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Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03670316
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 5, 2021
University of Washington
Harvard University
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham

Brief Summary:
To determine the efficacy of an algorithm designed to recommend smoking cessation-related pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS.

Condition or disease Intervention/treatment Phase
HIV AIDS Smoking Cessation Drug: Algorithm Treatment Other: Quitline only Phase 4

Detailed Description:
Smoking remains the leading cause of preventable death and disability in the United States. Whereas smoking has declined significantly among individuals in the general population, it is clustered in populations of vulnerable individuals such as people living with HIV/AIDS (PLWH) in whom smoking prevalence rates and resulting comorbidity rates remain high. Medical advances in the treatment of HIV have resulted in substantial increases in life expectancy among PLWH and as a consequence PLWH smokers are now, more than ever, at heightened risk for tobacco-related illnesses and death. PLWH smokers engaged in treatment lose more years of life due to smoking now than to HIV disease. Although PLWH smokers engaged in HIV care typically see a medical provider every 4-6 months, smoking cessation treatment and referral is often not part of routine HIV care. While 94% of HIV treatment providers indicated that they would be willing to provide smoking cessation services to their patients, few have received training in how to provide smoking cessation services. With seven first line pharmacotherapies available for smoking cessation, development of algorithms to assist providers in selecting the most appropriate pharmacotherapy is an important but untested strategy to increase smoking cessation in PLWH. The purpose of this proposal is to conduct a mixed efficacy/effectiveness trial comparing an algorithm treatment with prescription cost off sets and quit line referral (AT) to an enhanced Treatment as Usual (quit line referral only; eTAU) group. Six hundred PLWH smokers will be recruited at the University of Alabama at Birmingham, University of Washington, and Fenway Health HIV clinics and will be randomized to receive AT or eTAU. All AT smokers will receive active treatment for twelve weeks regardless of stated motivation or intention to quit. eTAU smokers will be referred to quit line services and HIV providers may elect to treat smoking as part of standard of care. Participants will remain in the study for 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either the Algorithm Treatment plus referral to a quitline (AT) or the quitline alone condition (eTAU).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Algorithm Treatment plus referral to quitline (AT)
will be assigned a pharmacotherapy treatment regimen recommended to their provider.
Drug: Algorithm Treatment
Varenicline was selected as the first line of treatment for patients willing to take a medication twice per day and wanting cessation. Following varenicline, bupropion and then NRT are subsequent options. In terms of preference for NRT, nicotine patches would be the first option followed by lozenge, gum, inhaler, and nasal spray. The order of NRT within the algorithm is based upon patient familiarity and number of clinical trials supporting their use. Combination NRT (e.g., patch and lozenge) or adding NRT to varenicline or bupropion is offered to participants who have made an unsuccessful quit attempt with these medications in the past. If none of these medications are appropriate, then the participant is offered counseling only.

Active Comparator: Quitline (eTAU)
will be referred to quitlines, telephone-based tobacco cessation services.
Other: Quitline only
eTAU participants will complete the same algorithm questions but will not have this information sent to their provider, although their provider may elect to prescribe medication as part of standard of care. Participants will be referred to a quitline for behavioral support services for cessation.

Primary Outcome Measures :
  1. 7-day point-prevalence abstinence [ Time Frame: 6 months ]
    Number of cigarettes smoked over the past 7 days

Secondary Outcome Measures :
  1. Cigarettes per day [ Time Frame: 6 months ]
    Number of cigarettes reported being smoked per day

  2. 24 hour quit attempts [ Time Frame: 6 months ]
    Attempt to not smoke for 24 hours

  3. Number of prescriptions written [ Time Frame: 6 months ]
    The number of prescriptions written for a participant

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Enrollment in the CNICS clinical cohort.
  2. 18 years or older;
  3. Receiving HIV care at the UAB, UW or Fenway Health clinics and not anticipating changing clinics over the next six months
  4. Smoking greater than or equal to 5 cigarettes per day (cpd) for the past month
  5. Living in an unrestricted environment that allows smoking.

Exclusion Criteria:

  1. Cognitive impairment such that unable to provide informed consent;
  2. Non-English speaking;
  3. Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent;
  4. Currently receiving smoking cessation treatment.

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 identifier (NCT number): NCT03670316

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Contact: Karen L Cropsey, Psy.D. 2059757809
Contact: Keith Chichester, B.A. 2059757809

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United States, Alabama
University of Alabama, Birmingham Recruiting
Birmingham, Alabama, United States, 35209
Contact: Mariel Parman, MPH    205-996-6377   
Principal Investigator: Karen Cropsey, Psy.D.         
Sponsors and Collaborators
University of Alabama at Birmingham
University of Washington
Harvard University
Seger, J. C., Horn, D. B., Westman, E. C., Lindquist, R., Scinta, W., Richardson, L. A., ... & Bays, H. E. (2013). American Society of Bariatric Physicians Obesity Algorithm: Adult Adiposity Evaluation and Treatment 2013.
Fiore, M. C., C. R. Jaen, et al. (2008). Treating tobacco use and dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD, US Public Health Service.

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Responsible Party: Karen Cropsey, Professor, University of Alabama at Birmingham Identifier: NCT03670316    
Other Study ID Numbers: 300000632
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes