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An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)

Primary Purpose

Tobacco Use Cessation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nicotine Patch
Phone Counseling
Questionnaires
Breath Test
Proactive Cell Phone Smoking Cessation Counseling
Text Message Smoking Cessation Support
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Cessation focused on measuring Tobacco Use Cessation, Cancer Prevention, HIV/AIDS, Questionnaires, Surveys, Nicotine patch, Breath test, Cell Phone Calls for Smoking Cessation Counseling, Text Message Smoking Cessation Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Receiving care for HIV/AIDS at a Legacy Community Health Services Clinic
  2. 18 years of age or older
  3. Self-reported current smoker (smoked at least 100 cigarettes in lifetime and smoking every day or most days)
  4. Able to provide written informed consent to participate
  5. English or Spanish speaking

Exclusion Criteria:

  1. Positive history of a medical condition that precludes use of the nicotine patch
  2. Current use of nicotine replacement therapy (NRT)
  3. Current use of other smoking cessation medications (e.g., Chantix or Zyban)
  4. Pregnant or nursing
  5. Enrolled in another smoking cessation study
  6. Unwilling to set a target quit date

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group 1 - Phone Call Support

    Group 2 - Text Messaging Support

    Arm Description

    Smoking cessation telephone hotline phone number provided to participants, along with a 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participant receives 11 phone calls from study staff over a 6-month period. Breath test performed at 3 month and 6 month visit.

    Participants receive 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participants receive text messages for support about quitting smoking over a 6 month period. Breath test performed at 3 month and 6 month visit.

    Outcomes

    Primary Outcome Measures

    Smoking Abstinence
    Smoking abstinence defined as biochemically confirmed 7-day abstinence. Expired CO will be used to biochemically verify abstinence.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 19, 2013
    Last Updated
    February 27, 2014
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Centers for Medicare and Medicaid Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02029612
    Brief Title
    An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)
    Official Title
    An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Centers for Medicare and Medicaid Services

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this research study is to compare 2 different phone-based programs for quitting smoking for people with HIV/AIDS.
    Detailed Description
    If participant agrees to take part in this study, the following will be done at the first visit (called the Baseline Visit): The study staff will give participant advice about quitting smoking. Participant will then set a quit date, after which they will plan to not smoke anymore. Participant will receive a 10-week supply of nicotine patches and instructions on how to use them. Participant will complete questionnaires on a laptop computer about their smoking habits, how much tobacco they use, how many times they have tried to quit, how ready they are to quit, and how dependent they are on nicotine. The questionnaires will take about 30 minutes to complete. Participant will then be assigned to 1 of 2 study groups. Participant will have a 1 in 5 (20%) chance of being assigned to Group 1, and a 4 in 5 (80%) chance of being assigned to Group 2. If participant is in Group 1: Participant will receive a telephone number to a hotline for them to use to call and talk to someone about quitting. Participant can call the hotline anytime they need support in their effort to quit smoking. Participant will also receive 11 phone calls from the study staff over a 6-month period. During each call, participant will be given support to help them quit. Each call will last about 15 minutes. If participant is in Group 2: Participant will receive text messages for support about quitting smoking. In the first week, participant will get about 20 text messages. Each week, participant will receive fewer text messages, until they get 1 message per week by week 4. Participant will then get 1 message each week after that through month 6. Participant will also receive another text message 1 time each week from the study staff asking if they have smoked within the past 24 hours. Participant will be asked to respond to this text message either by sending a text back to the study staff or calling the study staff. If the study staff does not receive participant's response they may receive a phone call from the staff asking about their smoking status over the past 24 hours. Follow-Up Visits (Both Groups): Three (3) and 6 months after the Baseline Visit, you will complete questionnaires on a laptop computer and participant will be asked for more information about their smoking status. At this visit, participant will also be asked to blow into a cardboard tube to check for byproducts of smoking. These visits will last about 20 minutes each. Length of Study: Participant will be on study for about 6 months. This is an investigational study. Up to 1000 patients will take part in this study. All will be enrolled at Legacy Community Health Services Clinic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tobacco Use Cessation
    Keywords
    Tobacco Use Cessation, Cancer Prevention, HIV/AIDS, Questionnaires, Surveys, Nicotine patch, Breath test, Cell Phone Calls for Smoking Cessation Counseling, Text Message Smoking Cessation Support

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 - Phone Call Support
    Arm Type
    Other
    Arm Description
    Smoking cessation telephone hotline phone number provided to participants, along with a 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participant receives 11 phone calls from study staff over a 6-month period. Breath test performed at 3 month and 6 month visit.
    Arm Title
    Group 2 - Text Messaging Support
    Arm Type
    Other
    Arm Description
    Participants receive 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participants receive text messages for support about quitting smoking over a 6 month period. Breath test performed at 3 month and 6 month visit.
    Intervention Type
    Drug
    Intervention Name(s)
    Nicotine Patch
    Intervention Description
    10 week supply of nicotine patches given to participants at baseline.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Phone Counseling
    Intervention Description
    Each participant counseled on quitting smoking at baseline.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Questionnaires
    Other Intervention Name(s)
    Surveys
    Intervention Description
    Questionnaires completed at baseline, 3 months, and at 6 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Breath Test
    Intervention Description
    Breath test performed at 3 month and 6 month visit.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Proactive Cell Phone Smoking Cessation Counseling
    Intervention Description
    Participant receives 11 phone calls from study staff over a 6-month period.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Text Message Smoking Cessation Support
    Intervention Description
    Participants receive text messages for support about quitting smoking over a 6 month period.
    Primary Outcome Measure Information:
    Title
    Smoking Abstinence
    Description
    Smoking abstinence defined as biochemically confirmed 7-day abstinence. Expired CO will be used to biochemically verify abstinence.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Receiving care for HIV/AIDS at a Legacy Community Health Services Clinic 18 years of age or older Self-reported current smoker (smoked at least 100 cigarettes in lifetime and smoking every day or most days) Able to provide written informed consent to participate English or Spanish speaking Exclusion Criteria: Positive history of a medical condition that precludes use of the nicotine patch Current use of nicotine replacement therapy (NRT) Current use of other smoking cessation medications (e.g., Chantix or Zyban) Pregnant or nursing Enrolled in another smoking cessation study Unwilling to set a target quit date
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damon Vidrine, MS, DRPH, BA
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    University of Texas MD Anderson Cancer Center Website

    Learn more about this trial

    An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)

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