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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01886924
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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- and 3-month follow-ups.

Condition or disease Intervention/treatment
Smoking Cessation Behavioral: Brief Computer MI for Smoking Cessation Behavioral: Nutrition Control

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Computer-based MI to Engage Smokers Living With HIV in Tobacco Quitline Treatment
Study Start Date : February 2014
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Brief Computer MI for Smoking Cessation
Brief computer MI intervention to motivate tobacco quitline use
Behavioral: Brief Computer MI for Smoking Cessation
Brief computer MI intervention to motivate tobacco quitline use
Active Comparator: Nutrition Control
Computer delivered nutrition education
Behavioral: Nutrition Control
Computer delivered nutrition education control condition


Outcome Measures

Primary Outcome Measures :
  1. Engaged in tobacco cessation treatment since end of treatment intervention [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of quit attempts since last assessment [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Point prevalence smoking abstinence - last 7 days from time of assessment [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886924


Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Richard A Brown, Ph.D. Butler Hospital
More Information

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT01886924     History of Changes
Other Study ID Numbers: DA034558
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Butler Hospital:
Tobacco
Nicotine
Dependence
Quitline