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Smettere di sperimentazione ibrida per virus dell'immunodeficienza umana (QMH)

25 settembre 2026 aggiornato da: Wake Forest University Health Sciences

Studio ibrido di una terapeutica digitale per la cessazione del fumo tra le persone che vivono con l'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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

314

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Learn to Quit - HIV (LTQ-H) App

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

Altri nomi:
  • A Smo
Comparatore attivo: QuitStart App

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

Altri nomi:
  • Un DTX basato sull'evidenza progettato per la popolazione generale

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 24 weeks

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

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Wake Forest University Health Sciences

Collaboratori

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

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 agosto 2025

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

12 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

12 marzo 2025

Primo Inserito (Effettivo)

19 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00112958
  • 7R01CA285331-02 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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