Site Nurse–Initiated Adherence and Symptom Support Telephone Calls for HIV-Positive Individuals Starting Antiretroviral Therapy, ACTG 5031: Substudy of ACTG 384
Year: 2013
Type: article
Abstract: BACKGROUND: Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed. OBJECTIVE: To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care. METHODS: A randomized controlled trial of site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy. Subjects were randomized to receive site nurse-initiated telephone calls (intervention) or no additional calls to the site's standard of care (control). Subjects received calls 1 to 3 days after initiating antiretrovirals, on weeks 1, 2, 3, 6, 10, 14, 18, 22, and 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits. RESULTS: A total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with ≯95% mean total adherence (87.9% and 91.2%; P = .34) and mean self-reported total adherence (97.9% and 98.4%) in the intervention and control groups, respectively, or in symptom distress and clinical endpoints. CONCLUSIONS: In the context of a clinical trial where self-reported adherence was exceptionally high, the site nurse-initiated telephone calls did not further improve self-reported adherence, symptom distress, or clinical outcomes.
Source: HIV Clinical Trials
DOI: 10.1310/hct1405-235
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: University of Southern California, University of Miami, Northwestern University, Harvard University, University of Minnesota, University of Washington, Tulane University, Johns Hopkins University, University of Rochester, University of Cincinnati, Case Western Reserve University, ACT Government, York University, National Institutes of Health, Medical Center, University of Rochester, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, National Institute of Dental and Craniofacial Research
Awards: G123932167, G1290643946, G1432718094, G1507718124, G1534260048, G1681955143, G174905615, G193111053, G1944963898, G229144670, G2368841045, G2381598486, G247953218, G2682253789, G2916982757, G3116536149, G3525517067, G367367271, G3788978964, G4205250407, G5161777734, ADULT ACTG CENTRAL GROUP, Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS CTU, G7348756, AIDS CLINICAL TRIALS UNIT, G8575939001, G9000008330, G9000041098, G9000041396, G9000057772, G9000061540, G9000156378, G9000191945, G9000211563, G9000211761, G9000222674, G9000225493, G9000253243, G9000276314, G9000293182, G9000294993, G9000305346, G9000309490, G9000352715, Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials Unit, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Boston HIV CTU, Bridging the Gap HIV Trials and Clinical Practice
OpenAlex ID: W1994834055