NCT02676128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

4.2 years

First QC Date

February 3, 2016

Last Update Submit

October 5, 2020

Conditions

HIVMedication AdherenceMobile Health

Keywords

HIVMedication AdherenceMobile Health

Outcome Measures

Primary Outcomes (1)

  • ART Adherence

    Percentage of ART adherence based on Electronic Pill Box data will be compared between the groups

    12 Months

Secondary Outcomes (6)

  • Self-Reported ART Adherence

    12 Months

  • Viral Load

    12 Months

  • Behavioral Skills

    12 Months

  • Information

    12 Months

  • Information, Motivation, and Behavioral Skills

    12 Months

  • +1 more secondary outcomes

Study Arms (2)

Mobile Health ART Adherence Application (mARTAA)

EXPERIMENTAL

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

Behavioral: Twine Collaborative Care Application

Face-to-Face ART Adherence Intervention

ACTIVE COMPARATOR

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

Behavioral: Information-Motivation-Behavioral Skills Model of ART Adherence

Interventions

Twine Collaborative Care ApplicationBEHAVIORAL

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.

Mobile Health ART Adherence Application (mARTAA)
Information-Motivation-Behavioral Skills Model of ART AdherenceBEHAVIORAL

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

Face-to-Face ART Adherence Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

    PMID: 34117965DERIVED

  • 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.

    PMID: 31719030DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Susan E Ramsey, Ph.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

US(1)