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
  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.

  • 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.

Condition Intervention
Human Immunodeficiency Virus
Behavioral: Cell Phone Intervention
Other: Recommended Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Innovative Telephone Intervention for HIV-Positive Smokers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 705
Study Start Date: January 2004
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Recommended Standard of Care
Recommended Standard of Care (RSOC) = 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.
Other Name: RSOC
RSOC + Cell Phone Intervention
Recommended Standard of Care (RSOC) + Cell Phone 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 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

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 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502827

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Thomas Street Clinic
Houston, Texas, United States, 77009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502827     History of Changes
Other Study ID Numbers: 2003-0784
Study First Received: July 16, 2007
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Human Immunodeficiency Virus
HIV positive
HIV Positive Smokers
AIDS
Cell Phone Intervention
CPI
Smoking Cessation
Interview

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014