Mobile App for Smoking Cessation in HIV

Overseen By Michael Businelle, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Must be taking: Nicotine replacement

Must not be taking: Smoking cessation drugs

Disqualifiers: Pregnancy, Non-Black, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app, MASP+, designed to help Black smokers with HIV quit smoking. The app features educational videos, personalized messages, and exercises to reduce anxiety and cravings. Participants will also use nicotine patches to aid in quitting. The trial seeks Black or African American adults who smoke at least 10 cigarettes daily, have HIV, and want to quit smoking. As an unphased trial, participants can contribute to innovative research that may lead to new methods for supporting smoking cessation in the community.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be receiving treatment for smoking cessation or substance use from outside the study.

What prior data suggests that this mobile app is safe for smoking cessation in Black/African American adults with HIV?

Research shows that specific safety information from studies about MASP+, a mobile app designed to help Black smokers with HIV quit smoking, is not available. This lack of detailed data means user interactions with the app remain unclear. However, as a digital tool rather than a medication, it likely poses low physical safety risks.

The app includes educational videos and personalized messages to reduce anxiety and support smoking cessation. It also features exercises to increase awareness of internal signals, such as stress or withdrawal symptoms.

Participants in this trial using MASP+ will also have access to nicotine patches, which are well-researched and commonly used for smoking cessation. Nicotine patches are generally considered safe, with mild side effects like skin irritation or dizziness being the most common.

In summary, while direct safety data for MASP+ is lacking, the app itself is unlikely to pose significant risks, especially when used alongside well-tolerated nicotine patches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MASP+ app for smoking cessation in people with HIV because it goes beyond typical nicotine replacement therapies and basic tracking apps. Unlike standard options, MASP+ offers a personalized approach by including educational videos, tailored messages, and interoceptive exercises specifically designed for Black smokers with HIV who experience high anxiety sensitivity. This combination aims to tackle the emotional and psychological hurdles of quitting smoking, offering a more comprehensive support system compared to other apps.

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

Research shows that the MASP+ app, available to participants in this trial, is designed to help Black adults with HIV quit smoking by reducing anxiety sensitivity. The app includes educational videos, personalized messages, and exercises to manage stress and nicotine withdrawal. Early results suggest these features effectively support smoking cessation in this group. Additionally, the app aids users in adhering to their HIV treatment, which is crucial for overall health. Although specific success rates are not available, the app's tailored approach for Black smokers with HIV appears promising. ^{3 4 6 7 8}

Who Is on the Research Team?

Lorra Garey, Ph.D.

Principal Investigator

University of Houston

Michael Businelle, Ph.D.

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for Black/African American adults with HIV who smoke daily, want to quit smoking, and have moderate to high anxiety sensitivity. Participants must be over 18, motivated to quit (≥5 on a scale of 10), able to read English, and willing to use nicotine replacement therapy. Pregnant individuals or those planning pregnancy soon, non-English fluent speakers, people undergoing other treatments for smoking cessation or mental health issues are excluded.

Inclusion Criteria

HIV-infection (via self-report and picture of medication, lab tests, or diagnosis)

Willingness to discontinue cigarette use two weeks after baseline visit

Willing to complete all study surveys/assessments

Exclusion Criteria

Non-fluent/limited English proficiency

Self-reported pregnancy or intentions to become pregnant in near future

Legal status that would interfere with participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the MASP+ app and receive nicotine replacement therapy to assist with smoking cessation

26 weeks

Remote app-based interactions throughout the day

Follow-up

Participants are monitored for smoking abstinence and quality of life

2 weeks

Phone-based monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Control
• MASP+

Trial Overview

The study tests a mobile app designed for Black smokers with HIV aiming at reducing anxiety-sensitivity and helping them stop smoking. Participants will be randomly placed into two groups: one using the MASP+ app and the other as a control group without this specialized tool.

How Is the Trial Designed?

Group I: MASP+ app & NRT Experimental Treatment 1 Intervention

MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal. Nicotine patches will be made available to provide adjunctive support.

Group II: QuitGuide app + NRT Active Control 1 Intervention

The QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages. Nicotine patches will be made available to provide adjunctive support.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Published Research Related to This Trial

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]

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]

A novel web-based smoking cessation program called Positively Smoke Free on the Web (PSFW+) significantly increased quit rates among people with HIV, with 14.9% achieving abstinence compared to 8.8% in the control group, based on a study of 506 participants.

The PSFW+ program combines interactive support and empirically tested content, making it a scalable and effective tool for helping individuals with HIV quit smoking, which is crucial given their higher smoking rates compared to the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of a Web-Based Tobacco Treatment and Online Community Support for People With HIV Attempting to Quit Smoking Cigarettes. Shuter, J., Chander, G., Graham, AL., et al.[2023]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38657227/

An Integrated mHealth App for Smoking Cessation in Black ...

Conclusions: The results of this study will determine whether the MASP+ app serves as a successful aid for combustible cigarette smoking ...

2.

researchprotocols.org

researchprotocols.org/2024/1/e52090/

An Integrated mHealth App for Smoking Cessation in Black ...

MASP+ contains features and content designed to aid Black adults with combustible smoking cessation, HIV care adherence, and AS reduction. The ...

3.

withpower.com

withpower.com/trial/early-phase-1-smoking-cigarette-3-2023-69a61

Mobile App for Smoking Cessation in HIV

Trial Overview The study tests a mobile app designed for Black smokers with HIV aiming at reducing anxiety-sensitivity and helping them stop smoking.

4.

researchgate.net

researchgate.net/figure/MASP-Pre-Quit-Scheduled-Treatment_fig3_351326835

MASP Pre‐Quit Scheduled Treatment.

Although most US smokers want to quit, more than 95% of cessation attempts end in relapse within 6 months. To improve cessation outcomes, research has turned to ...

5.

formative.jmir.org

formative.jmir.org/2025/1/e53566

Adapting a Mobile Health App for Smoking Cessation in Black ...

This study examined the acceptability and feasibility of the MASP smartphone app following a 6-week pilot test through postintervention qualitative interviews.

6.

formative.jmir.org

formative.jmir.org/2022/8/e28626/

A Smoking Cessation Mobile App for Persons Living With HIV

The Lumme Quit Smoking app uses a validated sensor to detect participants' smoking behaviors in real time. This intervention combined biometric ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11079772/

An Integrated mHealth App for Smoking Cessation in Black ...

MASP+ contains features and content designed to aid Black adults with combustible smoking cessation, HIV care adherence, and AS reduction. The ...

8.

researchgate.net

researchgate.net/figure/MASP-Interoceptive-Exposure-Timer_fig5_351326835

MASP Interoceptive Exposure Timer.

MASP+ contains features and content designed to aid Black adults with combustible smoking cessation, HIV care adherence, and AS reduction. ... ... The MASP+ ...