NCT01884233

Cell Phone Technology Targeting ART Adherence and Drug Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV
• Opioid Abuse

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-06-21
• Last updated: 2022-04-29

Locations

1 site across 1 country: United States