Dose Determination Trial for Evidence-Based Behavioral Counseling to Improve HIV Care Engagement and Treatment Adherence.

INTRODUCTION

The life-prolonging benefits of antiretroviral therapy (ART) are undermined by poor retention in care and suboptimal ART adherence. Although behavioral interventions have demonstrated efficacy in clinical trials and are widely disseminated, scaling up evidence-based interventions is hampered by not knowing answers to basic implementation questions, such as the minimally effective dose/minimum 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 United States (N = 295) who were either not engaged in care, nonadherent (<85%) to ART or HIV unsuppressed participated in a dose determination trial designed to (1) find the MED of counseling sessions for missed care appointments, ART adherence, and HIV suppression and (2) the moderators of dose for 12 months of observation.

RESULTS

We found that 31% of participants did not complete >2 sessions (ie, 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 (eg, social support) and barriers (eg, medication concerns).

CONCLUSIONS

Behavioral counseling in previous trials may have been underdosed when delivered in <5 sessions and overdosed when delivered in >6 sessions, depending on patient characteristics that moderate dose-response relationships.