Unobtrusive Sensing of Medication Intake ("USE-MI")
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/14/2018 |
| Start Date: | January 1, 2019 |
| End Date: | June 30, 2021 |
| Contact: | Julie Wallick |
| Email: | julie.wallick@swedish.org |
| Phone: | 206-215-3986 |
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.
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.
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 require an adherence of 95% or better. Similar high levels of adherence for
patients receiving pre-exposure prophylaxis (PrEP) to prevent HIV infection have also been
recommended for maximum protection. 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 failing to
prevent infection when someone is exposed.
Objectives: Conduct a long-term evaluation of USE-MI to assess accuracy, robustness,
acceptability of the system, and to evaluate the effects on ART and PrEP adherence.
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 at least 6 months. In the sustainability phase, up to 50 subjects will
be randomized to begin using the USE-MI system after 6 months of follow-up, or to begin using
the USE-MI system immediately. The investigators hypothesize that most subjects will achieve
95% or better adherence within 3 months of using the USE-MI system.
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 require an adherence of 95% or better. Similar high levels of adherence for
patients receiving pre-exposure prophylaxis (PrEP) to prevent HIV infection have also been
recommended for maximum protection. 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 failing to
prevent infection when someone is exposed.
Objectives: Conduct a long-term evaluation of USE-MI to assess accuracy, robustness,
acceptability of the system, and to evaluate the effects on ART and PrEP adherence.
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 at least 6 months. In the sustainability phase, up to 50 subjects will
be randomized to begin using the USE-MI system after 6 months of follow-up, or to begin using
the USE-MI system immediately. The investigators hypothesize that most subjects will achieve
95% or better adherence within 3 months of using the USE-MI system.
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
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