title: Site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy, ACTG 5031: substudy of ACTG 384.
abstract: BACKGROUND
  Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed.
  
  
  OBJECTIVE
  To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care.
  
  
  METHODS
  A randomized controlled trial of site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy. Subjects were randomized to receive site nurse-initiated telephone calls (intervention) or no additional calls to the site's standard of care (control). Subjects received calls 1 to 3 days after initiating antiretrovirals, on weeks 1, 2, 3, 6, 10, 14, 18, 22, and 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits.
  
  
  RESULTS
  A total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with ≯95% mean total adherence (87.9% and 91.2%; P = .34) and mean self-reported total adherence (97.9% and 98.4%) in the intervention and control groups, respectively, or in symptom distress and clinical endpoints.
  
  
  CONCLUSIONS
  In the context of a clinical trial where self-reported adherence was exceptionally high, the site nurse-initiated telephone calls did not further improve self-reported adherence, symptom distress, or clinical outcomes.
authors.affiliation: Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts Harvard Medical School, Boston, Massachusetts.
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Robbins
authors.forename: Marcia A
authors.initials: MA
authors.lastname: Testa
authors.forename: Max
authors.initials: M
authors.lastname: Su
authors.forename: Steven A
authors.initials: SA
authors.lastname: Safren
authors.forename: Gene
authors.initials: G
authors.lastname: Morse
authors.forename: Sara
authors.initials: S
authors.lastname: Lammert
authors.forename: Robert W
authors.initials: RW
authors.lastname: Shafer
authors.forename: Nancy R
authors.initials: NR
authors.lastname: Reynolds
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Chesney
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009726:Nurses; D010349:Patient Compliance; D013689:Telephone
chemical_list: D019380:Anti-HIV Agents
keywords: adherence intervention; antiretroviral therapy; human immunodeficiency virus (HIV); nursing telephone support; randomized controlled trial