Feasibility, acceptability, and pilot trial of a real-time electronic adherence monitoring intervention for antiretroviral therapy

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ABSTRACT African American men who have sex with men (AAMSM) have high HIV infection rates and disproportionate mortality. Critical to ending the HIV epidemic are efforts to reduce HIV transmission by optimizing ART adherence and suppressing viral load. We propose using responsive electronic adherence monitoring (EAM) in a tiered approach from least to most resource utilization where the EAM device alerts the medication user at the time nonadherence is detected and a pre-identified social support person or case manager when 2 or 7 consecutive days of nonadherence are detected, respectively. We call our approach “A-Team” (Antiretroviral Therapy Electronic Adherence Monitoring) because we provide a team serving a common goal to persons struggling with adherence. This intervention draws on the situated Information Motivation Behavioral Skills Model and is informed by emerging social support literature. Real-time ART adherence monitoring with a triaged response to missed doses informs the patient in real-time of each potential nonadherence event, motivates medication adherence, and positively influences adherence behavioral skills, resulting in viral suppression. This study will be the first to discover how social support persons and case managers perceive this approach, what concerns they may have, and how they respond to one or multiple notifications of missed doses. The aims of this application are to determine the acceptability and feasibility of real-time adherence monitoring in support persons and case managers of AAMSM and to pilot a triaged responsive real-time monitoring adherence intervention for AAMSM. We will implement a 6-month pilot randomized controlled trial among 54 AAMSM living with HIV and measure ART adherence and viral suppression (the primary outcome). Lessons learned from this project may be useful to the field of adherence in these and other persons living with HIV and other diseases.