QuitStart + LTQ-H App for Smoking Cessation in HIV

(QMH Trial)

Overseen By Clinical Studies Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Nicotine replacement

Disqualifiers: Acute psychosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

314 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different smartphone apps, QuitStart and Learn to Quit-HIV (LTQ-H), to help people with HIV quit smoking. Participants will use one of the apps and receive nicotine patches and gum to assist with quitting. The study aims to determine which app is most effective for smoking cessation among people living with HIV. Those who have smoked daily for the last 30 days, are living with HIV, and want to quit smoking might be a good fit for this trial. Participants will check in through video calls and provide feedback over approximately six months. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance smoking cessation strategies for people with HIV.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on any medication that could affect your safety, the study team will decide if you can participate.

What prior data suggests that these apps are safe for smoking cessation in people with HIV?

Research shows that the Learn to Quit-HIV (LTQ-H) app is being developed to help people with HIV quit smoking. Previous studies have used similar apps that offer behavioral techniques and real-time feedback to assist in smoking cessation. Users generally find these apps easy to handle, with no major side effects reported. Since apps like LTQ-H focus on behavioral support, they pose a low risk for physical side effects.

The QuitStart app is another evidence-based tool designed for everyone. Studies have shown that similar digital tools for quitting smoking are safe and easy to use. They provide support through practical advice and motivational content, with no known physical risks.

Both apps aim to help people change their habits, making them a safe choice for those wanting to quit smoking. They are designed to support users without causing significant health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Learn to Quit-HIV (LTQ-H) App because it's specially designed for people living with HIV who want to quit smoking. Unlike standard smoking cessation tools like nicotine replacement therapy or general apps such as QuitStart, LTQ-H tailors its support to the unique health needs and challenges faced by people with HIV. It's a digital therapeutic that offers personalized strategies, making it a potentially more effective option for this specific population. This targeted approach is what sets it apart from more generic smoking cessation options.

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

This trial will compare the effectiveness of two smoking cessation apps. Research shows that the Learn to Quit-HIV (LTQ-H) app, available to participants in this trial, is designed to help people with HIV quit smoking using behavioral techniques. This app employs Acceptance and Commitment Therapy, which aids users in managing cravings and maintaining motivation. Early studies suggest that the app's interactive features and real-time feedback could be effective for this group.

In contrast, the QuitStart app, another treatment option in this trial, targets the general public and has proven effective in helping people stop smoking with evidence-based content. Studies have shown that similar apps assist users in quitting by providing educational resources and tracking progress. Both apps, when combined with nicotine replacement therapy, are expected to help people reduce or quit smoking. ^{2 3 4 5 6}

Who Is on the Research Team?

Roger Vilardaga Viera, Ph.D.

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who smoke cigarettes daily, want to quit, are currently receiving HIV care, and own a smartphone. They must be willing and medically able to use nicotine replacement therapy (NRT) like patches and gums.

Inclusion Criteria

I have disclosed my HIV status.

I want to quit smoking.

I have smoked cigarettes daily for the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of two smartphone apps for smoking cessation and receive nicotine replacement therapy for 24 weeks

24 weeks

5 video call visits

Follow-up

Participants are monitored for smoking abstinence and app usage effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Learn to Quit-HIV (LTQ-H) App
• QuitStart

Trial Overview

The study compares two smartphone apps designed to help people living with HIV quit smoking. Participants will also receive NRT products. Over approximately six months, they'll have video calls with staff, use the apps, and provide breath and saliva samples.

How Is the Trial Designed?

Group I: Learn to Quit - HIV (LTQ-H) App Experimental Treatment 1 Intervention

a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)

Group II: QuitStart App Active Control 1 Intervention

an evidence-based DTx designed for the general population

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04609514

Study Details | NCT04609514 | Learn to Quit-HIV Pilot Study

A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation ...

2.

crosscomm.com

crosscomm.com/portfolio/learn-to-quit-mobile-app

Learn to Quit Mobile App

The new app incorporates behavioral principles that enhance comprehension and retention with updated modules, gamification of smoking cessation content.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9437787/

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 data with ...

4.

beinvolved.atriumhealth.org

beinvolved.atriumhealth.org/studies/5/irb00112958

Helping People with HIV Quit Smoking Using Apps

The purpose of this study is to learn more about two different ways to help people with HIV quit smoking. The first way is to use the app called QuitStart along ...

5.

researchprotocols.org

researchprotocols.org/2023/1/e49558/

Pilot Testing of an mHealth App for Tobacco Cessation in ...

The Sense2Quit app is a mobile app connected through Bluetooth to a smartwatch that tracks smoking gestures and distinguishes them from other ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04609514

Study Details | NCT04609514 | Learn to Quit-HIV Pilot Study

A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation ...