Personalized Text Messages to Improve Antiretroviral Treatment (ART) Adherence in HIV+ Methamphetamine Users
iTAB
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Apr 2011
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
August 27, 2021
CompletedAugust 27, 2021
August 1, 2021
3.2 years
March 16, 2011
May 6, 2021
August 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall MEMS Adherence to Antiretroviral Medication
Adherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., \[(# of bottle openings)/(# of prescribed doses)\*100\].
6 weeks
MEMS Adherence to Antiretroviral Medication Based on Dose Timing
Adherence using Medication Event Monitoring Systems (MEMS) based on dose timing; i.e., \[(# of bottle openings within a +/- 2-hour time window of the intended dosing time)/(# of prescribed doses)\*100\].
6 weeks
Secondary Outcomes (1)
Text-reported METH Use
Completion of 6-week intervention
Study Arms (2)
Personalized Reminder Texting (iTAB) + Psychoeducation
EXPERIMENTALParticipants in the individualized Texting for Adherence Building (iTAB) arm 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 a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications.
Psychoeducation (CTRL)
ACTIVE COMPARATORParticipants will receive a one-time psychoeducational intervention reviewing the importance of adherence to anti-HIV medications. They will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
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.
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.
Eligibility Criteria
You may not qualify if:
- Ability to provide informed consent
- 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
- Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features
- 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 text messaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hnrc-Tmarc
San Diego, California, 92013, United States
Related Publications (3)
Moore DJ, Pasipanodya EC, Umlauf A, Rooney AS, Gouaux B, Depp CA, Atkinson JH, Montoya JL. Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial. Drug Alcohol Depend. 2018 Aug 1;189:154-160. doi: 10.1016/j.drugalcdep.2018.05.013. Epub 2018 Jun 21.
PMID: 29958127RESULTPalmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
PMID: 32779730DERIVEDMoore DJ, Montoya JL, Blackstone K, Rooney A, Gouaux B, Georges S, Depp CA, Atkinson JH, Tmarc Group T. Preliminary Evidence for Feasibility, Use, and Acceptability of Individualized Texting for Adherence Building for Antiretroviral Adherence and Substance Use Assessment among HIV-Infected Methamphetamine Users. AIDS Res Treat. 2013;2013:585143. doi: 10.1155/2013/585143. Epub 2013 Sep 3.
PMID: 24078868DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1\) Small sample size; 2) Short time period; 3) MEMS adherence data based on # of cap openings, not directly whether the medication was ingested; 4) No group without psychoeducation component
Results Point of Contact
- Title
- Dr. David J Moore, Professor of Psychiatry
- Organization
- UCSD HIV Neurobehavioral Research Program (HNRP)
Study Officials
- PRINCIPAL INVESTIGATOR
David J Moore, Ph.D.
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 17, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 27, 2021
Results First Posted
August 27, 2021
Record last verified: 2021-08