Clinical trial NCT01317277: Personalized Text Messages to Improve Antiretroviral Treatment (ART) Adherence in HIV+ Methamphetamine Users
Official title: Personalized Text Messages to Improve ART Adherence in HIV+ Methamphetamine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Keywords: interventions
technology
drug abuse
methamphetamine
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

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

Primary outcomes:
measure: Overall MEMS Adherence to Antiretroviral Medication
timeFrame: 6 weeks
measure: MEMS Adherence to Antiretroviral Medication Based on Dose Timing
timeFrame: 6 weeks
Secondary outcomes:
measure: Text-reported METH Use
timeFrame: Completion of 6-week intervention
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Hnrc-Tmarc
state: California
Study officials:
affiliation: University of California, San Diego
name: David J Moore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Palmer 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.
citation: Moore 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.