Wellness Intervention for Smoking Cessation in Veterans with HIV

(WISH Trial)

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

226 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Wellness Intervention for Smokers with HIV?

The Wellness Intervention for Smokers with HIV (WISH) is based on evidence-based guidelines for nicotine dependence and uses a comprehensive approach that includes stress management and health behavior goals, which have shown promise in other studies. Additionally, interventions combining counseling and technology, like cell phone-delivered support, have been effective in increasing smoking cessation among people living with HIV. ^{1 2 3 4 5}

Is the Wellness Intervention for Smoking Cessation in Veterans with HIV safe?

The Wellness Intervention for Smokers Living with HIV (WISH) is based on evidence-based guidelines for nicotine dependence treatment and includes a comprehensive wellness approach, but specific safety data for this intervention is not detailed in the available research. ^{1 6 7 8 9}

How is the Wellness Intervention for Smokers with HIV different from other treatments for smoking cessation in veterans with HIV?

The Wellness Intervention for Smokers with HIV (WISH) is unique because it uses a comprehensive wellness approach that integrates smoking cessation with HIV self-management, addressing factors like stress management and substance use, and is designed for all smokers with HIV, regardless of their motivation to quit. ^{1 2 8 10 11}

What is the purpose of this trial?

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.

Research Team

Kristina A Crothers, MD

Principal Investigator

VA Puget Sound Health Care System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Design and methods of a randomized trial testing the novel Wellness Intervention for Smokers Living with HIV (WISH). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

HIV-positive smokers considering quitting: differences by race/ethnicity. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A Qualitative Systematic Review of Cigarette Smoking Cessation Interventions for Persons Living with HIV. [2020]

5. England pubmed.ncbi.nlm.nih.gov

A randomized trial of a proactive cellular telephone intervention for smokers living with HIV/AIDS. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of smoking cessation treatments provided in HIV clinical care settings. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A tailored telehealth group tobacco cessation treatment program for people with HIV: Study protocol for a randomized controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. New Zealand pubmed.ncbi.nlm.nih.gov

HIV and smoking: associated risks and prevention strategies. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of smoking cessation interventions for veterans in HIV clinics in the United States: a theory-informed concurrent mixed-method study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Smoking-cessation interventions in people living with HIV infection: a systematic review. [2022]