Dose Determination Trial for Evidence-Based Behavioral Counseling to Improve.

INTRODUCTION The life-prolonging benefits of antiretroviral therapy (ART) are undermined by poor retention in care and suboptimal ART adherence. While behavioral interventions have demonstrated efficacy in clinical trials and are widely disseminated, scaling-up of evidence-based interventions is hampered by not knowing answers to basic implementation questions, such as the minimally effective dose (MED) of counseling and how the MED varies across patients. This trial aimed to answer these questions.

METHODS People living with HIV in the southeastern US (N = 295) who were either not engaged in care, non-adherent (<85%) to ART or HIV unsuppressed participated in a dose determination trial designed to: (a) find the MED of counseling sessions for missed care appointments, ART adherence, and HIV suppression and (b) the moderators of dose over 12-months of observation.

RESULTS We found that 31% of participants did not complete more than two sessions (i.e., early dropout) of counseling. The MED for behavioral counseling on HIV care, adherence and viral load was 5 sessions, with an MED range of 4-6 depending on counseling facilitators (e.g., social support) and barriers (e.g., medication concerns).

CONCLUSIONS Behavioral counseling in previous trials may have been under-dosed when delivered in fewer than 5 sessions and over-dosed when delivered in greater than 6 sessions, depending on patient characteristics that moderate dose-response relationships.