Automated Video-Assisted Smoking Treatment for People Living With HIV

Not Applicable

Active, not recruiting

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine patch; Behavioral: Counseling; Drug: Nicotine lozenge; Behavioral: Smartphone-delivered automated treatment

• Registration Number: NCT05014282
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-20
• Study Start: 2021-12-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-09-23
• Study Completion: 2026-09-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 638

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated Treatment	Nicotine patch	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
Standard Treatment	Nicotine lozenge	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.
Standard Treatment	Counseling	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.
Automated Treatment	Nicotine lozenge	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
Standard Treatment	Nicotine patch	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.
Automated Treatment	Smartphone-delivered 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

Primary Outcome Measures

Name	Time	Method
Self Reported 7 Day Abstinence Smoking Status	12 Month Follow-Up	Participants will self report 7-day abstinence smoking status

Secondary Outcome Measures

Name	Time	Method
Continuous Smoking Abstinence	12 Month Follow-Up	Number of participants who report they quit smoking
Smoking Status by Saliva Cotinine Kit	12 Month Follow-Up	Investigators will verify smoking status by collecting cotinine sample from a saliva cotinine kit.
Self Reported 24 Hours Smoking Abstinence	12 Month Follow-Up	Number of participants who report they quit smoking for 24 hours
30 Day Smoking Abstinence	12 Month Follow-Up	Number of participants who report they quit smoking for 30 days

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States