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

NCT ID: NCT04505371

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-04
• Study Completion Date: 2026-02-28

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.

Conditions

HIV Infections; Smoking; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Wellness Intervention for Smokers with HIV

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Seattle Institute for Biomedical and Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristina Crothers, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, United States

Countries

United States

Other Identifiers

1R01CA243907-01

Identifier Type: NIH

Identifier Source: org_study_id

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