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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT04505371
Study groupRoleWhat they receive
Control - Standard CareNo interventionThe 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 HIVExperimentalThe 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.

  1. 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

  2. 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)
  1. 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

  2. 7-day Self-report Point-prevalence Abstinence (PPA)

    Self-report of abstinence from smoking, even a puff

    Measured: 3 and 6 months post-randomization

  3. 30-day Self-report Point-prevalence Abstinence (PPA)

    Self-report of abstinence from smoking, even a puff

    Measured: 3, 6, 12 months post-randomization

  4. Cigarettes Smoked Per Day

    Self-report; even a puff counts as smoking

    Measured: 3 and 6 months post-randomization

  5. 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

  6. Motivation to Quit Smoking

    1-10 likert scale

    Measured: 3 and 6 months post-randomization

  7. 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

  8. Nicotine Withdrawal Symptom Management (Behavioral Skills)

    Self-report Minnesota Smoking Withdrawal Scale, Revised

    Measured: 3 and 6 months post-randomization

  9. Cessation Medication Use and Adherence (Behavioral Skills)

    Self-report and health records (pharmacy) monitoring

    Measured: 3 and 6 months post-randomization

  10. Absolute CD4 Count

    Lab value of CD4 ascertained via EHR

    Measured: 6 and 12 months post-randomization

  11. VACS Index 2.0

    Composite score based of various lab values ascertained via EHR

    Measured: 6 and 12 months post-randomization

  12. 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.

  1. First posted10 Aug 2020
  2. Study start4 Jun 2021
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2026

Resources

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)
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
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

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