HIVPhase 4NCT03670316
Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
A Phase 4 study testing Algorithm Treatment and Quitline only in people with HIV and AIDS, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, AIDS, Smoking Cessation
- What is being tested?
- Algorithm Treatment and Quitline only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment in the CNICS clinical cohort.
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama, Birmingham
Birmingham, Alabama, 35209
About this study
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.
Read the 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
- Being tested
- Algorithm Treatment, Quitline only
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm TreatmentDrug
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 onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Algorithm Treatment plus referral to quitline (AT) | Experimental | will be assigned a pharmacotherapy treatment regimen recommended to their provider. Receives: Drug: Algorithm Treatment |
| Quitline (eTAU) | Active comparator | will be referred to quitlines, telephone-based tobacco cessation services. Receives: Other: Quitline only |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point-prevalence Abstinence
Self-report of cigarette smoking in the last 7 days
Measured: 6 months
Secondary outcomes (3)
Cigarettes Per Day
Number of cigarettes reported being smoked per day
Measured: 6 months
Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months
Attempt to not smoke for 24 hours
Measured: 6 months
Number of Prescriptions Written by 6-months
The count of participants who had a smoking cessation prescription written
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start17 Aug 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Harvard University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Karen Cropsey, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670316
- Sponsor's protocol ID
- 300000632
- Other IDs
- R01DA044112
- Status last verified
- Aug 2025
- First submitted
- 5 Sep 2018
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
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.
PubMed 19555861Nathan 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.
PubMed 18945920Hughes 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.
PubMed 23518288Hughes 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.
PubMed 17869475Bader 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.
PubMed 18845621Kunyk 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.
PubMed 25022640Fiore, M. C., C. R. Jaen, et al. (2008). Treating tobacco use and dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD, US Public Health Service.
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.
PubMed 22251785Schnoll 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.
PubMed 16905034Aveyard 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.
PubMed 22175545Carpenter 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.
PubMed 22123796Ingersoll 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.
PubMed 18066659Lloyd-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.
PubMed 19719796
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
- ClinicalTrials.gov ID
- NCT03670316
- Acronym / sponsor ID
- 300000632
- Conditions
- HIV, AIDS, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Washington, Harvard University, National Institute on Drug Abuse (NIDA)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the Algorithm Treatment plus referral to a quitline (AT) or the quitline alone condition (eTAU).
| Arm | Type | Receives |
|---|---|---|
| Algorithm Treatment plus referral to quitline (AT) | Experimental | Drug: Algorithm Treatmentwill be assigned a pharmacotherapy treatment regimen recommended to their provider. |
| Quitline (eTAU) | Active comparator | Other: Quitline onlywill be referred to quitlines, telephone-based tobacco cessation services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Enrollment in the CNICS clinical cohort.
- 18 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm TreatmentVarenicline 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. | Drug | Algorithm Treatment plus referral to quitline (AT) |
| Quitline onlyeTAU 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. | Other | Quitline (eTAU) |
Primary outcome
7-day Point-prevalence Abstinence
Time frame: 6 months
Self-report of cigarette smoking in the last 7 days
3 secondary outcomes
Cigarettes Per Day
Time frame: 6 months
Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months
Time frame: 6 months
Number of Prescriptions Written by 6-months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSeger, 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: PubMed 19555861Barst 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.
- Background: PubMed 18945920Nathan 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.
- Background: PubMed 23518288Hughes 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.
- Background: PubMed 17869475Hughes 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.
- Background: PubMed 18845621Bader 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.
- Background: PubMed 25022640Kunyk 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.
- BackgroundFiore, 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: PubMed 22251785Shuter 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.
- Background: PubMed 16905034Schnoll 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.
- Background: PubMed 22175545Aveyard 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.
- Background: PubMed 22123796Carpenter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Algorithm Treatment and Quitline only in people with HIV and AIDS, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Point-prevalence Abstinence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670316, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.