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

72 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for smoking cessation in HIV?

Research shows that smoking cessation interventions using cell phone technology have been effective for people living with HIV, with some studies reporting high success rates. Additionally, combining nicotine replacement therapy with intensive counseling delivered via cell phone has shown promising results in helping HIV-positive individuals quit smoking. ^{1 2 3 4 5}

Is the mobile app for smoking cessation safe for people with HIV?

The studies reviewed do not provide specific safety data for the mobile app itself, but they do suggest that smoking cessation interventions, including those using cell phone technology, are generally safe and can lead to health improvements like reduced blood pressure and increased immune function in people living with HIV. ^{1 3 4 6 7}

How is the MASP+ treatment for smoking cessation in HIV unique?

MASP+ is unique because it leverages a mobile app to deliver smoking cessation support, which can increase accessibility and engagement for people living with HIV, a group with high smoking rates. This approach is novel compared to traditional methods, as it offers a potentially more sustainable and cost-effective way to reach and support this population. ^{1 2 3 8 9}

What is the purpose of this trial?

The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black persons with HIV/AIDS. (2) To conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among Black smokers with HIV.

Research Team

Lorra Garey, Ph.D.

Principal Investigator

University of Houston

Michael Businelle, Ph.D.

Principal Investigator

University of Oklahoma

Eligibility Criteria

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)

Willing to complete all study surveys/assessments

Willingness to discontinue cigarette use two weeks after baseline visit

Exclusion Criteria

I am currently getting treatment for quitting smoking or substance use, not from this study.

Cognitive impairment (assessed via the 6-item Cognitive Impairment Test)

Non-fluent/limited English proficiency

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial. [2022]

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

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

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

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

5. United States 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. [2023]

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

Receipt and predictors of smoking cessation pharmacotherapy among veterans with and without HIV. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

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

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

9. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. [2022]