Phase 4 N=371 Randomized Treatment

Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

HIV · AIDS · Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT03670316 ↗

Enrolled (actual)

371

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: 7-day Point-prevalence Abstinence — 16; 12; 110; 114 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Algorithm Treatment (Drug); Quitline only (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Jun 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY 7-day Point-prevalence Abstinence	16; 12; 110; 114	—
SECONDARY Cigarettes Per Day	9; 10	—
SECONDARY Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months	61; 72; 68; 61	—
SECONDARY Number of Prescriptions Written by 6-months	109; 33	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03670316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.