DHFS for Medication Adherence Support During Hospital Admissions for Person Living With HIV
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|ClinicalTrials.gov Identifier: NCT04418037|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Device: Digital Health Feedback System(DHFS)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Digital Health Feedback System (DHFS) for Anti-Retroviral Therapy Medication Adherence and Transitions of Care Support During Hospital Admissions for Persons Living With HIV|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Single arm using the Digital Health Feedback System
This protocol is designed to evaluate a novel technology that employs an ingestible sensor to detect medication ingestion for use by persons initiating or restarting antiretroviral (ARV) treatment for HIV infection during a hospital admission.
Device: Digital Health Feedback System(DHFS)
We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.
- An accurate measure of medication taking adherence captured by the DHFS [ Time Frame: 16 weeks ]The number of doses ingested as captured by the DHFS over the number of doses prescribed, adjusted for positive detection accuracy (PDA). The system positive detection accuracy (PDA), based on prior studies, will allow an accurate measure of adherence with CI calculated.
- Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16). [ Time Frame: 16 weeks ]Participants with <90% adherence as detected by DHFS over the study intervention will be identified.
- Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16. [ Time Frame: 16 weeks ]Percentage of participants who require adherence support to maintain adherence over 90% will be calculated.
- Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher. [ Time Frame: 16 weeks ]Characterize participant responses to study questionnaires on usability and exit questionnaire and summarize information regarding patient experience with the DHFS.
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): NCT04418037
|Contact: Sara H Browne, MD MPH||619 firstname.lastname@example.org|
|Contact: Amanda J Tucker maytom, MD||619 543 email@example.com|
|United States, California|
|UCSD AntiViral Research Center||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Sara H Browne, MD MPH 858-822-6563 firstname.lastname@example.org|
|Contact: Myrna J Castro 619543 8080 email@example.com|
|Principal Investigator: Sara H Browne, MD MPH|
|Principal Investigator: Constance A Benson, MD|
|Principal Investigator:||Sara H Browne, MD MPH||UC San Diego|