Quitting Matters: a smoking quit program for people living with HIV
Hybrid Trial of a Digital Therapeutic for Smoking Cessation Among Persons Living With HIV
This 6-month program will test whether a tailored smartphone app plus nicotine patches and gum helps people living with HIV quit smoking better than a standard quit app.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06883097 on ClinicalTrials.gov |
What this trial studies
Participants who smoke and are receiving HIV care will be randomized to use one of two smartphone smoking-cessation apps for about 24 weeks while receiving nicotine replacement therapy (patches and gum). The trial includes five video-call visits during which staff collect questionnaires, interviews, and breath or saliva samples to measure smoking outcomes. One app is specifically tailored for people with HIV and the other is a general quit app, allowing comparison of effectiveness and implementation barriers. The study also documents feasibility and factors that affect adoption of digital therapeutics in this population.
Who should consider this trial
Good fit: Ideal participants are adults (18+) living with HIV who smoke daily, want to quit, are currently in HIV care, can use NRT, and own an Android or iOS smartphone.
Not a fit: People who are pregnant, currently receiving other smoking-cessation treatments, medically ineligible for NRT, not fluent in English, or who cannot use a smartphone are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, a tailored app plus NRT could increase quit rates among people living with HIV and reduce smoking-related illness in this group.
How similar studies have performed: Digital smoking-cessation apps have shown effectiveness in the general population, but large trials of tailored apps for people with HIV are lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University, Implementation Science — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Roger Vilardaga Viera, Ph.D. — Wake Forest University Health Sciences
- Study coordinator: Roger Vilardaga Vierra, Ph.D.
- Email: Roger.Vilardaga@wfusm.edu
- Phone: 336-716-1495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.