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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04505371
Acronym
WISH
Enrollment
235
Registered
2020-08-10
Start date
2021-06-04
Completion date
2026-03-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Smoking, Smoking Cessation

Keywords

HIV, Smoking, Smoking Cessation, Behavioral Intervention, Remote Intervention, Motivational Interviewing, Veterans

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.

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.

Interventions

BEHAVIORALWellness 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.

Sponsors

Seattle Institute for Biomedical and Clinical Research
Lead SponsorOTHER
Kaiser Permanente
CollaboratorOTHER
University of California, Davis
CollaboratorOTHER
Fred Hutchinson Cancer Center
CollaboratorOTHER
US Department of Veterans Affairs
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
7-day Point-prevalence Abstinence (PPA)6 months post-randomizationSelf-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 Attempt6 months post-randomizationThe 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

MeasureTime frameDescription
Floating Prolonged Abstinence3 and 6 months post-randomizationA 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-randomizationSelf-report of abstinence from smoking, even a puff
30-day Self-report Point-prevalence Abstinence (PPA)3, 6, 12 months post-randomizationSelf-report of abstinence from smoking, even a puff
Cigarettes Smoked Per Day3 and 6 months post-randomizationSelf-report; even a puff counts as smoking
HIV-specific Smoking Knowledge3 and 6 months post-randomizationItems 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 Smoking3 and 6 months post-randomization1-10 likert scale
Smoking Cessation Related to Self-efficacy3 and 6 months post-randomization1-10 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-randomizationSelf-report Minnesota Smoking Withdrawal Scale, Revised
Cessation Medication Use and Adherence (Behavioral Skills)3 and 6 months post-randomizationSelf-report and health records (pharmacy) monitoring
Absolute CD4 Count6 and 12 months post-randomizationLab value of CD4 ascertained via EHR
VACS Index 2.06 and 12 months post-randomizationComposite score based of various lab values ascertained via EHR
Intentional Quit Attempt Frequency and Duration3 and 6 months post-randomizationBehavioral Risk Factor Surveillance System (BRFSS)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKristina Crothers, MD

VA Puget Sound Health Care System

Participant flow

Pre-assignment details

One participant fully withdrew from study participation/follow-up.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
63 Participants
Age, Categorical
Between 18 and 65 years
171 Participants
Age, Continuous55 years
STANDARD_DEVIATION 12
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
53 Participants
Race (NIH/OMB)
More than one race
22 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants
Race (NIH/OMB)
White
93 Participants
Region of Enrollment
United States
118 participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
112 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 1163 / 118
other
Total, other adverse events
0 / 1162 / 118
serious
Total, serious adverse events
2 / 1167 / 118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026