existing data management systems and establish systems and collaborations enabling the collection of CDISC-compliant data and analysis datasets; (6) Establish and maintain strong scientific, policymaker, and community partnerships to facilitate implementation and uptake of priority HIV research in Western Kenya throughout the 5 year period.