Phase 4
Completed N=323
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Tobacco Use Cessation
Source: ClinicalTrials.gov NCT04490057 ↗
Enrolled (actual)
323
Serious AEs
6.1%
Results posted
Nov 2025
Primary outcomePrimary: Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks — 5.2; 4.9 cigarettes per day
◆ Published Evidence
Established
27citations · ~5 / year
A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study.
Summary
Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH.
Linked Publications (2)
-
A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study.
-
Clinical Pharmacists, Medications, and Contingency Management for Targeting Smoking in HIV Clinics: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks |
5.2; 4.9 | — |
| PRIMARY Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks |
7.90; 6.23; 2.97; 10.92; 4.00; 4.20 | — |
| SECONDARY Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks |
16; 36 | — |
| SECONDARY Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks |
4; 6; 7; 23; 3; 8 | — |
| SECONDARY VACS Index 2.0 Score |
42.88; 47.26; 49.42; 42.65; 42.66; 43.63 | — |
| SECONDARY CD4 Count |
668.00; 576.53; 648.38; 640.57; 724.92; 696.97 | — |
| SECONDARY HIV Viral Load, Detectable |
0; 10; 14; 3; 5; 7 | — |
Eligibility Criteria
Inclusion Criteria
- HIV positive;
- >= 18 years old
- Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
- Have smoked >= 100 cigarettes in lifetime;
- Currently smokes some days or every day;
- Smokes, on average, >= 5 cigarettes per day;
- Able to provide written informed consent.
Exclusion Criteria
- Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);
- Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);
- Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
- Life-threatening or unstable medical, surgical, or psychiatric condition;
- Inability to provide at least one collateral contact (family member or friend);
- Living out of state;
- Unable to read or understand English (except at Mount Sinai site).
Data sourced from ClinicalTrials.gov (NCT04490057) and the linked publication. 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. Informational only — not medical advice.