title: Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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, 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
  A 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.
  
  
  CONCLUSIONS
  If 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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT02329782 . Registered on 22 December 2014.
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407, USA. gwagner@rand.org.
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Wagner
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407, USA.
authors.forename: Sebastien
authors.initials: S
authors.lastname: Linnemayr
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407, USA.
authors.forename: Bonnie
authors.initials: B
authors.lastname: Ghosh-Dastidar
authors.affiliation: Department of Medicine, UCLA, Los Angeles, CA, USA.
authors.forename: Judith S
authors.initials: JS
authors.lastname: Currier
authors.affiliation: Department of Medicine, UCLA, Los Angeles, CA, USA.
authors.forename: Risa
authors.initials: R
authors.lastname: Hoffman
authors.affiliation: Long Beach Education and Research Consultants, Long Beach, CA, USA.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schneider
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000191:economics; D002140:California; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics; D004334:Drug Administration Schedule; D016527:Drug Costs; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000523:psychology; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D055118:Medication Adherence; D009042:Motivation; D010353:Patient Education as Topic / Q000191:economics; D012107:Research Design; D012944:Social Support; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents
keywords: Adherence; Antiretroviral; HIV; Intervention; Randomized controlled trial; Readiness