Ignite Creation Date:
2024-05-06 @ 7:47 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02603471
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2014-07-15
Brief Title:
Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use
Status:
COMPLETED
Status Verified Date:
2022-04
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:
ALCTXT
Brief 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
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
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
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