Computer MI for Tobacco Quitline Engagement in Smokers Living With HIV (MI-HIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Butler Hospital
Sponsor:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT01886924
First received: June 24, 2013
Last updated: March 3, 2014
Last verified: March 2014

June 24, 2013
March 3, 2014
February 2014
March 2015   (final data collection date for primary outcome measure)
Engaged in tobacco cessation treatment since end of treatment intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01886924 on ClinicalTrials.gov Archive Site
Number of quit attempts since last assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Point prevalence smoking abstinence - last 7 days from time of assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
 
Computer MI for Tobacco Quitline Engagement in Smokers Living With HIV
Computer-based MI to Engage Smokers Living With HIV in Tobacco Quitline Treatment

The long-term goal of this program of research is to disseminate an effective, brief computer-based intervention that can be readily integrated into HIV treatment settings to motivate tobacco quitline use among smokers living with HIV. The overall objective of this application is to develop this computer intervention, modify it based on initial piloting and feedback, and obtain preliminary data supporting the efficacy of the intervention. This will be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot testing (n=16) of a brief, computer-based intervention intended to motivate tobacco quitline use among cigarette smokers living with HIV (Computer Intervention to Motivate Engagement in Tobacco Quitline treatment; CI-METQ) and to develop and pilot (n=4) a computer-based, time matched nutrition education for PLWH control intervention (NC) equated for the offer of a tobacco quitline referral and 8 weeks of free nicotine patch for those who engage in quitline treatment, 2) to conduct a preliminary smoking cessation, randomized controlled trial (RCT) with 100 people living with HIV (PLWH) who smoke cigarettes, comparing CI-METQ vs. NC, with predictions that CI-METQ relative to NC will result in increased readiness, higher rates of tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1-, 3- and 6-month follow-ups. Health-related quality of life over this period will also be examined, and 3) to examine CI-METQ's effects on key mechanisms during the computer session and their associations with tobacco treatment engagement and smoking outcomes at 1-, 3- and 6-month follow-ups.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Brief Computer Motivational Interviewing for Smoking Cessation
    Brief computer motivational interviewing intervention to motivate tobacco quitline use
  • Behavioral: Nutrition Control
    Computer delivered nutrition education control condition
  • Experimental: Brief Computer Motivational Interviewing for Smoking Cessation
    Brief computer motivational interviewing intervention to motivate tobacco quitline use
    Intervention: Behavioral: Brief Computer Motivational Interviewing for Smoking Cessation
  • Active Comparator: Nutrition Control
    Computer delivered nutrition education
    Intervention: Behavioral: Nutrition Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 - 70 years of age
  • current smoker (i.e., at least 10 cigarettes/day)
  • HIV seropositive
  • English speaking
  • reliable access to a telephone (own cellular phone or a landline in their home)
  • agreed to be available over the next 6 months.

Exclusion Criteria:

  • cognitive impairment sufficient to impair provision of informed consent or study participation
  • current use of nicotine replacement therapy (NRT) or other pharmacotherapy for smoking cessation
  • use of other tobacco products
Both
18 Years to 70 Years
Yes
Contact: Jacki Hecht, MS 401 455-6502 jhecht@butler.org
United States
 
NCT01886924
DA034558
No
Butler Hospital
Butler Hospital
Not Provided
Principal Investigator: Richard A Brown, Ph.D. Butler Hospital
Butler Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP