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금연 문제 인간 면역 결핍 바이러스 하이브리드 시험 (QMH)

2026년 9월 25일 업데이트: Wake Forest University Health Sciences

HIV와 함께 사는 사람의 금연을위한 디지털 치료의 하이브리드 시험

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

314

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Learn to Quit - HIV (LTQ-H) App

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

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.

다른 이름들:
  • 흡연 중단 디지털 치료 (DTX)
활성 비교기: QuitStart App

an evidence-based DTx designed for the general population

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.

다른 이름들:
  • 일반 인구를 위해 설계된 증거 기반 DTX

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 24 weeks

Change in self-reported number of cigarettes smoked per day, averaged within groups.

24 weeks
Average number of quit attempts
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Weeks 0-24

Average duration of app use over the 24-week study period.

Weeks 0-24
Average number of app modules completed
기간: Weeks 0-24

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

Weeks 0-24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 18일

기본 완료 (추정된)

2028년 9월 1일

연구 완료 (추정된)

2028년 9월 1일

연구 등록 날짜

최초 제출

2025년 3월 12일

QC 기준을 충족하는 최초 제출

2025년 3월 12일

처음 게시됨 (실제)

2025년 3월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 25일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IRB00112958
  • 7R01CA285331-02 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .