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

通过科学合作伙伴关系和强大的系统对用于艾滋病毒和怀孕预防的阴道环进行评估，以加强肯尼亚西部的艾滋病毒研究

• 批准号: 9464763
• 负责人: Nelly Rwamba Mugo
• 金额: $ 72.35万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9464763
• 关键词: Evaluation; intravaginal; ring; HIV; pregnancy

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.

抽象的 该项目将推进科学的新型生物医学艾滋病毒预防工具，并提高对 验证模型用于经过验证的生物医学艾滋病毒预防工具，特别关注西方的年轻女性 肯尼亚。这些进步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行为的专家，地方和国家 代表肯尼亚卫生部和主要的肯尼亚利益相关者，并建立了严格的 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HIV预防干预措施。推进产品开发管道和交付 生物医学艾滋病毒预防策略，六个目标包括：（1）在2A期随机试验中， 评估对多用途的HIV和HSV-2的安全性，可接受性，依从性和初步效率 预防阴道基质环，含有Tenofovir与左甲虫（TFV-LNG）结合使用6个月 使用； （2）在一项IIIB/IV期研究中，评估妇女对口腔准备的选择和粘附性或阴道静脉内的依从性 Dapivirine Ring，使用面向患者的决策支持工具，两种不同的，经过验证的预防艾滋病毒预防产品 偏好和产品选择； （3）在实施科学试验试验中，评估艾滋病毒自我测试的使用 通过男性伴侣测试和 与孕妇的伴侣之间的艾滋病毒护理和治疗联系； （4）发展实验室能力和 合作，包括生物标志物评估，以评估遵守口腔和阴道内戒指的粘附 在突破性感染和阴道微生物组中； （5）加强现有的数据管理系统和 建立系统和协作，可以收集符合CDISC的数据和分析数据集； （6） 建立并维持强大的科学，决策者和社区伙伴关系，以托管实施 在整个5年期间，肯尼亚西部的优先艾滋病毒研究的吸收。