Randomized Controlled Trial: 4 Month versus 6 Month Monitoring of HIV-infected Patients on Highly Active Antiretroviral Therapy

As HIV treatment becomes more widely available and efficacious, and persons with HIV live longer, considerations for the financial and healthcare impact are of important. The best interval for routine HIV monitoring has been identified as area in which gaps in knowledge exist. The goal of this study is to determine the impact of changing scheduled follow up care for persons with HIV from a 4 to 6 months interval. HIV infected adults with a CD4 count ≥250 cells/μl, and an undetectable HIV viral load (VL) by an ultrasensitive assay for at least 1 year were randomized to routine HIV care at either a 4 or 6 months interval. Subjects were monitored for virological failure, adherence and quality of life (QOL). 142 subjects were enrolled and completed study protocol. Two subjects in the 6 months arm developed virological failure, p value = 0.5. There was no difference in adherence, or QOL scores. Subjects in the 4 months arm had higher rates of HIV visits (8.5/100 vs. 5.2/100 person months, p = 0.01) and non-HIV related visits (9.4/100 vs. 6.0/100 person months, p = 0.01) and were more likely to change antiretroviral regimen (34.8 vs. 15.8 %, p = 0.01). Despite strict inclusion criteria in this relatively short follow up time, 2/142 (1.4 %) subjects developed virological failure and many more had transient detectable VL. While not statistically significant a larger study with longer follow up is needed.