Skip to main content
Clinical Trials/NCT02676128
NCT02676128CompletedNot Applicable

Mobile Health Application to Improve HIV Medication Adherence

Rhode Island Hospital1 site in 1 country80 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
ART Adherence

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Prescribed ART, infected with HIV, have a detectable viral load (>20 copies/mL) with the past 6 months, report less than 100% medication adherence, and have a smart phone capable of downloading the mARTAA application.

Exclusion Criteria

  • •Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension, active psychosis, and not fluent in English.

Arms & Interventions

Mobile Health ART Adherence Application (mARTAA)

Experimental

mARTAA will use a smartphone-delivered application developed by Twine Health, Inc.

Intervention: Twine Collaborative Care Application (Behavioral)

Face-to-Face ART Adherence Intervention

Active Comparator

A single face-to-face ART adherence intervention will be administered.

Intervention: Information-Motivation-Behavioral Skills Model of ART Adherence (Behavioral)

Outcomes

Primary Outcomes

ART Adherence

Time Frame: 12 Months

Percentage of ART adherence based on Electronic Pill Box data will be compared between the groups

Secondary Outcomes

  • Information, Motivation, and Behavioral Skills(12 Months)
  • Viral Load(12 Months)
  • Self-Reported ART Adherence(12 Months)
  • Information(12 Months)
  • Self-Efficacy(12 Months)
  • Behavioral Skills(12 Months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials