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Smoking Cessation for HIV/AIDS Patients

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Completed

Conditions

Human Immunodeficiency Virus

Treatments

Behavioral: Cell Phone Intervention
Other: Recommended Standard of Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00502827
NCI-2012-02109 (Registry Identifier)
2003-0784

Details and patient eligibility

About

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

Full 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.

Enrollment

706 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

706 participants in 2 patient groups

Recommended Standard of Care
Other group
Description:
Recommended Standard of Care (RSOC) = Physician Advice + Written Materials
Treatment:
Other: Recommended Standard of Care
RSOC + Cell Phone Intervention
Other group
Description:
Recommended Standard of Care (RSOC) + Cell Phone Intervention
Treatment:
Other: Recommended Standard of Care
Behavioral: Cell Phone Intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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