Wellness Intervention for Smoking Cessation in Veterans with HIV

(WISH Trial)

Not currently recruiting at 1 trial location

Overseen By John Kundzins, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Must not be taking: Smoking cessation treatments

Disqualifiers: Psychosis, Dementia, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help veterans with HIV who smoke by testing a new wellness program designed specifically for them. It compares this program to standard services like the VA Quitline and SmokefreeVET texting. Both groups can use medication to support quitting. Veterans with HIV who smoke 5 or more cigarettes a day and have a cell phone for texting are a good fit for this study.

As an unphased trial, this study offers veterans a unique opportunity to contribute to innovative wellness solutions tailored to their needs.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, participants will have access to smoking cessation treatments through their VA healthcare providers.

What prior data suggests that this wellness intervention is safe for smokers with HIV?

Research has shown that wellness programs for smokers with HIV are generally easy to manage. In one study involving 209 HIV-positive smokers, three different smoking cessation methods proved equally effective and well-tolerated, with no major safety issues reported.

These wellness programs often include counseling through phone calls and texts, which are unlikely to cause physical side effects, making the program safe for most individuals. Participants typically find the support helpful without any serious drawbacks.

While this specific program remains under study, past research on similar programs suggests it is a safe option for those seeking to quit smoking. It is advisable to consult healthcare providers if there are concerns about starting a new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wellness Intervention for Smokers with HIV because it offers a fresh approach to quitting smoking, designed specifically for veterans living with HIV. Unlike standard options such as the National VA Quitline and SmokefreeVET texting program, this intervention integrates phone and text counseling into a comprehensive wellness program tailored for HIV-positive individuals. This personalized support aims to increase engagement and success rates by addressing the unique challenges faced by this group, making it a promising option for those looking to quit smoking.

What evidence suggests that this trial's treatments could be effective for smoking cessation in veterans with HIV?

Studies have shown that smokers with HIV face higher health risks, and quitting smoking can significantly improve their health. In this trial, participants will join one of two groups. One group will receive the Wellness Intervention for Smokers with HIV, which offers phone and text counseling tailored specifically for people with HIV. This customization may enhance its effectiveness compared to standard care. The other group will receive standard care, including referrals to evidence-based cessation services available nationally to Veterans. Early findings suggest that personalized support, even for those not ready to quit, can be more engaging and helpful for smokers with HIV. While data collection continues, focusing on the specific needs of people with HIV aims to improve their chances of successfully quitting smoking. ^{1 3 6 7 8}

Who Is on the Research Team?

Kristina A Crothers, MD

Principal Investigator

VA Puget Sound Health Care System

Are You a Good Fit for This Trial?

This trial is for veterans living with HIV who smoke at least 5 cigarettes a day, are in VA care, can text, and speak English. It's not for those with hearing/comprehension issues, institutionalized individuals, people with severe cognitive impairments, pregnant women or anyone already getting help to quit smoking.

Inclusion Criteria

I am HIV positive.

English speaking

In care in the VA

Exclusion Criteria

You are currently pregnant.

I am currently trying to quit smoking with counseling or FDA-approved treatments.

You have a history of severe mental illness, memory problems, or difficulty thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the WISH intervention or standard care cessation services, including phone and text counseling, and access to pharmacotherapy through VA.

6 months

Follow-up

Participants are monitored for smoking cessation outcomes, including abstinence and quit attempts, as well as changes in smoking-related knowledge and motivation.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Wellness Intervention for Smokers with HIV

Trial Overview The study compares a wellness intervention tailored for smokers with HIV against standard services like the National VA Quitline and SmokefreeVET texting. Participants also have access to quitting medications through their VA healthcare providers.

How Is the Trial Designed?

Group I: Intervention - Wellness Intervention for Smokers with HIV Experimental Treatment 1 Intervention

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 II: Control - Standard Care Active Control 1 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.

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

Cigarette smoking is alarmingly common among people living with HIV, affecting 40-75% of this population, which leads to significant health risks including increased mortality and various diseases.

Despite many smokers with HIV wanting to quit and attempting to do so, there is a lack of effective smoking cessation interventions specifically designed for them, highlighting the need for more tailored treatment options and support from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Use, Use Disorders, and Smoking Cessation Interventions in Persons Living With HIV. Pacek, LR., Cioe, PA.[2019]

Cigarette smoking is significantly more common among HIV-infected adults (50-70%) compared to the general population, and many express a desire to quit, indicating a need for targeted cessation interventions.

Smoking cessation rates in HIV-infected adults vary widely (6%-50%) across studies, with emotional distress and declining adherence to treatment being major barriers; however, combining nicotine replacement therapy with intensive counseling via cell phones shows promise for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation Interventions in HIV-Infected Adults in North America: A Literature Review. Cioe, PA.[2021]

A study of 444 HIV-positive smokers revealed that low self-efficacy in quitting smoking and a higher desire to quit are linked to greater nicotine dependence, highlighting psychological factors in smoking behavior.

The research found that older Hispanic Americans are less likely to be nicotine dependent, suggesting that smoking cessation interventions should be customized to address the unique needs of different racial and ethnic groups within the HIV-positive population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-positive smokers considering quitting: differences by race/ethnicity. Lloyd-Richardson, EE., Stanton, CA., Papandonatos, GD., et al.[2023]

A smoking cessation intervention delivered via cellular telephone significantly increased smoking abstinence rates among HIV-positive individuals, with a 36.8% quit rate compared to 10.3% in the usual care group.

Participants receiving the cellular telephone intervention were 3.6 times more likely to quit smoking than those receiving standard care, highlighting the effectiveness of tailored support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a proactive cellular telephone intervention for smokers living with HIV/AIDS. Vidrine, DJ., Arduino, RC., Lazev, AB., et al.[2022]

Smoking cessation interventions for people living with HIV (PLWH) are effective, particularly those using cell phone technology, which showed a high likelihood of success with odds ratios between 4.33 and 5.6.

Successful smoking cessation in PLWH led to clinically significant health improvements, including reductions in systolic blood pressure, weight gain, and increased CD(4+) T-cell counts, highlighting the importance of tailored interventions that address individual needs and co-occurring issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking-cessation interventions in people living with HIV infection: a systematic review. Moscou-Jackson, G., Commodore-Mensah, Y., Farley, J., et al.[2022]

The Positively Quit Trial is a randomized controlled trial designed to evaluate the effectiveness of the Positively Smoke Free intervention delivered via videoconferencing for people with HIV who smoke, with a focus on smoking cessation over a 1-year period.

Participants in the trial receive nicotine replacement therapy and attend 12 group sessions, with the primary outcome being biochemically confirmed smoking abstinence at day 360, which aims to address the high smoking rates and related health risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tailored telehealth group tobacco cessation treatment program for people with HIV: Study protocol for a randomized controlled trial. Marhefka, S., Lockhart, E., Chen, H., et al.[2022]

In a study involving 209 HIV-positive smokers, three different smoking cessation interventions showed similar effectiveness, with cessation rates ranging from 15% to 29%, indicating that various methods can be integrated into HIV treatment settings.

Factors such as employment status, a strong desire to quit, and lower mood disturbance were associated with higher chances of quitting smoking, suggesting that these personal characteristics may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of smoking cessation treatments provided in HIV clinical care settings. Humfleet, GL., Hall, SM., Delucchi, KL., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/14EACF0B4B8AC6D57598B8961CAA4A01A2FFCEB861BF/project-details/10923803

RePORT RePORTER - National Institutes of Health (NIH) | This project will compare the effectiveness of an HIV-specific comprehensive wellness intervention designed to have broad appeal to smokers living with HIV to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8597894/

Design and Methods of a Randomized Trial Testing the ... [32] This trial will compare the effectiveness and reach of the Wellness Intervention for Smokers' living with HIV (WISH) against standard care services ...

3. withpower.com withpower.com/trial/wellness-intervention-for-smoking-cessation-in-veterans-with-hiv-f722e

Wellness Intervention for Smoking Cessation in Veterans ... This project will compare the effectiveness of an HIV-specific comprehensive wellness intervention designed to have broad appeal to smokers living with HIV ...

4. researchgate.net researchgate.net/publication/355675334_Design_and_methods_of_a_randomized_trial_testing_the_novel_Wellness_Intervention_for_Smokers_Living_with_HIV_WISH

Design and methods of a randomized trial testing the novel ... This study was conducted as a supplement to the broader Wellness Intervention for Smokers Living with HIV (WISH) trial (R01 CA 243907-01; ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT03999411/Prot_001.pdf

A Novel smartphone-based intervention to support PLWHIV are at high risk for tobacco-related health disparities. Smoking prevalence in. PLWHIV is triple that of the general population (47% - 65% vs.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04725617

NCT04725617 | Wellness Intervention for Smoking and HIV The investigators will also explore the impact of smoking cessation and changes in sleep on changes in inflammatory biomarkers of cardiovascular disease risk.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04505371

Improving the Reach & Effectiveness of Smoking Cessation ... This project will compare the effectiveness of an HIV-specific comprehensive wellness intervention designed to have broad appeal to smokers living with HIV ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4021585/

Smoking Cessation Interventions in HIV-Infected Adults ... The purpose of this paper is to provide a state of the science review of the extant literature on smoking cessation interventions in HIV-infected adults.