Site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy, ACTG 5031: substudy of ACTG 384

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.

Keywords: adherence intervention; antiretroviral therapy; human immunodeficiency virus (HIV); nursing telephone support; randomized controlled trial.

Figure 1

Consort Flow Diagram

Figure 2

Mean self-reported adherence by study group by week. Differences between the two adherence arms were not significant. Adherence increased over the first 48 weeks and then remained high during the 160 weeks of follow-up.

Figure 3

Time to primary 384 endpoint, first four-drug or second three-drug regimen failure (3a), Time to 1^st virologic failure (3b), and Time to first regimen failure (3c). Subjects participating in the 5031 Adherence substudy are shown: Additional phone support group (red) and standard care group (blue). For the 384 clinical endpoints differences between the two adherence arms were not significant.