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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    60
  • sponsor
    Swedish Medical Center
Updated on 15 March 2021

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.

Description

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.

Details
Condition Noncompliance with medication regimen
Treatment USE-MI System
Clinical Study IdentifierNCT03571022
SponsorSwedish Medical Center
Last Modified on15 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Noncompliance with medication regimen?
Do you have any of these conditions: Do you have Noncompliance with medication regimen??
Do you have any of these conditions: Do you have Noncompliance with medication regimen??
Do you have any of these conditions: Do you have Noncompliance with medication regimen??
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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