Mobile Health Application to Improve HIV Medication Adherence
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|ClinicalTrials.gov Identifier: NCT02676128|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2016
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Medication Adherence Mobile Health||Behavioral: Twine Collaborative Care Application Behavioral: Information-Motivation-Behavioral Skills Model of ART Adherence||Not Applicable|
The CDC estimates that 1.1 million people living in the U.S. are infected with HIV . Only a quarter of person living with HIV (PLWH) successfully keep the virus under control . 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 . 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 . However, the impact of the interventions is generally not sustained over time , 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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Mobile Health Application to Improve HIV Medication Adherence|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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.
- ART Adherence [ Time Frame: 12 Months ]Percentage of ART adherence based on Electronic Pill Box data will be compared between the groups
- 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.
- 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.
- 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.
- Information [ Time Frame: 12 Months ]Group differences will be examined in information as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.
- 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.
- Self-Efficacy [ Time Frame: 12 Months ]Group differences will be examined in self-efficacy as assessed by the HIV Treatment Adherence Self-Efficacy Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676128
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Susan E Ramsey, Ph.D.||Rhode Island Hospital|