NCT03571022

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 5, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

4.5 years

First QC Date

June 5, 2018

Last Update Submit

April 21, 2022

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • System Acceptability

    Evaluate the use of the USE-MI system after 6 months of follow-up. At each monthly visit, subjects will complete a questionnaire about their medication-taking habits, plus the study staff will perform a manual count of their pills. Subjects will be asked for feedback about improving the system, whether they found it helpful, and whether they would be willing to continue to use such a system

    6 Months

Secondary Outcomes (1)

  • Accuracy of Capture of Pill-Taking by USE-MI

    6 Months

Study Arms (1)

USE-MI System

EXPERIMENTAL

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

Behavioral: USE-MI System

Interventions

USE-MI SystemBEHAVIORAL

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).

USE-MI System

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Barry Saver, MD

    Swedish Medical Center

    PRINCIPAL INVESTIGATOR

  • Jenna Marquard, PhD

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Karr

CONTACT

206-215-4226jacob.karr@swedish.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 27, 2018

Study Start

January 8, 2019

Primary Completion

June 30, 2023

Study Completion

December 31, 2025

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

US(1)