SiS-H App for Smoking Cessation

Overseen By Susanne Hoeppner, PhD, MApStat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: No smartphone access, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new app designed to help people with HIV quit smoking. It compares two smartphone apps: "Smiling instead of Smoking for HIV" (SiS-H) and "QuitGuide". Both apps support participants in quitting smoking over an 8-week period. The trial seeks participants who have HIV, currently smoke, and actively receive HIV care.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may enhance smoking cessation strategies for people with HIV.

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 prior data suggests that the SiS-H app is safe for people with HIV?

Research has shown that the "Smiling Instead of Smoking" app (SiS) is generally easy to use and safe. This app employs fun and positive activities to assist people in quitting smoking. Users report that it helps them reduce smoking. No major problems have been reported from using the app. The SiS app aims to replace smoking with positive actions, providing a safe and supportive tool for those seeking to quit. For those considering joining a trial with this app, current evidence suggests it is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SiS-H App for smoking cessation because it offers a novel approach by using a smartphone app to encourage users to smile instead of smoke. Unlike traditional smoking cessation methods, which often rely on nicotine replacement therapy or prescription medications, this app leverages positive reinforcement to help users quit. The app is designed specifically for individuals with HIV, addressing unique challenges they face in quitting smoking. This targeted and accessible approach could make it easier for users to manage cravings and successfully quit smoking, offering a fresh alternative to more conventional treatments.

What evidence suggests that the SiS-H app is effective for smoking cessation in people with HIV?

Research shows that the "Smiling Instead of Smoking - HIV" (SiS-H) app, available to participants in this trial, might help people with HIV quit smoking by using positive reinforcement, such as smiling. Early findings suggest that daily positive exercises can aid in smoking cessation. Initial versions of the app have successfully increased user engagement and motivation to quit. Although specific data on SiS-H's effectiveness is limited, the app relies on proven behavior-change methods. It aims to help users replace smoking with healthier habits, potentially benefiting people with HIV who want to quit smoking. ^{4 5 6 7 8}

Who Is on the Research Team?

Bettina Hoeppner, PhD, MS

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

Currently engaged in HIV clinical care (i.e., saw an HIV care provider within the last year)

Exclusion Criteria

Does not own a smartphone

Does not have daily access to the owned smartphone

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Smiling instead of Smoking - HIV

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

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 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]

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]

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 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]

HIV-infected individuals who smoke face significantly higher risks of non-AIDS-related mortality compared to the general population, even when receiving effective antiretroviral therapy.

Smoking negatively impacts the quality of life for HIV patients, affecting their physical and cognitive functioning, and quitting smoking could potentially reduce the risk of serious health issues like lung and heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco and HIV. Patel, N., Talwar, A., Reichert, VC., et al.[2006]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05886621

Testing the Integrated mHealth App Intervention "SiS-H" 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663587/

A Smoking Cessation App for Nondaily Smokers (Version 2 ... This study aims to test the feasibility, acceptability, and conceptual underpinnings of version 2 of the Smiling Instead of Smoking (SiS2) smartphone app, which ...

3. withpower.com withpower.com/trial/phase-smoking-cessation-5-2023-b31f2

SiS-H App for Smoking Cessation · Info for Participants 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 ...

4. bettina-hoeppner.mgh.harvard.edu bettina-hoeppner.mgh.harvard.edu/sis/

Smiling Instead of Smoking SiS (“Smiling Instead of Smoking”) is an app that engages you in daily positive psychology exercises over the course of 7 weeks.

5. formative.jmir.org formative.jmir.org/2022/7/e38234

Feature-Level Analysis of a Smoking Cessation Smartphone ... In this paper, we present a feature-level analysis of app usage over time of the Smiling Instead of Smoking (SiS) app. To our knowledge, this is ...

6. play.google.com play.google.com/store/apps/details?id=com.previewlabs.sishiv&hl=en_US

Smiling instead of Smoking-HIV - Apps on Google Play Welcome to the SiS-H app! This smoking cessation app is designed for people with HIV who smoke. “SiS” stands for “Smiling instead of Smoking ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28197846/

Smiling Instead of Smoking - PubMed - NIH The purpose of this paper is to describe the program of research that led to the creation of a smoking cessation app for non-daily smokers, so as to stimulate ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03951766

Version 2 of the Smoking Cessation Smartphone App ... The overall goal of this pilot study is to solicit feedback from nondaily smokers looking for smoking cessation support online (n=90) about Version 2 of a ...