NCT02090634: iTAB

Texting to Improve Adherence in HIV+ With Bipolar Disorder

Completed NA Results posted Last updated 3 August 2021

What this trial tests

NA trial testing Psychoeducation in HIV Disease in 58 participants. Completed in 1 March 2012.

Timeline

1 April 2010

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	58
Start date	1 April 2010
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	1 location across United States

Drugs / interventions tested

• Psychoeducation
• individualized Texting for Adherence Building (iTAB)

Conditions studied

• HIV Disease — all drugs for HIV Disease →
• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with HIV Disease or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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%).
• 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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Accuracy of measures for antiretroviral adherence in people living with HIV.
   Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2