N/A
N=75
Personalized Text Messages to Improve Antiretroviral Treatment (ART) Adherence in HIV+ Methamphetamine Users
HIV · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT01317277 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Overall MEMS Adherence to Antiretroviral Medication — 68.0; 70.4 percentage of taken doses — p=0.68
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- individualized Texting for Adherence Building (iTAB) (Behavioral); Psychoeducation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall MEMS Adherence to Antiretroviral Medication |
68.0; 70.4 | 0.68 |
| PRIMARY MEMS Adherence to Antiretroviral Medication Based on Dose Timing |
43.9; 45.5 | 0.95 |
| SECONDARY Text-reported METH Use |
14.4; 22.0 | 0.05 |
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
Data sourced from ClinicalTrials.gov (NCT01317277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.