Texting to Improve Adherence in HIV+ With Bipolar Disorder (iTAB)

August 3, 2021 updated by: David J. Moore, Ph.D., University of California, San Diego

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 (HIV+/BD+), when compared to demographically similar HIV+/BD- 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. HIV+/BD+ 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 (i.e., mHealth) technologies to improve everyday functioning is growing. mHealth interventions capitalize on technology already incorporated into most people's daily lives (e.g., 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 HIV+/BD+ 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 HIV+/BD+ 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 HIV+/BD+ 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 (i.e., MEMS caps) over a 4-week period via a pilot RCT with 58 participants were randomized into 2 groups (30 HIV+/BD+ assigned to the iTAB intervention and 28 HIV+/BD+ 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • HIV Neurobehavioral Research Program (HNRP), Department of Psychiatry, Univeristy of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to provide informed consent
  • 18 years or older at the time of enrollment
  • HIV-infected
  • DSM-IV diagnosis Bipolar Disorder
  • Taking at least one medication to treat HIV illness
  • Taking at least one medication to treat bipolar disorder
  • Indication of less than 100% adherence to antiretroviral (ART) medication
  • Willingness to use electronic monitoring caps to track ART medication and BD medication
  • Willingness to respond to text messages

Exclusion Criteria:

  • Axis I psychiatric diagnosis of psychotic spectrum disorder (e.g., schizophrenia)
  • Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)
  • Unwillingness or inability to use electronic medication monitoring technology
  • Unwillingness or inability to use daily texting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized Reminder Texting + Psychoeducation (iTAB)
Participants in the individualized Texting for Adherence Building (iTAB) arm will receive daily text messaging reminders for antiretroviral and psychotropic medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive a text message that assesses mood. Finally, participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications.
Behavioral: Psychoeducation
Participants will also receive daily text messages to evaluate mood, but these messages will not remind participants about medication adherence.
Behavioral: individualized Texting for Adherence Building (iTAB)
Intervention is designed to send automated text messages to HIV+ persons who have bipolar disorder (BD+). Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART and psychotropic medications among HIV+/BD+ persons above and beyond an active comparator group.
Active Comparator: Psychoeducation (CTRL)
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV and psychotropic medications. They will also receive daily text messages to assess mood, but these messages will not receive the medication reminder text messages.
Behavioral: Psychoeducation
Participants will also receive daily text messages to evaluate mood, but these messages will not remind participants about medication adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)
Time Frame: 4-week
MEMS-derived percent adherence to HIV and psychotropic medications over the study period, i.e., ([# of bottle openings]/[# of prescribed doses]*100%).
4-week
Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).
Time Frame: 4-week
Medication "dose timing window" for participants was calculated by subtracting the time at which the MEMS cap was opened (i.e., dose taken) from the previously indicated targeted time for dosing (i.e., the time at which participants received adherence text messages for the iTAB intervention group, or time at which participants indicated they would take their medication for the control group). Dose timing windows were used in analyses to indicate the discrepancy between intended dosing time and actual dosing time (in minutes) such that higher values indicate more variable dosing (i.e., decreased therapeutic coverage).
4-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: David J Moore, Ph.D., University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDEA Award ID09-SD-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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