Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
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|ClinicalTrials.gov Identifier: NCT02797262|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Medication Adherence||Device: Proteus digital health feedback (PDHF) system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Building on the available Proteus devices, the investigators will design and create a Proteus digital health feedback (PDHF) system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT).
The investigators will test overall utility (including feasibility, acceptability and sustainability) of the PDHF system, its accuracy for measuring adherence and its impact on enhancing patients' level of adherence and the effect on virologic and clinical outcomes (exploratory), the retention of its impact on keeping up with adherence and improvement of plasma HIV RNA and CD4 cell count after the 16-week usage of the PDHF system.
Device: Proteus digital health feedback (PDHF) system
Building on the available Proteus devices, the investigators will design and create a PDHF system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT).
No Intervention: Control
UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment. Eligible patients will be randomized to one of the two conditions using a stratified urn randomization procedure to increase the likelihood of balanced allocation of prognostic variables at baseline.
- Adherence measured by sensor [ Time Frame: Adherence to ART measured by PDHF system for 16 weeks, ]Adherence to ART measured by PDHF system for 16 weeks, including percent of prescribed medication taken.
- Drug level concentration from blood draw [ Time Frame: 3 times at baseline and week 4, 8, 12, 16, 20, 24, and 28. ]Drug level concentration from blood draw. Drug level concentration will used to obtain adherence. Drug level concentration adherence will be quantified with cutting-edge pharmacokinetic (PK) approach.
- Self-Reported Medication Adherence and "change" over time is being assessed [ Time Frame: Selfreport adherence will be measured at baseline, and week 4, 8, 12, 16, 20, 24, and 28. ]The investigators will use a widely-used measure of self-reported adherence for percent of prescribed dose taken during the preceding seven days. This tool is easy to use and has been significantly associated with virological and immunological outcomes. Due to its potential bias, self-reported adherence will be calibrated by drug level concentration to leverage its accuracy and used in analysis when calibrated self-report adherence is appropriate to be used.
- Viral Load and Cluster of Differentiation 4 (CD4) [ Time Frame: baseline, week 4, 8, 12, 16, 20, 24, and 28. ]Viral Load and CD4 will be measured at baseline, week 4, 8, 12, 16, 20, 24, and 28.
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): NCT02797262
|Contact: Honghu Liu, PhDfirstname.lastname@example.org|
|Contact: Jie Shen, PhDemail@example.com|
|United States, California|
|Los Angeles, California, United States, 90095|
|Contact: Lisa Lisa Siqueiros 310-222-3773 ext 3848 firstname.lastname@example.org|
|Principal Investigator:||Honghu Liu, PhD||University of California, Los Angeles|