Pragmatic Efficacy Trial of mHealth to Improve HIV Outcomes in the DC Cohort

In order to achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care
continuum, including improving retention in care and viral suppression among persons living with HIV (PLWH).
Currently, in the U.S., it is estimated that less than 50% of PLWH are retained in care and even fewer are
virally suppressed. Studies have shown that these PLWH have poorer clinical outcomes and are at risk of
transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent
viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-
risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that
includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient
cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It
has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-
monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information
resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study
in poorly retained adults with HIV found that PL increased RIC and VS, with app usage related to benefit as
well as improved social support and stigma. PL is a promising existing mHealth tool for PLWH, but its efficacy
has not been tested in a rigorous randomized trial, nor in urban populations. We propose to test the efficacy of
PositiveLinks to improve retention in care and viral suppression among a cohort of PLWH in a high HIV
prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal
observational prospective cohort of PLWH receiving HIV care at 14 clinical sites in Washington, DC. First, we
will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this
urban cohort and conduct subsequent adaptations based on these findings. We will then conduct an efficacy
study through a cluster randomized controlled trial at 14 DC Cohort sites among 560 PLWH. Clinics will be
randomized to PL or usual care. Our primary outcomes will include viral suppression, retention in care and visit
constancy at 12 months. Finally, we will conduct mixed methods implementation science research guided by
the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and
system factors that characterize best practices in program implementation. If successful, this research will lead
to the development of a novel and efficacious approach to improving retention in care and viral suppression
among PLWH which could lead to next-generation dissemination research that will contribute to HIV epidemic
control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic
goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve
sustained viral suppression in a geographic hotspot for HIV.

Grant Number: 5R01MH122375-05
NIH Institute/Center: NIH
Principal Investigator: Amanda Castel