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 该项目将推进新的生物医学艾滋病毒预防工具的科学，并促进对 提供经证实的生物医学艾滋病毒预防工具的模式，特别侧重于西方国家的年轻妇女 肯尼亚.这些进展将通过加强肯尼亚科学家与 国际公认的艾滋病毒预防临床试验设计和实施专家，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， 数据管理支持和实验室合作伙伴关系的骨干，以支持临床试验和公共卫生 评估艾滋病毒预防干预措施。推进产品开发管道和交付 生物医学HIV预防策略，描述了六个目标，包括：（1）在2a期随机试验中， 评估安全性、可接受性、依从性和抗HIV和HSV-2的初步疗效 预防阴道基质环含有替诺福韦与左炔诺孕酮（TFV-LNG）组合6个月 （2）在IIIb/IV期研究中，评估女性对口服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， 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情况 通过男性伴侣检测改善预防母婴传播的成果， （4）发展实验室能力， 合作，包括生物标志物检测，以评估对口服和阴道环的依从性，艾滋病毒耐药性 （5）加强现有的数据管理系统， 建立系统和协作，以便收集符合CDISC的数据和分析数据集;（6） 建立和维护强有力的科学、决策者和社区伙伴关系，以促进实施 在整个5年期间，在肯尼亚西部开展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.