Viewing Study NCT01317277



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Last Modification Date: 2024-10-26 @ 10:33 AM
Study NCT ID: NCT01317277
Status: COMPLETED
Last Update Posted: 2021-08-27
First Post: 2011-03-16

Brief Title: Personalized Text Messages to Improve Antiretroviral Treatment ART Adherence in HIV Methamphetamine Users
Sponsor: University of California San Diego
Organization: University of California San Diego

Study Overview

Official Title: Personalized Text Messages to Improve ART Adherence in HIV Methamphetamine Users
Status: COMPLETED
Status Verified Date: 2021-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: iTAB
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 HIVMETH 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 HIVMETH 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 HIVMETH 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 HIVMETH 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 ie MEMS caps over a 6-week period via a pilot RCT with 40 HIVMETH assigned to the iTAB intervention and 20 HIVMETH 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None