WISH: Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV
Study Details
Study Description
Brief 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. Participants in both arms will have access to pharmacotherapy available through their Veterans Affairs (VA) healthcare providers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: 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. |
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| Experimental: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 7-day point-prevalence abstinence (PPA) [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.
- Any 24-hour intentional quit attempt [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 Outcome Measures
- Floating prolonged abstinence [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
- 7-day self-report point-prevalence abstinence (PPA) [3 and 6 months post-randomization]
Self-report of abstinence from smoking, even a puff
- 30-day self-report point-prevalence abstinence (PPA) [3, 6, 12 months post-randomization]
Self-report of abstinence from smoking, even a puff
- Cigarettes smoked per day [3 and 6 months post-randomization]
Self-report; even a puff counts as smoking
- HIV-specific smoking knowledge [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)
- Motivation to quit smoking [3 and 6 months post-randomization]
1-10 likert scale
- Smoking cessation related to self-efficacy [3 and 6 months post-randomization]
1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control
- Nicotine withdrawal symptom management (behavioral skills) [3 and 6 months post-randomization]
Self-report Minnesota Smoking Withdrawal Scale, Revised
- Cessation medication use and adherence (behavioral skills) [3 and 6 months post-randomization]
Self-report and health records (pharmacy) monitoring
- Absolute CD4 count [6 and 12 months post-randomization]
Lab value of CD4 ascertained via EHR
- VACS index 2.0 [6 and 12 months post-randomization]
Composite score based of various lab values ascertained via EHR
- Intentional quit attempt frequency and duration [3 and 6 months post-randomization]
Behavioral Risk Factor Surveillance System (BRFSS)
Eligibility Criteria
Criteria
Inclusion Criteria:
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In care in the VA
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HIV+ serostatus
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Currently smoking 5+ cigarettes daily
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Access to cell phone with text messaging capabilities
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English speaking
Exclusion Criteria:
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Psychosis, dementia or significant cognitive impairment documented in the EHR
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Documented or observed hearing or comprehension difficulties that would preclude participation in study telephone calls
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Currently receiving cessation counseling or using an FDA approved treatment to quit smoking
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Institutionalized/imprisoned
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Pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Puget Sound Health Care System Seattle Division | Seattle | Washington | United States | 98108 |
Sponsors and Collaborators
- Seattle Institute for Biomedical and Clinical Research
- Kaiser Permanente
- University of California, Davis
- Yale University
- Fred Hutchinson Cancer Center
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Kristina Crothers, MD, VA Puget Sound Health Care System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1R01CA243907-01