Mobile Health Application to Improve HIV Medication Adherence

HIV Clinical Trial

Official title:

Mobile Health Application to Improve HIV Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676128
• Other study ID #: R34MH108431
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2020

Study information

• Verified date: October 2020
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Medication Adherence
• Mobile Health

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ART Adherence	Percentage of ART adherence based on Electronic Pill Box data will be compared between the groups	12 Months
Secondary	Self-Reported ART Adherence	Self-reported ART adherence as measured by the AACTG Medication Adherence Questionnaire will be compared between the groups.	12 Months
Secondary	Viral Load	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
Secondary	Behavioral Skills	Group differences will be examined in behavioral skills as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.	12 Months
Secondary	Information	Group differences will be examined in information as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.	12 Months
Secondary	Information, Motivation, and Behavioral Skills	Group differences will be examined in motivation as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.	12 Months
Secondary	Self-Efficacy	Group differences will be examined in self-efficacy as assessed by the HIV Treatment Adherence Self-Efficacy Questionnaire	12 Months