An interventional study of Wellness Intervention for Smokers with HIV in HIV Infections, Smoking and Smoking Cessation, sponsored by Seattle Institute for Biomedical and Clinical Research. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Seattle Institute for Biomedical and Clinical Research · Not applicable, Interventional, and Treatment
This project will compare the effectiveness of an HIV-specific comprehensive wellness intervention designed to have broad appeal to smokers living with HIV to the effectiveness of standard care services that include referral to the National VA Quitline and SmokefreeVET texting program. Participants in both arms will have access to pharmacotherapy available through their Veterans Affairs (VA) healthcare providers.
Tobacco use remains the leading preventable cause of death and illness in our society, and smoking rates are disproportionately high among people living with HIV. NCI, nicotine dependence researchers, and HIV clinicians have all called for research to evaluate targeted and tailored smoking cessation programs for smokers living with HIV (SLWH). Research suggests SLWH are largely unaware of the HIV-specific deleterious effects of smoking and often lack motivation and confidence in their ability to quit. For these reasons, we developed the Wellness Intervention for Smokers with HIV (WISH).
Similar to standard care cessation services available to Veterans, WISH is delivered remotely by mobile phone (voice and text message). The program is designed for all SLWH, regardless of their initial motivation to quit. WISH follows evidence-based, best practice guidelines for nicotine dependence treatment, but is innovative in its use of a more comprehensive wellness approach. That is, the intervention 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 SLWH, 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, allowing use of these standard services to be compared across study groups.
In this two-group randomized trial, we will compare the effectiveness of WISH to standard care services offered through the National VA Quitline and the SmokefreeVET texting program (tobacco cessation services available to all Veterans). Participants in both study groups can receive phone/ text counseling and have access to pharmacotherapy through VA. Cessation services in both study groups will be provided and overseen by the non-VA sites that developed each program.
Smoking-related outcomes will include 7-day point prevalence smoking abstinence and presence of any 24-hour intentional quit attempts, prolonged abstinence, and change in cigarettes per day. We will measure change in smoking-related knowledge, motivation and behavioral skills, as well as intervention reach and implementation. We will also describe comorbidities and explore intervention impact on markers of immune status and mortality risk using clinical data resources available through the Veterans Aging Cohort Study (VACS).
If effective, WISH could meaningfully increase the reach of cessation services and reduce smoking among HIV+ Veterans nationwide. To support this goal, dissemination efforts are planned in Year 5 to share the WISH program with the National VA Quitline. Because VA is the largest U.S. provider of HIV care, this research has the potential for significant public health impact.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 235 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Seattle Institute for Biomedical and Clinical Research is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Behavioral: 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)
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.
Time frame: 6 months post-randomization
Any 24-hour Intentional Quit Attempt
The 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.
Time frame: 6 months post-randomization
Floating Prolonged Abstinence
A 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
Time frame: 3 and 6 months post-randomization
7-day Self-report Point-prevalence Abstinence (PPA)
Self-report of abstinence from smoking, even a puff
Time frame: 3 and 6 months post-randomization
30-day Self-report Point-prevalence Abstinence (PPA)
Self-report of abstinence from smoking, even a puff
Time frame: 3, 6, 12 months post-randomization
Cigarettes Smoked Per Day
Self-report; even a puff counts as smoking
Time frame: 3 and 6 months post-randomization
HIV-specific Smoking Knowledge
Items 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)
Time frame: 3 and 6 months post-randomization
Motivation to Quit Smoking
1-10 likert scale
Time frame: 3 and 6 months post-randomization
Smoking Cessation Related to Self-efficacy
1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control
Time frame: 3 and 6 months post-randomization
Nicotine Withdrawal Symptom Management (Behavioral Skills)
Self-report Minnesota Smoking Withdrawal Scale, Revised
Time frame: 3 and 6 months post-randomization
Cessation Medication Use and Adherence (Behavioral Skills)
Self-report and health records (pharmacy) monitoring
Time frame: 3 and 6 months post-randomization
Absolute CD4 Count
Lab value of CD4 ascertained via EHR
Time frame: 6 and 12 months post-randomization
VACS Index 2.0
Composite score based of various lab values ascertained via EHR
Time frame: 6 and 12 months post-randomization
Intentional Quit Attempt Frequency and Duration
Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: 3 and 6 months post-randomization
| Milestone | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV |
|---|---|---|
| Started | 116 | 119 |
| Completed | 116 | 118 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Percentage of participants | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV |
|---|---|---|
| 7-day Point-prevalence Abstinence (PPA) | 8.6 | 25.4 |
The 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.
| Percent of participants | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV |
|---|---|---|
| Any 24-hour Intentional Quit Attempt | 56 | 70 |
A 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
Results for this outcome have not been posted.
Self-report of abstinence from smoking, even a puff
Results for this outcome have not been posted.
Self-report of abstinence from smoking, even a puff
Results for this outcome have not been posted.
Self-report; even a puff counts as smoking
Results for this outcome have not been posted.
Items 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)
Results for this outcome have not been posted.
1-10 likert scale
Results for this outcome have not been posted.
1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control
Results for this outcome have not been posted.
Self-report Minnesota Smoking Withdrawal Scale, Revised
Results for this outcome have not been posted.
Self-report and health records (pharmacy) monitoring
Results for this outcome have not been posted.
Lab value of CD4 ascertained via EHR
Results for this outcome have not been posted.
Composite score based of various lab values ascertained via EHR
Results for this outcome have not been posted.
Behavioral Risk Factor Surveillance System (BRFSS)
Results for this outcome have not been posted.
Collected over Six months following randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control - Standard Care | 2/116 (1.7%) | 2/116 (1.7%) | 0/116 (0%) |
| Intervention - Wellness Intervention for Smokers With HIV | 3/118 (2.5%) | 7/118 (5.9%) | 2/118 (1.7%) |
| Event | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV |
|---|---|---|
| Death (cause not specified)General disorders | 1/116 | 1/118 |
| Death (GI bleed from alcohol related cirrhosis)General disorders | 1/116 | 0/118 |
| Hospitalization for GI and hip painGeneral disorders | 0/116 | 1/118 |
| Hospitalization for sepsis and respiratory failureGeneral disorders | 0/116 | 1/118 |
| Hospitalization for depression and suicidal ideationGeneral disorders | 0/116 | 1/118 |
| Hospitalization (not specifed)General disorders | 0/116 | 1/118 |
| Death (terminal illness, cause of death not specified)General disorders | 0/116 | 1/118 |
| Death (suicide)General disorders | 0/116 | 1/118 |
| Event | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV |
|---|---|---|
| ED visit for gallbladder pain and bronchitisGeneral disorders | 0/116 | 1/118 |
| COVID-19 DiagnosisRespiratory, thoracic and mediastinal disorders | 0/116 | 1/118 |
| Age, Categorical(Participants) | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 83 | 88 | 171 |
| >=65 years | 33 | 30 | 63 |
| Age, Continuous(years) | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV | Total |
|---|---|---|---|
| Mean | 55 ± 12 | 54 ± 12 | 55 ± 12 |
| Sex: Female, Male(Participants) | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 111 | 112 | 223 |
| Race (NIH/OMB)(Participants) | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 53 | 52 | 105 |
| White | 50 | 43 | 93 |
| More than one race | 7 | 15 | 22 |
| Unknown or Not Reported | 4 | 5 | 9 |
| Region of Enrollment(participants) | Control - Standard Care | Intervention - Wellness Intervention for Smokers With HIV | Total |
|---|---|---|---|
| United States | 116 | 118 | 234 |
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