JMIR Publications

ABSTRACT

Background:

Gaps remain in achieving retention in care and durable human immunodeficiency virus (HIV) viral load suppression for people with HIV (PWH) in Washington, D.C. While PWH seeking care in DC have access to a range of supportive services, innovative strategies are needed to bridge individual and structural barriers that reduce patient engagement in this setting. Mobile health (mHealth) interventions have shown promise in reaching previously under-engaged groups and improving HIV-related outcomes in various settings.

Objective:

This study will evaluate the implementation and effectiveness of a clinic-deployed, multi-feature mHealth intervention called PositiveLinks (PL) among PWH enrolled in the DC Cohort, a longitudinal cohort of PWH receiving care in DC. A cluster randomized controlled trial will be conducted using a hybrid effectiveness-implementation design, and will compare HIV-related outcomes between clinics randomized to PL versus usual care.

Methods:

The study aims are three-fold. We will 1) perform a formative evaluation of PL in the context of DC Cohort clinics, to test the feasibility, acceptability and usability of PL and tailor the platform for use in this context. We will 2) conduct a cluster randomized controlled trial with 12 DC Cohort clinics randomized to PL or usual care (n=6 per arm). Effectiveness of PL will be measured by the primary outcomes of patient visit constancy, retention in care and HIV viral load suppression. We aim to enroll and complete baseline assessments with a total of 482 participants from Cohort clinic sites, specifically including PWH who show evidence of inconsistent retention in care or lack of viral suppression. We will 3) use the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) Framework to measure implementation success and identify site, patient, provider, and system factors associated with successful implementation. Evaluation activities occur pre-, mid- and post-implementation.

Results:

Formative data collection was completed between April 2021 and January 2022. Preliminary mHealth platform modifications have been performed and the first round of user testing has been completed. A pre-implementation evaluation was performed to identify relevant implementation outcomes and design a suite of instruments to guide data collection for evaluation of PL implementation throughout the trial period. Instruments include those already developed to support DC Cohort Study activities and PL implementation in other cohorts, which required modification for use in the study, as well as novel instruments designed to complete collection of qualitative and quantitative data as guided by the CFIR and RE-AIM frameworks.

Conclusions:

Formative and implementation evaluation aims are underway while the trial aim is preparing for launch. Specifically, comprehensive formative data analysis is underway following data collection, coding, preliminary review, and synthesis. Corresponding platform modifications needed for the DC Cohort setting are ready for beta testing by PWH enrolled in the DC Cohort. Finalization of the PL platform for use in the trial will follow beta testing. Trial enrollment is planned to begin in Spring 2022. Clinical Trial: NCT04998019