NCT01886924

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

June 24, 2013

Last Update Submit

July 19, 2016

Conditions

Keywords

TobaccoNicotineDependenceQuitline

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

EXPERIMENTAL

Brief computer MI intervention to motivate tobacco quitline use

Behavioral: Brief Computer MI for Smoking Cessation

Nutrition Control

ACTIVE COMPARATOR

Computer delivered nutrition education

Behavioral: Nutrition Control

Interventions

Brief computer MI intervention to motivate tobacco quitline use

Brief Computer MI for Smoking Cessation

Computer delivered nutrition education control condition

Nutrition Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Richard A Brown, Ph.D.

    Butler Hospital

    PRINCIPAL INVESTIGATOR

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

Locations