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Avsluta frågor Human immunbristvirus Hybrid Trial (QMH)

25 september 2026 uppdaterad av: Wake Forest University Health Sciences

Hybridprövning av en digital terapeutisk för rökavvänjning bland personer som lever med HIV

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Tobacco use has alarmingly high rates among people with Human Immunodeficiency Virus (HIV) (PWH), 43% compared with 15% in the general population. Due to the development of highly effective treatments for HIV and the resulting increased longevity among PWH, this population now loses more life years to smoking than to HIV infection itself. Novel and effective models to deliver wider reaching smoking cessation interventions for PWH are highly needed and indicated as a priority for National Institute of Health. Digital therapeutics (DTx) may be a novel, scalable, and highly available approach for engaging and treating smoking in this population. However, although DTx for smoking cessation have been shown effective in the general population, no large trial to date has examined the effectiveness of a tailored DTx for smoking cessation in PWH, and no implementation science work has examined barriers and facilitators of implementation of DTx for smoking cessation in this population.

Studietyp

Interventionell

Inskrivning (Beräknad)

314

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Learn to Quit - HIV (LTQ-H) App

a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)
Beteende: Learn to Quit-HIV (LTQ-H) App

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.

Andra namn:
  • En Digital Therapeutic (DTX från rökning (DTX)
Aktiv komparator: QuitStart App

an evidence-based DTx designed for the general population
Beteende: QuitStart

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.

Andra namn:
  • en evidensbaserad DTX utformad för den allmänna befolkningen

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
Tidsram: Weeks 6, 12, 18, and 24

Abstinence is determined by a self-report of not smoking any cigarettes for greater than or equal to 7 days prior to Weeks 6, 12, 18, and 24 and biochemically verified by an expired carbon monoxide breath test or a cotinine level saliva test at Weeks 6, 12, 18, and 24. Criteria for the bioverification tests to be considered abstinent includes a reading of <6 parts per million using an iCOquit Smokerlyzer carbon monoxide breath test OR a cotinine level of 30 or less ng/ml using an iScreen saliva test.

If the participant does not meet both criteria of the self report of 7 or more days of abstinence plus a bioverification test below the thresholds listed above, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 6 ppm.
Weeks 6, 12, 18, and 24

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Self-reported 7-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 6 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
6 weeks
Self-reported 7-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 12 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
12 weeks
Self-reported 7-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 18 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
18 weeks
Self-reported 7-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 24 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
24 weeks
Self-reported 30-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 6 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the timepoint.
6 weeks
Self-reported 30-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 12 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
12 weeks
Self-reported 30-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 18 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
18 weeks
Self-reported 30-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Tidsram: 24 weeks

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
24 weeks
Change in average number of cigarettes smoked per day
Tidsram: 6 weeks

Change in self-reported number of cigarettes smoked per day, averaged within groups.
6 weeks
Change in average number of cigarettes smoked per day
Tidsram: 12 weeks

Change in self-reported number of cigarettes smoked per day, averaged within groups.
12 weeks
Change in average number of cigarettes smoked per day
Tidsram: 18 weeks

Change in self-reported number of cigarettes smoked per day, averaged within groups.
18 weeks
Change in average number of cigarettes smoked per day
Tidsram: 24 weeks

Change in self-reported number of cigarettes smoked per day, averaged within groups.
24 weeks
Average number of quit attempts
Tidsram: 6 weeks

Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
6 weeks
Average number of quit attempts
Tidsram: 12 weeks

Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
12 weeks
Average number of quit attempts
Tidsram: 18 weeks

Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
18 weeks
Average number of quit attempts
Tidsram: 24 weeks

Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
24 weeks
Average acceptance of physical smoking cravings
Tidsram: 6 weeks

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
6 weeks
Average acceptance of physical smoking cravings
Tidsram: 12 weeks

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
12 weeks
Average acceptance of physical smoking cravings
Tidsram: 18 weeks

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
18 weeks
Average acceptance of physical smoking cravings
Tidsram: 24 weeks

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
24 weeks
Average frequency of app use
Tidsram: Weeks 0-24

Average frequency of app use over the 24-week study period. Measured by average number of app openings.
Weeks 0-24
Average duration of app use
Tidsram: Weeks 0-24

Average duration of app use over the 24-week study period.
Weeks 0-24
Average number of app modules completed
Tidsram: Weeks 0-24

Average number of app modules completed over the 24-week study period.
Weeks 0-24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wake Forest University Health Sciences

Samarbetspartners

National Cancer Institute (NCI)
National Institutes of Health (NIH)
University at Buffalo

Utredare

  • Huvudutredare: Roger Vilardaga Viera, Ph.D., Wake Forest University Health Sciences

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 augusti 2025

Primärt slutförande (Beräknad)

1 september 2028

Avslutad studie (Beräknad)

1 september 2028

Studieregistreringsdatum

Först inskickad

12 mars 2025

Först inskickad som uppfyllde QC-kriterierna

12 mars 2025

Första postat (Faktisk)

19 mars 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00112958
  • 7R01CA285331-02 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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produkt tillverkad i och exporterad från U.S.A.

Nej

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