Overview

This trial is active, not recruiting.

Conditions hiv, opioid abuse
Treatments standard care, text messaging cbt (txt-cbt)
Phase phase 2
Sponsor University of California, Los Angeles
Collaborator National Institute on Drug Abuse (NIDA)
Start date December 2012
End date January 2016
Trial size 50 participants
Trial identifier NCT01884233, 1R34DA033196

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
standard care
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.
text messaging cbt (txt-cbt)
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.
(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.
standard care
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.

Primary Outcomes

Measure
Substance Use Measures
time frame: 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.
HIV Risk
time frame: RBS will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
Adherence Measures
time frame: 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

Measure
Quality of life
time frame: week 0, week 12 and week 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria for participants in both Phase I and Phase II will be: 1. Age 18 or older; 2. DSM-IV diagnosis of Opioid Dependence; 3. HIV-infected serostatus; 4. Able to provide informed consent; 5. Willing and able to participate in study procedures, 6. 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. Exclusion Criteria: 1. Lack of proficiency in English; 2. Currently homeless (unless residing in a recovery home for which contact information can be provided); 3. Dependence on an illicit substance for which medical detoxification is imminently needed. 4. 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.

Additional Information

Official title Cell Phone Technology Targeting ART Adherence and Drug Use
Principal investigator Suzette Glasner-Edwards, PhD
Description the specific aims of this research are 1) To develop and refine, with user feedback, a cognitive behavioral therapy-based text-messaging intervention (TXT-CBT) for HIV-infected adults with opioid dependence; 2) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of TXT-CBT over and above standard care (SC) on opioid use, HIV medication adherence, and healthcare outcomes. Both SC and SC+TXT-CBT participants will be assessed at baseline, treatment-end, and 12 weeks post-treatment; and 3) To examine potential mechanisms of action of TXT-CBT, including self-efficacy, affect regulation, and social support. The investigators hypothesize that TXT-CBT delivered in conjunction with SC will produce greater reductions in opioid use and HIV-risk behaviors, and will improve HIV treatment regimen adherence, relative to MM alone. Further, the investigators expect that SC+TXT-CBT will facilitate greater changes in negative affect, self-efficacy, and social support, and these changes will be associated with substance use outcomes. TXT-CBT incorporates specific substance- and adherence-focused cognitive therapy techniques with a concurrent emphasis on reducing HIV-risk behaviors. By providing support to maximize HIV treatment regimen adherence, coupled with coping skills to address withdrawal symptoms and stress, two important factors in opioid relapse, TXT-CBT may provide a promising, cost-effective, and easily deployable augmenting strategy for the treatment of opioid users who are HIV-infected.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.