跳至主要内容
临床试验/NCT04505371
NCT04505371已完成不适用

Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV

Seattle Institute for Biomedical and Clinical Research2 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2021年6月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
235
试验地点
2
主要终点
Any 24-hour intentional quit attempt

研究概览

简要总结

This project will compare the effectiveness of an HIV-specific comprehensive wellness intervention designed to have broad appeal to smokers living with HIV to the effectiveness of standard care services that include referral to the National VA Quitline and SmokefreeVET texting program. Participants in both arms will have access to pharmacotherapy available through their Veterans Affairs (VA) healthcare providers.

详细描述

Tobacco use remains the leading preventable cause of death and illness in our society, and smoking rates are disproportionately high among people living with HIV. NCI, nicotine dependence researchers, and HIV clinicians have all called for research to evaluate targeted and tailored smoking cessation programs for smokers living with HIV (SLWH). Research suggests SLWH are largely unaware of the HIV-specific deleterious effects of smoking and often lack motivation and confidence in their ability to quit. For these reasons, we developed the Wellness Intervention for Smokers with HIV (WISH).

Similar to standard care cessation services available to Veterans, WISH is delivered remotely by mobile phone (voice and text message). The program is designed for all SLWH, regardless of their initial motivation to quit. WISH follows evidence-based, best practice guidelines for nicotine dependence treatment, but is innovative in its use of a more comprehensive wellness approach. That is, the intervention addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all SLWH, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.

Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study, allowing use of these standard services to be compared across study groups.

In this two-group randomized trial, we will compare the effectiveness of WISH to standard care services offered through the National VA Quitline and the SmokefreeVET texting program (tobacco cessation services available to all Veterans). Participants in both study groups can receive phone/ text counseling and have access to pharmacotherapy through VA. Cessation services in both study groups will be provided and overseen by the non-VA sites that developed each program.

Smoking-related outcomes will include 7-day point prevalence smoking abstinence and presence of any 24-hour intentional quit attempts, prolonged abstinence, and change in cigarettes per day. We will measure change in smoking-related knowledge, motivation and behavioral skills, as well as intervention reach and implementation. We will also describe comorbidities and explore intervention impact on markers of immune status and mortality risk using clinical data resources available through the Veterans Aging Cohort Study (VACS).

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
Double (Investigator, Outcomes Assessor)

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

  • In care in the VA
  • HIV+ serostatus
  • Currently smoking 5+ cigarettes daily
  • Access to cell phone with text messaging capabilities
  • English speaking

排除标准

  • Psychosis, dementia or significant cognitive impairment documented in the EHR
  • Documented or observed hearing or comprehension difficulties that would preclude participation in study telephone calls
  • Currently receiving cessation counseling or using an FDA approved treatment to quit smoking
  • Institutionalized/imprisoned

研究组 & 干预措施

Control - Standard Care

No Intervention

The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.

Intervention - Wellness Intervention for Smokers with HIV

Experimental

The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.

干预措施: Wellness Intervention for Smokers with HIV (Behavioral)

结局指标

主要结局

Any 24-hour intentional quit attempt

时间窗: 3 and 6 months postrandomization

The primary outcome will be presence of an intentional quit attempt \[yes/no\] reported between randomization and 6 month follow-up. Quit attempts will be assessed at each follow-up.

7-day point-prevalence abstinence (PPA)

时间窗: 6 months post-randomization

Smoking abstinence at 6-month follow-up by self-report and biochemically confirmed via saliva cotinine for a small selected group of individuals. Cotinine levels \< 10 ng/ml and a self-report of 7 day PPA will be required to be coded a nonsmoker.

7-day Point-prevalence Abstinence (PPA)

时间窗: 6 months post-randomization

Self-reported smoking abstinence at 6-month follow-up. To assess disconfirmation rates, abstinence will be biochemically confirmed via saliva cotinine among a random subset of people reporting tobacco abstinence. In this subset, abstinence will be defined by a negative reading on the Alere iScreen saliva dipstick, which uses a cut-point of \<30 ng/ml cotinine to indicate no nicotine exposure.

Any 24-hour Intentional Quit Attempt

时间窗: 6 months post-randomization

The primary outcome will be presence of an intentional quit attempt \[yes/no\] reported between randomization and 6 month follow-up. Quit attempts will be assessed at each follow-up.

次要结局

  • Floating prolonged abstinence(3 and 6 months post-randomization)
  • HIV-specific smoking knowledge(3 and 6 months post-randomization)
  • Intentional quit attempt frequency and duration(3 and 6 months post-randomization)
  • 7-day self-report point-prevalence abstinence (PPA)(3 and 6 months post-randomization)
  • 30-day self-report point-prevalence abstinence (PPA)(3, 6, 12 months post-randomization)
  • Smoking cessation related to self-efficacy(3 and 6 months post-randomization)
  • Absolute CD4 count(6 and 12 months post-randomization)
  • VACS index 2.0(6 and 12 months post-randomization)
  • Cigarettes smoked per day(3 and 6 months post-randomization)
  • Motivation to quit smoking(3 and 6 months post-randomization)
  • Nicotine withdrawal symptom management (behavioral skills)(3 and 6 months post-randomization)
  • Cessation medication use and adherence (behavioral skills)(3 and 6 months post-randomization)
  • Floating Prolonged Abstinence(3 and 6 months post-randomization)
  • 7-day Self-report Point-prevalence Abstinence (PPA)(3 and 6 months post-randomization)
  • 30-day Self-report Point-prevalence Abstinence (PPA)(3, 6, 12 months post-randomization)
  • Cigarettes Smoked Per Day(3 and 6 months post-randomization)
  • HIV-specific Smoking Knowledge(3 and 6 months post-randomization)
  • Motivation to Quit Smoking(3 and 6 months post-randomization)
  • Smoking Cessation Related to Self-efficacy(3 and 6 months post-randomization)
  • Nicotine Withdrawal Symptom Management (Behavioral Skills)(3 and 6 months post-randomization)
  • Cessation Medication Use and Adherence (Behavioral Skills)(3 and 6 months post-randomization)
  • Absolute CD4 Count(6 and 12 months post-randomization)
  • VACS Index 2.0(6 and 12 months post-randomization)
  • Intentional Quit Attempt Frequency and Duration(3 and 6 months post-randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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