NCT02603471

Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study, for HIV positive alcohol dependent adults currently taking naltrexone, is a pilot randomized controlled trial (RCT) examining the outcomes of a 12-week behavioral support program delivered via text-messaging. It is expected that the text messaging intervention will reduce alcohol use and HIV-risk behaviors. The investigators also hypothesize that the intervention will improve adherence to HIV treatment and naltrexone. To test the effects of the intervention on these target outcomes, 25 participants receiving the text messaging intervention will be compared to 25 participants receiving an informational pamphlet. The pamphlet will contain information about the importance of HIV treatment adherence, reducing HIV risk behaviors, and health consequences associated with alcohol use. By providing support to maximize HIV treatment regimen and naltrexone adherence, coupled with coping skills to promote abstinence from alcohol, the text messaging intervention may provide a promising, cost-effective, and easily deployable behavioral support program for alcohol users who are HIV-infected.

Detailed description

The aims of this study are to: 1) implement and evaluate a 12-week cognitive behavioral therapy (CBT) intervention using text messaging via mobile phone technology (ALC-TXT-CBT) to reduce alcohol use, reduce HIV-risk behaviors and facilitate medication adherence in a population of alcohol dependent adults with HIV-infection and 2) examine potential mechanisms of action of ALC-TXT-CBT. The investigators hypothesize that ALC-TXT-CBT will produce greater reductions in alcohol use and HIV-risk behaviors, and will improve HIV treatment regimen and naltrexone (Vivitrol) adherence, relative to the control condition (informational pamphlet). Further, the investigators expect that ALC-TXT-CBT will facilitate greater changes in negative affect, self-efficacy, and social support, and these changes will be associated with substance use outcomes.

Conditions

• HIV Infections
• Alcohol Dependence

Interventions

Type	Name	Description
OTHER	Informational group	A pamphlet will be provided to the participants with information about ART adherence, HIV 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: 2014-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-11-11
• Last updated: 2022-04-29

Locations

1 site across 1 country: United States