Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

NCT ID: NCT03670316

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-17
• Study Completion Date: 2025-06-30

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.

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.

Conditions

HIV; AIDS; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Algorithm Treatment plus referral to quitline (AT)

will be assigned a pharmacotherapy treatment regimen recommended to their provider.

Group Type: EXPERIMENTAL

Algorithm Treatment

Intervention Type: DRUG

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.

Quitline (eTAU)

will be referred to quitlines, telephone-based tobacco cessation services.

Group Type: ACTIVE_COMPARATOR

Quitline only

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Karen Cropsey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama, Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19555861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18945920 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23518288 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17869475 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18845621 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25022640 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 22251785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16905034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22175545 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22123796 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18066659 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19719796 (View on PubMed)

Other Identifiers

R01DA044112

Identifier Type: NIH

Identifier Source: secondary_id

View Link

300000632

Identifier Type: -

Identifier Source: org_study_id