IMPACTA PERU CLINICAL TRIALS UNIT

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DESCRIPTION (provided by applicant): The overarching goal of the proposed renewal of the IMPACTA PERU CTU is to continue contributing to the design and implementation of the DAIDS scientific research agenda, across the continuum from prevention to treatment of HIV and tuberculosis (TB). It builds upon 12 years of experience and over $43 million of NIH investment to establish comprehensive clinical and laboratorial infrastructure for designing and implementing DAIDS scientific research studies, including those from the HVTN, HPTN, ACTG, MTN and INSIGHT, as well as non-network clinical trials, including the "Chemoprophylaxis for HIV Prevention in Men" (iPrEx) study. The consortium between the Asociacion Civil Impacta Salud y Educacion and the Asociacion Civil Selva Amazonica (ACSA), two nonprofit Peruvian research organizations, will continue under the leadership of Dr. Jorge Sanchez 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 five resource units) and production functions (trials from DAIDS research networks). This 3D matrix interplay is transparent, flexible, responsive and adaptable; and 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 the successful community participation in all stages of research. The CTU proposes to continue conducting the clinical research agenda proposed by the HVTN, HPTN, ACTG and MTN, at Barranco, San Miguel and ACSA CRSs. The specific areas of research have been chosen considering the networks research priorities and CRS strengths. In each proposed area, there is a track record of significant accomplishments and great potential for future contribution. The CTU aims to: 1) evaluate individual and combination HIV prevention interventions among men who have sex with men, with focus on pre-exposure prophylaxis and antiretroviral treatment for prevention; 2) implement Phase 1, 2, and 3 clinical trials to develop rectal microbicides; 3) evaluate vaccine candidates for clade B HIV; 4) evaluate novel therapeutic interventions targeting HIV and TB, in a setting where both diseases are prevalent; 5) maintain the highest standards of resource management for efficient and timely implementation of clinical trials; and 6) continue building relationships and effective communications with the Peruvian community and stakeholders promoting good participatory practices in clinical trials.