HIV InfectionsWISHNCT04505371
Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV
A study testing Wellness Intervention for Smokers with HIV in people with HIV Infections and Smoking, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Smoking, Smoking Cessation
- What is being tested?
- Wellness Intervention for Smokers with HIV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2021to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In care in the VA
- HIV+ serostatus
- Currently smoking 5+ cigarettes daily
- Access to cell phone with text messaging capabilities
- English speaking
Who cannot join
- Psychosis, dementia or significant cognitive impairment documented in the EHR
- Documented or observed hearing or comprehension difficulties that would preclude participation in study telephone calls
- Currently receiving cessation counseling or using an FDA approved treatment to quit smoking
- Institutionalized/imprisoned
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division
Seattle, Washington, 98108
About this study
Official title: Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV
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.
Read the detailed description
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.
- Conditions
- HIV Infections, Smoking, Smoking Cessation
- Being tested
- Wellness Intervention for Smokers with HIV
- Keywords
- HIV, Smoking, Smoking Cessation, Behavioral Intervention, Remote Intervention, Motivational Interviewing, Veterans
- Medical subject headings
- HIV Infections, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Intervention for Smokers with HIVBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard Care | No intervention | 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 | Experimental | The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit. Receives: Behavioral: Wellness Intervention for Smokers with HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months post-randomization
Secondary outcomes (12)
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
Measured: 3 and 6 months post-randomization
7-day Self-report Point-prevalence Abstinence (PPA)
Self-report of abstinence from smoking, even a puff
Measured: 3 and 6 months post-randomization
30-day Self-report Point-prevalence Abstinence (PPA)
Self-report of abstinence from smoking, even a puff
Measured: 3, 6, 12 months post-randomization
Cigarettes Smoked Per Day
Self-report; even a puff counts as smoking
Measured: 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)
Measured: 3 and 6 months post-randomization
Motivation to Quit Smoking
1-10 likert scale
Measured: 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
Measured: 3 and 6 months post-randomization
Nicotine Withdrawal Symptom Management (Behavioral Skills)
Self-report Minnesota Smoking Withdrawal Scale, Revised
Measured: 3 and 6 months post-randomization
Cessation Medication Use and Adherence (Behavioral Skills)
Self-report and health records (pharmacy) monitoring
Measured: 3 and 6 months post-randomization
Absolute CD4 Count
Lab value of CD4 ascertained via EHR
Measured: 6 and 12 months post-randomization
VACS Index 2.0
Composite score based of various lab values ascertained via EHR
Measured: 6 and 12 months post-randomization
Intentional Quit Attempt Frequency and Duration
Behavioral Risk Factor Surveillance System (BRFSS)
Measured: 3 and 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start4 Jun 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, University of California, Davis, Fred Hutchinson Cancer Center, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Kristina Crothers, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505371
- Sponsor's protocol ID
- 1R01CA243907-01
- Acronym
- WISH
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2020
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV
- ClinicalTrials.gov ID
- NCT04505371
- Acronym / sponsor ID
- WISH / 1R01CA243907-01
- Conditions
- HIV Infections, Smoking, Smoking Cessation
- Keywords
- HIV, Smoking, Smoking Cessation, Behavioral Intervention, Remote Intervention, Motivational Interviewing, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- Kaiser Permanente, University of California, Davis, Fred Hutchinson Cancer Center, US Department of Veterans Affairs
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Standard Care | No intervention | –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 | Experimental | Behavioral: Wellness Intervention for Smokers with HIVThe experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In care in the VA
- HIV+ serostatus
- Currently smoking 5+ cigarettes daily
- Access to cell phone with text messaging capabilities
- English speaking
Key exclusion criteria (5 listed)
- Psychosis, dementia or significant cognitive impairment documented in the EHR
- Documented or observed hearing or comprehension difficulties that would preclude participation in study telephone calls
- Currently receiving cessation counseling or using an FDA approved treatment to quit smoking
- Institutionalized/imprisoned
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Intervention for Smokers with HIVWISH 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. | Behavioural | Intervention - Wellness Intervention for Smokers with HIV |
Primary outcome
7-day Point-prevalence Abstinence (PPA)
Time frame: 6 months post-randomization
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.
Any 24-hour Intentional Quit Attempt
Time frame: 6 months post-randomization
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.
12 secondary outcomes
Floating Prolonged Abstinence
Time frame: 3 and 6 months post-randomization
7-day Self-report Point-prevalence Abstinence (PPA)
Time frame: 3 and 6 months post-randomization
30-day Self-report Point-prevalence Abstinence (PPA)
Time frame: 3, 6, 12 months post-randomization
Cigarettes Smoked Per Day
Time frame: 3 and 6 months post-randomization
HIV-specific Smoking Knowledge
Time frame: 3 and 6 months post-randomization
Motivation to Quit Smoking
Time frame: 3 and 6 months post-randomization
Smoking Cessation Related to Self-efficacy
Time frame: 3 and 6 months post-randomization
Nicotine Withdrawal Symptom Management (Behavioral Skills)
Time frame: 3 and 6 months post-randomization
Cessation Medication Use and Adherence (Behavioral Skills)
Time frame: 3 and 6 months post-randomization
Absolute CD4 Count
Time frame: 6 and 12 months post-randomization
VACS Index 2.0
Time frame: 6 and 12 months post-randomization
Intentional Quit Attempt Frequency and Duration
Time frame: 3 and 6 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Crothers, MD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Intervention for Smokers with HIV in people with HIV Infections and Smoking, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Point-prevalence Abstinence (PPA) (time frame: 6 months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.