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