Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study



Status:Completed
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:January 2015
End Date:March 2016

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Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study

The goal of this research study is to learn about 2 different interactive methods that are
designed to help people with HIV/AIDS stop smoking.

Baseline Questionnaire:

If you agree to take part in this study, you will complete a questionnaire on a laptop about
your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking
history, and some demographic information such as age, education level, and income level.
This should take about 15-20 minutes to complete.

Study Groups:

After completing the questionnaire, you will be randomly assigned (as in the flip of a coin)
to 1 of 2 study groups. You will have an equal chance of being placed in either group.

Both groups will receive smart phones and an 8-week supply of nicotine patches with
instructions on how to use them. Each group will receive different methods of advice for
quitting smoking.

If you are assigned to Group 1, the following study procedures will be performed:

- You will receive brief advice on how to quit smoking once at the time of enrollment. The
advice will be given from a pamphlet that has information such as health problems
related to smoking, how many Americans are affected each year, financial problems
related to smoking, nicotine replacement therapy options, preparation for quitting
smoking, and encouragement to quit.

- On the smart phone, you will have 5 phone counseling sessions for support in quitting
smoking throughout the 8-week intervention treatment. The calls should last about 15
minutes.

If you are assigned to Group 2, the following study procedures will be performed:

- On the smart phone, you will receive brief video clips with advice on how to quit
smoking, as well as interactive text and picture messages once a week for 8 weeks. The
video clips will be about 5 minutes long.

- You will also have access to additional counseling content on the smart phone, which you
can use at any time.

Weekly Smart Phone Questionnaires:

Both groups will complete questionnaires on the smart phone every week for 8 weeks. Each
questionnaire will have questions about your current smoking status, your motivation level to
stop smoking, and things that may have a negative effect on your quitting. The questionnaire
should take about 15 minutes to complete.

Follow-up Saliva Test and Questionnaire:

About 3 months after your first smart phone intervention, both groups will complete a saliva
test and take a photograph of the test results. The saliva test results will be used to check
your smoking activity. Supplies and instructions will be given to you when you are enrolled
on the study and the instructions will be available on the smart phone. You will also
complete a questionnaire similar to the baseline questionnaire.

Length of Study:

You will be on study for about 3 months.

This is an investigational study. Up to 50 participants will take part in this study. All
will be enrolled at the Harris Health System (Thomas Street Health Center).

Inclusion Criteria:

1. 18 years of age or older

2. Smoked at least 100 cigarettes in lifetime

3. English speaking

4. HIV-positive patient at Thomas Street Health Center

5. Currently smoking 5 or more cigarettes per day

6. Willing to make a quit attempt within 1 week of enrollment

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
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