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As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as cardiovascular diseases and cancers on these people have consistently increased. Smoking is one of the major contributing factors to these health problems and rates of cigarette smoking in this group are substantially higher than those of the general population: 40-70% vs. 17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative consequence of smoking than their male counterparts. They are also less likely to see tobacco dependence treatment for dual stigma associated with both conditions: HIV infection and nicotine addiction. This is a pilot study to develop smoking cessation intervention for these women.
Women are at high risk of becoming HIV positive due to biological vulnerabilities, low socioeconomic status, dominant sexual practices of males and epidemiological factors. For example, the risk of being infected with HIV during unprotected sex is two to four times greater for women than for men. With the use of combined antiretroviral therapies, these women now live longer than ever before which now faces the healthcare community with the need for evolving understanding of HIV and aging. However, the burden of non-AIDS related health problems such as cardiovascular diseases and cancers on people living with HIV/AIDS while aging has considerably increased. Smoking is one of the major contributing factors to these health problems. Rates of current cigarette smoking are substantially higher among people living with HIV/AIDS than the general population: 40-75% versus 19%. Women smokers living with HIV have a 36% higher risk for developing AIDS and 53% higher mortality when compared to non-smoking women with HIV. This study is a pilot randomized controlled trial (RCT) testing the feasibility and acceptability of a videoconferencing smoking cessation intervention (video arm) for women with HIV in comparison with a telephone-based smoking cessation intervention (telephone arm). Both arms will receive 8, 30-minute weekly cessation counseling sessions plus 8-week nicotine replacement therapy. Participants will be followed up at 1, 3 and 6 months from the target quit day. Self-reported abstinence will be verified with a saliva cotinine test using an Nicotine Alert test strip and the testing process will be monitored via mobile-phone video call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video | Experimental | Video-call delivered cognitive behavioral therapy |
|
| Voice | Active Comparator | Voice-call delivered cognitive behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Received 8 weekly individualized counseling sessions of cognitive behavioral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abstinence | Self-reported abstinence since the quit day, which will be verified with a salivary cotinine test at both 3-month and 6-month follow-ups | 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun S Kim, PhD | University of Massachusetts, Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Massachusetts Boston | Boston | Massachusetts | 02125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26032304 | Background | Paudel V, Baral KP. Women living with HIV/AIDS (WLHA), battling stigma, discrimination and denial and the role of support groups as a coping strategy: a review of literature. Reprod Health. 2015 Jun 2;12:53. doi: 10.1186/s12978-015-0032-9. | |
| 22049380 | Background | Bancroft A. Women, Families & HIV/AIDS: A Sociological Perspective on the Epidemic in America. J Health Psychol. 2001 May;6(3):356-8. doi: 10.1177/135910530100600309. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Video | Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling |
| FG001 | Telephone | Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The women who are living with HIV.
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| ID | Title | Description |
|---|---|---|
| BG000 | Video | This is the group that received the cognitive behavioral therapy for smoking cessation via video calls. |
| BG001 | Voice | This is the group that received the cognitive behavioral therapy for smoking cessation via voice calls. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Abstinence | Self-reported abstinence since the quit day, which will be verified with a salivary cotinine test at both 3-month and 6-month follow-ups | Women living with HIV | Posted | Count of Participants | Participants | 6-month follow-up |
|
6 months
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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 | Video | Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney failure | Renal and urinary disorders | Non-systematic Assessment | The patient had a stroke and then diseased from kidney failure. The adverse event was not study-related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sun Kim | University of Massachusetts Boston | 617-287-6831 | sun.kim@umb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2017 | Feb 20, 2019 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 31, 2018 | Feb 20, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2017 | Feb 20, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 16878047 | Background | Palella FJ Jr, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, Holmberg SD; HIV Outpatient Study Investigators. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006 Sep;43(1):27-34. doi: 10.1097/01.qai.0000233310.90484.16. |
| 20724677 | Background | Lifson AR, Neuhaus J, Arribas JR, van den Berg-Wolf M, Labriola AM, Read TR; INSIGHT SMART Study Group. Smoking-related health risks among persons with HIV in the Strategies for Management of Antiretroviral Therapy clinical trial. Am J Public Health. 2010 Oct;100(10):1896-903. doi: 10.2105/AJPH.2009.188664. Epub 2010 Aug 19. |
| 15122518 | Background | Minkoff H, Feldman JG, Strickler HD, Watts DH, Bacon MC, Levine A, Palefsky JM, Burk R, Cohen MH, Anastos K. Relationship between smoking and human papillomavirus infections in HIV-infected and -uninfected women. J Infect Dis. 2004 May 15;189(10):1821-8. doi: 10.1086/383479. Epub 2004 Apr 27. |
| 23876816 | Background | Moscou-Jackson G, Commodore-Mensah Y, Farley J, DiGiacomo M. Smoking-cessation interventions in people living with HIV infection: a systematic review. J Assoc Nurses AIDS Care. 2014 Jan-Feb;25(1):32-45. doi: 10.1016/j.jana.2013.04.005. Epub 2013 Jul 20. |
| 21669958 | Background | Vidrine DJ, Marks RM, Arduino RC, Gritz ER. Efficacy of cell phone-delivered smoking cessation counseling for persons living with HIV/AIDS: 3-month outcomes. Nicotine Tob Res. 2012 Jan;14(1):106-10. doi: 10.1093/ntr/ntr121. Epub 2011 Jun 13. |
| 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. |
| 34999667 | Derived | Kim SS, DeMarco RF. The Intersectionality of HIV-Related Stigma and Tobacco Smoking Stigma With Depressive and Anxiety Symptoms Among Women Living With HIV in the United States: A Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):523-533. doi: 10.1097/JNC.0000000000000323. Epub 2022 Jan 7. |
| 31977840 | Derived | Kim SS, Cooley ME, Lee SA, DeMarco RF. Prediction of Smoking Abstinence in Women Living With Human Immunodeficiency Virus Infection. Nurs Res. 2020 May/Jun;69(3):167-175. doi: 10.1097/NNR.0000000000000421. |
| 30288127 | Derived | Kim SS, Darwish S, Lee SA, Sprague C, DeMarco RF. A randomized controlled pilot trial of a smoking cessation intervention for US women living with HIV: telephone-based video call vs voice call. Int J Womens Health. 2018 Sep 25;10:545-555. doi: 10.2147/IJWH.S172669. eCollection 2018. |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nicotine Dependence | The measure is based on its total score that ranges from 0 to 10. Lower scores indicate less nicotine dependence. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Telephone | Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling | 1 | 24 | 1 | 24 | 0 | 24 |
|
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