Clinical trial NCT02676128: Mobile Health Application to Improve HIV Medication Adherence
Official title: Mobile Health Application to Improve HIV Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Medication Adherence
Mobile Health
Keywords: HIV
Medication Adherence
Mobile Health
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: ART Adherence
timeFrame: 12 Months
Secondary outcomes:
measure: Self-Reported ART Adherence
timeFrame: 12 Months
measure: Viral Load
timeFrame: 12 Months
measure: Behavioral Skills
timeFrame: 12 Months
measure: Information
timeFrame: 12 Months
measure: Information, Motivation, and Behavioral Skills
timeFrame: 12 Months
measure: Self-Efficacy
timeFrame: 12 Months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Susan E Ramsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramsey SE, Ames EG, Uber J, Habib S, Clark S, Waldrop D. A Preliminary Test of an mHealth Facilitated Health Coaching Intervention to Improve Medication Adherence among Persons Living with HIV. AIDS Behav. 2021 Nov;25(11):3782-3797. doi: 10.1007/s10461-021-03342-5. Epub 2021 Jun 12.
citation: Ramsey S, Ames E, Uber J, Habib S, Clark S. A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 13;8(11):e15356. doi: 10.2196/15356.