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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02109 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.
If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.
If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.
You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.
If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.
If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.
You will be asked to complete three more interviews about 3-, 6-, and 12-months after the first interview. During these interviews, you will again be asked questions about your smoking behavior, mood, quality of life, and stress. All three of these interviews will take about one hour to complete. Your participation in this study will be complete after the 12-month interview.
Lost, stolen, or broken cell phones will not be replaced, but participants will remain on study.
This is an investigational study. Up to 705 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recommended Standard of Care | Other | Recommended Standard of Care (RSOC) = Physician Advice + Written Materials |
|
| RSOC + Cell Phone Intervention | Other | Recommended Standard of Care (RSOC) + Cell Phone Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell Phone Intervention | Behavioral | Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence | 1 year after quit date |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Street Clinic | Houston | Texas | 77009 | United States | ||
| University of Texas MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39101506 | Derived | Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3. | |
| 26666313 | Derived | Buchberg MK, Gritz ER, Kypriotakis G, Arduino RC, Vidrine DJ. The role of BMI change on smoking abstinence in a sample of HIV-infected smokers. AIDS Care. 2016;28(5):603-7. doi: 10.1080/09540121.2015.1120854. Epub 2015 Dec 15. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006679 | HIV Seropositivity |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C110747 | cyclopropapyrroloindole |
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|
| Recommended Standard of Care | Other | Advice from your physician to stop smoking and written materials designed to help you quit smoking. |
|
|
| Houston |
| Texas |
| 77030 |
| United States |
| 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 |
| D015438 | Health Behavior |
| D001519 | Behavior |