title: Telephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial.
abstract: OBJECTIVE
  To determine whether proactive telephone support improves adherence to antiretroviral therapy (ART) and clinical outcomes when compared to standard care.
  
  
  METHODS
  A multisite, randomized controlled trial (RCT) was conducted with 109 ART-naive subjects coenrolled in AIDS Clinical Trials Group (ACTG) 384. Subjects received standard clinic-based patient education (SC) or SC plus structured proactive telephone calls. The customized calls were conducted from a central site over 16 weeks by trained registered nurses. Outcome measures (collected over 64 weeks) included an ACTG adherence questionnaire and 384 study endpoints.
  
  
  RESULTS
  For the primary endpoint, self-reported adherence, a significantly better overall treatment effect was observed in the telephone group (P = 0.023). In a post hoc analysis, composite adherence scores, taken as the first 2 factor scores from a principal components analysis, also found significant intervention benefit (P = 0.023 and 0.019 respectively). For the 384 primary study endpoint, time to regimen failure, the Kaplan-Meier survival curve for the telephone group remained above the SC group at weeks 20 to 64; a Cox proportional hazard model that controlled for baseline RNA stratification, CD4, gender, age, race/ethnicity, and randomized ART treatment arm suggested the telephone group tended to have a lower risk for failure (hazard ratio = 0.68; 95% confidence interval: 0.38 to 1.23).
  
  
  CONCLUSIONS
  Findings indicate that customized, proactive telephone calls have good potential to improve long-term adherence behavior and clinical outcomes.
authors: AIDS Clinical Trials Unit, Ohio State University, Columbus, OH, USA. reynolds.1@osu.edu
authors: Nancy R
authors: NR
authors: Reynolds
authors: Marcia A
authors: MA
authors: Testa
authors: Max
authors: M
authors: Su
authors: Margaret A
authors: MA
authors: Chesney
authors: Judith L
authors: JL
authors: Neidig
authors: Ian
authors: I
authors: Frank
authors: Scott
authors: S
authors: Smith
authors: Jeannette
authors: J
authors: Ickovics
authors: Gregory K
authors: GK
authors: Robbins
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009723:Nurse-Patient Relations; D010349:Patient Compliance; D010353:Patient Education as Topic; D013689:Telephone
chemical_list: D019380:Anti-HIV Agents