Randomized controlled trial of an intervention to prevent adherence failure among HIV-infected patients initiating antiretroviral therapy.

OBJECTIVE: Compare the efficacy of a multicomponent social support intervention to standard-of-care counseling on medication adherence among HIV-infected patients initiating antiretroviral therapy. DESIGN: Randomized controlled trial. Generalized estimating equations tested for differences in the percentage of participants achieving 90% adherence. MAIN OUTCOME MEASURES: Pill-taking, electronically monitored over 6 consecutive months; plasma viral load (VL), assessed at 3 and 6 months following initiation of therapy. RESULTS: Of 226 participants who were randomized and began the trial, 87 (38%) were lost to the study by 6 months. The proportion of adherent participants declined steadily over time, with no time by group interaction. Sustained adherence was associated with increased odds of achieving an undetectable VL (OR=1.78; 95% CI=1.01, 3.13). In intention-to-treat analyses, a larger proportion of the intervention group than the control group was adherent (40.15% vs. 27.59%, p=.02) and achieved an undetectable VL p=.04). However, the majority of participants who remained on study experienced some reduction in VL (>or=1-log drop or undetectable), regardless of experimental condition. CONCLUSION: The multicomponent social support intervention significantly improved medication adherence over standard-of-care counseling; evidence for improved virologic outcomes was inconsistent. Early discontinuation of care and treatment may be a greater threat to the health of HIV patients than imperfect medication-taking.