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Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Study acronym: QMH
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion moved earlier from Dec 2028 to Sep 2028
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 10 of 23 entries
  2. Primary endpoint revised
    • Secondary endpoints: 18 to 23
    v7
  3. Enrollment target: 474 to 314v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2025 to Aug 18, 2025
    • Interventions: Learn to Quit-HIV (LTQ-H) App (Behavioral), QuitGuide (Behavioral) to Learn to Quit-HIV (LTQ-H) App (Behavioral), QuitStart (Behavioral)
    v5
  5. Start date: Oct 2025 to Aug 2025v4
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  1. Start date: Jul 2025 to Oct 2025v3
  2. Start date: May 2025 to Jul 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06883097
Lead Sponsor Wake Forest University Health Sciences
Collaborators: University at Buffalo, National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions
(from sponsor)		 Tobacco, Tobacco Abstinence, Smoking Cessation, Smoking Cessation; Tobacco Dependence, Human Immunodeficiency Virus (HIV), Tobacco Dependence Caused by Cigarettes, Cancer Prevention
Related terms Acquired Immunodeficiency Syndrome, Smoking Cessation, Tobacco Use Disorder
Enrollment 314 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov