RECRUITING

Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-18
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06883097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Self-reported daily cigarette smoking over the past 30 days
  2. 2. Self-reported HIV status
  3. 3. Age 18 or older
  4. 4. Desire to quit smoking
  5. 5. Willing and medically eligible to use NRT
  6. 6. Currently receiving HIV care
  7. 7. Currently owning an Android or iOS smartphone
  1. 1. Current acute psychotic episode or unsafe to participate in the study
  2. 2. Pregnant or intending to become pregnant in the next 6 months
  3. 3. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
  4. 4. Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
  5. 5. Not able to fluently speak and write in English
  6. 6. Hearing, comprehension, visual, speech, or motor limitations that preclude study participation

Contacts and Locations

Study Contact

Roger Vilardaga Vierra, Ph.D.
CONTACT
336-716-1495
Roger.Vilardagaviera@advocatehealth.org
Clinical Studies Coordinator
CONTACT
(984) 377-4306
caitlyn.arnold@advocatehealth.org

Principal Investigator

Roger Vilardaga Viera, Ph.D.
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University, Implementation Science
Winston-Salem, North Carolina, 27101
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Roger Vilardaga Viera, Ph.D., PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-18
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-08-18
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Tobacco
  • Smoking Cessation
  • Human immunodeficiency virus (HIV)
  • Tobacco Abstinence
  • Quit Smoking

Additional Relevant MeSH Terms

  • Tobacco
  • Tobacco Abstinence
  • Smoking Cessation
  • Smoking Cessation; Tobacco Dependence
  • Human Immunodeficiency Virus (HIV)
  • Tobacco Dependence Caused by Cigarettes
  • Cancer Prevention