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Completed

NCT Number: NCT04505371

Improving the Reach & 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In care in the VA
  • HIV+ serostatus
  • Currently smoking 5+ cigarettes daily
  • Access to cell phone with text messaging capabilities
  • English speaking

Exclusion criteria

  • 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

Treatment and study plan

Wellness Intervention for Smokers with HIV

Behavioral

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.

Primary outcomes

  1. 7-day point-prevalence abstinence (PPA)

    Time frame: 6 months post-randomization

    Smoking abstinence at 6-month follow-up by self-report and biochemically confirmed via saliva cotinine for a small selected group of individuals. Cotinine levels < 10 ng/ml and a self-report of 7 day PPA will be required to be coded a nonsmoker.

  2. Any 24-hour intentional quit attempt

    Time frame: 3 and 6 months postrandomization

    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.

Secondary outcomes

  1. Floating prolonged abstinence

    Time frame: 3 and 6 months post-randomization

    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

  2. 7-day self-report point-prevalence abstinence (PPA)

    Time frame: 3 and 6 months post-randomization

    Self-report of abstinence from smoking, even a puff

  3. 30-day self-report point-prevalence abstinence (PPA)

    Time frame: 3, 6, 12 months post-randomization

    Self-report of abstinence from smoking, even a puff

  4. Cigarettes smoked per day

    Time frame: 3 and 6 months post-randomization

    Self-report; even a puff counts as smoking

  5. HIV-specific smoking knowledge

    Time frame: 3 and 6 months post-randomization

    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)

  6. Motivation to quit smoking

    Time frame: 3 and 6 months post-randomization

    1-10 likert scale

  7. Smoking cessation related to self-efficacy

    Time frame: 3 and 6 months post-randomization

    1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control

  8. Nicotine withdrawal symptom management (behavioral skills)

    Time frame: 3 and 6 months post-randomization

    Self-report Minnesota Smoking Withdrawal Scale, Revised

  9. Cessation medication use and adherence (behavioral skills)

    Time frame: 3 and 6 months post-randomization

    Self-report and health records (pharmacy) monitoring

  10. Absolute CD4 count

    Time frame: 6 and 12 months post-randomization

    Lab value of CD4 ascertained via EHR

  11. VACS index 2.0

    Time frame: 6 and 12 months post-randomization

    Composite score based of various lab values ascertained via EHR

  12. Intentional quit attempt frequency and duration

    Time frame: 3 and 6 months post-randomization

    Behavioral Risk Factor Surveillance System (BRFSS)

Sponsors and collaborators

Lead sponsor

Seattle Institute for Biomedical and Clinical Research

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • Kaiser Permanente
  • US Department of Veterans Affairs
  • University of California, Davis

Registry information

Official study title

Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV

Acronym: WISH

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 10, 2020
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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