SteadyRx: Smartphone ART Adherence Intervention for Drug Users

NCT02317614 | Completed Results

• 2 other identifiers: IRB00026315R34DA037130
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals infected with HIV, and can reduce the chance of HIV transmission, but a high degree of adherence to ART is required to achieve these benefits. Unfortunately, only 59% of patients in North America report ART adherence \>90%. Thus, ART adherence interventions are a critical part of the fight against HIV/AIDS. Injection drug use and crack cocaine use are major factors in the transmission of HIV, and are associated with non-adherence to ART. Several types of interventions, most notably directly administered antiretroviral therapy (direct observation of antiretroviral administration and patient supports) and contingency management (the provision of incentives contingent upon objective evidence of adherence) have been effective in promoting ART adherence in drug users. However, a core problem with all ART adherence interventions is that their effects do not last after the interventions are discontinued. The common finding of post-intervention dissipation of effects suggests that ART adherence interventions may need to be long-term or even permanent adjuncts to ART for drug users. The investigators intend to develop an intensive intervention that incorporates the most effective techniques for promoting ART adherence in drug users, and delivers them in a manner that allows for their large-scale implementation as long-term or even permanent adjuncts to ART. Thus, we will bundle a targeted group of effective component interventions into a smartphone application that is easy for patients to use, simple to manage, and maximally convenient for all stakeholders. Our ultimate goal is to produce an intervention that is highly effective and scalable. Toward that end, the SteadyRX intervention to be developed under this project will be largely automated and will (1) facilitate consultation with care providers (2) provide reminders when a dose is overdue, (3) provide electronic remote observation of medication-taking, and (4) reward ART adherence. In addition to developing this smartphone-based intervention, a pilot study will be conducted in 50 HIV+ adults with a history of problem drug use. In this study, participants will be randomly assigned to receive usual care, or usual care plus the SteadyRX intervention.

Conditions

HIV; Medication Adherence

Keywords

Incentives; Smartphone; Mobile intervention; eDOT; Adherence reinforcement; Drug users

Outcome Measures

Primary Outcomes (2)

• Medication Adherence as Assessed by the Medication Event Monitoring System (MEMS) Cap

  The MEMS cap is a device that records the date and time whenever a patient opens a vial to monitor medication adherence. Percentage of participant to achieve 95% adherence will then be recorded.

  Six months

• Percentage of Participants Achieving an Undetectable Viral Load in Six Months

  Measured twice in six months to assess the percentage of participants to achieve a viral load \<400 HIV-RNA/mL (Y/N)

  Six months

Secondary Outcomes (2)

• Monthly Percent Adherence to Antiretroviral Medications.

  Six months

• Viral Load

  Six months

Other Outcomes (2)

• Mental and Physicial Health as Assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)

  Six months

• Opiate and Cocaine Use

  Six months

Study Arms (2)

SteadyRx

EXPERIMENTAL

This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.

Behavioral: SteadyRx

Usual Care

NO INTERVENTION

This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.

Interventions

SteadyRx BEHAVIORAL

The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.

SteadyRx

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Applicants will be eligible to participate in the study if they:
• are 18 to 100 years old;
• are HIV positive;
• have a primary care physician who is providing their HIV-related care including prescribed ART;
• have a substance use disorder
• can operate a smartphone
• speak English fluently

You may not qualify if:

• Applicants will be excluded if they:
• report current suicidal or homicidal ideation;
• report active hallucinations;
• are participating in another HIV related study.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Western Michigan University: collaborator

Study Sites (1)

Comprehensive Care Practice

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Medication Adherence; Drug Misuse

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Anthony DeFulio
• Organization: Western Michigan University

anthony.defulio@wmich.edu

269-387-4459

Study Officials

• Michael Fingerhood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 16, 2014
• Study Start: May 2, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: November 20, 2018
• Results First Posted: November 20, 2018

Record last verified: 2018-11

Locations

US (1)