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

August 3, 2021 updated by: David J. Moore, Ph.D., University of California, San Diego

Personalized Text Messages to Improve 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92013
        • Hnrc-Tmarc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized Reminder Texting (iTAB) + Psychoeducation
Participants 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.
Behavioral: individualized Texting for Adherence Building (iTAB)

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.
Active Comparator: Psychoeducation (CTRL)
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 and methamphetamine use, but these messages will not remind participants about medication adherence.
Behavioral: Psychoeducation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
6 weeks
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].
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)].
Completion of 6-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: David J Moore, Ph.D., University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R34DA031058-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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