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

Not Applicable

Completed

Conditions: AIDS
HIV

Interventions: Behavioral: Psychoeducation
Behavioral: individualized Texting for Adherence Building (iTAB)

Registration Number: NCT01317277

Lead Sponsor: University of California, San Diego

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation (CTRL)	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 and methamphetamine use, but these messages will not remind participants about medication adherence.
Personalized Reminder Texting (iTAB) + Psychoeducation	individualized Texting for Adherence Building (iTAB)	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.

Primary Outcome Measures

Name	Time	Method
Overall MEMS Adherence to Antiretroviral Medication	6 weeks	Adherence was defined as the percentage of taken doses using Medication Event Monitoring Systems (MEMS); i.e., \[(# of bottle openings)/(# of prescribed doses)\*100\].
MEMS Adherence to Antiretroviral Medication Based on Dose Timing	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 Outcome Measures

Name	Time	Method
Text-reported METH Use	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 \[i.e., (# of days endorsing METH use)/(# of texts responded to)\].