Clinical trial NCT02302859: Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study
Official title: Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: Cancer Prevention
Tobacco Use Cessation
HIV-positive
Nicotine patch
NRT
Questionnaire
Survey
Smartphone
Counseling
Saliva test
Saliva cotinine test
Nicotine replacement therapy
Smoking abstinence
Aids
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Abstinence: 3-month Assessment Via Smart Phone
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Health Center -Harris Health System
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Diana S. Hoover, PHD
role: PRINCIPAL_INVESTIGATOR
References: