Medical advancements in the treatment of pediatric HIV infection are hindered by poor adherence with antiretroviral medications. Adherence is believed to be poor due to the aversive properties of these medications (e.g., taste) and the complexity of the regimens (e.g., dosing schedules). Nonadherence is even more problematic in pediatric HIV than in other chronic conditions because inconsistent adherence causes the rapid development of viral resistance to protease inhibitors. In addition, the aversiveness of the regimen may result in diminished quality of life in pediatric HIV patients and their caregivers. In the proposed study, a clinical intervention will be implemented to increase adherence rates with antiretroviral medications in pediatric HIV patients. The intervention will be developed in five phases. In the first phase, focus groups will be conducted with HIV-infected children and their caregivers to identify psychosocial barriers to adherence. The second phase will be devoted to the refinement of a behavioral treatment protocol tailored to address adherence barriers. In the third phase, the intervention will be replicated across 12 individual subjects to test its feasibility and effectiveness. A multiple baseline across subjects design will be used, such that the length of the baseline condition will be varied across subjects. It is predicted that changes in adherence rates will occur only after the intervention has been implemented. The clinical intervention itself will be based on the principles of Social Learning Theory which have been effectively applied to modify a variety of child behaviors. In the fourth phase, follow-up adherence data will be collected and analyzed. Several measures of adherence will be obtained throughout treatment. Additionally, changes in child and caregiver quality of life will be assessed. Assuming demonstrated effectiveness of the intervention, the fifth phase of the investigation will involve refinement of the treatment manual and submission of a grant for funding to support a full-scale randomized clinical efficacy trial. It is hypothesized that following participation in the clinical intervention: 1. Adherence rates with antiretroviral therapies in children infected with HIV will increase; 2. Levels of parent-child conflict associated with medication administration will decrease; and 3. Increased rates of medication adherence will be associated with improved quality of life in both children infected with HIV and their caregivers.
