Smoking Cessation for HIV/AIDS Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502827
First received: July 16, 2007
Last updated: September 19, 2013
Last verified: September 2013

July 16, 2007
September 19, 2013
January 2004
August 2015   (final data collection date for primary outcome measure)
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence [ Time Frame: Follow-up assessments conducted on 3 occasions: 3 months after the initial quit date, 6 months after the initial quit date, and 12 months after the quit date. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00502827 on ClinicalTrials.gov Archive Site
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Smoking Cessation for HIV/AIDS Patients
An Innovative Telephone Intervention for HIV-Positive Smokers

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.

  • To compare a Cell Phone Intervention (CPI) - a targeted, proactive cellular telephone delivered smoking cessation treatment focused on the special needs and concerns of a low income, multi-ethnic, HIV-positive population - to a Recommended Standard of Care (RSOC) treatment in a randomized controlled trial.
  • To evaluate the association of self-efficacy, negative affect, coping behavior, and quality of life with smoking status.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus
  • 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
  • Recommended Standard of Care
    Recommended Standard of Care (RSOC) = Physician Advice + Written Materials
    Intervention: Other: Recommended Standard of Care
  • RSOC + Cell Phone Intervention
    Recommended Standard of Care (RSOC) + Cell Phone Intervention
    Interventions:
    • Behavioral: Cell Phone Intervention
    • Other: Recommended Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
705
Not Provided
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00502827
2003-0784
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP