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

NCT03571022 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-28

No results posted yet for this study

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.

Conditions

  • Medication Adherence

Interventions

BEHAVIORAL

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).

Sponsors & Collaborators

  • University of Massachusetts, Amherst

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Swedish Medical Center

    lead OTHER

Principal Investigators

  • Barry Saver, MD · Swedish Medical Center

  • Jenna Marquard, PhD · University of Massachusetts, Amherst

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2023-06-30
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03571022 on ClinicalTrials.gov