A randomized study of serial telephone call support to increase adherence and thereby improve virologic outcome in persons initiating antiretroviral therapy

Background. Adherence to antiretroviral therapy is difficult, and methods to increase it are needed. Methods. We tested the impact of supportive telephone calls in an adherence substudy of a treatment trial. Subjects initiating antiretroviral therapy received either each site's usual adherence support measures or usual support measures and scripted serial telephone calls ( 16 calls during 96 weeks). Results. A total of 282 subjects enrolled: 140 in the usual support measures group and 142 in the calls group. A total of 75% of expected calls were completed. Virologic failure occurred in 97 ( 34%) subjects: 52 ( 37%) of those in the usual support measures group and 45 ( 32%) of those in the calls group; time to virologic failure was not different (P = .32). In each group, > 72% of subjects reported >= 95% adherence, with no difference between P = .32 groups. Independent predictors of higher rates of virologic failure were < 95% adherence, receiving the 4-drug regimen with nelfinavir, and female sex; older age was associated with decreased likelihood of virologic failure. Receiving the 4-drug regimen with nelfinavir, higher stress scores, older age, and higher call completion rates were independently associated with higher adherence. Conclusions. Serial telephone calls did not improve virologic outcome but had an impact on self-reported adherence.