Automated Video-Assisted Smoking Treatment for People Living With HIV

NCT ID: NCT05014282

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2026-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

Participants will be provided with a 10-week supply of nicotine patches

Counseling

Intervention Type BEHAVIORAL

Phone counseling with the state tobacco quitline.

Nicotine lozenge

Intervention Type DRUG

Participants will be provided with a 10-week supply of nicotine lozenges

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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Participants will be provided with a 10-week supply of nicotine patches

Nicotine lozenge

Intervention Type DRUG

Participants will be provided with a 10-week supply of nicotine lozenges

Smartphone-delivered automated treatment

Intervention Type BEHAVIORAL

An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotine patch

Participants will be provided with a 10-week supply of nicotine patches

Intervention Type DRUG

Counseling

Phone counseling with the state tobacco quitline.

Intervention Type BEHAVIORAL

Nicotine lozenge

Participants will be provided with a 10-week supply of nicotine lozenges

Intervention Type DRUG

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Damon J Vidrine, Dr.PH

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34787590 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CA243552

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-20262

Identifier Type: -

Identifier Source: org_study_id