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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00502827 |
Purpose
Within the HIV-positive population, an estimated 50-70%[1-3] of individuals smoke. Despite this alarmingly high rate, HIV-positive smokers have not been targeted for intervention due to the poor prognosis of their disease. However, with new antiretroviral regimens, HIV-positive individuals are now living longer. As longevity increases, HIV-positive individuals are more vulnerable to both the long- and short-term impact of cigarette smoking. Smoking is a significant factor in the course, management, and quality of life for patients with HIV/AIDS. Preliminary research suggests that 62% of HIV-positive smokers are considering quitting smoking [3]. Currently no published studies have explored the efficacy of a smoking cessation intervention for HIV-positive smokers who are interested in quitting smoking. Our goal is cto assess a smoking cessation intervention targeted to an HIV/AIDS patient population.
| Condition | Intervention |
|---|---|
|
Human Immunodeficiency Virus |
Behavioral: Cell Phone Intervention Other: Recommended Standard of Care |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | An Innovative Telephone Intervention for HIV-Positive Smokers |
| Estimated Enrollment: | 595 |
| Study Start Date: | January 2004 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Recommended Standard of Care: 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.
|
|
2
Recommended Standard of Care + Cell Phone Intervention
|
Behavioral: Cell Phone Intervention
Study participants will be called on a cell phone 11 times over the course of a 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.
Other: Recommended Standard of Care
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
|
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 595 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| Contact: Ellen R. Gritz, PhD | 713-792-8270 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Ellen R. Gritz, PhD | |
| Sub-Investigator: Damon Vidrine, DrPH | |
| Thomas Street Clinic | Recruiting |
| Houston, Texas, United States, 77009 | |
| Principal Investigator: | Ellen R. Gritz, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Ellen R. Gritz, PhD/Professor ) |
| Study ID Numbers: | 2003-0784 |
| Study First Received: | July 16, 2007 |
| Last Updated: | November 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00502827 |
| Health Authority: | United States: Institutional Review Board |
|
Human Immunodeficiency Virus HIV positive HIV Positive Smokers AIDS |
Cell Phone Intervention CPI Smoking Cessation Interview |
|
Virus Diseases Smoking Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections |
