Computer MI for Tobacco Quitline Engagement in Smokers Living With HIV
MI-HIV
Computer-based MI to Engage Smokers Living With HIV in Tobacco Quitline Treatment
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 26, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 20, 2016
July 1, 2016
1.2 years
June 24, 2013
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Engaged in tobacco cessation treatment since end of treatment intervention
6 months
Secondary Outcomes (1)
Number of quit attempts since last assessment
6 months
Other Outcomes (1)
Point prevalence smoking abstinence - last 7 days from time of assessment
6 months
Study Arms (2)
Brief Computer MI for Smoking Cessation
EXPERIMENTALBrief computer MI intervention to motivate tobacco quitline use
Nutrition Control
ACTIVE COMPARATORComputer delivered nutrition education
Interventions
Brief computer MI intervention to motivate tobacco quitline use
Computer delivered nutrition education control condition
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
Study Sites (1)
The Miriam Hospital
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard A Brown, Ph.D.
Butler Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2013
First Posted
June 26, 2013
Study Start
February 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 20, 2016
Record last verified: 2016-07