Smoking Cessation Intervention for Women Living With HIV

AIDS/HIV Clinical Trial

— SoCIWHIV  

Official title:

Smoking Cessation Intervention for Women With HIV/AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898597
• Other study ID #: 2016059
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: August 2019
• Source: University of Massachusetts, Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 31, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• English speaking

• Diagnosis of HIV infection

• Age 18 or older

• Smoking at least 5 cigarettes a day

• Having access to a mobile-phone with Internet connection

• Willing to quit smoking within the next 4 weeks

Exclusion Criteria:

• Inability to speak English

• Involvement in another cessation program

• Being pregnant or lactating

• Having an active skin disease

• History of serious mental illnesses (e.g., schizophrenia and bipolar disorder)

• Serious alcohol use problem

• Use of any illegal substances excluding marijuana

Related Conditions & MeSH terms

• AIDS/HIV

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Received 8 weekly individualized counseling sessions of cognitive behavioral therapy

Locations

Country	Name	City	State
United States	University Massachusetts Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Epub 2004 Apr 27. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	6-month follow-up