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Smoking Cessation Intervention for Women Living With HIV (SoCIWHIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898597
Recruitment Status : Completed
First Posted : September 13, 2016
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sun S Kim, University of Massachusetts, Boston

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
AIDS/HIV Behavioral: Cognitive Behavioral Therapy Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smoking Cessation Intervention for Women With HIV/AIDS
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Video
Video-call delivered cognitive behavioral therapy
 Behavioral: Cognitive Behavioral Therapy
Received 8 weekly individualized counseling sessions of cognitive behavioral therapy
Active Comparator: Voice
Voice-call delivered cognitive behavioral therapy
 Behavioral: Cognitive Behavioral Therapy
Received 8 weekly individualized counseling sessions of cognitive behavioral therapy


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Abstinence [ Time Frame: 6-month follow-up ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898597


Locations
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United States, Massachusetts
University Massachusetts Boston
Boston, Massachusetts, United States, 02125
Sponsors and Collaborators
University of Massachusetts, Boston
Investigators
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Principal Investigator: Sun S Kim, PhD University of Massachusetts, Boston
  Study Documents (Full-Text)

Documents provided by Sun S Kim, University of Massachusetts, Boston:
Informed Consent Form  [PDF] January 31, 2017
Study Protocol  [PDF] March 31, 2018
Statistical Analysis Plan  [PDF] January 31, 2017

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sun S Kim, Associate Professor, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT02898597    
Other Study ID Numbers: 2016059
First Posted: September 13, 2016    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No