Automated Video-Assisted Smoking Treatment for People Living With HIV

Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living With HIV (Project RESOURCE)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine patch; Behavioral: Counseling; Drug: Nicotine lozenge; Behavioral: Smartphone-delivered automated treatment

• Study Type: Interventional
• Enrollment (Actual): 638
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Nicotine patch; Participants will be provided with a 10-week supply of nicotine patches; Behavioral: Counseling; Phone counseling with the state tobacco quitline.; Drug: Nicotine lozenge; Participants will be provided with a 10-week supply of nicotine lozenges
Experimental: 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	Drug: Nicotine patch; Participants will be provided with a 10-week supply of nicotine patches; Drug: Nicotine lozenge; Participants will be provided with a 10-week supply of nicotine lozenges; Behavioral: Smartphone-delivered automated treatment; An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Reported 7 Day Abstinence Smoking Status	Participants will self report 7-day abstinence smoking status	12 Month Follow-Up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Damon J Vidrine, Dr.PH, Moffitt Cancer Center

Publications and helpful links

General Publications

• Vidrine DJ, Bui TC, Businelle MS, Shih YT, Sutton SK, Shahani L, Hoover DS, Bowles K, Vidrine JI. Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 17;10(11):e33183. doi: 10.2196/33183.

Helpful Links

• Moffitt Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): September 23, 2025
• Study Completion (Estimated): September 23, 2026

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Tobacco Use Cessation Devices; Counseling
• Other Study ID Numbers: MCC-20262; R01CA243552 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No