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Principal Investigator: Susan E Ramsey
Organization: RHODE ISLAND HOSPITAL
Fiscal Year: 2024
Award: $677,305
Funding agency: National Institute of Mental Health
There are more than a million persons living with HIV in the United States. Despite the effectiveness of
antiretroviral therapy (ART), viral suppression, particularly durable viral suppression, can be difficult to achieve.
Suboptimal ART adherence plays a significant role in unsuccessful viral suppression, which increases the risk
of disease progression, a shortened lifespan, transmission to others, and the development of treatment
resistant strains of HIV. As a result, interventions targeting adherence have been developed. There have been
some signs of success, particularly with more intensive interventions. However, there is a need to develop
efficacious ART adherence interventions that are readily disseminable and make efficient use of available
resources. To that end, PI Ramsey developed and tested an mHealth facilitated ART adherence intervention
that includes a single face-to-face ART adherence session delivered by a health coach, followed by 12 months
of access to an app and health coaching delivered via the app. The app generates a push notification
medication reminder, and adherence data are available to the health coach via a “dashboard,” allowing the
health coach to monitor adherence in real time and provide support. The health coach uses a two-way secure
messaging feature on the app to message participants and to provide support, encouragement, and resources,
including links and attachments, in response to adherence lapses and in response to participant-generated
messages. The combination of a face-to-face intervention component followed by app facilitated health
coaching represents a novel combination that affords participants with a personal connection to a health coach
while minimizing the resources needed to deliver the intervention and maximizing timely responsiveness to
adherence lapses and other participant needs. A preliminary randomized controlled trial (RCT) compared the
intervention to a control condition in which participants received the single face-to-face ART adherence session
alone. Based on pilot data, the protocol and intervention are highly feasible and acceptable, and results are
consistent with preliminary efficacy of the intervention on objective measures of ART adherence. The proposed
study will expand on this preliminary test of the intervention using a fully powered RCT (n=400) across two
sites (Providence, RI and Atlanta, GA). The long-term goal of this line of research is to disseminate an
efficacious, mHealth facilitated ART adherence intervention that can be readily integrated into clinical care. The
present proposal will examine the impact of the intervention, relative to control, on electronic pillbox ART
adherence and viral load data. In addition, we will explore the role of theoretically supported variables in the
mediation and moderation of intervention effects. Interviews will be conducted at baseline, 1, 3, 6, and 12
months. A subset of participants will also complete interviews at 18 and 24 months to explore sustained
intervention effects. If found efficacious, the intervention could be broadly integrated into clinical care for HIV,
reducing morbidity and mortality among PLWH in a manner that makes efficient use of available resources.
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