Clinical trial NCT04505371: Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living with HIV
Official title: Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living with HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Smoking
Smoking Cessation
Keywords: HIV
Smoking
Smoking Cessation
Behavioral Intervention
Remote Intervention
Motivational Interviewing
Veterans
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: University of California, Davis
name: Fred Hutchinson Cancer Center
name: US Department of Veterans Affairs
First posted: 2020-08-10
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 7-day point-prevalence abstinence (PPA)
timeFrame: 6 months post-randomization
measure: Any 24-hour intentional quit attempt
timeFrame: 3 and 6 months postrandomization
Secondary outcomes:
measure: Floating prolonged abstinence
timeFrame: 3 and 6 months post-randomization
measure: 7-day self-report point-prevalence abstinence (PPA)
timeFrame: 3 and 6 months post-randomization
measure: 30-day self-report point-prevalence abstinence (PPA)
timeFrame: 3, 6, 12 months post-randomization
measure: Cigarettes smoked per day
timeFrame: 3 and 6 months post-randomization
measure: HIV-specific smoking knowledge
timeFrame: 3 and 6 months post-randomization
measure: Motivation to quit smoking
timeFrame: 3 and 6 months post-randomization
measure: Smoking cessation related to self-efficacy
timeFrame: 3 and 6 months post-randomization
measure: Nicotine withdrawal symptom management (behavioral skills)
timeFrame: 3 and 6 months post-randomization
measure: Cessation medication use and adherence (behavioral skills)
timeFrame: 3 and 6 months post-randomization
measure: Absolute CD4 count
timeFrame: 6 and 12 months post-randomization
measure: VACS index 2.0
timeFrame: 6 and 12 months post-randomization
measure: Intentional quit attempt frequency and duration
timeFrame: 3 and 6 months post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Kristina Crothers, MD
role: PRINCIPAL_INVESTIGATOR
References: