HIV DiseaseiTABNCT02090634
Texting to Improve Adherence in HIV+ With Bipolar Disorder
A study testing Psychoeducation and individualized Texting for Adherence Building (iTAB) in people with HIV Disease and Bipolar Disorder, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Disease, Bipolar Disorder
- What is being tested?
- Psychoeducation and individualized Texting for Adherence Building (iTAB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
HIV Neurobehavioral Research Program (HNRP), Department of Psychiatry, Univeristy of California
San Diego, California, 92103
About this study
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.
Read more
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.
- Conditions
- HIV Disease, Bipolar Disorder
- Being tested
- Psychoeducation, individualized Texting for Adherence Building (iTAB)
- Keywords
- HIV, Bipolar Disorder, Medication Adherence
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Bipolar Disorder, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Participants will also receive daily text messages to evaluate mood, but these messages will not remind participants about medication adherence.
individualized Texting for Adherence Building (iTAB)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Reminder Texting + Psychoeducation (iTAB) | Experimental | 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. Receives: Behavioral: Psychoeducation; Behavioral: individualized Texting for Adherence Building (iTAB) |
| Psychoeducation (CTRL) | Active comparator | 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. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)
MEMS-derived percent adherence to HIV and psychotropic medications over the study period, i.e., ([# of bottle openings]/[# of prescribed doses]*100%).
Measured: 4-week
Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).
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).
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Moore, Ph.D., University of California, San Diego
- Investigators
- David J Moore, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090634
- Sponsor's protocol ID
- IDEA Award ID09-SD-047
- Acronym
- iTAB
- Status last verified
- Aug 2021
- First submitted
- 7 Mar 2014
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Moore DJ, Poquette A, Casaletto KB, Gouaux B, Montoya JL, Posada C, Rooney AS, Badiee J, Deutsch R, Letendre SL, Depp CA, Grant I, Atkinson JH; HIV Neurobehavioral Research Program (HNRP) Group. Individualized texting for adherence building (iTAB): improving antiretroviral dose timing among HIV-infected persons with co-occurring bipolar disorder. AIDS Behav. 2015 Mar;19(3):459-71. doi: 10.1007/s10461-014-0971-0.
PubMed 25504449
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting to Improve Adherence in HIV+ With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02090634
- Acronym / sponsor ID
- iTAB / IDEA Award ID09-SD-047
- Conditions
- HIV Disease, Bipolar Disorder
- Keywords
- HIV, Bipolar Disorder, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Reminder Texting + Psychoeducation (iTAB) | Experimental | Behavioral: Psychoeducation, Behavioral: individualized Texting for Adherence Building (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. |
| Psychoeducation (CTRL) | Active comparator | Behavioral: PsychoeducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationParticipants will also receive daily text messages to evaluate mood, but these messages will not remind participants about medication adherence. | Behavioural | Personalized Reminder Texting + Psychoeducation (iTAB), Psychoeducation (CTRL) |
| 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. | Behavioural | Personalized Reminder Texting + Psychoeducation (iTAB) |
Primary outcome
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 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25504449Moore DJ, Poquette A, Casaletto KB, Gouaux B, Montoya JL, Posada C, Rooney AS, Badiee J, Deutsch R, Letendre SL, Depp CA, Grant I, Atkinson JH; HIV Neurobehavioral Research Program (HNRP) Group. Individualized texting for adherence building (iTAB): improving antiretroviral dose timing among HIV-infected persons with co-occurring bipolar disorder. AIDS Behav. 2015 Mar;19(3):459-71. doi: 10.1007/s10461-014-0971-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Moore, Ph.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and individualized Texting for Adherence Building (iTAB) in people with HIV Disease and Bipolar Disorder, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS) (time frame: 4-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02090634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.