Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02090634
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2014-03-07
Brief Title:
Texting to Improve Adherence in HIV With Bipolar Disorder
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Texting to Improve Adherence in HIV With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2021-08
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:
iTAB
Brief Summary:
Adherence to combination antiretroviral therapy ART is critical for successful HIV viral suppression Nonadherence to ART poses several potentially serious health consequences including higher viral loads faster progression to AIDS and a heightened risk of viral mutations treatment resistance and HIV transmission
The prevalence of serious mental illness SMI conditions including bipolar disorder BD is elevated among HIV-infected populations and is associated with poor ART adherence HIV-infected individuals with co-occurring BD HIVBD when compared to demographically similar HIVBD- persons demonstrated poorer ART and psychotropic medication adherence and were twice as likely to be non adherent to their ART regimen using a 90 cutoff score HIVBD individuals are particularly at-risk for medication non adherence and there is a critical need to develop interventions to improve adherence in this population
Poor psychotropic medication adherence is also common among people with SMI - it has been estimated that 40 of those with BD do not take their mood stabilizer as prescribed Among persons with BD nonadherence to psychotropic medications can lead to greater risk for manic and depressive episodes decreased quality of life suicide attempts and hospitalization
The utilization of mobile health ie mHealth technologies to improve everyday functioning is growing mHealth interventions capitalize on technology already incorporated into most peoples daily lives eg cell phones to assist people with behavior modification and disease self-management Text messaging in particular may support daily ART adherence by delivering reminders at precise times to match an individuals dosing schedule The initial evidence for using text messaging to improve ART medication adherence has been compelling Researchers and clinicians have also started employing technology-based approaches to improve treatment for individuals with BD
Taken together a distinct need for RCTs utilizing text messaging to improve medication adherence within an at-risk HIV population is warranted Individualized Texting for Adherence Building iTAB is one such intervention
The investigators propose an intervention development study designed to address these potential mechanisms of nonadherence with the following Specific Aims 1 To further develop and refine a personalized automated real-time mobile phone text messaging intervention iTAB designed to improve adherence to ART and psychotropic medications among HIVBD persons 2 To evaluate the acceptability and effectiveness of a brief psychoeducation plus text messaging intervention iTAB as compared to psychoeducation alone CTRL for the improvement of objectively measured medication adherence among HIVBD persons and 3 To examine predictors of within-person trajectories of nonadherence using the longitudinal data collected over the study In order to realize these aims the investigators will leverage the infrastructure of two unique UCSD resources increasing likelihood of study success impact and innovation 1 the HIV Neurobehavioral Research Program HNRP which encompasses multiple NIH-funded studies that focus on the effects of HIV infection and 2 the California Institute for Telecommunications and Information Technology Calit2 which conducts research on state-of-the-art wireless means of health promotion Initially the investigators will refine the iTAB intervention to ensure that it is user-centered and tailored to the needs of HIVBD persons via focus groups and rapid prototyping Once refined the proposed iTAB intervention will use text messages that are automated scalable personalized interactive flexible and motivating The investigators will assess the acceptability and effectiveness of iTAB in improving objectively measured adherence ie MEMS caps over a 4-week period via a pilot RCT with 58 participants were randomized into 2 groups 30 HIVBD assigned to the iTAB intervention and 28 HIVBD assigned to a psychoeducational control Predictors of nonadherence including neuropsychological impairment and mood will be examined to determine whether iTAB is better able to compensate for these factors associated with nonadherence as compared to CTRL Further refinement to the iTAB intervention will be made in order to pursue a large-scale R01 using the investigators tailored intervention
The prevalence of serious mental illness SMI conditions including bipolar disorder BD is elevated among HIV-infected populations and is associated with poor ART adherence HIV-infected individuals with co-occurring BD HIVBD when compared to demographically similar HIVBD- persons demonstrated poorer ART and psychotropic medication adherence and were twice as likely to be non adherent to their ART regimen using a 90 cutoff score HIVBD individuals are particularly at-risk for medication non adherence and there is a critical need to develop interventions to improve adherence in this population
Poor psychotropic medication adherence is also common among people with SMI - it has been estimated that 40 of those with BD do not take their mood stabilizer as prescribed Among persons with BD nonadherence to psychotropic medications can lead to greater risk for manic and depressive episodes decreased quality of life suicide attempts and hospitalization
The utilization of mobile health ie mHealth technologies to improve everyday functioning is growing mHealth interventions capitalize on technology already incorporated into most peoples daily lives eg cell phones to assist people with behavior modification and disease self-management Text messaging in particular may support daily ART adherence by delivering reminders at precise times to match an individuals dosing schedule The initial evidence for using text messaging to improve ART medication adherence has been compelling Researchers and clinicians have also started employing technology-based approaches to improve treatment for individuals with BD
Taken together a distinct need for RCTs utilizing text messaging to improve medication adherence within an at-risk HIV population is warranted Individualized Texting for Adherence Building iTAB is one such intervention
The investigators propose an intervention development study designed to address these potential mechanisms of nonadherence with the following Specific Aims 1 To further develop and refine a personalized automated real-time mobile phone text messaging intervention iTAB designed to improve adherence to ART and psychotropic medications among HIVBD persons 2 To evaluate the acceptability and effectiveness of a brief psychoeducation plus text messaging intervention iTAB as compared to psychoeducation alone CTRL for the improvement of objectively measured medication adherence among HIVBD persons and 3 To examine predictors of within-person trajectories of nonadherence using the longitudinal data collected over the study In order to realize these aims the investigators will leverage the infrastructure of two unique UCSD resources increasing likelihood of study success impact and innovation 1 the HIV Neurobehavioral Research Program HNRP which encompasses multiple NIH-funded studies that focus on the effects of HIV infection and 2 the California Institute for Telecommunications and Information Technology Calit2 which conducts research on state-of-the-art wireless means of health promotion Initially the investigators will refine the iTAB intervention to ensure that it is user-centered and tailored to the needs of HIVBD persons via focus groups and rapid prototyping Once refined the proposed iTAB intervention will use text messages that are automated scalable personalized interactive flexible and motivating The investigators will assess the acceptability and effectiveness of iTAB in improving objectively measured adherence ie MEMS caps over a 4-week period via a pilot RCT with 58 participants were randomized into 2 groups 30 HIVBD assigned to the iTAB intervention and 28 HIVBD assigned to a psychoeducational control Predictors of nonadherence including neuropsychological impairment and mood will be examined to determine whether iTAB is better able to compensate for these factors associated with nonadherence as compared to CTRL Further refinement to the iTAB intervention will be made in order to pursue a large-scale R01 using the investigators tailored intervention
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None