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临床试验/NCT05746442
NCT05746442招募中不适用

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (Project END-IT)

H. Lee Moffitt Cancer Center and Research Institute3 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年1月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
3
主要终点
Self Reported 7 Day Abstinence Smoking Status

研究概览

简要总结

The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • •1) being aged ≥18 years
  • •2) being HIV-positive
  • •3) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day)
  • •4) willing to set a date for a quit attempt within 2 weeks of study enrollment
  • •5) being able to provide written informed consent to participate
  • •6) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form

排除标准

  • •1) history of a medical condition that precludes use of nicotine replacement therapy
  • •2) physician/clinician deemed ineligible to participate based on medical or psychiatric condition
  • •3) enrolled in another cessation program or use of other cessation medications.

研究组 & 干预措施

Standard Care Group

Active Comparator

Participants will receive brief advice and education materials to quit smoking along with brief weekly assessments to be completed on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

干预措施: Diet Assessment (Behavioral)

Automated Messaging Treatment Group

Experimental

Participants will receive brief advice and education materials to quit smoking, along with brief weekly assessments and an interactive phone-based treatment program delivered on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

干预措施: Brief Advice to Quit and Smoking Cessation Self Help Materials (Behavioral)

Standard Care Group

Active Comparator

Participants will receive brief advice and education materials to quit smoking along with brief weekly assessments to be completed on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

干预措施: Brief Advice to Quit and Smoking Cessation Self Help Materials (Behavioral)

Automated Messaging Treatment Group

Experimental

Participants will receive brief advice and education materials to quit smoking, along with brief weekly assessments and an interactive phone-based treatment program delivered on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

干预措施: Smartphone-delivered Automated Messaging (Behavioral)

Automated Messaging Treatment Group

Experimental

Participants will receive brief advice and education materials to quit smoking, along with brief weekly assessments and an interactive phone-based treatment program delivered on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

干预措施: Nicotine patch (Drug)

Standard Care Group

Active Comparator

Participants will receive brief advice and education materials to quit smoking along with brief weekly assessments to be completed on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

干预措施: Nicotine patch (Drug)

结局指标

主要结局

Self Reported 7 Day Abstinence Smoking Status

时间窗: 12 Month Follow-Up

Participants will self report 7-day abstinence smoking status

Smoking Status by Expired Carbon Monoxide

时间窗: 12 Month Follow-up

Investigators will use a CO monitor to verify smoking status biochemically

次要结局

  • Self Reported 7 Day Abstinence Smoking Status at 3 Months(At 3 Months)
  • Smoking Status by Expired Carbon Monoxide at 3 Months(At 3 Months)
  • Self Reported 7 Day Abstinence Smoking Status at 6 Months(At 6 Months)
  • Smoking Status by Expired Carbon Monoxide at 6 Months(At 6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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