The success of HIV antiretroviral therapy (ART) is dependent on high levels of adherence, yet many patients find it difficult to consistently adhere well, resulting in a risk for development of drug resistant virus and incomplete viral suppression. With recent treatment guidelines and the emerging emphasis on Treatment as Prevention pushing for patients to start ART earlier than ever, the public health risks related to nonadherence may now be even greater than before. There is some evidence that patients with earlier stage disease are less adherent, and if patients are started on treatment before they are ready to adhere well there is greater risk for an expanding community pool of resistance, and less than adequate reduction in infectiousness to limit transmission. Treatment guidelines emphasize the need for patients to be ready to adhere well before starting ART; however, there are no established methods for determining sufficient adherence readiness prior to starting treatment, and most adherence interventions target patients once they are on ART and are having adherence problems. The Adherence Readiness Program (ARP), based on the Information Motivation Behavioral skills model of behavior change, addresses these needs and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patients and conserve limited resources. In our pilot RCT, the ARP had effects on both behavioral adherence and virologic suppression, with effect sizes estimates that were more than double the average found for similar interventions in a recent published meta-analysis. With these promising results, the proposed 5-year study will evaluate the ARP in a fully powered multi-site randomized controlled trial. A sample of 240 patients will be randomized to receive the ARP or usual care. Primary outcomes will be optimal dose-taking (85+% prescribed doses taken) adherence, as measured by MEMS caps, and undetectable HIV viral load. Secondary outcomes will include dose-timing (85+% prescribed doses taken on time) adherence and CD4 count. Primary end points will be Month 6 (short-term effect) and Month 24 (to test the durability of effect), making it one of the few studies to examine intervention effects longer than one year. If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination. This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention.
This study is important to public health as its findings could provide evidence of an intervention that effectively enables HIV patients to adhere well from the start of ART and throughout the course of treatment, and obtain optimal virologic and clinical outcomes, as well as optimize efficient use of limited resources for enhancing adherence.
|Wagner, Glenn J; Linnemayr, Sebastien; Ghosh-Dastidar, Bonnie et al. (2016) Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial. Trials 17:162|