Smoking Cessation for HIV/AIDS Patients
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cell Phone Intervention
Recommended Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, HIV positive, HIV Positive Smokers, AIDS, Cell Phone Intervention, CPI, Smoking Cessation, Interview
Eligibility Criteria
Inclusion Criteria:
- HIV-positive
- 18 years of age or older
- Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
- English or Spanish speaking
- Able to provide written informed consent to participate
- Willing to set a quit date within 1 week of baseline assessment
Exclusion Criteria:
- Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
- Current participation in another smoking cessation program
Sites / Locations
- Thomas Street Clinic
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Recommended Standard of Care
RSOC + Cell Phone Intervention
Arm Description
Recommended Standard of Care (RSOC) = Physician Advice + Written Materials
Recommended Standard of Care (RSOC) + Cell Phone Intervention
Outcomes
Primary Outcome Measures
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
Secondary Outcome Measures
Full Information
NCT ID
NCT00502827
First Posted
July 16, 2007
Last Updated
February 25, 2016
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00502827
Brief Title
Smoking Cessation for HIV/AIDS Patients
Official Title
An Innovative Telephone Intervention for HIV-Positive Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.
Detailed Description
If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.
If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.
You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.
If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.
If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.
You will be asked to complete three more interviews about 3-, 6-, and 12-months after the first interview. During these interviews, you will again be asked questions about your smoking behavior, mood, quality of life, and stress. All three of these interviews will take about one hour to complete. Your participation in this study will be complete after the 12-month interview.
Lost, stolen, or broken cell phones will not be replaced, but participants will remain on study.
This is an investigational study. Up to 705 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Human Immunodeficiency Virus, HIV positive, HIV Positive Smokers, AIDS, Cell Phone Intervention, CPI, Smoking Cessation, Interview
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
706 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recommended Standard of Care
Arm Type
Other
Arm Description
Recommended Standard of Care (RSOC) = Physician Advice + Written Materials
Arm Title
RSOC + Cell Phone Intervention
Arm Type
Other
Arm Description
Recommended Standard of Care (RSOC) + Cell Phone Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cell Phone Intervention
Other Intervention Name(s)
CPI
Intervention Description
Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.
Intervention Type
Other
Intervention Name(s)
Recommended Standard of Care
Other Intervention Name(s)
RSOC
Intervention Description
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
Primary Outcome Measure Information:
Title
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
Time Frame
1 year after quit date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-positive
18 years of age or older
Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
English or Spanish speaking
Able to provide written informed consent to participate
Willing to set a quit date within 1 week of baseline assessment
Exclusion Criteria:
Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
Current participation in another smoking cessation program
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
Facility Information:
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26666313
Citation
Buchberg MK, Gritz ER, Kypriotakis G, Arduino RC, Vidrine DJ. The role of BMI change on smoking abstinence in a sample of HIV-infected smokers. AIDS Care. 2016;28(5):603-7. doi: 10.1080/09540121.2015.1120854. Epub 2015 Dec 15.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
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Smoking Cessation for HIV/AIDS Patients
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