Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 5, 2019
Date Accepted: Aug 31, 2019
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mHealth Application to Improve HIV Medication Adherence: Protocol to Establish Feasibility, Acceptability, and Preliminary Efficacy
ABSTRACT
Background:
Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV (PLWH) to live longer, healthier lives. However, a large portion of PLWH have suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.
Objective:
The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus application enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.
Methods:
This study will be conducted in two phases. The intervention will be developed and piloted with a small group of participants during Phase 1. Pilot participants will provide feedback, which will be used to refine the intervention for Phase 2. In Phase 2, a preliminary randomized controlled (RCT) trial comparing Fitbit Plus to a condition that approximates the standard-of-care (SOC) will be conducted with 60 PLWH. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes (EPBs). Effect sizes will be generated using a fractional logit model estimated by Generalized Estimating Equations.
Results:
Phase 1 of this trial is complete; data collection for Phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.
Conclusions:
This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Due to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus. Clinical Trial: ClinicalTrials.gov Identifier: NCT02676128
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