Optimizing Tobacco Treatment Delivery for People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Tobacco use abstinence
研究概览
简要总结
The purpose of this study is to conduct a randomized trial to evaluate a proactive, opt-out model of provider contact to deliver smoking cessation support for people living with HIV compared to standard care support delivered through traditional clinic pathways. Investigators will also evaluate implementation outcomes to identify barriers and facilitators towards future implementation. Investigators hope to define best practices and optimize the delivery of smoking cessation interventions for people living with HIV.
详细描述
This hybrid effectiveness-implementation trial presents on opportunity to optimize tobacco treatment delivery for people living with HIV (PLWH), and identify barriers and facilitators towards future implementation. We are proposing a comparison of Treatment As Usual (TAU; reactive, opt-in tobacco treatment using standard clinical pathways) vs Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Participants will be randomized in a 1:1 allocation. The primary aim is to compare rates of cessation and quit attempts at the Week 12 follow-up between participants who received TAU versus PrOMOTE. As a secondary aim we will characterize key determinants of PrOMOTE reach, implementation fidelity, adherence, and acceptability. We hypothesize that the PrOMOTE intervention will increase cessation rates and number of quit attempts, and that it will result in greater reach and pharmacotherapy delivery compared to TAU. Key determinants of PrOMOTE implementation outcomes will also be characterized. An exploratory assessment of CD4 cell count and HIV viral load, in addition to durability of smoking cessation outcomes, will also be assessed. By optimizing the delivery of effective tobacco treatments for PLWH, we hope to increase the number of people receiving tobacco treatment, increase tobacco cessation rates, and reduce the risk of morbidity and mortality from smoking-related causes.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 and older
- •Current diagnosis of HIV
- •Current smoker (defined as self-report of current smoking)
- •Willing to be randomized
- •English speaking
排除标准
- •Currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking nicotine replacement therapy or other cessation medications, enrolled in the Quitline, or in another study)
- •Currently imprisoned
- •Pregnant women
- •Non-English speaking persons
研究组 & 干预措施
Treatment as Usual
Treatment as Usual (TAU) participants will follow traditional clinic pathways for receiving tobacco treatment in the Medical University of South Carolina Health Infectious Disease outpatient clinic. All patients randomized to TAU will have the opportunity to access smoking cessation pharmacotherapy from the Infectious Disease clinical pharmacist.
ProMOTE
In the PrOMOTE group, the participants will be contacted by the clinical pharmacist on the tobacco treatment staff three times for medication prescriptions and refills. They will also receive brief counseling and motivational interviewing by the clinical pharmacist.
干预措施: PrOMOTE (Behavioral)
结局指标
主要结局
Tobacco use abstinence
时间窗: 7 days
Self-reported and confirmed by breath carbon monoxide test
次要结局
- Reach(24 weeks (study completion))
- Fidelity of intervention(24 weeks (study completion))
- Perceived barriers to the outcomes(24 weeks (study completion))
- Acceptability of intervention(24 weeks (study completion))
研究者
Alana Rojewski
Assistant Professor
Medical University of South Carolina