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Texting to Improve Adherence in HIV+ With Bipolar Disorder

Texting to Improve Adherence in HIV+ With Bipolar Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02090634
Acronym
iTAB
Enrollment
58
Registered
2014-03-18
Start date
2010-04-30
Completion date
2012-03-31
Last updated
2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, HIV Disease

Keywords

HIV, Bipolar Disorder, Medication Adherence

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 (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.

Interventions

BEHAVIORALPsychoeducation

Participants will also receive daily text messages to evaluate mood, but these messages will not remind participants about medication adherence.

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.

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)4-weekMEMS-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).4-weekMedication 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).

Countries

United States

Participant flow

Recruitment details

HIV+/BD+ participants were recruited from ongoing studies at the UCSD HIV Neurobehavioral Research Program (HNRP).

Pre-assignment details

62 participants were assessed for eligibility, and 4 participants were excluded prior to randomization; 2 did not meet study criteria, 2 withdrew. 58 participants were enrolled and randomized into iTAB (n=30) or control group (n=28). 50 participants completed the study and were included in analyses; excluded from analyses were 5 iTAB participants (3 lost MEMS, 2 had adverse events unrelated to study participation) and 3 control participants (1 lost MEMS, 1 lost contact, 1 was deceased).

Participants by arm

ArmCount
Personalized Reminder Texting + Psychoeducation (iTAB)
The individualized Texting for Adherence Building (iTAB) intervention is designed to improve adherence to antiretroviral and psychotropic medications for HIV+ persons who have bipolar disorder using automated text message reminders. These text messages will be targeted to the specific medication schedule and needs of the individual. Participants will also receive daily text messages to assesses mood. Additionally, participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications.
30
Psychoeducation (CTRL)
HIV+ persons who have bipolar disorder will receive a one-time psychoeducational intervention reviewing the importance of adherence to antiretroviral and psychotropic medications. Participants will also receive daily text messages to assess mood, but these participants will not receive the medication reminder text messages.
28
Total58

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event20
Overall StudyDeath01
Overall StudyLost to Follow-up01
Overall StudyProtocol Violation31

Baseline characteristics

CharacteristicPsychoeducation (CTRL)Personalized Reminder Texting + Psychoeducation (iTAB)Total
Age, Continuous45.9 years
STANDARD_DEVIATION 10.2
48.4 years
STANDARD_DEVIATION 9.2
47.1 years
STANDARD_DEVIATION 9.7
Race/Ethnicity, Customized
Hispanic
5 Participants2 Participants7 Participants
Race/Ethnicity, Customized
Hispanic Black
2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Native American
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
6 Participants7 Participants13 Participants
Race/Ethnicity, Customized
Non-Hispanic White
11 Participants16 Participants27 Participants
Region of Enrollment
United States
25 participants25 participants50 participants
Sex: Female, Male
Female
4 Participants2 Participants6 Participants
Sex: Female, Male
Male
21 Participants23 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 301 / 28
other
Total, other adverse events
2 / 300 / 28
serious
Total, serious adverse events
0 / 300 / 28

Outcome results

Primary

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).

Time frame: 4-week

Population: Of the 30 participants in iTAB intervention group, 25 were analyzed; 3 lost MEMS cap, 1 in rehabilitation facility, 1 too sick.Of the 28 participants in CTRL group, 25 were analyzed; 1 lost MEMS cap, 1 lost to follow up, 1 deceased.

ArmMeasureGroupValue (MEDIAN)
Personalized Reminder Texting + Psychoeducation (iTAB)Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).Dose timing window for ART27.8 minutes from dosing target time
Personalized Reminder Texting + Psychoeducation (iTAB)Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).Dose timing window for PST46.8 minutes from dosing target time
Psychoeducation (CTRL)Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).Dose timing window for ART77.0 minutes from dosing target time
Psychoeducation (CTRL)Dose Timing for ARV and Psychotropic Medications as Determined by Electronic Medication Monitoring System (MEMS).Dose timing window for PST66.5 minutes from dosing target time
Comparison: We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for ARV medications.p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for PSY medications.p-value: 0.42Wilcoxon (Mann-Whitney)
Primary

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%).

Time frame: 4-week

Population: Of the 30 participants in iTAB intervention group, 25 were analyzed; 3 lost MEMS cap, 1 in rehabilitation facility, 1 too sick.Of the 28 participants in CTRL group, 25 were analyzed; 1 lost MEMS cap, 1 lost to follow up, 1 deceased.

ArmMeasureGroupValue (MEDIAN)
Personalized Reminder Texting + Psychoeducation (iTAB)Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)ARV adherence90.3 percentage of taken doses
Personalized Reminder Texting + Psychoeducation (iTAB)Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)PSY adherence83.9 percentage of taken doses
Psychoeducation (CTRL)Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)ARV adherence90.0 percentage of taken doses
Psychoeducation (CTRL)Proportion Adherent to ARV and Psychotropic Medication by Electronic Monitoring System (MEMS)PSY adherence90.0 percentage of taken doses
Comparison: We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to ARV medications.p-value: 0.95Wilcoxon (Mann-Whitney)
Comparison: We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to PSY medications.p-value: 0.43Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026