Clinical trial NCT00502827: Smoking Cessation for HIV/AIDS Patients
Official title: An Innovative Telephone Intervention for HIV-Positive Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
HIV positive
HIV Positive Smokers
AIDS
Cell Phone Intervention
CPI
Smoking Cessation
Interview
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-18
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
timeFrame: 1 year after quit date
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Damon Vidrine, MS, DRPH, BA
role: PRINCIPAL_INVESTIGATOR
References:
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.