Automated Video-Assisted Smoking Treatment for People Living With HIV

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Smoking Cessation

Treatments: Drug: Nicotine patch; Behavioral: Counseling; Behavioral: Smartphone-delivered automated treatment; Drug: Nicotine lozenge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05014282

R01CA243552 (U.S. NIH Grant/Contract)

MCC-20262

Details and patient eligibility

About

This study will evaluate if Automated Treatment performs better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.

Enrollment: 638 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

638 participants in 2 patient groups

Standard Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine lozenge

Behavioral: Counseling

Drug: Nicotine patch

Automated Treatment

Experimental group

Description:

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

Treatment:

Drug: Nicotine lozenge

Behavioral: Smartphone-delivered automated treatment

Drug: Nicotine patch