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Trial record 1 of 3 for:    16878047 [PUBMED-IDS]
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Smoking Cessation Intervention for Women Living With HIV (SoCIWHIV)

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ClinicalTrials.gov Identifier: NCT02898597
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Boston

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 [1-3]. For example, the risk of being infected with HIV during unprotected sex is two to four times greater for women than for men [4]. 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 [5, 6]. 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% [6]. 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 [6]. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smoking Cessation Intervention for Women With HIV/AIDS
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Video
Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)
Behavioral: Cognitive Behavioral Therapy
Receive cognitive behavioral cessation counseling

Active Comparator: Telephone
Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch)
Behavioral: Cognitive Behavioral Therapy
Receive cognitive behavioral cessation counseling




Primary Outcome Measures :
  1. Abstinence [ Time Frame: 6 months ]
    Self-reported abstinence verified with a saliva cotinine test will be reported


Secondary Outcome Measures :
  1. Recruitment and Retention [ Time Frame: 12 months ]
    The rates of recruitment and retention will be estimated by month



Information from the National Library of Medicine

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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 WiFi 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

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


Contacts
Contact: Sun S Kim, PhD 617-287-6831 sun.kim@umb.edu
Contact: Sabreen Darwish, MS 781-492-7096 Sabreen.Darwish001@umb.edu

Locations
United States, Massachusetts
University Massachusetts Boston Recruiting
Boston, Massachusetts, United States, 02125
Contact: Sun S Kim, PhD    617-287-6831    sun.kim@umb.edu   
Sponsors and Collaborators
University of Massachusetts, Boston
Investigators
Principal Investigator: Sun S Kim, PhD University of Massachusetts, Boston

Publications:

Responsible Party: University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT02898597     History of Changes
Other Study ID Numbers: 2016059
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No