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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02572 | Registry Identifier | NCI CTRP |
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At the request of the PI
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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:
If you are assigned to Group 2, the following study procedures will be performed:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment (ST) | Experimental | Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention. Participants complete saliva cotinine test 3 months after intervention. |
|
| Automated Treatment (AT) | Experimental | Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months. Participants complete saliva cotinine test 3 months after intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | Participants receive an 8 week supply of Nicotine patches. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence: 3-month Assessment Via Smart Phone | Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana S. Hoover, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Street Health Center -Harris Health System | Houston | Texas | 77009 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period Opened January 2015 and Closed March 2016. Recruitment was accomplished in clinic setting of a large comprehensive HIV-care center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment (ST) | Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking. |
| FG001 | Automated Treatment (AT) | Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment (ST) | Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking. |
| BG001 | Automated Treatment (AT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Abstinence: 3-month Assessment Via Smart Phone | Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers. | Data were not collected due to early termination of the protocol | Posted | 3 months |
|
Adverse event data collected over 3 month treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment (ST) | Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking. |
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Early termination leading to small number of subjects registered, study halted without analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lorna McNeill, MPH,PHD/ Chair, Health Disparities Research | The University of Texas (UT) MD Anderson Cancer Center | 713- 563-1103 | lmcneill@mdanderson.org |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D006679 | HIV Seropositivity |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| Questionnaires | Behavioral | Questionnaire completion at baseline on laptop, then weekly for 8 weeks on smartphone, then 3 months after smartphone intervention. |
|
|
| Pamphlet | Other | Pamphlet given to participant describing health and financial reasons to quit smoking. |
|
| Phone Counseling Sessions | Behavioral | Standard Treatment (ST) Group: Participants receive 8 phone counseling sessions (one session per week) for support in quitting smoking. The calls should last about 15 minutes. Automated Treatment (AT) Group: Participants receive brief video clips with advice on how to quit smoking over smartphone, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long. Participants also have access to additional counseling content on the smart phone, which can be used at any time. |
|
| Saliva Test | Other | Participants complete saliva cotinine test 3 months after intervention. |
|
| Smart phone | Device | Standard Treatment (ST) Group: Participants receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes. Automated Treatment (AT) Group: Participants receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone. |
|
Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Automated Treatment (AT) | Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking. |
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Automated Treatment (AT) | Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D003141 |
| Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D017531 |
| Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |