Cell Phone Technology Targeting ART Adherence and Drug Use

NCT01884233 | Completed DMC

• 1 other identifier: 1R34DA033196
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the current research is to improve treatment for injection opioid users by augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.

Conditions

HIV; Opioid Abuse

Keywords

HIV; Opioid Abuse; Mobile technology

Outcome Measures

Primary Outcomes (3)

• Change in Substance Use

  Addiction Severity Index (ASI) is an instrument widely used in addiction research to quantify drug use frequency and related problem areas. Urine Drug Screen (UDS). Urine drug screens will be collected monthly using temperature controlled test cups. An FDA-approved one-step test will be used. During the 12-week treatment period, one full-screen panel and two panels only testing for opioids (heroin and prescription opioids) will be conducted. The UDS will test for the presence of: amphetamines, benzodiazepines, methadone, cocaine, methamphetamine, morphine (heroin), hydrocodone (Vicodin), oxycodone (OxyContin), and marijuana. The participants' change in substance use over time (as assessed by the ASI and UDS results) is being assessed from each timepoint to the next.

  The ASI is to be collected at baseline (week 0), treatment-end (week 12), and Follow-Up (wek 24). UDS is collected weekly during the intervetion.

• Change in HIV Risk Behaviors

  Risk Behavior Survey (RBS): The RBS (Darke et al., 1991) is a brief interview assessing involvement in HIV risk behaviors in the areas of drug use and sex in the previous 30 days. Additional items include whether the sexual partner uses or injects drugs. The participants' change in RBS scores is being assessed from each timepoint to the next.

  RBS will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)

• Change in treatment adherence

  ART Adherence. The investigator will use monthly phone-based unannounced pill counts (UPCs); Pharmacy information from pill bottles will also be collected to verify the number of pills dispensed between calls. Self-reported adherence will be assessed monthly using a brief adherence survey developed by Lu et al. Viral load will serve as a biological indicator of adherence. Consistent with the typical frequency with which viral load is assessed in clinical settings, data concerning viral load will be collected at baseline (week 0), treatment end (week 12), and FU (week 24) via chart review from the participant's medical provider. The participants' change in Adherence scores is being assessed from each timepoint to the next.

  Pill bottle collection will be weekly during the intervention. Pill counts and Viral load will be collected at baseline (week 0), treatment end (week 12), and FU (week 24).

Secondary Outcomes (1)

• Change in health-related quality of life

  week 0, week 12 and week 24

Study Arms (2)

Text Messaging CBT (TXT-CBT)

EXPERIMENTAL

This condition will receive CBT based text messaging (TXT-CBT). Those assigned to TXT-CBT will also be given a treatment manual (developed in Phase I) containing descriptions of core therapeutic content/topics for each week. HIV-infected participants will have an initial meeting with a CBT clinician to review the Life-Steps concepts. The 3 most applicable medication adherence skills will be identified for emphasis in tailored messages. A research coordinator will meet with the participants weekly at data collection visits throughout the intervention phase to answer any technical questions and ensure that the intervention program is working properly.

Behavioral: Standard Care; Behavioral: Text Messaging CBT (TXT-CBT)

Standard Care

ACTIVE COMPARATOR

Those assigned to the Standard Care condition will receive the standard monthly medical management physician visit typically associated with HIV care. In addition, a pamphlet with information about HIV, the importance of ART adherence, and relapse prevention will be provided to participants in this condition.

Behavioral: Standard Care

Interventions

Standard Care BEHAVIORAL

Standard care will include usual treatment for HIV and a pamphlet that will be provided to the participants with information about ART adherence and relapse prevention.

Standard Care; Text Messaging CBT (TXT-CBT)

Text Messaging CBT (TXT-CBT) BEHAVIORAL

Those assigned to TXT-CBT will be given a treatment manual (developed in Phase I) containing descriptions of core therapeutic content/topics for each week. HIV-infected participants will have initial meeting with a CBT clinician to review the core CBT concepts for promoting ART adherence. The 3 most applicable medication adherence skills will be identified for emphasis in tailored messages. A research coordinator will meet with the participants weekly at data collection visits throughout the intervention phase to answer any technical questions and ensure that the intervention program is working properly.

Text Messaging CBT (TXT-CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older;
• DSM-IV diagnosis of Opioid Dependence;
• HIV-infected serostatus;
• Able to provide informed consent;
• Willing and able to participate in study procedures,
• Good general health or, in the case of a medical/psychiatric condition needing ongoing treatment, potential participant should be under the care of a physician who provides documented willingness to continue participant's medical management and coordinate care with the study physicians.

You may not qualify if:

• Lack of proficiency in English;
• Currently homeless (unless residing in a recovery home for which contact information can be provided);
• Dependence on an illicit substance for which medical detoxification is imminently needed.
• Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis, acute mania, or suicide risk that would require immediate treatment or make study compliance difficult.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UCLA Isap Ocrc

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Suzette Glasner, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 21, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

US (1)