Mobile Health Application to Improve HIV Medication Adherence

October 5, 2020 updated by: Rhode Island Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Health ART Adherence Application (mARTAA)
mARTAA will use a smartphone-delivered application developed by Twine Health, Inc.
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.
Active Comparator: Face-to-Face ART Adherence Intervention
A single face-to-face ART adherence intervention will be administered.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ART Adherence
Time Frame: 12 Months
Percentage of ART adherence based on Electronic Pill Box data will be compared between the groups
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported ART Adherence
Time Frame: 12 Months
Self-reported ART adherence as measured by the AACTG Medication Adherence Questionnaire will be compared between the groups.
12 Months
Viral Load
Time Frame: 12 Months
Viral load will be dichotomized into three levels (20, 48, and 400 copies/ML) and intervention effects will be examined at each of these levels.
12 Months
Behavioral Skills
Time Frame: 12 Months
Group differences will be examined in behavioral skills as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.
12 Months
Information
Time Frame: 12 Months
Group differences will be examined in information as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.
12 Months
Information, Motivation, and Behavioral Skills
Time Frame: 12 Months
Group differences will be examined in motivation as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.
12 Months
Self-Efficacy
Time Frame: 12 Months
Group differences will be examined in self-efficacy as assessed by the HIV Treatment Adherence Self-Efficacy Questionnaire
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: Susan E Ramsey, Ph.D., Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R34MH108431 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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