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临床试验/NCT03670316
NCT03670316已完成4 期

Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 371 人开始时间: 2020年8月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
371
试验地点
2
主要终点
7-day point-prevalence abstinence

研究概览

简要总结

To determine the efficacy of an algorithm designed to recommend smoking cessation-related pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS.

详细描述

Smoking remains the leading cause of preventable death and disability in the United States. Whereas smoking has declined significantly among individuals in the general population, it is clustered in populations of vulnerable individuals such as people living with HIV/AIDS (PLWH) in whom smoking prevalence rates and resulting comorbidity rates remain high. Medical advances in the treatment of HIV have resulted in substantial increases in life expectancy among PLWH and as a consequence PLWH smokers are now, more than ever, at heightened risk for tobacco-related illnesses and death. PLWH smokers engaged in treatment lose more years of life due to smoking now than to HIV disease. Although PLWH smokers engaged in HIV care typically see a medical provider every 4-6 months, smoking cessation treatment and referral is often not part of routine HIV care. While 94% of HIV treatment providers indicated that they would be willing to provide smoking cessation services to their patients, few have received training in how to provide smoking cessation services. With seven first line pharmacotherapies available for smoking cessation, development of algorithms to assist providers in selecting the most appropriate pharmacotherapy is an important but untested strategy to increase smoking cessation in PLWH. The purpose of this proposal is to conduct a mixed efficacy/effectiveness trial comparing an algorithm treatment with prescription cost off sets and quit line referral (AT) to an enhanced Treatment as Usual (quit line referral only; eTAU) group. Six hundred PLWH smokers will be recruited at the University of Alabama at Birmingham, University of Washington, and Fenway Health HIV clinics and will be randomized to receive AT or eTAU. All AT smokers will receive active treatment for twelve weeks regardless of stated motivation or intention to quit. eTAU smokers will be referred to quit line services and HIV providers may elect to treat smoking as part of standard of care. Participants will remain in the study for 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrollment in the CNICS clinical cohort.
  • 18 years or older;
  • Receiving HIV care at the UAB, UW or Fenway Health clinics and not anticipating changing clinics over the next six months
  • Smoking greater than or equal to 5 cigarettes per day (cpd) for the past month
  • Living in an unrestricted environment that allows smoking.

排除标准

  • Cognitive impairment such that unable to provide informed consent;
  • Non-English speaking;
  • Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent;
  • Currently receiving smoking cessation treatment.

研究组 & 干预措施

Algorithm Treatment plus referral to quitline (AT)

Experimental

will be assigned a pharmacotherapy treatment regimen recommended to their provider.

干预措施: Algorithm Treatment (Drug)

Quitline (eTAU)

Active Comparator

will be referred to quitlines, telephone-based tobacco cessation services.

干预措施: Quitline only (Other)

结局指标

主要结局

7-day point-prevalence abstinence

时间窗: 6 months

Number of cigarettes smoked over the past 7 days

7-day Point-prevalence Abstinence

时间窗: 6 months

Self-report of cigarette smoking in the last 7 days

次要结局

  • Number of prescriptions written(6 months)
  • Cigarettes per day(6 months)
  • 24 hour quit attempts(6 months)
  • Cigarettes Per Day(6 months)
  • Number of Participants Who Attempt to Not Smoke for 24-Hours at 6 Months(6 months)
  • Number of Prescriptions Written by 6-months(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Cropsey

Professor

University of Alabama at Birmingham

研究点 (2)

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