A randomized trial of directly administered antiretroviral therapy and adherence case management intervention

Background. A randomized, controlled trial was conducted to evaluate the impact of a directly administered antiretroviral therapy program (DAART) and intensive adherence case management (IACM) intervention on virologic and immunologic response to highly active antiretroviral therapy (HAART) among patients at 3 public human immunodeficiency virus clinics in Los Angeles County, California. Methods. Participants included 250 treatment-naive and treatment-experienced persons for whom no more than 1 prior HAART regimen had failed. Five days per week for 6 months, a community worker delivered 1 HAART dose to DAART participants and observed the participant take it. IACM participants met weekly with a case manager to overcome barriers to HAART adherence. A control group (the standard of care [SOC] group) received the usual care. Results. The majority of patients were Latino (64%) or African American (24%); 57% were monolingual Spanish speakers. Seventy-five percent of the patients were male, and 64% reported an annual income of <$10,000. In an intent-to-treat analysis, no statistical differences were observed in the percentage of patients with an undetectable viral load (i.e., < 400 copies/mL) at 6 months between the DAART group (54%), IACM group (60%), and SOC group (54%; P > .05). An on-treatment analysis determined that there were no statistical differences in the percentage of patients with an undetectable viral load at 6 months between the DAART group (71%), IACM group (80%), and SOC group (74%; P > .05). Additionally, there were no statistical differences in 6-month changes in the CD4(+) cell count or in self-reported adherence to therapy. Conclusions. Among patients with limited prior HAART experience and adherence barriers that had not been assessed before randomization, no differences were found in virologic or immunologic response for DAART or IACM, compared with SOC, at 6 months. DAART and IACM did not improve short-term outcomes when SOC included other means of adherence support that were not controlled for by the study design.