SiS-H App for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen by Bettina Hoeppner, PhD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: No smartphone access, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The present study is a pilot randomized controlled trial (RCT) that seeks to test the feasibility, acceptability, process outcomes, and exploratory outcomes of a newly integrated, app-based smoking cessation treatment (SiS-H, which stands for "Smiling instead of Smoking for people with HIV") for people with HIV who smoke. This treatment will be compared to onboarding to the National Cancer Institute's smartphone app "QuitGuide" (QG). Persons with HIV who smoke and are engaged in HIV clinical care (n=64) will be randomized (1:1) to smoking cessation support via SiS-H vs. "QuitGuide".

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the SiS-H App treatment for smoking cessation in people with HIV?

Research shows that smoking cessation interventions, including those using cell phone counseling, can help people with HIV reduce smoking and improve mental health, which may support the effectiveness of the SiS-H App treatment. ^{1 2 3 4 5}

How is the SiS-H App for Smoking Cessation unique compared to other smoking cessation treatments for people with HIV?

The SiS-H App for Smoking Cessation is unique because it focuses on using positive reinforcement, like smiling, as a strategy to help people with HIV quit smoking, which is different from traditional methods that often rely on medications or counseling alone. ^{1 6 7 8 9}

Research Team

Bettina Hoeppner, PhD, MS

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 who are HIV positive, smoke at least weekly, and have smoked more than 100 cigarettes in their lifetime. Participants must be receiving regular HIV care and willing to attempt quitting smoking as part of the study. They also need to allow access to their medical records and app usage data.

Inclusion Criteria

HIV positive, by self-report

I am 18 years old or older.

I currently smoke and have smoked over 100 cigarettes in my lifetime.

Exclusion Criteria

Does not own a smartphone

Does not have daily access to the owned smartphone

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive smoking cessation support via the SiS-H or QuitGuide app for 8 weeks, including face-to-face sessions and optional nicotine replacement patches.

8 weeks

2 face-to-face sessions

Follow-up

Participants are monitored for smoking cessation outcomes and app usage, with assessments at baseline, 2, 6, and 12 weeks post-quit.

12 weeks

Online surveys and biochemical tests

Long-term Follow-up

Participants provide additional data on smoking abstinence and HIV medication adherence 3 months after the end of treatment.

3 months

Treatment Details

Interventions

• Smiling instead of Smoking - HIV (Behavioral Intervention)

Trial Overview The trial is testing 'SiS-H,' an integrated mobile health app designed for smoking cessation in people with HIV, against the National Cancer Institute's 'QuitGuide' app. It aims to assess how feasible, acceptable, and effective SiS-H is compared to QuitGuide through a pilot randomized controlled trial.

Participant Groups

Group I: Smiling instead of Smoking - HIV Experimental Treatment 1 Intervention

Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.

Group II: QuitGuide Active Control 1 Intervention

Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

In a pilot study involving 60 participants living with HIV, the integration of a smoking cessation decisional algorithm during routine clinic visits led to a significant reduction in smoking, from an average of 14.4 cigarettes per day to 7.1 cigarettes per day over three months (p = .001).

The study also found that 45% of participants made a 24-hour quit attempt and 65% used cessation medication, demonstrating the algorithm's effectiveness in engaging smokers in cessation therapies, despite some delays in medication access due to insurance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery and implementation of an algorithm for smoking cessation treatment for people living with HIV and AIDS. Cropsey, KL., Bean, MC., Haynes, L., et al.[2020]

A cell phone intervention (CPI) for smoking cessation in HIV-positive individuals led to greater reductions in anxiety and depression, and increased self-efficacy compared to standard care, suggesting it may be a more effective approach for this population.

The study involved 95 participants from an inner-city AIDS clinic, and the results indicate that improvements in mental health and self-efficacy may help explain the better cessation outcomes observed in the CPI group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a cell phone intervention on mediating mechanisms of smoking cessation in individuals living with HIV/AIDS. Vidrine, DJ., Arduino, RC., Gritz, ER.[2019]

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]

In a study of 173 people living with HIV/AIDS, varenicline significantly reduced anxiety levels compared to placebo, which may help improve smoking cessation efforts.

Reductions in anxiety were linked to a higher likelihood of quitting smoking, suggesting that addressing anxiety could be crucial for smokers with HIV who want to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of varenicline on mood and cognition in smokers with HIV. Thompson, M., Schnoll, R., Serrano, K., et al.[2022]

In a study of 5550 hospitalized smokers, including 202 people living with HIV (PLWH), smoking cessation rates at 6 months were similar for both PLWH and those without HIV, indicating that HIV status does not significantly affect the likelihood of quitting smoking after hospital discharge.

Confidence in quitting was identified as a key factor associated with smoking cessation among PLWH, suggesting that enhancing this confidence could improve quit rates in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. Triant, VA., Grossman, E., Rigotti, NA., et al.[2021]

In a study of 509 HIV-infected patients, 51% were regular smokers, with a significant portion (60%) showing medium to strong nicotine dependence, highlighting the need for targeted smoking cessation programs in this population.

Depressive symptoms were prevalent among smokers, with 62% of those with high nicotine dependence also experiencing depression, indicating that effective cessation interventions must address both mental health and substance codependencies alongside nicotine addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco addiction and HIV infection: toward the implementation of cessation programs. ANRS CO3 Aquitaine Cohort. Benard, A., Bonnet, F., Tessier, JF., et al.[2022]

References

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

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

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

Delivery and implementation of an algorithm for smoking cessation treatment for people living with HIV and AIDS. [2020]

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

Impact of a cell phone intervention on mediating mechanisms of smoking cessation in individuals living with HIV/AIDS. [2019]

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

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

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

Tobacco and HIV. [2006]

7. Germany pubmed.ncbi.nlm.nih.gov

The effect of varenicline on mood and cognition in smokers with HIV. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. [2021]

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

Tobacco addiction and HIV infection: toward the implementation of cessation programs. ANRS CO3 Aquitaine Cohort. [2022]