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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to compare the advantages and disadvantages of two approaches for quitting smoking among people living with HIV (PWH). Participants will complete a 24- week (\ 6-month) study where the Participants will be assigned to one of two smartphone apps to help with quitting smoking. Regardless of the group participants are assigned to, they will also receive a combination of nicotine replacement therapy (patches and gums) that have been shown to help people quit smoking. The main questions this study aims to answer are: Participants will complete 5 video call visits over about 6 months. Participants will install their assigned smoking cessation app onto their phone and will be asked to use the app for the duration of the study along with their provided Nicotine Replacement Therapy (NRT) products. During the study visits, participants will meet with study staff to complete questionnaires and interviews. Participants may be asked to provide breath and saliva samples to measure the level of carbon monoxide and nicotine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Self-reported daily cigarette smoking over the past 30 days

• Self-reported HIV status

• Age 18 or older

• Desire to quit smoking

• Willing and medically eligible to use NRT

• Currently receiving HIV care

• Currently owning an Android or iOS smartphone

Locations
United States
North Carolina
Wake Forest University, Implementation Science
RECRUITING
Winston-salem
Contact Information
Primary
Roger Vilardaga Vierra, Ph.D.
Roger.Vilardagaviera@advocatehealth.org
336-716-1495
Backup
Clinical Studies Coordinator
caitlyn.arnold@advocatehealth.org
(984) 377-4306
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2028-12
Participants
Target number of participants: 474
Treatments
Experimental: Learn to Quit - HIV (LTQ-H) App
a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)
Active_comparator: QuitStart App
an evidence-based DTx designed for the general population
Related Therapeutic Areas
Sponsors
Collaborators: University at Buffalo, National Institutes of Health (NIH), National Cancer Institute (NCI)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov