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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Smoking; Smoking Cessation
• Intervention / Treatment: Behavioral: Wellness Intervention for Smokers with HIV

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 Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Kundzins, BS; Phone Number: (206) 268-5278; Email: John.Kundzins@VA.gov
• Study Contact Backup: Name: Kristina Crothers, MD; Phone Number: (206) 277-3013

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • Recruiting
      • VA Puget Sound Health Care System Seattle Division
      • Contact: John Kundzins, BS; Phone Number: 206-768-5278; Email: John.Kundzins@va.gov
      • Principal Investigator: Kristina A Crothers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day point-prevalence abstinence (PPA)	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.	6 months post-randomization
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.	3 and 6 months postrandomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 and 6 months post-randomization
7-day self-report point-prevalence abstinence (PPA)	Self-report of abstinence from smoking, even a puff	3 and 6 months post-randomization
30-day self-report point-prevalence abstinence (PPA)	Self-report of abstinence from smoking, even a puff	3, 6, 12 months post-randomization
Cigarettes smoked per day	Self-report; even a puff counts as smoking	3 and 6 months post-randomization
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)	3 and 6 months post-randomization
Motivation to quit smoking	1-10 likert scale	3 and 6 months post-randomization
Smoking cessation related to self-efficacy	1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control	3 and 6 months post-randomization
Nicotine withdrawal symptom management (behavioral skills)	Self-report Minnesota Smoking Withdrawal Scale, Revised	3 and 6 months post-randomization
Cessation medication use and adherence (behavioral skills)	Self-report and health records (pharmacy) monitoring	3 and 6 months post-randomization
Absolute CD4 count	Lab value of CD4 ascertained via EHR	6 and 12 months post-randomization
VACS index 2.0	Composite score based of various lab values ascertained via EHR	6 and 12 months post-randomization
Intentional quit attempt frequency and duration	Behavioral Risk Factor Surveillance System (BRFSS)	3 and 6 months post-randomization

Collaborators and Investigators

• Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: University of California, Davis; US Department of Veterans Affairs; Fred Hutchinson Cancer Center; Kaiser Permanente
• Investigators: Principal Investigator: Kristina Crothers, MD, VA Puget Sound Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Motivational Interviewing; HIV; Smoking; Veterans; Smoking Cessation; Behavioral Intervention; Remote Intervention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 1R01CA243907-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No