Personalized Text Messages to Improve Antiretroviral Treatment (ART) Adherence in HIV+ Methamphetamine Users (iTAB)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV AIDS |
Behavioral: individualized Texting for Adherence Building (iTAB) |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Personalized Text Messages to Improve ART Adherence in HIV+ Methamphetamine Users |
- Adherence to Antiretroviral Medication [ Time Frame: Completion of 6-week intervention ] [ Designated as safety issue: No ]Adherence will be measured using Medication Event Monitoring Systems (MEMS)
| Estimated Enrollment: | 70 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Texting + Psychoeducation
Participants in the 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.
|
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;
|
|
Active Comparator: Psychoeducation
Participants 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, 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;
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
- 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 texting
Contacts and Locations| Contact: Jennifer Marquie-Beck, MPH | 619-543-5000 | jmarquie@ucsd.edu |
| United States, California | |
| Hnrc-Tmarc | Recruiting |
| San Diego, California, United States, 92013 | |
| Contact: Jennifer Marquie-Beck, MPH 619-543-5000 jmarquie@ucsd.edu | |
| Principal Investigator: David J Moore, Ph.D. | |
| Principal Investigator: | David J Moore, Ph.D. | University of California, San Diego |
More Information
No publications provided
| Responsible Party: | David J. Moore, Ph.D., Associate Professor of Psychiatry, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01317277 History of Changes |
| Other Study ID Numbers: | 1R34DA031058-01A1 |
| Study First Received: | March 16, 2011 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of California, San Diego:
|
interventions technology drug abuse methamphetamine |
Additional relevant MeSH terms:
|
Methamphetamine Amphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013