Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06883097

Hybrid Trial of a Digital Therapeutic for Smoking Cessation Among Persons Living With HIV

Led by Wake Forest University Health Sciences · Updated on 2025-12-17

314

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

U

University at Buffalo

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare two different smartphone apps designed to help people living with HIV (PWH) quit smoking. Smoking rates are much higher among PWH compared to the general population, and smoking causes more life years lost in this group than HIV itself. The study focuses on evaluating digital therapeutics tailored for smoking cessation in PWH, addressing a critical need for effective and scalable interventions in this population. Participants will be randomly assigned to use either a digital therapeutic app tailored for people with HIV or an app designed for the general population. Both groups will also receive nicotine replacement therapy (patches and gums) to support quitting smoking. The apps provide smoking cessation education, skills training, and support over a 24-week period, with content delivered in modules across the study duration. During the approximately 6-month study, participants will complete five video call visits to meet with study staff, complete questionnaires, and participate in interviews. They may provide breath and saliva samples to measure carbon monoxide and nicotine levels. Researchers will assess smoking abstinence through biochemical verification and self-reported measures at multiple timepoints, as well as track app usage and quit attempts. Safety and adherence will be monitored throughout the study.

CONDITIONS

Brief Title

Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-reported daily cigarette smoking over the past 30 days
  • Self-reported HIV status
  • 18 years of age or older
  • Desire to quit smoking
  • Willing and medically eligible to use nicotine replacement therapy
  • Currently receiving HIV care
  • Currently own an Android or iOS smartphone
Not Eligible

You will not qualify if you...

  • Current acute psychotic episode or unsafe to participate in the study
  • Pregnant or intending to become pregnant in the next 6 months
  • Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
  • Any medical condition or medication that could compromise safety, as determined by study physicians
  • Not able to fluently speak and write in English
  • Hearing, comprehension, visual, speech, or motor limitations that prevent participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 14 days

Participants use a digital therapeutic app designed to help with smoking cessation tailored for people with HIV or a general population smoking cessation app. The content is delivered over 14 days with ongoing support.

Initial baseline visit followed by weekly visits for up to 6 weeks

Follow-up

Duration - Up to 24 weeks

Participants are monitored for smoking abstinence and app engagement for up to 24 weeks after the treatment period.

Visits at Weeks 6, 12, 18, and 24

Trial Site Locations

Total: 1 location

1

Wake Forest University, Implementation Science

Winston-Salem, North Carolina, United States, 27101

Actively Recruiting

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Research Team

R

Roger Vilardaga Vierra, Ph.D.

C

Clinical Studies Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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