Recruiting

USE-MI

Sponsor:

Swedish Medical Center

Code:

NCT03571022

Conditions

Medication Adherence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

USE-MI System

Study Details

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.

Conditions

Medication Adherence

Study ID

NCT03571022

Start date

Jan 8, 2019

Status verified date

Apr, 2022

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: USE-MI System

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

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).

Primary outcome measure

  • System Acceptability [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Jacob Karr

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

Locations

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Jacob Karr

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

More Information

Sponsor

Swedish Medical Center

Last update posted

Apr 28, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Swedish Medical Center on 2022-04-28.