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
  Purpose

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.


Condition Intervention
Smoking Cessation
Behavioral: Brief Computer Motivational Interviewing for Smoking Cessation
Behavioral: Nutrition Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Computer-based MI to Engage Smokers Living With HIV in Tobacco Quitline Treatment

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Engaged in tobacco cessation treatment since end of treatment intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of quit attempts since last assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Point prevalence smoking abstinence - last 7 days from time of assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief Computer Motivational Interviewing for Smoking Cessation
Brief computer motivational interviewing intervention to motivate tobacco quitline use
Behavioral: Brief Computer Motivational Interviewing for Smoking Cessation
Brief computer motivational interviewing intervention to motivate tobacco quitline use
Active Comparator: Nutrition Control
Computer delivered nutrition education
Behavioral: Nutrition Control
Computer delivered nutrition education control condition

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886924

Contacts
Contact: Jacki Hecht, MS 401 455-6502 jhecht@butler.org

Locations
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Patricia Delgado       pdelgado@Lifespan.org   
Principal Investigator: Karen Tashima, M.D.         
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Richard A Brown, Ph.D. Butler Hospital
  More Information

No publications provided

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT01886924     History of Changes
Other Study ID Numbers: DA034558
Study First Received: June 24, 2013
Last Updated: March 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
Tobacco
Nicotine
Dependence
Quitline

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 29, 2014