Unobtrusive Sensing of Medication Intake ("USE-MI") (USE-MI)
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|ClinicalTrials.gov Identifier: NCT03571022|
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Behavioral: USE-MI System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Unobtrusive Sensing of Medication Intake ("USE-MI")|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: USE-MI System
Immediate use of the USE-MI smartwatch and smartphone app.
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 come to the research office every month to complete a brief questionnaire about how they are taking their daily ART or PrEP pill(s).
- System Acceptability [ Time Frame: 6 Months ]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
- Accuracy of Capture of Pill-Taking by USE-MI [ Time Frame: 6 Months ]Compare the pill count using the USE-MI system versus the study staff manually counting at each monthly visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571022
|Contact: Julie Wallickemail@example.com|
|United States, Washington|
|Swedish Medical Center||Recruiting|
|Seattle, Washington, United States, 98122|
|Contact: Julie Wallick 206-215-3986 firstname.lastname@example.org|
|Principal Investigator:||Barry Saver, MD||Swedish Medical Center|
|Principal Investigator:||Jenna Marquard, PhD||University of Massachusetts, Amherst|