Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480578
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-15
Brief Title:
An Integrated Intervention Using a Pill Ingestible Sensor System
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sensor-SBDOH
Brief Summary:
This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health SBDOH to improve HIV treatment outcomes It involves 110 adult patients from a Los Angeles County HIV clinic focusing on those at risk for poor adherence Participants will be randomized into intervention or usual care groups with endpoints including intervention acceptability SBDOH interventions adherence to ART viral load and high-risk sexual activity The study aims to assess the effectiveness of the integrated intervention in improving adherence virologic outcomes and reducing high-risk behavior among PLWH
Detailed Description:
Undetectable equals Untransmittable UU reduces HIV stigma empowers people living with HIV PLWH and has become a pillar in the goal of ending the HIV epidemic Viral suppression eliminating risk of sexual HIV transmission emphasizes the importance of adherence to antiretroviral therapy ART Strategies to enhance adherence have typically not intervened in real-time and have focused on pill-taking reminders without interventions that address adverse social and behavioral determinants of health SBDOH associated with poor adherence and engagement in care The complex multifactorial pathways of SBDOH such as food insecurity unstable housing and substance use disorders have led to inequities in achieving optimal adherence and sustained viral suppression Los Angeles LA County a hot spot for HIV infection and transmission has been reported to have viral suppression rates of 60 well below the 95 target of Ending HIV Epidemic by 2030 Our team has an extensive track record of research on measurement of and interventions to enhance adherence to ART The investigators have used novel technology-based adherence measures of ART developed in the past two decades including the cutting-edge ingestible sensor IS technology to obtain non-inferred real-time adherence monitoring by Proteus Digital Health Feedback PDHF system Despite its validation reported in our recent publications the PDHF system has been limited by the lack of incorporation of SBDOH For many years a major focus in HIV clinics has been to have multidisciplinary teams of nurses social workers and case managers to address SBDOH however timing of interventions are often weeks to months after such problems have been identified This study will develop and test an integrated intervention that combines IS technology and adverse SBDOH alerts to maximize adherence and viral suppression Using real-time IS monitoring our integrated intervention will be able to immediately trigger the existing multidisciplinary team at clinic to address SBDOH issues as soon as predefined patterns of poor adherence are observed A cohort of 110 adult patients who have or are at high risk for sub-optimal adherence will be recruited from a LA County safety net HIV clinic located in a geographic HIV hotspot dealing many adverse SBDOH issues Participants will be randomized into the intervention or usual care The integrated intervention will run for 20 weeks followed by a 10-week period to assess sustainability The primary end points include acceptability of the integrated intervention frequency and timeliness of SBDOH interventions level of challenges of SBDOH in HIV treatment and adherence to ART The secondary end points include viral load high-risk sexual activity defined by self-report and detection of sexually transmitted infections The overarching goals are to evaluate i acceptability of the integrated intervention frequency and timeliness of SBDOH intervention and level of challenges of SBDOH in HIV treatment ii the efficacy of the integrated intervention for monitoring facilitating and improving adherence to ART and iii the efficacy of the integrated intervention for improving virologic outcome and reducing high-risk sexual activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MD019188 | NIH | None | None |