Mobile Health Programs for Smoking Cessation

(ESCAPE Trial)

Overseen By Jessica Thai, B.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Houston

Must be taking: Nicotine replacement

Disqualifiers: Uncontrolled hypertension, Recent heart attack, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two mobile apps designed to help Black individuals with HIV quit smoking. It compares the new ESCAPE app with the existing quitSTART app, both in conjunction with nicotine replacement therapy (NRT). Participants will join one of three groups: ESCAPE + NRT, quitSTART + NRT, or a control group with NRT. Individuals who identify as Black, have HIV, smoke at least five cigarettes daily, and are motivated to quit may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be willing to use nicotine replacement therapy (NRT) as part of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the ESCAPE app and the quitSTART app are user-friendly. Although detailed safety information for the ESCAPE app is lacking, smoking cessation apps, in general, have successfully helped people quit smoking, suggesting they are safe to use.

For the quitSTART app, studies indicate it is effective and well-received by users trying to quit smoking. One study found that 25% of users successfully quit smoking, demonstrating its effectiveness without any major safety issues reported.

Both apps aim to help people quit smoking and generally have no known serious side effects. It is common and generally safe to use these apps alongside nicotine replacement therapy (NRT). While specific data on side effects is limited, previous studies suggest that using these apps with NRT is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the ESCAPE and quitSTART apps for smoking cessation because they leverage mobile health technology to offer personalized support, which is different from traditional methods like nicotine replacement therapy (NRT) alone. These apps provide interactive features and tailored guidance, making quitting smoking more engaging and accessible. By combining these apps with NRT, there's potential for a more comprehensive approach, addressing both behavioral and physical aspects of nicotine addiction in a way that many current options do not.

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

Research has shown that mobile health (mHealth) apps can help people quit smoking. In this trial, participants will join different treatment arms. The ESCAPE app, one of the interventions tested, combines smoking cessation treatments with other health supports. This holistic approach has shown promise in aiding smoking cessation.

Another treatment arm involves the quitSTART app. Research has found that personalized digital programs like quitSTART can increase quit rates by 77% compared to standard methods. The app works even better with nicotine replacement therapy (NRT), significantly boosting the chances of quitting smoking. Both apps, when used with NRT, provide helpful tools that can improve the success of quitting smoking. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael S. Businelle, Ph.D.

Principal Investigator

University of Oklahoma Health Sciences

Are You a Good Fit for This Trial?

This trial is for Black individuals living with HIV who smoke at least 5 cigarettes daily for a year, are motivated to quit, and willing to use a mobile app and nicotine replacement therapy (NRT). They must be adults fluent in English without cognitive impairments or recent heart attacks. Pregnant individuals or those planning pregnancy soon cannot participate.

Inclusion Criteria

Living with HIV

I am motivated to quit smoking, scoring at least a 5 out of 10.

I am willing to download and use a mobile app for the trial.

Exclusion Criteria

Cognitive impairment (a score of > 8 on the Six-Item Cognitive Impairment Test [6-CIT])

Residing in a location (Urban/Rural) for which the corresponding study cell has been filled

Not being fluent in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a baseline appointment to assess initial conditions

1 day

1 visit (in-person or virtual)

Treatment

Participants engage in the intervention or control condition with ecological momentary assessments and weekly follow-ups

8 weeks

Daily EMAs (2x per day), 8 weekly follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

46 weeks

10 monthly check-in surveys, 28-week follow-up, 54-week follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Control (CTRL)
• ESCAPE app
• quitSTART app

Trial Overview The study tests the effectiveness of two smoking cessation methods among Black persons with HIV: the ESCAPE app plus NRT versus the quitSTART app plus NRT. A control group receives only assessments along with NRT. Participants will be randomly assigned to one of these three groups.

How Is the Trial Designed?

Group I: ESCAPE intervention + NRT Experimental Treatment 1 Intervention

Group II: quitSTART intervention + NRT Active Control 1 Intervention

Group III: Control (CTRL) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23072513/

A Randomised Controlled Trial of Computer-Tailored ... Aims: To evaluate the effectiveness of tailored cessation advice reports, including levels of reading ability, compared with a generic self-help booklet.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06746025

Study Details | NCT06746025 | Examining the Efficacy of a ... The primary purpose of this trial is to assess the efficacy of the holistic approach to quitting, and to gauge the program results against any ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16718

intEgrating Smoking Cessation treatment As part of usual ... Follow-up was at 3 and 6 months. The primary outcome was 'study completion' by 3 months. Other outcomes included acceptability, satisfaction, ...

4. isrctn.com isrctn.com/ISRCTN99531779

The ESCAPE study: offering smoking cessation treatment ... This study will offer mental health service users help to quit smoking alongside their routine psychological therapy.

5. ucl.ac.uk ucl.ac.uk/population-health-sciences/epidemiology-health-care/research/behavioural-science-and-health/research/ucl-tobacco-alcohol-research-group-utarg/escape-trial

ESCAPE Trial | Faculty of Population Health Sciences The ESCAPE trial will assess whether offering PWMI e-cigarettes in addition to standard support is better than standard support alone.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11986290/

intEgrating Smoking Cessation treatment As part of usual ... There is evidence that smoking cessation may improve depression and anxiety symptoms. We assessed the feasibility of implementing and trialling a smoking ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003317

Protocol for a randomized controlled trial of the Enhanced ... This study will test a smoking cessation intervention using personal stories and a lung cancer screening decision-aide compared to standard care.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36396069/

Protocol for a randomized controlled trial of the Enhanced ... This study will test a smoking cessation intervention using personal stories and a lung cancer screening decision-aide compared to standard care.