An Innovative Telephone Intervention for HIV-Positive Smokers
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
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.
Ellen R. Gritz, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|Thomas Street Clinic||Houston, Texas 77009|