Titre du document / Document title

Telephone Support to Improve Antiretroviral Medication Adherence : A Multisite, Randomized Controlled Trial

Auteur(s) / Author(s)

AIDS Clinical Trials Group 731 and 384 Teams
REYNOLDS Nancy R. ⁽¹⁾ ; TESTA Marcia A. ⁽²⁾ ; SU Max ⁽³⁾ ; CHESNEY Margaret A. ⁽⁴⁾ ; NEIDIG Judith L. ⁽⁵⁾ ; FRANK Ian ⁽⁶⁾ ; SMITH Scott ⁽⁷⁾ ; ICKOVICS Jeannette ⁽⁸⁾ ; ROBBINS Gregory K. ⁽⁹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ AIDS Clinical Trials Unit, Ohio State University, Columbus, OH, ETATS-UNIS
⁽²⁾ Department of Biostatistics, Harvard School of Public Health, Boston, MA, ETATS-UNIS
⁽³⁾ Phase V Technologies, Inc, Boston, MA, ETATS-UNIS
⁽⁴⁾ AIDS Clinical Trials Unit, University of California at San Francisco, National Center for Complementary and Alternative Medicine, National Institutes of Health (NIH), Bethesda, MA, ETATS-UNIS
⁽⁵⁾ AIDS Clinical Trials Unit, Office of Responsible Research Practices, Ohio State University, Columbus, OH, ETATS-UNIS
⁽⁶⁾ Infectious Diseases Division, Hospital of the University of Pennsylvania, Philadelphia, PA, ETATS-UNIS
⁽⁷⁾ AIDS Clinical Trials Unit, University of North Carolina, Center for Outcomes and Evidence Agency for Healthcare Research and Quality, Rockville, MD, ETATS-UNIS
⁽⁸⁾ Epidemiology and Public Health, Yale University, New Haven, CT, ETATS-UNIS
⁽⁹⁾ Infectious Disease Unit, Massachusetts General Hospital, Boston, MA, ETATS-UNIS

Résumé / 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.

Revue / Journal Title

Journal of acquired immune deficiency syndromes   ISSN 1525-4135 

Source / Source

2008, vol. 47, n^o1, pp. 62-68 [7 page(s) (article)] (25 ref.)

Langue / Language

Anglais

Editeur / Publisher

Lippincott Williams & Wilkins, Hagerstown, MD, ETATS-UNIS  (1999) (Revue)

Mots-clés anglais / English Keywords

Virus ; Retroviridae ; Lentivirus ; Virology ; Microbiology ; Adhesion ; Antiretroviral agent ; Antiviral ; Human immunodeficiency virus ;

Mots-clés français / French Keywords

Virus ; Retroviridae ; Lentivirus ; Virologie ; Microbiologie ; Adhérence ; Antirétroviral ; Antiviral ; Virus immunodéficience humaine ;

Mots-clés espagnols / Spanish Keywords

Virus ; Retroviridae ; Lentivirus ; Virología ; Microbiología ; Adherencia ; Antiretroviral ; Antiviral ; Human immunodeficiency virus ;

Mots-clés d'auteur / Author Keywords

HIV ; adherence ; randomized controlled trial ; phone intervention ;

Localisation / Location

INIST-CNRS, Cote INIST : 21576, 35400016269277.0070