Dose Determination Trial The StartPersist Studies to Improve HIV Treatment Adherence with Behavioral Counseling

What this Trial Is About

This research aims to find the best number of behavioral counseling sessions needed to help people with HIV improve and maintain their treatment adherence and viral suppression. It is the first dose-determination trial that studies how much counseling is needed for different patients facing various individual and social challenges. The results will help guide health policy and how behavioral interventions are used to support lasting HIV viral suppression among patients on antiretroviral therapy ART. Participants who are confirmed HIV positive and non-adherent to ART will be randomly assigned to one of two groups. One group receives up to 16 weekly phone counseling sessions that adjust based on their response to achieve viral suppression. The other group gets a fixed dose of five weekly counseling sessions over the phone focused on improving medication adherence. Counseling aims to support cognitive-behavioral skills for HIV treatment adherence, with follow-up assessments for 12 months. During the study, researchers will regularly measure changes in ART adherence and HIV viral load from baseline through 12 months. Participants who respond but later experience viral rebound can receive additional counseling sessions. The study will analyze how counseling dose relates to patient subgroups and costs to help make informed decisions about resource allocation for behavioral interventions. Overall, the trial involves phone counseling sessions, adherence and viral load monitoring, and 12 months of follow-up to assess outcomes and intervention dose effectiveness.

HIV Treatment Adherence Dose Determination Trial