Pilot of an ART Adherence Readiness Intervention

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DESCRIPTION (provided by applicant): Recommended treatment guidelines emphasize the need for patients to be ready to adhere well prior to starting ART. Yet we are unaware of any intervention that is designed to not only help patients achieve and maintain adherence readiness, but also includes mechanisms for regulating the amount of adherence training provided and informing the provider when the patient is ready to start treatment. In response, the proposed study will pilot test the Adherence Readiness Program, an intensive and comprehensive program of adherence training based on the IMB model of health behavior and learning theory. Informed by formative evaluation work in Phase 1, the ARP will be evaluated in a pilot RCT in Phase 2. The ARP utilizes conventional adherence counseling components, but is innovative in its (1) inclusion of pre-treatment, early-treatment and ongoing maintenance training phases, (2) use of brief placebo practice trials for enhancing pre-treatment adherence readiness and determining the timing of treatment initiation, (3) inclusion of a dose regulation mechanism that adjusts the amount of pre-treatment and maintenance training provided based on the patient's adherence performance, and (4) administration of the intervention in the patient's home where the process of training patients to identify and control retrieval cues for adherence can be enhanced. Participants will be randomized to receive the ARP training at home, ARP training at the clinic, or usual care (no intervention). Primary assessments will be administered at screening and Weeks 8 and 24, with electronic monitored adherence being the primary outcome. If effective, the ARP may provide clinicians with an intervention that (1) enhances patient's adherence readiness throughout the course of therapy, thereby improving clinical outcomes, and (2) tailors the amount of training provided based on patient need and performance, thus facilitating a more efficient use of clinic resources, and fostering better acceptance from both providers and patients. Findings from this pilot project will provide information on critical design parameters for a larger, more rigorous evaluation in an R01 application, if warranted. PUBLIC HEALTH RELEVANCE: This study is important to public health as its findings could provide critical information for the evaluation of an intervention aimed at enhancing patient adherence readiness over the entire course of treatment, facilitating optimal clinical outcomes of treatment, and informing efficient use of clinic resources for enhancing adherence.