NCT02676128

Mobile Health Application to Improve HIV Medication Adherence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Inadequate adherence to antiretroviral therapy (ART) can impede successful viral suppression and consequently lead to negative health consequences. This study aims to refine and test the efficacy of a mobile health ART adherence application (ARTAA), delivered over a smartphone, with helping individuals improve their ART adherence.

Detailed description

The CDC estimates that 1.1 million people living in the U.S. are infected with HIV \[1\]. Only a quarter of person living with HIV (PLWH) successfully keep the virus under control \[2\]. Medication non-adherence is a significant contributor to unsuccessful viral suppression; a recent meta-analysis found that only an estimated 59% of participants in North American studies were adherent at a commonly accepted minimal threshold for successful viral suppression \[3\]. While newer antiretroviral therapy (ART) medications can produce viral suppression at lower levels of adherence, relatively high adherence is still necessary to avoid disease progression and shortened lifespan \[4-6\]. In addition, low levels of adherence increase the risk of infecting others and contribute to the development of treatment resistant strains of HIV \[7;8\]. Interventions have been developed to address the significant public health problem presented by poor adherence, with most studies demonstrating some degree of success in the short-term \[9\]. However, the impact of the interventions is generally not sustained over time \[9\], and most HIV treatment settings do not have the resources to deliver more intensive interventions. As a result, there has been interest in developing efficacious electronically-delivered interventions. Very little research has focused on establishing the efficacy of mobile health applications for ART adherence. Further, no published studies have examined a single session face-to-face intervention combined with a mobile application and coaching support to reinforce sustained adherence. Delivered over a smartphone, portable applications would allow for real-time adherence tracking and feedback and ready access to content or services to enhance adherence. The long-term goal of this line of research is to disseminate an efficacious, mobile health ART adherence application that can be integrated readily into clinical care. The objective of this application is to develop a mobile health ART adherence application, to pilot the application, and to conduct a preliminary randomized controlled trial of the application.

Conditions

• HIV
• Medication Adherence
• Mobile Health

Interventions

Type	Name	Description
BEHAVIORAL	Twine Collaborative Care Application	This application features a 24-hour medication clock that displays ART dosing schedule and allows participants to record the doses taken. It also features an interactive health coaching feature which will be used to provide support, encouragement, and resources to participants.
BEHAVIORAL	Information-Motivation-Behavioral Skills Model of ART Adherence	Combines brief motivational interviewing, cognitive behavior therapy, and problem-solving skills to help participants formulate and follow ART adherence goals.

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2016-02-08
• Last updated: 2020-10-06

Locations

1 site across 1 country: United States