Abstract
OBJECTIVE: To provide data on the actual costs associated with behavioral ART adherence interventions and electronic drug monitoring used in a clinical trial to inform their implementation in future studies and real-world practice. METHODS: Direct and time costs were calculated from a multisite 3-arm randomized controlled ART adherence trial. HIV-positive participants (n = 204) were randomized to standard care, enhanced counseling (EC), or EC and modified directly observed therapy (mDOT) interventions. Electronic drug monitoring (EDM) was used. Costs were calculated for various components of the 24-week adherence intervention. This economic evaluation was conducted from the perspective of an agency that may wish to implement these strategies. Sensitivity analyses were conducted to examine costs and savings associated with different scenarios. RESULTS: Total direct costs were $126,068 ($618 per patient). Initial time costs were $53,590 ($262 per patient). Base cost of labor was $0.36/min. EC costs for 134 patients were $18,427 ($137 per patient) and mDOT for 64 patients cost $18,638 ($291 per patient). Total per patient costs were as follows: standard care = $880, EC = $1018, EC/mDOT = $1309. Removing driving costs evidenced the most variable impact on savings between the 3 study arms. The tornado diagram (sensitivity analysis) showed a graphical representation of how each sensitivity assumption reduced costs compared with each other and the resulting comparative costs for each group. CONCLUSIONS: This novel economic analysis provides valuable cost information to guide treatment implementation and research design decisions.