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Aufhören von Angelegenheiten menschlicher Immundefizienz -Virus Hybridversuch (QMH)

25. September 2026 aktualisiert von: Wake Forest University Health Sciences

Hybridversuch mit einem digitalen Therapeutika für die Raucherentwöhnung bei Personen mit 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

314

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Learn to Quit - HIV (LTQ-H) App

a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)
Verhalten: 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.

Andere Namen:
  • Eine digitale Therapeutikerin für Raucherentwöhnung (DTX)
Aktiver Komparator: QuitStart App

an evidence-based DTx designed for the general population
Verhalten: 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.

Andere Namen:
  • ein evidenzbasierter DTX für die allgemeine Bevölkerung entwickelt

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 24 weeks

Change in self-reported number of cigarettes smoked per day, averaged within groups.
24 weeks
Average number of quit attempts
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Weeks 0-24

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

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. August 2025

Primärer Abschluss (Geschätzt)

1. September 2028

Studienabschluss (Geschätzt)

1. September 2028

Studienanmeldedaten

Zuerst eingereicht

12. März 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. März 2025

Zuerst gepostet (Tatsächlich)

19. März 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00112958
  • 7R01CA285331-02 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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