China is facing an HIV/AIDS crisis. Although treatment, including free medication, is increasingly available, reports of nonadherence are already surfacing. Within the current window of opportunity, there is an urgent need for research for the development of adherence enhancement programs, which will bolster the efficacy of the medication regimens and thwart the development and transmission of drug resistant virus. The proposed R34 application in response to PAR-03-078 involves a 3-year developmental project to design and pilot a culturally appropriate, clinical feasible, and generalizable program. This project is a multidisciplinary collaboration among experienced investigators at the University of Washington, expert consultants across the U.S., researchers from China's CDC, and care providers at Ditan Hospital in Beijing. The primary aims of the project are to (1) Conduct qualitative research including in-depth interviews and focus groups with patients, their family and caretakers, and providers to determine common barriers and likely facilitators to antiretroviral adherence, which will further guide intervention development; (2) Design a culturally sensitive and theoretically driven adherence program suitable for the Chinese HIV-Positive population, including development of an intervention manual and training materials; (3) Pilot test the program on 10 patients; and (4) After adjustments based on findings from the pilot, implement a preliminary randomized controlled trial (RCT) of 60 patients with 2 arms (minimal vs. enhanced intervention) to assess feasibility and initial efficacy. Although the exact nature of the intervention will depend upon findings from the qualitative phase of the project, research from studies based in the West as well as preliminary work in country suggest the potential acceptability and usefulness of a comprehensive program involving such components as informational group meetings, one-on-one psycho-educational counseling with nurses, DOT provided by family members, alarm reminders, and peer support.
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