Mobile Health Application to Improve HIV Medication Adherence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence

NCT04990583

Pre-Exposure Prophylaxis Telemedicine Medication Adherence

WITHDRAWN NA

mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV

NCT05046392

HIV Medication Adherence Telemedicine

UNKNOWN NA

mHealth Intervention Supporting HIV Treatment Adherence and Retention

NCT01951092

HIV Adherence Retention

COMPLETED NA

An Automated, Tailored Information Application for Medication Health Literacy

NCT01304186

Human Immunodeficiency Virus I Infection

COMPLETED NA

Adherence Intervention for People With Low-literacy

NCT01061762

HIV Infections

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Medication Adherence Mobile Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mobile Health ART Adherence Application (mARTAA)

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

Group Type EXPERIMENTAL

Twine Collaborative Care Application

Intervention Type BEHAVIORAL

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.

Face-to-Face ART Adherence Intervention

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

Group Type ACTIVE_COMPARATOR

Information-Motivation-Behavioral Skills Model of ART Adherence

Intervention Type BEHAVIORAL

Combines brief motivational interviewing, cognitive behavior therapy, and problem-solving skills to help participants formulate and follow ART adherence goals.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No