Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

HIV Clinical Trial

Official title:

Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670316
• Other study ID #: 300000632
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: Karen L Cropsey, Psy.D.
• Phone: 2059757809
• Email: kcropsey[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• HIV
• Smoking Cessation

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Harvard University, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (14)

Aveyard P, Begh R, Parsons A, West R. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance. Addiction. 2012 Jun;107(6):1066-73. doi: 10.1111/j.1360-0443.2011.03770.x. Epub 2012 Feb 28. — View Citation

Bader P, McDonald P, Selby P. An algorithm for tailoring pharmacotherapy for smoking cessation: results from a Delphi panel of international experts. Tob Control. 2009 Feb;18(1):34-42. doi: 10.1136/tc.2008.025635. Epub 2008 Oct 9. — View Citation

Barst RJ, Gibbs JSR, Ghofrani HA, Hoeper MM, McLaughlin VV, Rubin LJ, Sitbon O, Tapson VF, Galie N. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol. 2009 Jun 30;54(1 Suppl):S78-S84. doi: 10.1016/j.jacc.2009.04.017. — View Citation

Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011 Nov 28;171(21):1901-7. doi: 10.1001/archinternmed.2011.492. — View Citation

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.

Hughes J. An algorithm for choosing among smoking cessation treatments. J Subst Abuse Treat. 2008 Jun;34(4):426-32. doi: 10.1016/j.jsat.2007.07.007. Epub 2007 Sep 14. — View Citation

Hughes JR. An updated algorithm for choosing among smoking cessation treatments. J Subst Abuse Treat. 2013 Aug;45(2):215-21. doi: 10.1016/j.jsat.2013.01.011. Epub 2013 Mar 19. — View Citation

Ingersoll KS, Cropsey KL, Heckman CJ. A test of motivational plus nicotine replacement interventions for HIV positive smokers. AIDS Behav. 2009 Jun;13(3):545-54. doi: 10.1007/s10461-007-9334-4. Epub 2007 Dec 8. — View Citation

Kunyk D, Els C, Papadakis S, Selby P. Tobacco use disorder treatment in primary care: implementing a clinical system pathway in Alberta. Can Fam Physician. 2014 Jul;60(7):646-55. — View Citation

Lloyd-Richardson EE, Stanton CA, Papandonatos GD, Shadel WG, Stein M, Tashima K, Flanigan T, Morrow K, Neighbors C, Niaura R. Motivation and patch treatment for HIV+ smokers: a randomized controlled trial. Addiction. 2009 Nov;104(11):1891-900. doi: 10.1111/j.1360-0443.2009.02623.x. Epub 2009 Aug 28. — View Citation

Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22. — View Citation

Schnoll RA, Rukstalis M, Wileyto EP, Shields AE. Smoking cessation treatment by primary care physicians: An update and call for training. Am J Prev Med. 2006 Sep;31(3):233-9. doi: 10.1016/j.amepre.2006.05.001. Epub 2006 Jul 24. — View Citation

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.

Shuter J, Bernstein SL, Moadel AB. Cigarette smoking behaviors and beliefs in persons living with HIV/AIDS. Am J Health Behav. 2012 Jan;36(1):75-85. doi: 10.5993/ajhb.36.1.8. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point-prevalence abstinence	Number of cigarettes smoked over the past 7 days	6 months
Secondary	Cigarettes per day	Number of cigarettes reported being smoked per day	6 months
Secondary	24 hour quit attempts	Attempt to not smoke for 24 hours	6 months
Secondary	Number of prescriptions written	The number of prescriptions written for a participant	6 months