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Smoking Cessation for HIV/AIDS Patients

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ClinicalTrials.gov Identifier: NCT00502827
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : February 26, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Cell Phone Intervention Other: Recommended Standard of Care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Innovative Telephone Intervention for HIV-Positive Smokers
Study Start Date : January 2004
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Recommended Standard of Care
Recommended Standard of Care (RSOC) = Physician Advice + Written Materials
Other: Recommended Standard of Care
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
Other Name: RSOC

RSOC + Cell Phone Intervention
Recommended Standard of Care (RSOC) + Cell Phone Intervention
Behavioral: Cell Phone Intervention
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.
Other Name: CPI

Other: Recommended Standard of Care
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
Other Name: RSOC




Primary Outcome Measures :
  1. Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence [ Time Frame: 1 year after quit date ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-positive
  2. 18 years of age or older
  3. Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
  4. English or Spanish speaking
  5. Able to provide written informed consent to participate
  6. Willing to set a quit date within 1 week of baseline assessment

Exclusion Criteria:

  1. Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
  2. Current participation in another smoking cessation program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502827


Locations
United States, Texas
Thomas Street Clinic
Houston, Texas, United States, 77009
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Damon Vidrine, MS, DRPH, BA M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502827     History of Changes
Other Study ID Numbers: 2003-0784
NCI-2012-02109 ( Registry Identifier: NCI CTRP )
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by M.D. Anderson Cancer Center:
Human Immunodeficiency Virus
HIV positive
HIV Positive Smokers
AIDS
Cell Phone Intervention
CPI
Smoking Cessation
Interview

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases