Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
NCT03670316 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 371
Last updated 2026-05-22
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
Interventions
- DRUG
-
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.
- OTHER
-
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.
Sponsors & Collaborators
- collaborator OTHER
- collaborator OTHER
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
University of Alabama at Birmingham
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-17
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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