Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

NCT03670316 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 300000632R01DA044112
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; AIDS; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 7-day Point-prevalence Abstinence

  Self-report of cigarette smoking in the last 7 days

  6 months

Secondary Outcomes (3)

• Cigarettes Per Day

  6 months

• Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months

  6 months

• Number of Prescriptions Written by 6-months

  6 months

Study Arms (2)

Algorithm Treatment plus referral to quitline (AT)

EXPERIMENTAL

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

Drug: Algorithm Treatment

Quitline (eTAU)

ACTIVE COMPARATOR

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

Other: Quitline only

Interventions

Algorithm Treatment 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.

Algorithm Treatment plus referral to quitline (AT)

Quitline only 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.

Quitline (eTAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Washington: collaborator
• Harvard University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Alabama, Birmingham

Birmingham, Alabama, 35209, United States

Location

Related Publications (14)

• 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.

  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.

  PMID: 19555861 BACKGROUND

• 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.

  PMID: 18945920 BACKGROUND

• 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.

  PMID: 23518288 BACKGROUND

• 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.

  PMID: 17869475 BACKGROUND

• 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.

  PMID: 18845621 BACKGROUND

• 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.

  PMID: 25022640 BACKGROUND

• 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.

  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.

  PMID: 22251785 BACKGROUND

• 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.

  PMID: 16905034 BACKGROUND

• 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.

  PMID: 22175545 BACKGROUND

• 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.

  PMID: 22123796 BACKGROUND

• 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.

  PMID: 18066659 BACKGROUND

• 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.

  PMID: 19719796 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Smoking Cessation

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Karen Cropsey
• Organization: University of Alabama at Birmingham

kcropsey@uab.edu

205-975-4204

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to either the Algorithm Treatment plus referral to a quitline (AT) or the quitline alone condition (eTAU).

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 13, 2018
• Study Start: August 17, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2025-08

Locations

US (1)