This application is a request for a Mentored Patient-Oriented Research Career Award (K23) to provide Dr. Robert Paul the requisite training and expertise to investigate treatment outcome in patients infected with human immunodeficiency virus (HIV). Training will be obtained through intensive didactic and hands-on research experiences available through collaboration with Dr. Timothy Flanigan (sponsor), and Drs. Charles Carpenter, Bradford Navia, Charles Hinkin, and Ronald Cohen. The applicant will also participate in training opportunities associated with the Center for AIDS Research and T32 Training Programs based at Miriam Hospital/Brown Medical School. Training in basic and clinical immunology of HIV infection, measurement of adherence and psychosocial variables associated with adherence, statistics/research methods, and cognitive sequelae of HIV infection will be obtained through coursework, directed readings, and completion of the research study. The research component will examine the efficacy of a compensatory strategy to support adherence to HIV treatment. A total of 125 HIV-positive individuals will be recruited and adherence will be monitored during a four-week baseline period. Immunological status, psychosocial variables associated with behavior change, and cognitive function will be examined at baseline. The participants will then be randomized into one of two treatment arms. One group will receive standard clinical care (SC). The second group will receive standard care and a pre-programmed wristwatch that will deliver a mnemonic aid (MA) to facilitate HAART dosing. Adherence will be measured using electronic monitoring and pill count. Immunological status, psychosocial variables, cognitive function, and adherence will be re-examined after six months and again one month after the end of the trial. Analyses will determine the efficacy of the MA to support adherence to HAART. Regression analyses will be conducted to determine the degree to which adherence is associated with CD4/CD8 cell count, plasma viral load, and cognitive function. The relationship between psychosocial factors associated with behavior change and adherence will be examined in both treatment groups. The results will provide important insights regarding the clinical care of patients with HIV. The study will also provide the applicant the opportunity to implement research skills obtained throughout the training period of the award.
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