Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06883097
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Learn to Quit-HIV (LTQ-H) App — BEHAVIORAL
    LTQ-H consists of 319 screens divided into: (a) HIV-tailored smoking cessation ACT skills, (b) education about tobacco dependence and treatment (USCPG), and (c) NRT psychoeducation and adherence. Content is gradually presented across 28 modules (14 education and 14 skills) that can be completed in 14 days.
  • QuitStart — BEHAVIORAL
    This DTx, QuitGuide was adapted from the National Cancer Institute Smokefree.gov Initiative's QuitGuide's 5 modules have the following intervention components: (a) psychoeducation about the impact of smoking on health, (b) setting up a quit date and a quit plan, (c) selecting reasons for quitting, (d) tracking triggers and smoking habits, and (e) tips for quitting.

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
314 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks [ Time Frame: Weeks 6, 12, 18, and 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University, Implementation ScienceWinston-SalemNorth Carolina27101
Principal Investigator
[email protected]
919-439-3498
Clinical Studies Coordinator
[email protected]
(984)377-4306
Roger Vilardaga (PRINCIPAL_INVESTIGATOR)

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By research site
Wake Forest University, Implementation Science· Winston-Salem, NC

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