Abstract
BackgroundFew HIV antiretroviral adherence interventions target patients before they start treatment, assess adherence readiness to determine the timing of treatment initiation, or tailor the amount of adherence support. The Supporting Treatment Adherence Readiness through Training (START) intervention, based on the information-motivation-behavioral skills model of behavior change, is designed to address these gaps with the inclusion of (1) brief pill-taking practice trials for enhancing pretreatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the timing of treatment initiation and (2) a performance-driven dose regulation mechanism to tailor the amount of counseling to the individual needs of the patient and conserve resources. The primary aim of this randomized controlled trial is to examine the effects of START on antiretroviral adherence and HIV virologic suppression.Methods/designA sample of 240 patients will be randomized to receive START or usual care at one of two HIV clinics. Primary outcomes will be optimal dose-taking adherence (>85 % prescribed doses taken), as measured with electronic monitoring caps, and undetectable HIV viral load. Secondary outcomes will include dose-timing adherence (>85 % prescribed doses taken on time) and CD4 count. Primary endpoints will be month 6 (short-term effect) and month 24 (to test durability of effect), though electronic monitoring will be continuous and a fully battery of assessments will be administered every 6 months for 24 months.DiscussionIf efficacious and cost-effective, START will provide clinicians with a model for assessing patient adherence readiness and helping patients to achieve and sustain readiness and optimal treatment benefits.Trial registrationClinicalTrials.gov identifier NCT02329782. Registered on 22 December 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1287-3) contains supplementary material, which is available to authorized users.
Highlights
Few HIV antiretroviral adherence interventions target patients before they start treatment, assess adherence readiness to determine the timing of treatment initiation, or tailor the amount of adherence support
Unlike most other antiretroviral therapy (ART) adherence interventions that target people who are already on ART [12, 15, 20], Supporting Treatment Adherence Readiness through Training (START) attempts to provide the field with an evidencebased intervention that works with patients before they start treatment to ensure adherence readiness before initiation—an approach that is timely as more patients with early stage disease start ART and may be less ready to adhere well
An added innovation of START is highlighted in its design, which features components that are lacking in most ART adherence interventions to date: (1) inclusion of pretreatment, early-treatment, and ongoing maintenance training phases; (2) use of brief practice trials for determining adherence readiness and the timing of ART initiation; and (3) inclusion of a dose regulation mechanism that adjusts the amount of pretreatment and maintenance training based on the patient’s recent adherence performance
Summary
Few HIV antiretroviral adherence interventions target patients before they start treatment, assess adherence readiness to determine the timing of treatment initiation, or tailor the amount of adherence support. The Supporting Treatment Adherence Readiness through Training (START) intervention is based on the information-motivation-behavioral skills (IMB) model of behavior change [13] It includes (1) brief pill-taking practice trials for enhancing pretreatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the timing of treatment initiation and (2) a performance-driven dose regulation mechanism to tailor the amount of counseling to the individual needs of the patient and conserve resources. The small sample size (N = 54) precluded adequate statistical power, but effect size estimates were 0.22 (dose-taking adherence), 0.75 (dose-timing adherence), and 0.41 (complete virologic suppression) over the first 6 months of treatment, with the latter two far exceeding the average 0.19 effect size found in a recent meta-analysis of ART adherence interventions that, like START, were not focused solely on patients already demonstrating adherence problems [12] These promising results provide the rationale for the current, more rigorous, larger controlled trial of START
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