Clinical trial NCT03670316: Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
Official title: Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HIV
AIDS
Smoking Cessation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Harvard University
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-09-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the Algorithm Treatment plus referral to a quitline (AT) or the quitline alone condition (eTAU).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 7-day point-prevalence abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Cigarettes per day
timeFrame: 6 months
measure: 24 hour quit attempts
timeFrame: 6 months
measure: Number of prescriptions written
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
Study officials:
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