Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living With HIV (Project RESOURCE)
Overview
- Phase
- Not Applicable
- Intervention
- Nicotine patch
- Conditions
- Smoking Cessation
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 638
- Locations
- 1
- Primary Endpoint
- Self Reported 7 Day Abstinence Smoking Status
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This study will evaluate if Automated Treatment performs better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's tobacco quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
Intervention: Nicotine patch
Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's tobacco quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
Intervention: Counseling
Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's tobacco quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
Intervention: Nicotine lozenge
Automated Treatment
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content
Intervention: Nicotine patch
Automated Treatment
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content
Intervention: Nicotine lozenge
Automated Treatment
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content
Intervention: Smartphone-delivered automated treatment
Outcomes
Primary Outcomes
Self Reported 7 Day Abstinence Smoking Status
Time Frame: 12 Month Follow-Up
Participants will self report 7-day abstinence smoking status
Secondary Outcomes
- 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)