OBJECTIVE: The conduct of a multi-site randomized clinical trial (RCT) is complex and demanding, but may have significant practice and scientific benefits. Challenges include site and investigator diversity, scientific rigor and quality control, communication, and required technical support. The benefits include larger samples sizes, better representation of the population being studied, and greater impact and potential to change practice. PURPOSE: To examine the implementation of a multi-site RCT testing a structured and individualized adherence intervention to improve adherence to antiretroviral therapy over time (NIHR01NR04749). METHOD: Procedures to address training of staff, scientific rigor and quality control, communication, and technical support were implemented. FINDINGS: Investigator expertise, staff availability and support, securing graduate student researchers, and resources varied between the sites; IRB protocol requirements and submission formats also varied. Geographic distance between sites and diversity of settings and investigators make uniformity in the protocol implementation a challenge. Investigators need to be prepared for anticipated and unanticipated problems, and to be flexible to accommodate clinical realities yet adhere to the protocol to preserve scientific rigor of the project. Time and effort are required to monitor protocol adherence and training of personnel. Regularly scheduled communication (meetings, conference calls, electronic technology) are essential to maintain control over the vital aspects of the study. Internet technologies that house shared randomization programs, tracking systems, and code files facilitate an efficient exchange of information and data. CONCLUSIONS: Successful multi-site research requires thorough planning to ensure its feasibility and acceptability. Preparing for the challenges associated with multi-site projects can facilitate results that are more generalizable and relevant to practice. IMPLICATIONS: Rapid changes in HIV care necessitate timely clinical research to evaluate the effect of interventions on patient outcomes. Multi-site RCTs can address this demand and potentially generate support for evidence-based practice changes.
Session #1219 - Poster Session I
The 29th Annual MNRS Research Conference (April 1-4, 2005)