NCT06883097Recruiting
Quitting Matters Human Immunodeficiency Virus Hybrid Trial
Hybrid Trial of a Digital Therapeutic for Smoking Cessation Among Persons Living With HIV
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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 6 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 314 (estimated)
- First submitted
- 12 Mar 2025
- Start date
- 18 Aug 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- HIV
- NCT number
- NCT06883097
What you commit to
- Study type: Interventional
- Planned participants: 314
- From 18 Aug 2025 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
Other illness
- Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
Other
- Current acute psychotic episode or unsafe to participate in the study
- Pregnant or intending to become pregnant in the next 6 months
- Not able to fluently speak and write in English
- Hearing, comprehension, visual, speech, or motor limitations that preclude study participation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest University, Implementation Science Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.