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J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):62-8.

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

Author information

  • 1AIDS Clinical Trials Unit, Ohio State University, Columbus, OH, USA. reynolds.1@osu.edu

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.

[PubMed - indexed for MEDLINE]
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