NCT06883097 Quitting Matters Human Immunodeficiency Virus Hybrid Trial
| NCT ID | NCT06883097 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Tobacco |
| Study Type | INTERVENTIONAL |
| Enrollment | 314 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 314 participants in total. It began in 2025-08-18 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Self-reported daily cigarette smoking over the past 30 days 2. Self-reported HIV status 3. Age 18 or older 4. Desire to quit smoking 5. Willing and medically eligible to use NRT 6. Currently receiving HIV care 7. Currently owning an Android or iOS smartphone Exclusion Criteria: 1. Current acute psychotic episode or unsafe to participate in the study 2. Pregnant or intending to become pregnant in the next 6 months 3. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation 4. Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician 5. Not able to fluently speak and write in English 6. Hearing, comprehension, visual, speech, or motor limitations that preclude study participation
Contact & Investigator
Roger Vilardaga Viera, Ph.D.
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT06883097 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883097 currently recruiting?
Yes, NCT06883097 is actively recruiting participants. Contact the research team at Roger.Vilardaga@wfusm.edu for enrollment information.
Where is the NCT06883097 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT06883097 clinical trial?
NCT06883097 is sponsored by Wake Forest University Health Sciences. The principal investigator is Roger Vilardaga Viera, Ph.D. at Wake Forest University Health Sciences. The trial plans to enroll 314 participants.