Smoking Cessation for HIV/AIDS Patients

Human Immunodeficiency Virus Clinical Trial

Official title:

An Innovative Telephone Intervention for HIV-Positive Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502827
• Other study ID #: 2003-0784
• Secondary ID: NCI-2012-02109
• Status: Completed
• Phase: N/A
• First received: July 16, 2007
• Last updated: February 25, 2016
• Start date: January 2004
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

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

Locations

Country	Name	City	State
United States	Thomas Street Clinic	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence		1 year after quit date	No

External Links

•   University of Texas MD Anderson Cancer Center Website