JMIR Publications

ABSTRACT

Background:

Despite significant investments in Ending the HIV Epidemic, disparities in HIV care persist and there is an urgent need to evaluate novel and scalable approaches to improving HIV care engagement and viral suppression in real-world settings.

Objective:

To describe a study protocol for a pragmatic type II hybrid effectiveness-implementation randomized controlled trial comparing existing standard of care clinic HIV linkage, adherence and retention (LAR) protocols to a mobile Health (mHealth)-enhanced linkage, adherence, and retention (mLAR) intervention.

Methods:

500 participants will be enrolled into the study from clinics in Baltimore City. Eligibility criteria includes age ≥ 18 years of age and 1. new HIV diagnosis or 2. HIV-infected and out of care or 3. HIV-infected and deemed by clinic staff as someone who could benefit from linkage and retention services. Participants randomized to the intervention receive mHealth-supported patient navigation for 12 months. Participants in the control group receive the referring clinic’s standard of care patient support. The primary outcome is HIV virologic suppression at 12 months. A subset of participants will be interviewed at 12 months to learn about their HIV care experiences and, for those in the intervention arm, their experiences with the mLAR intervention. This protocol was developed in collaboration with the Baltimore City Health Department (BCHD) and the Maryland Department of Health (MDH), and with input from a community advisory board.

Results:

Enrollment began on February 25, 2020. As of August 11, 2022, 411 of the 500 target participants had been enrolled.

Conclusions:

Pragmatic implementation science trials designed with input from key stakeholders, including health department and community members, can help evaluate the evidence for mHealth interventions to reduce HIV health disparities. Clinical Trial: NCT 03934437