Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living With HIV (Project RESOURCE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Self-Reported 7-Day Point-Prevalence Smoking Abstinence
研究概览
简要总结
This study evaluates whether Automated Treatment performed better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.
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
- 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
- 否
入选标准
- •smoked >/=100 cigarettes in lifetime
- •English or Spanish speaking
- •Currently smoke > 5 cigarettes/day
- •Willing to make a quit attempt within 1 week of enrollment
- •HIV positive
- •Process a smartphone compatible with the project app
- •Have a valid email address
排除标准
- •Currently pregnant or breastfeeding
- •Current use of smoking cessation medications
- •Enrolled in a smoking cessation study
- •Household member enrolled in the study
- •Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone
研究组 & 干预措施
Standard Treatment
Participants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment.
干预措施: Nicotine patch (Drug)
Standard Treatment
Participants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment.
干预措施: Nicotine lozenge (Drug)
Automated Treatment
Participants randomized to Automated Treatment (AT) were given a 10-week supply of nicotine patches and lozenges. AT comprised: 1) 12 proactive video-based treatment sessions, delivered weekly, that were tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
干预措施: Nicotine patch (Drug)
Automated Treatment
Participants randomized to Automated Treatment (AT) were given a 10-week supply of nicotine patches and lozenges. AT comprised: 1) 12 proactive video-based treatment sessions, delivered weekly, that were tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
干预措施: Nicotine lozenge (Drug)
Standard Treatment
Participants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment.
干预措施: Counseling (Behavioral)
Automated Treatment
Participants randomized to Automated Treatment (AT) were given a 10-week supply of nicotine patches and lozenges. AT comprised: 1) 12 proactive video-based treatment sessions, delivered weekly, that were tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
干预措施: Smartphone-delivered automated treatment (Behavioral)
结局指标
主要结局
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
时间窗: 12 Month Follow-Up
Participants who reported no smoking, not even a puff, within the past 7 days.
Self Reported 7 Day Abstinence Smoking Status
时间窗: 12 Month Follow-Up
Participants will self report 7-day abstinence smoking status
次要结局
- Biochemical Verification Via Salivary Cotinine(12 Month Follow-Up)
- Self-Reported 30-Day Point-Prevalence Smoking Abstinence(12 Month Follow-Up)
- Continuous Smoking Abstinence(12 Month Follow-Up)
- Smoking Status by Saliva Cotinine Kit(12 Month Follow-Up)
- Self Reported 24 Hours Smoking Abstinence(12 Month Follow-Up)
- 30 Day Smoking Abstinence(12 Month Follow-Up)