A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Official Title
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Acronym
SMARTTT
Organization
Yale UniversityOTHER
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 27, 2020Actual
Primary Completion Date
Oct 24, 2024Actual
Completion Date
Oct 24, 2025Actual
First Submitted Date
Jul 22, 2020
First Submission Date that Met QC Criteria
Jul 25, 2020
First Posted Date
Jul 28, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Oct 15, 2025
Results First Submitted that Met QC Criteria
Nov 14, 2025
Results First Posted Date
Nov 28, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 11, 2025
Last Update Posted Date
Jan 5, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Yale UniversityOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 320 adult PWH who smoke cigarettes and receive care in one of three health systems (targeted enrollment changed from 632 to 320 with NCI approval and IRB protocol amendment). At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM). At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide [eCO] or collateral verification) in both arms will receive 12 more weeks of the same treatment. Non-responders (participants with continued smoking by self-report and/or eCO) in both the NRT and NRT+CM arms will be re-randomized to 12 weeks of treatment, either with medication switch to oral medication, varenicline or bupropion, or intensified level of CM (start CM if no CM during first 12 weeks, or CM with higher reward schedule ["CM plus"] if NRT+CM group initially). The intervention will be delivered by trained clinical pharmacists. The primary outcomes will be self-reported reduction in average cigarettes smoked per day at 24 weeks and 12 weeks (primary outcome changed from eCO-confirmed abstinence to self-reported abstinence with NCI approval and IRB protocol amendment). The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote reduced tobacco use (changed from eCO-confirmed smoking abstinence with NCI approval and protocol amendment) (2) study the effectiveness of various adaptive strategies on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) grounded in implementation science and using aHybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.
Conditions Module
Conditions
Tobacco Use Cessation
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
323Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
12 wks NRT+CM / 12 wks NRT+CM
Experimental
Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.
Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.
Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.
Edelman EJ, Deng Y, Dziura J, Nahum-Shani I, Weiss JM, Aoun-Barakat L, Bold KW, Harsono D, Mistler C, Payne E, Aiudi S, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. Clinical Pharmacists, Medications, and Contingency Management for Targeting Smoking in HIV Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2560593. doi: 10.1001/jamanetworkopen.2025.60593.
Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2021 Nov;110:106379. doi: 10.1016/j.cct.2021.106379. Epub 2021 Mar 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Participants were consented, completed baseline and randomized to one of 2 arms in Stage 1: nicotine replacement therapy (NRT) or NRT+ CM (contingency management). At week 12, participants who were abstinent remained in their original arm. Participants who were not abstinent were re-randomized. If NRT in Stage 1, re-randomized to NRT+CM or varenicline (VAR). If NRT+CM Stage 1, re-randomized to NRT+CM intensified or VAR+CM.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1: NRT
Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12
FG001
Stage 1: NRT+CM
Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)
Periods
Title
Milestones
Reasons Not Completed
Stage 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 22, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Sequential multiple assignment randomized trial
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.
Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).
12 wks NRT+CM/ 12 wks VAR or bupropion+CM
12 wks NRT/ 12 wks VAR or bupropion
Contingency Management
Behavioral
Participants will be financially rewarded for abstinence to tobacco.
12 wks NRT+CM / 12 wks NRT+CM
12 wks NRT+CM/ 12 wks VAR or bupropion+CM
12 wks NRT+CM/12 wks NRT+CM plus
12 wks NRT/ 12 wks NRT+CM
Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification
24 weeks from baseline
VACS Index 2.0 Score
The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.
24 weeks from baseline
CD4 Count
CD4 lymphocyte cell count. Normal range is 500-1200 cells per cubic millimeter. As HIV infection progresses, CD4 count drops.
24 weeks from baseline
HIV Viral Load, Detectable
HIV viral load greater than 200 copies per milliliter of blood and detectable on standard lab test
24 weeks from baseline
New Haven
Connecticut
06510
United States
SUNY Downstate STAR Clinic
Brooklyn
New York
11203
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10029
United States
FG002
Stage 2: NRT Responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
FG003
Stage 2: Varenicline or Bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
FG004
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
FG005
Stage 2: NRT+CM Responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
FG006
Stage 2: Varenicline or Bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
FG007
Stage 2: NRT+CM Plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
FG000163 subjects
FG001160 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG000160 subjects
FG001158 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00216 subjects
FG00370 subjects
FG00474 subjects
FG00536 subjects
FG00660 subjects
FG00762 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00216 subjects
FG00359 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00311 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Includes all participants who started Stage 1
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1: Nicotine Replacement Only (NRT)
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000163
BG001160
BG002323
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Age in years
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000163
ParticipantsBG001160
ParticipantsBG002323
Title
Measurements
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000163
ParticipantsBG001160
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000163
ParticipantsBG001160
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000163
ParticipantsBG001160
ParticipantsBG002
Region of Enrollment
Number
Participants
Title
Denominators
Categories
United States
ParticipantsBG000163
ParticipantsBG001160
ParticipantsBG002
Cigarettes per day
Number of cigarettes smoked per day
Median
Inter-Quartile Range
cigarettes per day
Title
Denominators
Categories
ParticipantsBG000163
ParticipantsBG001160
ParticipantsBG002
Exhaled carbon monoxide at baseline
exhaled carbon monoxide at baseline, measured in parts per million (ppm)
eCO was not collected for 5 participants at baseline due to staff error.
Median
Inter-Quartile Range
parts per million (ppm)
Title
Denominators
Categories
ParticipantsBG000159
ParticipantsBG001159
ParticipantsBG002
VACS 2.0 score
The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.
8 participants were missing a lab value required to calculate VACS 2.0
Median
Inter-Quartile Range
score on a scale
Title
Denominators
Categories
ParticipantsBG000159
ParticipantsBG001156
Participants
HIV viral load, detectable
HIV viral load greater than 200 copies per milliliter of blood and detectable on standard lab test
HIV viral load was not available at baseline for 3 participants
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000162
ParticipantsBG001158
ParticipantsBG002
CD4 cell count
CD4 lymphocyte cell count. Normal range is 500-1200 cells per cubic millimeter. As HIV infection progresses, CD4 count drops.
CD4 count was not available for 1 participant at baseline
Median
Inter-Quartile Range
cells per cubic millimeter
Title
Denominators
Categories
ParticipantsBG000162
ParticipantsBG001160
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks
Self reported reduction in average cigarettes smoked per day at 12 weeks
Posted
Least Squares Mean
97.5% Confidence Interval
cigarettes per day
Week 12
ID
Title
Description
OG000
Stage 1: Nicotine Replacement only (NRT)
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
Units
Counts
Participants
OG000163
OG001160
Title
Denominators
Categories
Title
Measurements
OG0005.2(3.9 to 6.5)
OG0014.9(3.5 to 6.2)
Primary
Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks
Self reported reduction in cigarettes smoked per day at 24 weeks
Posted
Least Squares Mean
99% Confidence Interval
cigarettes per day
24 weeks
ID
Title
Description
OG000
Stage 2: NRT responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
OG001
Stage 2: varenicline or bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
OG002
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
OG003
Stage 2: NRT+CM responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
OG004
Stage 2: varenicline or bupropion + CM
Secondary
Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks
Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification
Posted
Count of Participants
Participants
12 weeks from baseline
ID
Title
Description
OG000
Stage 1: Nicotine Replacement only (NRT)
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
Units
Counts
Participants
OG000
Secondary
Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks
Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification
Posted
Count of Participants
Participants
24 weeks from baseline
ID
Title
Description
OG000
Stage 2: NRT responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
OG001
Stage 2: varenicline or bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
OG002
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
OG003
Stage 2: NRT+CM responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
OG004
Secondary
VACS Index 2.0 Score
The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.
Lab results were collected for all participants at Week 24 including those who did not complete the Week 24 assessment battery.
Posted
Mean
Standard Deviation
score on a scale
24 weeks from baseline
ID
Title
Description
OG000
Stage 2: NRT responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
OG001
Stage 2: varenicline or bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
OG002
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
OG003
Stage 2: NRT+CM responders
Secondary
CD4 Count
CD4 lymphocyte cell count. Normal range is 500-1200 cells per cubic millimeter. As HIV infection progresses, CD4 count drops.
Lab results were collected for all participants at Week 24 including those who did not complete the Week 24 assessment battery.
Posted
Mean
Standard Deviation
Cells per cubic millimeter
24 weeks from baseline
ID
Title
Description
OG000
Stage 2: NRT responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
OG001
Stage 2: varenicline or bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
OG002
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
OG003
Stage 2: NRT+CM responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
Secondary
HIV Viral Load, Detectable
HIV viral load greater than 200 copies per milliliter of blood and detectable on standard lab test
Lab results were collected for all participants at Week 24 including those who did not complete the Week 24 assessment battery.
Posted
Count of Participants
Participants
24 weeks from baseline
ID
Title
Description
OG000
Stage 2: NRT responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
OG001
Stage 2: varenicline or bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
OG002
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
OG003
Stage 2: NRT+CM responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
Time Frame
Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage 1: NRT
Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12
1
163
13
163
6
163
EG001
Stage 1: NRT+CM
Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)
2
160
9
160
14
160
EG002
Stage 2: NRT Responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
0
16
1
16
0
16
EG003
Stage 2: Varenicline or Bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
0
70
5
70
2
70
EG004
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
1
74
4
74
0
74
EG005
Stage 2: NRT+CM Responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
0
36
1
36
1
36
EG006
Stage 2: Varenicline or Bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
0
60
3
60
3
60
EG007
Stage 2: NRT+CM Plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
Anticipated side effects of nicotine replacement therapy: sleep disturbances, jittery/shaking, etc.
EG0001 events1 affected163 at risk
EG0016 events6 affected160 at risk
EG0020 events0 affected16 at risk
EG003
Urinary Tract Infection
Renal and urinary disorders
Non-systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected160 at risk
EG0020 events0 affected16 at risk
EG003
Psychiatric issues
Psychiatric disorders
Non-systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected160 at risk
EG0020 events0 affected16 at risk
EG003
1. The COVID-19 pandemic delayed enrollment leading to a reduction in sample size and change in endpoint to reduction in # of cigarettes/day. Due to these changes, we may have been underpowered to detect improved abstinence in Stage 2. 2. Participants were given prescriptions for medication, not actual medication and we observed access issues. 3. The study was conducted in urban HIV clinics in the Northeast US which may limit generalizability.
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
OG005
Stage 2: NRT+CM plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
Units
Counts
Participants
OG00016
OG00159
OG00256
OG00332
OG00439
OG00548
Title
Denominators
Categories
Title
Measurements
OG0007.90(4.355 to 11.44)
OG0016.23(4.45 to 8.02)
OG0022.97(1.50 to 4.44)
OG00310.92(8.40 to 13.43)
OG0044.00(2.48 to 5.52)
OG0054.20(2.60 to 5.80)
163
OG001160
Title
Denominators
Categories
Title
Measurements
OG00016(3.3 to 18.7)
OG00136(9.8 to 36.8)
Stage 2: varenicline or bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
OG005
Stage 2: NRT+CM plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
Units
Counts
Participants
OG00016
OG00159
OG00256
OG00332
OG00439
OG00548
Title
Denominators
Categories
Title
Measurements
OG0004(4.55 to 59.91)
OG0016(4.58 to 32.82)
OG0027(6.43 to 32.21)
OG00323(47.77 to 89.36)
OG0043(11.58 to 48.44)
OG0058(15.61 to 53.04)
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
OG004
Stage 2: varenicline or bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
OG005
Stage 2: NRT+CM plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
Units
Counts
Participants
OG00016
OG00170
OG00269
OG00334
OG00459
OG00560
Title
Denominators
Categories
Title
Measurements
OG00042.88± 15.09
OG00147.26± 17.61
OG00249.42± 19.61
OG00342.65± 15.38
OG00442.66± 15.66
OG00543.63± 15.70
OG004
Stage 2: varenicline or bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
OG005
Stage 2: NRT+CM plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
Units
Counts
Participants
OG00016
OG00170
OG00269
OG00335
OG00459
OG00560
Title
Denominators
Categories
Title
Measurements
OG000668.00± 384.08
OG001576.53± 347.76
OG002648.38± 423.08
OG003640.57± 370.12
OG004724.92± 521.86
OG005696.97± 421.36
OG004
Stage 2: varenicline or bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
OG005
Stage 2: NRT+CM plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).