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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02029612
First received: November 19, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

The goal of this research study is to compare 2 different phone-based programs for quitting smoking for people with HIV/AIDS.


Condition Intervention
Tobacco Use Cessation
Drug: Nicotine Patch
Behavioral: Phone Counseling
Behavioral: Questionnaires
Behavioral: Breath Test
Behavioral: Proactive Cell Phone Smoking Cessation Counseling
Behavioral: Text Message Smoking Cessation Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Smoking abstinence defined as biochemically confirmed 7-day abstinence. Expired CO will be used to biochemically verify abstinence.


Enrollment: 0
Study Start Date: April 2014
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1 - Phone Call Support
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.
Drug: Nicotine Patch
10 week supply of nicotine patches given to participants at baseline.
Behavioral: Phone Counseling
Each participant counseled on quitting smoking at baseline.
Behavioral: Questionnaires
Questionnaires completed at baseline, 3 months, and at 6 months.
Other Name: Surveys
Behavioral: Breath Test
Breath test performed at 3 month and 6 month visit.
Behavioral: Proactive Cell Phone Smoking Cessation Counseling
Participant receives 11 phone calls from study staff over a 6-month period.
Group 2 - Text Messaging Support
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.
Drug: Nicotine Patch
10 week supply of nicotine patches given to participants at baseline.
Behavioral: Phone Counseling
Each participant counseled on quitting smoking at baseline.
Behavioral: Questionnaires
Questionnaires completed at baseline, 3 months, and at 6 months.
Other Name: Surveys
Behavioral: Breath Test
Breath test performed at 3 month and 6 month visit.
Behavioral: Text Message Smoking Cessation Support
Participants receive text messages for support about quitting smoking over a 6 month period.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT02029612

Sponsors and Collaborators
M.D. Anderson Cancer Center
Centers for Medicare and Medicaid Services
Investigators
Principal Investigator: Damon Vidrine, MS, DRPH, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02029612     History of Changes
Other Study ID Numbers: 2013-0495
Study First Received: November 19, 2013
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014