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Personalized Text Messages to Improve Antiretroviral Treatment (ART) Adherence in HIV+ Methamphetamine Users

Personalized Text Messages to Improve ART Adherence in HIV+ Methamphetamine Users

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01317277
Acronym
iTAB
Enrollment
75
Registered
2011-03-17
Start date
2011-04-30
Completion date
2014-06-30
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

AIDS, HIV

Keywords

interventions, technology, drug abuse, methamphetamine

Brief summary

Methamphetamine (METH) is a debilitating and frequently abused substance that is often comorbid with HIV infection. HIV+ persons with current METH abuse or dependence (HIV+/METH+) have several characteristics, in addition to their substance use, that make them particularly susceptible to nonadherence to antiretroviral treatment (ART) including elevated rates of neurocognitive impairment, co-occurrence of psychiatric disorders, and unstable living situations. 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 medications among HIV+/METH+ 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+/METH+ 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 Translational Methamphetamine AIDS Research Center (TMARC), which is a NIDA-funded center that focuses on the combined effects of METH and 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+/METH+ 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 6-week period via a pilot RCT with 40 HIV+/METH+ assigned to the iTAB intervention and 20 HIV+/METH+ assigned to a psychoeducational control. Predictors of nonadherence including frequency of METH use, 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 our tailored intervention.

Interventions

Behavioral: Psychoeducation Participants will also receive daily text messages to evaluate mood and methamphetamine use, 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 are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group.

BEHAVIORALPsychoeducation

Behavioral: Psychoeducation Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.

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

Inclusion/

Exclusion criteria

are generally lenient in order to ensure that our sample is as representative as possible of the overall HIV+/METH+ population. Inclusion Criteria: * Ability to provide informed consent * 18 years or older at the time of enrollment * HIV-infected * DSM-IV diagnosis of methamphetamine abuse or dependence in the past 30 days * Taking at least one medication to treat HIV illness * Indication of less than 100% adherence to antiretroviral (ART) medication * Willingness to use electronic monitoring caps to track ART medication * Willingness to respond to text messages

Design outcomes

Primary

MeasureTime frameDescription
Overall MEMS Adherence to Antiretroviral Medication6 weeksAdherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., \[(# of bottle openings)/(# of prescribed doses)\*100\].
MEMS Adherence to Antiretroviral Medication Based on Dose Timing6 weeksAdherence using Medication Event Monitoring Systems (MEMS) based on dose timing; i.e., \[(# of bottle openings within a +/- 2-hour time window of the intended dosing time)/(# of prescribed doses)\*100\].

Secondary

MeasureTime frameDescription
Text-reported METH UseCompletion of 6-week interventionFor each participant, we calculated the responsiveness to texts assessing METH use \[i.e., (# of texts responded to)/(# of texts received)\], and proportion of days a participants endorsed METH use \[i.e., (# of days endorsing METH use)/(# of texts responded to)\].

Countries

United States

Participant flow

Participants by arm

ArmCount
iTAB + Psychoeducation
individualized Texting for Adherence Building (iTAB): Participants will receive daily text messaging reminders for antiretroviral medication adherence. These text messages will be targeted to the specific schedule and needs of the individual. Participants will also receive daily text messages to assess mood and methamphetamine use. Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
50
Psychoeducation
Participants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
25
Total75

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10
Overall StudyLost MEMS11
Overall StudyLost to Follow-up31
Overall StudyUnable to comply with intervention10
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristiciTAB + PsychoeducationPsychoeducationTotal
Age, Continuous45.4 years
STANDARD_DEVIATION 7.7
46.0 years
STANDARD_DEVIATION 8.9
45.6 years
STANDARD_DEVIATION 8.1
Race/Ethnicity, Customized
Hispanic
5 Participants8 Participants13 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
15 Participants7 Participants22 Participants
Race/Ethnicity, Customized
Non-Hispanic White
23 Participants7 Participants30 Participants
Race/Ethnicity, Customized
Pacific Islander
0 Participants1 Participants1 Participants
Region of Enrollment
United States
50 participants25 participants75 participants
Sex: Female, Male
Female
3 Participants0 Participants3 Participants
Sex: Female, Male
Male
40 Participants23 Participants63 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 25
other
Total, other adverse events
1 / 500 / 25
serious
Total, serious adverse events
0 / 500 / 25

Outcome results

Primary

MEMS Adherence to Antiretroviral Medication Based on Dose Timing

Adherence using Medication Event Monitoring Systems (MEMS) based on dose timing; i.e., \[(# of bottle openings within a +/- 2-hour time window of the intended dosing time)/(# of prescribed doses)\*100\].

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
iTAB + PsychoeducationMEMS Adherence to Antiretroviral Medication Based on Dose Timing43.9 percentage of taken dosesStandard Deviation 32.2
PsychoeducationMEMS Adherence to Antiretroviral Medication Based on Dose Timing45.5 percentage of taken dosesStandard Deviation 30.5
Comparison: Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).p-value: 0.95Wilcoxon (Mann-Whitney)
Primary

Overall MEMS Adherence to Antiretroviral Medication

Adherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., \[(# of bottle openings)/(# of prescribed doses)\*100\].

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
iTAB + PsychoeducationOverall MEMS Adherence to Antiretroviral Medication68.0 percentage of taken dosesStandard Deviation 0.3
PsychoeducationOverall MEMS Adherence to Antiretroviral Medication70.4 percentage of taken dosesStandard Deviation 0.3
Comparison: Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).p-value: 0.68Wilcoxon (Mann-Whitney)
Secondary

Text-reported METH Use

For each participant, we calculated the responsiveness to texts assessing METH use \[i.e., (# of texts responded to)/(# of texts received)\], and proportion of days a participants endorsed METH use \[i.e., (# of days endorsing METH use)/(# of texts responded to)\].

Time frame: Completion of 6-week intervention

ArmMeasureValue (MEAN)
iTAB + PsychoeducationText-reported METH Use14.4 METH use days
PsychoeducationText-reported METH Use22.0 METH use days
Comparison: Text-reported METH use daysp-value: 0.05Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026