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Opuszczenie ma znaczenie ludzkie badanie hybrydowe wirusa niedoboru odporności (QMH)

25 września 2026 zaktualizowane przez: Wake Forest University Health Sciences

Hybrydowe badanie cyfrowego terapeutycznego do rzucenia palenia wśród osób żyjących z 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

314

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Learn to Quit - HIV (LTQ-H) App

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

Inne nazwy:
  • cyfrowe terapeutyczne (DTX) palenie
Aktywny komparator: QuitStart App

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

Inne nazwy:
  • DTX oparty na dowodach zaprojektowany dla ogólnej populacji

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 24 weeks

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

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

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Wake Forest University Health Sciences

Współpracownicy

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

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 sierpnia 2025

Zakończenie podstawowe (Szacowany)

1 września 2028

Ukończenie studiów (Szacowany)

1 września 2028

Daty rejestracji na studia

Pierwszy przesłany

12 marca 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 marca 2025

Pierwszy wysłany (Rzeczywisty)

19 marca 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00112958
  • 7R01CA285331-02 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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