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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA044112 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Harvard University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Algorithm Treatment plus referral to quitline (AT) | Experimental | will be assigned a pharmacotherapy treatment regimen recommended to their provider. |
|
| Quitline (eTAU) | Active Comparator | will be referred to quitlines, telephone-based tobacco cessation services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point-prevalence Abstinence | Self-report of cigarette smoking in the last 7 days | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes Per Day | Number of cigarettes reported being smoked per day | 6 months |
| Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months | Attempt to not smoke for 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 19555861 | 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. | |
| 18945920 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Algorithm Treatment (AT) | Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits. |
| FG001 | Enhanced Treatment as Usual (eTAU) | Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Region of Enrollment: Alabama, Massachusetts, and Washington state.
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| ID | Title | Description |
|---|---|---|
| BG000 | Algorithm Treatment (AT) | Algorithm Treatment: The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Point-prevalence Abstinence | Self-report of cigarette smoking in the last 7 days | 118 missing | Posted | Count of Participants | Participants | 6 months |
|
Adverse event data were collected from the time a participant provided informed consent and was randomized in the study through ~ 10 months post-randomization.
We collected systematic information on serious adverse events via a study collection form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Treatment as Usual (eTAU) | Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal distress | Gastrointestinal disorders | Non-systematic Assessment | Self report of medication side effects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Cropsey | University of Alabama at Birmingham | 205-975-4204 | kcropsey@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2025 | Mar 20, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2024 | Feb 6, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Participants will be randomized to either the Algorithm Treatment plus referral to a quitline (AT) or the quitline alone condition (eTAU).
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|
| 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. |
|
| 6 months |
| Number of Prescriptions Written by 6-months | The count of participants who had a smoking cessation prescription written | 6 months |
| 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. |
| 23518288 | 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. |
| 17869475 | 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. |
| 18845621 | 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. |
| 25022640 | 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. |
| 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. |
| 22251785 | 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. |
| 16905034 | 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. |
| 22175545 | 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. |
| 22123796 | 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. |
| 18066659 | 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. |
| 19719796 | 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. |
| BG001 | Enhanced Treatment as Usual (eTAU) | Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Enhanced Treatment as Usual (eTAU) | Participants in the enhanced treatment as usual group will complete a survey with questions designed to inform the algorithm, but the results of the algorithm will not be sent to their medical provider. Independent of the study, a medical provider may elect to prescribe smoking cessation pharmacotherapy as part of standard of care. All participants will receive a brief handout on behavioral strategies and tips for smoking cessation, and will also be referred to the national quit line. |
|
|
| Secondary | Cigarettes Per Day | Number of cigarettes reported being smoked per day | Posted | Median | Inter-Quartile Range | Cigarettes per day | 6 months |
|
|
|
| Secondary | Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months | Attempt to not smoke for 24 hours | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Number of Prescriptions Written by 6-months | The count of participants who had a smoking cessation prescription written | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 4 |
| 186 |
| 0 |
| 186 |
| 0 |
| 186 |
| EG001 | Algorithm Treatment (AT) | The intervention is an algorithm-guided smoking cessation treatment recommendation sent to the medical provider, based on participants responses to enrollment survey questions. All participants will complete a survey with questions designed to inform the algorithm, but only those randomized to the AT condition will have their algorithm results sent to their medical provider. The algorithm is structured so that participants who report current motivation to quit smoking will be prescribed varenicline (if no contraindications), bupropion, or a combination of bupropion and nicotine replacement therapy (NRT). Those who do not report current motivation to quit smoking will still be recommended NRT, with dosing based on past quit attempts and current smoking habits. | 3 | 184 | 0 | 184 | 5 | 184 |
|
| Unspecified side effects of medication | General disorders | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |