Telephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial.

TitleTelephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial.
Publication TypeJournal Article
Year of Publication2008
AuthorsReynolds NR, Testa MA, Su M, Chesney MA, Neidig JL, Frank I, Smith S, Ickovics J, Robbins GK
Corporate AuthorsAIDS Clinical Trials Group 731 and 384 Teams
JournalJ Acquir Immune Defic Syndr
Volume47
Issue1
Pagination62-8
Date Published2008 Jan 1
ISSN1525-4135
KeywordsAdult, Anti-HIV Agents, Female, HIV Infections, Humans, Male, Nurse-Patient Relations, Patient Compliance, Patient Education as Topic, Telephone
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.

DOI10.1097/QAI.0b013e3181582d54
Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID17891043
Grant List1K01AI062435 / AI / NIAID NIH HHS / United States
AI-45008 / AI / NIAID NIH HHS / United States
AI032783 / AI / NIAID NIH HHS / United States
AI068636 / AI / NIAID NIH HHS / United States
AI069419 / AI / NIAID NIH HHS / United States
AI069472 / AI / NIAID NIH HHS / United States
AI25868 / AI / NIAID NIH HHS / United States
R01 NR05108 / NR / NINR NIH HHS / United States