Wednesday, January 15, 2025
1/15/2025
Project Summary/Abstract The overarching goal of the proposed renewal of the PERU CTU is to continue contributing to the design and implementation of the NIH HIV/AIDS clinical trial networks research agenda, across the continuum from prevention to treatment of HIV and tuberculosis (TB). It builds upon 19 years of experience and over $110 million of NIH investment to establish a comprehensive clinical and laboratorial infrastructure for designing and implementing network research studies, including those from the HVTN, HPTN, ACTG, MTN and INSIGHT, as well as several non-network clinical trials. The consortium is led by Asociacion Civil Impacta Salud y Educacion (IMPACTA) and is also composed by the Centro de Investigaciones Tecnologicas, Biomedicas y Medioambientales (CITBM), the Asociacion Civil Selva Amazonica (ACSA) and the Asociación Via Libre. Multiple principal investigators are Dr. Jorge Sanchez (based at CITBM) and Dr. Alberto La Rosa (based at IMPACTA) and supported by a cadre of experienced researchers and promising junior investigators. A consolidated three-dimensional (3D) matrix organizational structure integrates organizational functions (CTU governance and Clinical Research Sites, CRSs), support functions (through four resource units) and production functions (local teams leading specific trials). This 3D matrix interplay allows for operations that are cohesive, synergistic, integrated, transparent, flexible, responsive and adaptable. It provides efficient utilization of infrastructure and resources, avoiding redundancies, providing centralized services, sharing strategies and optimizing cost containment. Two mature Community Advisory Boards are the cornerstone for successful community participation in all stages of research. The PERU CTU proposes to continue conducting the networks research agenda at five CRSs: ACSA (HPTN, HVTN), Barranco (HVTN, ACTG), CITBM (HPTN, HVTN), San Miguel (ACTG, HPTN), and Via Libre (HVTN, HPTN). The specific areas of research proposed for the next grant cycle have been chosen considering both the networks research priorities and our CRS strengths. In each area, there is a track record of significant accomplishments and great potential for future contributions. The CTU aims to: 1) evaluate individual and combination vaccine and non-vaccine HIV prevention interventions among men who have sex with men and transgender women; 2) evaluate novel therapeutic interventions targeting HIV and strategies to address toxicities, drug-drug interactions, and comorbidities; 3) improve the prevention and treatment of tuberculosis; 4) maintain the highest standards of resource management for efficient and timely implementation of clinical trials; and 5) continue building relationships and effective communications with the Peruvian community and stakeholders promoting good participatory practices in clinical trials. These feasible aims, our increasing capacity to conduct clinical trials and our ability to adapt to challenges, uniquely position the PERU CTU to continue contributing towards an HIV/AIDS- and TB-free generation.
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