(PI David Fiellin)
YDCC is the data coordination center for the NIAAA multi-center randomized trial titled “Integrated Stepped Care for Unhealthy Alcohol Use in HIV”. Unhealthy alcohol use has adverse effects on patients with HIV, including interfering with combined antiretroviral therapy (cART) adherence, enhancing disease progression, and promoting liver injury. Counseling and medications have proven efficacy in addressing unhealthy alcohol use in HIV-negative patients but have not been thoroughly investigated in HIV-infected patients where their benefit could extend to standard (CD4, viral load) and expanded (VACS Index) biomarkers and changes in HIV transmission risk. Compared to patients without HIV, HIV-infected patients tend to have higher levels of psychiatric comorbidity and multiple substance use (MSU) along with medical comorbidities (e.g. HCV) that may interact to lessen efficacy or safety of both counseling and medications to treat unhealthy alcohol use. Getting non-treatment seeking patients to engage in an appropriate level of alcohol treatment is challenging. In addition, counseling and medication interventions do not uniformly decrease alcohol consumption or related harms in all patients – intervention effects tend to be modest. Two strategies to address these challenges include on-site integrated alcohol treatment in the HIV specialty clinic and stepped care. Integrated HIV care combines HIV primary care with mental health and substance abuse services into a single coordinated treatment program that simultaneously, rather than in parallel or sequential fashion, addresses the clinical complexities associated with having multiple needs and conditions. Stepped care continually assesses the efficacy of an intervention on a specific patient and adapts the intensity of the intervention to the patient’s response. This multicenter randomized controlled trial compares the effectiveness of an integrated stepped care (ISC) approach to unhealthy alcohol to treatment as usual in HIV-infected patients. Unhealthy alcohol use usually refers to those with at-risk drinking, alcohol abuse and alcohol dependence. For this study we have expanded this to include any alcohol consumption in those with liver disease including Hepatitis C (HCV), a common comorbid condition in those with HIV.The YDCC is responsible for data management using TrialDB, a web-based clinical trial management system (CTMS) designed to support clinical trials and clinical research projects. To facilitate data monitoring the CTMS is used to generate web accessible reports as well as reminders to help monitor and manage the data collection process to assure completeness of evaluation. The system checks for data inconsistencies, omissions, and errors regularly. Data questions or problems trigger data queries and analyses of missing data is perfromed periodically to assure that all forms are entered and available for analysis. Data Security is achieved via; 1) CTMS staff receives HIPAA training and Human Subjects Protection training, 2) Users certify that they are HIPAA trained and act in full compliance of HIPAA regulations, and 3) Sensitive data is encrypted in transit and in storage. The web data-entry interface allows data entry to be performed from anywhere on the Internet and uses 128-bit secure sockets layer (SSL) security to protect the confidentiality of the data. The CTMS also maintains an electronic audit trail of all modifications to a study’s data, including the user who made the change, the date and time, and each data item changed and its previous value and new value. Yale University houses and maintains the security and backup of all servers and workstations. The CTMS’s Oracle database is housed in a central machine room maintained by Yale IT staff. Passwords and patient identifying personal health information (PHI) data are stored encrypted in the database server. Several levels of backup of the database are performed on a regular basis, including full backup daily and incremental backup during the day.
Data management services include setting up data entry screens for remote data entry, training coordinators on data entry system and on the use of the subject calendar to track individual subjects and data quality within each site. The YDCC also prepares the quarterly Data and Safety Monitoring Board reports and study data for analysis. YDCC biostatisticians collaborate with the clinical leadership to carryout statistical analysis.