CLINICAL TRIALS OF COPING EFFECTIVENESS TRAINING IN HIV INFECTED MEN

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The estimated 1 million people in the U.S. infected with HIV face a chronic and debilitating disease that can create profound psychological distress. Medical guidelines do not address these negative consequences of hIV and are unlikely to do so until there is evidence from controlled clinical trials that psychosocial interventions are effective in helping hIV- infected persons cope with stress over the course of t heir progressive disease. To address this need, we propose a randomized clinical trial of Coping Effectiveness Training (CET), an innovative intervention for HIV- infected persons that is based on recent advances in stress and coping theory. We will; . Evaluate the effect of CET on the ability of HIV-infected men to decrease psychological distress and increase psychological well-being. . Compare the efficacy of two alternative CET maintenance programs to sustain treatment effects over 12 months. Determine the extent to which improvements in distress and well-being are associated with changes in adherence to medical care. . Identify the potential psychological and social mechanisms by which CET affects psychological and adherence outcomes. . Examine the cost effectiveness of CET by evaluating its effect on health care utilization and health care costs. We will randomly assign 300 HIV-infected, distressed men to one of three conditions; (1) CET with an enhanced maintenance program (CET-E), (2) CET with standard maintenance (CET-S), and (3) a waiting list control. The CET groups will receive training during a 3-month Intervention phase and changes in mediating and outcome variables will be compared with the control group. After this initial phase, the control group will receive training and the CET groups will proceed to the maintenance phase. The CET-S group will meet monthly and bimonthly, in a standard series of booster sessions. Immediately after the Intervention Phase and at 6- and 12-month follow-up, we will assess the effect of CET and the two maintenance strategies on psychological distress and well-being, adherence to care, and costs.