Telephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial.
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.
Reynolds
Nancy R
NR
AIDS Clinical Trials Unit, Ohio State University, Columbus, OH, USA. reynolds.1@osu.edu
Testa
Marcia A
MA
Su
Max
M
Chesney
Margaret A
MA
Neidig
Judith L
JL
Frank
Ian
I
Smith
Scott
S
Ickovics
Jeannette
J
Robbins
Gregory K
GK
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
D019380:Anti-HIV Agents