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Completed

NCT Number: NCT01317277

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 text messaging

Treatment and study plan

individualized Texting for Adherence Building (iTAB)

Behavioral

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.

Psychoeducation

Behavioral

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.

Primary outcomes

  1. Overall MEMS Adherence to Antiretroviral Medication

    Time frame: 6 weeks

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

  2. MEMS Adherence to Antiretroviral Medication Based on Dose Timing

    Time frame: 6 weeks

    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].

Secondary outcomes

  1. Text-reported METH Use

    Time frame: Completion of 6-week intervention

    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)].

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Acronym: iTAB

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2011
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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