Proactive Telephone Support Can Improve Adherence to Therapy

By Brian Boyle, MD

Multiple studies over the past 10 years have made it abundantly clear that adherence to medication is critical to the success of antiretroviral therapy (ART). Still, clinicians and patients are frustrated by the limited number of adherence interventions that have actually been shown to be effective and the even smaller number that are clinically practicable.

In a pilot study, ACTG 731, the effectiveness of a reasonably simple and inexpensive intervention, structured telephone calls, was evaluated regarding its ability to improve adherence in 109 ARV-naïve persons (85% male, 51% white, median HIV RNA of 5.0 log₁₀) starting ART in ACTG 384 at 5 U.S. sites.

The enrolled subjects were randomly assigned to receive standard care (SOC group) or standard care plus 12 structured telephone calls (telephone group). The calls were delivered over the first 16 weeks of ART by a nurse at a central site and were structured to proactively address common barriers to ART adherence and recommend self-management strategies.

The rate of self-reported adherence was high in both treatment groups [98%, mean weeks 4-64] with over 64% reporting perfect adherence. A significantly better overall treatment effect was observed in the telephone group (p=0.023).

In a post-hoc analysis, the difference in overall treatment effect was strengthened (p<0.001) when the comparison was limited to subjects reporting <100% early adherence [mean week 64 adherence = 96% telephone group vs. 91% SOC group].

Self-reported adherence was significantly associated with adherence as measured with MEMS. Comparing time to primary regimen failure, the Kaplan Meier survival curve for the telephone group remained above the SOC group across weeks 20-64. A multivariate model that controlled for baseline RNA stratification, baseline CD4, gender, age, race/ethnicity, and randomized ART Tx arm, showed a trend for telephone calls decreasing the risk of regimen failure (HR = .68; 95% CI .38-1.23); however, the difference was not significant (p=0.21).

The authors conclude, “Findings indicate that proactive telephone calls delivered from a central site unaffiliated with subjects’ trial sites can improve adherence. The treatment effects appear durable, however, the intervention needs to be tested in a larger population with greater variance in rates of adherence to fully establish clinical benefits.”

02/10/06

Reference
N Reynolds and others. Proactive telephone support from a central site to improve antiretroviral medication adherence: A multi-site, randomized controlled trial (ACTG 731, an adherence substudy of ACTG 384). 13^th Conference on Retroviruses and Opportunistic Infections, Denver, CO. February 5-8, 2006. Abstract 531.