Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Health Application to Improve HIV Medication Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02676128
Recruitment Status : Active, not recruiting
First Posted : February 8, 2016
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

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.

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

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. ART Adherence [ Time Frame: 12 Months ]
    Percentage of ART adherence based on Electronic Pill Box data will be compared between the groups


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Information [ Time Frame: 12 Months ]
    Group differences will be examined in information as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.

  5. 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.

  6. Self-Efficacy [ Time Frame: 12 Months ]
    Group differences will be examined in self-efficacy as assessed by the HIV Treatment Adherence Self-Efficacy Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Layout table for investigator information
Principal Investigator: Susan E Ramsey, Ph.D. Rhode Island Hospital

Layout table for additonal information
Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02676128     History of Changes
Other Study ID Numbers: R34MH108431 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Keywords provided by Rhode Island Hospital:
HIV
Medication Adherence
Mobile Health