An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)



Status:Not yet recruiting
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/1/2014
Start Date:April 2014
Contact:Damon Vidrine, MS, DRPH, BA
Phone:713-792-8270

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An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS

The goal of this research study is to compare 2 different phone-based programs for quitting
smoking for people with HIV/AIDS.

If participant agrees to take part in this study, the following will be done at the first
visit (called the Baseline Visit):

- The study staff will give participant advice about quitting smoking. Participant will
then set a quit date, after which they will plan to not smoke anymore.

- Participant will receive a 10-week supply of nicotine patches and instructions on how
to use them.

- Participant will complete questionnaires on a laptop computer about their smoking
habits, how much tobacco they use, how many times they have tried to quit, how ready
they are to quit, and how dependent they are on nicotine. The questionnaires will take
about 30 minutes to complete.

Participant will then be assigned to 1 of 2 study groups. Participant will have a 1 in 5
(20%) chance of being assigned to Group 1, and a 4 in 5 (80%) chance of being assigned to
Group 2.

If participant is in Group 1:

- Participant will receive a telephone number to a hotline for them to use to call and
talk to someone about quitting. Participant can call the hotline anytime they need
support in their effort to quit smoking.

- Participant will also receive 11 phone calls from the study staff over a 6-month
period. During each call, participant will be given support to help them quit. Each
call will last about 15 minutes.

If participant is in Group 2:

- Participant will receive text messages for support about quitting smoking. In the
first week, participant will get about 20 text messages. Each week, participant will
receive fewer text messages, until they get 1 message per week by week 4. Participant
will then get 1 message each week after that through month 6.

- Participant will also receive another text message 1 time each week from the study
staff asking if they have smoked within the past 24 hours. Participant will be asked to
respond to this text message either by sending a text back to the study staff or
calling the study staff. If the study staff does not receive participant's response
they may receive a phone call from the staff asking about their smoking status over the
past 24 hours.

Follow-Up Visits (Both Groups):

Three (3) and 6 months after the Baseline Visit, you will complete questionnaires on a
laptop computer and participant will be asked for more information about their smoking
status. At this visit, participant will also be asked to blow into a cardboard tube to check
for byproducts of smoking. These visits will last about 20 minutes each.

Length of Study:

Participant will be on study for about 6 months.

This is an investigational study.

Up to 1000 patients will take part in this study. All will be enrolled at Legacy Community
Health Services Clinic.

Inclusion Criteria:

1. Receiving care for HIV/AIDS at a Legacy Community Health Services Clinic

2. 18 years of age or older

3. Self-reported current smoker (smoked at least 100 cigarettes in lifetime and smoking
every day or most days)

4. Able to provide written informed consent to participate

5. English or Spanish speaking

Exclusion Criteria:

1. Positive history of a medical condition that precludes use of the nicotine patch

2. Current use of nicotine replacement therapy (NRT)

3. Current use of other smoking cessation medications (e.g., Chantix or Zyban)

4. Pregnant or nursing

5. Enrolled in another smoking cessation study

6. Unwilling to set a target quit date
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