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

NCT04505371 | Completed DMC

• 1 other identifier: 1R01CA243907-01
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Smoking; Smoking Cessation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Floating prolonged abstinence

  3 and 6 months post-randomization

• 7-day self-report point-prevalence abstinence (PPA)

  3 and 6 months post-randomization

• 30-day self-report point-prevalence abstinence (PPA)

  3, 6, 12 months post-randomization

• Cigarettes smoked per day

  3 and 6 months post-randomization

• HIV-specific smoking knowledge

  3 and 6 months post-randomization

Study Arms (2)

Control - Standard Care

NO INTERVENTION

The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.

Intervention - Wellness Intervention for Smokers with HIV

EXPERIMENTAL

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

Interventions

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.

Intervention - Wellness Intervention for Smokers with HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• Kaiser Permanente: collaborator
• University of California, Davis: collaborator
• Fred Hutchinson Cancer Center: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

HIV Infections; Smoking; Smoking Cessation

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Kristina Crothers, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 10, 2020
• Study Start: June 4, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

US (1)