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

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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.