Trial Outcomes & Findings for Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV (NCT NCT04505371)
NCT ID: NCT04505371
Last Updated: 2026-08-31
Results Overview
Self-reported smoking abstinence at 6-month follow-up. To assess disconfirmation rates, abstinence will be biochemically confirmed via saliva cotinine among a random subset of people reporting tobacco abstinence. In this subset, abstinence will be defined by a negative reading on the Alere iScreen saliva dipstick, which uses a cut-point of \<30 ng/ml cotinine to indicate no nicotine exposure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
235 participants
Primary outcome timeframe
6 months post-randomization
Results posted on
2026-08-31
Participant Flow
One participant fully withdrew from study participation/follow-up.
Participant milestones
| Measure |
Control - Standard Care
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
|
Intervention - Wellness Intervention for Smokers With HIV
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Wellness Intervention for Smokers with HIV: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
119
|
|
Overall Study
COMPLETED
|
116
|
118
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control - Standard Care
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
|
Intervention - Wellness Intervention for Smokers With HIV
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Wellness Intervention for Smokers with HIV: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV
Baseline characteristics by cohort
| Measure |
Control - Standard Care
n=116 Participants
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
|
Intervention - Wellness Intervention for Smokers With HIV
n=118 Participants
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Wellness Intervention for Smokers with HIV: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=14 Participants
|
88 Participants
n=36 Participants
|
171 Participants
n=324 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=14 Participants
|
30 Participants
n=36 Participants
|
63 Participants
n=324 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 12 • n=14 Participants
|
54 years
STANDARD_DEVIATION 12 • n=36 Participants
|
55 years
STANDARD_DEVIATION 12 • n=324 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
11 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=14 Participants
|
112 Participants
n=36 Participants
|
223 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=14 Participants
|
52 Participants
n=36 Participants
|
105 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=14 Participants
|
43 Participants
n=36 Participants
|
93 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=14 Participants
|
15 Participants
n=36 Participants
|
22 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=14 Participants
|
5 Participants
n=36 Participants
|
9 Participants
n=324 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=14 Participants
|
118 participants
n=36 Participants
|
234 participants
n=324 Participants
|
PRIMARY outcome
Timeframe: 6 months post-randomizationSelf-reported smoking abstinence at 6-month follow-up. To assess disconfirmation rates, abstinence will be biochemically confirmed via saliva cotinine among a random subset of people reporting tobacco abstinence. In this subset, abstinence will be defined by a negative reading on the Alere iScreen saliva dipstick, which uses a cut-point of \<30 ng/ml cotinine to indicate no nicotine exposure.
Outcome measures
| Measure |
Control - Standard Care
n=116 Participants
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
|
Intervention - Wellness Intervention for Smokers With HIV
n=118 Participants
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Wellness Intervention for Smokers with HIV: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
|
|---|---|---|
|
7-day Point-prevalence Abstinence (PPA)
|
8.6 Percentage of participants
|
25.4 Percentage of participants
|
PRIMARY outcome
Timeframe: 6 months post-randomizationThe primary outcome will be presence of an intentional quit attempt \[yes/no\] reported between randomization and 6 month follow-up. Quit attempts will be assessed at each follow-up.
Outcome measures
| Measure |
Control - Standard Care
n=116 Participants
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
|
Intervention - Wellness Intervention for Smokers With HIV
n=118 Participants
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Wellness Intervention for Smokers with HIV: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
|
|---|---|---|
|
Any 24-hour Intentional Quit Attempt
|
56 Percent of participants
|
70 Percent of participants
|
SECONDARY outcome
Timeframe: 3 and 6 months post-randomizationA proxy for sustained abstinence appropriate for evaluating a motivational intervention, in which the start point floats based on one's actual quit date rather than a pre-determined quit date
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomizationSelf-report of abstinence from smoking, even a puff
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3, 6, 12 months post-randomizationSelf-report of abstinence from smoking, even a puff
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomizationSelf-report; even a puff counts as smoking
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomizationItems validated in a survey of Smokers Living with HIV conducted by the study team during a study titled "Smoking cessation-related information, motivation, and behavioral skills specific to HIV-infected smokers" (likert scale)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomization1-10 likert scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomization1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomizationSelf-report Minnesota Smoking Withdrawal Scale, Revised
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomizationSelf-report and health records (pharmacy) monitoring
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 months post-randomizationLab value of CD4 ascertained via EHR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 months post-randomizationComposite score based of various lab values ascertained via EHR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months post-randomizationBehavioral Risk Factor Surveillance System (BRFSS)
Outcome measures
Outcome data not reported
Adverse Events
Control - Standard Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Intervention - Wellness Intervention for Smokers With HIV
Serious events: 7 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Control - Standard Care
n=116 participants at risk
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
|
Intervention - Wellness Intervention for Smokers With HIV
n=118 participants at risk
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Wellness Intervention for Smokers with HIV: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
|
|---|---|---|
|
General disorders
Hospitalization for GI and hip pain
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
|
General disorders
Hospitalization for sepsis and respiratory failure
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
|
General disorders
Hospitalization for depression and suicidal ideation
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
|
General disorders
Hospitalization (not specifed)
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
|
General disorders
Death (cause not specified)
|
0.86%
1/116 • Number of events 1 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
|
General disorders
Death (terminal illness, cause of death not specified)
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
|
General disorders
Death (GI bleed from alcohol related cirrhosis)
|
0.86%
1/116 • Number of events 1 • Six months following randomization.
|
0.00%
0/118 • Six months following randomization.
|
|
General disorders
Death (suicide)
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
Other adverse events
| Measure |
Control - Standard Care
n=116 participants at risk
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
|
Intervention - Wellness Intervention for Smokers With HIV
n=118 participants at risk
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Wellness Intervention for Smokers with HIV: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
|
|---|---|---|
|
General disorders
ED visit for gallbladder pain and bronchitis
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 Diagnosis
|
0.00%
0/116 • Six months following randomization.
|
0.85%
1/118 • Number of events 1 • Six months following randomization.
|
Additional Information
Dr. Kristina Crothers
VA Puget Sound Health Care System
Phone: (206) 277-3013
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place