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| Name | Class |
|---|---|
| Centers for Medicare and Medicaid Services | FED |
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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):
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:
If participant is in Group 2:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Phone Call Support | Other | Smoking cessation telephone hotline phone number provided to participants, along with a 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participant receives 11 phone calls from study staff over a 6-month period. Breath test performed at 3 month and 6 month visit. |
|
| Group 2 - Text Messaging Support | Other | Participants receive 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participants receive text messages for support about quitting smoking over a 6 month period. Breath test performed at 3 month and 6 month visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | 10 week supply of nicotine patches given to participants at baseline. |
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| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | Smoking abstinence defined as biochemically confirmed 7-day abstinence. Expired CO will be used to biochemically verify abstinence. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damon Vidrine, MS, DRPH, BA | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Phone Counseling | Behavioral | Each participant counseled on quitting smoking at baseline. |
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| Questionnaires | Behavioral | Questionnaires completed at baseline, 3 months, and at 6 months. |
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| Breath Test | Behavioral | Breath test performed at 3 month and 6 month visit. |
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| Proactive Cell Phone Smoking Cessation Counseling | Behavioral | Participant receives 11 phone calls from study staff over a 6-month period. |
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| Text Message Smoking Cessation Support | Behavioral | Participants receive text messages for support about quitting smoking over a 6 month period. |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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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 |
| 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 |
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