Unobtrusive Sensing of Medication Intake ("USE-MI")

NCT ID: NCT03571022

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related medications and help them remember to take these medications. With the use of a smartwatch and smartphone "app", investigators hope to be able to monitor medication adherence in real-time and send subjects electronic reminders when they may have forgotten to take their medication.

Detailed Description

Human immunodeficiency virus (HIV) treatment is most likely to be successful when patients are committed to taking their medications as prescribed (medication adherence). For maximum benefit, researchers found that patients receiving antiretroviral therapy (ART) to treat HIV infection and pre-exposure prophylaxis (PrEP) to prevent HIV infection have need consistent, high levels of adherence for maximum benefit. However, some patients struggle to take their HIV-related medications regularly and that can lead to losing on the benefits the medication can provide - either suppressing the HIV infection so people do not get sick from it or transmit it, or failing to prevent infection when someone is exposed.

Objectives: Conduct an evaluation of USE-MI to assess accuracy, robustness, acceptability of the system.

All subjects will continue to take their ART or PrEP medication as prescribed by their regular doctor. The USE-MI system is being developed as a behavioral intervention to enhance medication adherence. In the pilot phase, the investigators plan to enroll 10 subjects to use the USE-MI system for 1 month to get initial feedback about the system. In the second phase, up to 50 subjects will begin using the USE-MI for up to 6 months to assess accuracy, robustness and acceptability of the system.

Conditions

Medication Adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

USE-MI System

Immediate use of the USE-MI smartwatch and smartphone app.

Group Type: EXPERIMENTAL

USE-MI System

Intervention Type: BEHAVIORAL

Pilot Phase: 10 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for 1 month and receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s).

Second Phase: Up to 50 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for up to 6 months. During their first month, subjects will receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s). Subjects will then have monthly follow-up visits to complete a brief questionnaire about how they are taking their daily ART or PrEP pill(s).

Interventions

USE-MI System

Pilot Phase: 10 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for 1 month and receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s).

Second Phase: Up to 50 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for up to 6 months. During their first month, subjects will receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s). Subjects will then have monthly follow-up visits to complete a brief questionnaire about how they are taking their daily ART or PrEP pill(s).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Either a) have an HIV infection and are taking ART, or b) risk factors for contracting HIV infection and are taking PrEP
• Taking their medications from pill bottles, or other containers that the USE-MI system can monitor properly
• Reasonable proficiency in English
• Able to come to the research office for monthly follow-up visits

Exclusion Criteria

• Not responsible for taking their own HIV medications (e.g. residing in a supervised setting where their medications are administered to them)
• Taking medications using a method that the USE-MI system cannot monitor properly
• Lacking proficiency in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Amherst

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Swedish Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry Saver, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center

Jenna Marquard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Amherst

Locations

Swedish Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacob Karr

Role: CONTACT

jacob.karr@swedish.org

206-215-4226

Facility Contacts

Jacob Karr

Role: primary

jacob.karr@swedish.org

206-215-4226

Other Identifiers

5R01MH109319

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SWD5984S-16

Identifier Type: -

Identifier Source: org_study_id