Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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

The purpose of this study is to evaluate the first web-based cessation program developed expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care with a primary outcome of 3 month point-prevalence abstinence.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers

NCT02781090

Tobacco Use Disorder HIV

COMPLETED NA

The Positively Quit Trial for Smoking Cessation

NCT04449458

Cigarette Smoking

RECRUITING NA

Smoking, Stress, HIV and Mobile Technology

NCT05709002

Cigarette Smoking

COMPLETED NA

Motivation and Patch Treatment for HIV-positive Smokers

NCT00551720

HIV Infections Smoking Cessation

COMPLETED PHASE3

V+PSF-M for Tobacco Cessation in HIV Care in India

NCT05786547

Human Immunodeficiency Virus Smoking Cessation Smoking, Tobacco

RECRUITING PHASE3

Detailed Description

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

Positively Smoke Free on the Web is the first web-based cessation program developed expressly for people living with HIV (PLWH) who smoke tobacco. It is a resource that is ready for clinical use, but its feasibility and efficacy have yet to be studied. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) in a cohort of 69 PLWH smokers, and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care (total N = 138) with a primary outcome of 3 month point-prevalence abstinence.

Conditions

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

Tobacco Use Cessation Tobacco Cessation Tobacco Use Disorder Tobacco Dependence Tobacco-Use Disorder Virus, Human Immunodeficiency

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Web-Based Intervention

This group will be asked to participate in the online quit smoking program. At their first visit, they will be given an ID number to log in to the quit smoking program, and they will complete their first log in with the research assistant. The online program is made up of 8 separate online sessions that are supposed to be completed approximately once per week. Each sessions is written to take an average reader 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. At the first visit, participants are asked to provide an email address and/or cell phone number so reminders can be sent, by email or text message, to complete the sessions. If participants are late completing a session, they may receive call from clinic staff as a reminder.

Group Type EXPERIMENTAL

Web-Based Tailored Smoking Cessation Intervention

Intervention Type BEHAVIORAL

The Experimental group will be given an ID number to log in to the quit smoking program, and complete their first log-in with a research assistant. The online program is made up of 8 separate, weekly online sessions that take approximately 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. Participants are asked to provide an email address and/or cell phone number so reminders can be sent to complete the sessions. If participants are late completing a session, they will receive a call from clinic staff as a reminder. The "standard care" group will receive advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

Standard Care

This group will receive "standard care" for their smoking, including advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

Group Type ACTIVE_COMPARATOR

Web-Based Tailored Smoking Cessation Intervention

Intervention Type BEHAVIORAL

The Experimental group will be given an ID number to log in to the quit smoking program, and complete their first log-in with a research assistant. The online program is made up of 8 separate, weekly online sessions that take approximately 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. Participants are asked to provide an email address and/or cell phone number so reminders can be sent to complete the sessions. If participants are late completing a session, they will receive a call from clinic staff as a reminder. The "standard care" group will receive advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

Standard of Care

Intervention Type BEHAVIORAL

advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

Interventions

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

Web-Based Tailored Smoking Cessation Intervention

The Experimental group will be given an ID number to log in to the quit smoking program, and complete their first log-in with a research assistant. The online program is made up of 8 separate, weekly online sessions that take approximately 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. Participants are asked to provide an email address and/or cell phone number so reminders can be sent to complete the sessions. If participants are late completing a session, they will receive a call from clinic staff as a reminder. The "standard care" group will receive advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

Intervention Type BEHAVIORAL

Standard of Care

advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tailored Cessation Web-Based Intervention Web-Based Cessation

Eligibility Criteria

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

Inclusion Criteria

* Laboratory confirmation of HIV infection
* Montefiore Medical Center Infectious Disease Clinic patient
* Current tobacco user
* Affirmed motivation to quit within the next 6 months
* Have home access to the Internet
* Read above 4th grade level (by REALM)
* Willingness to grant informed consent and undergo randomization

Exclusion Criteria

* Pregnant or breastfeeding women
* People with contraindications to nicotine replacement therapy
* People currently receiving other tobacco treatment
* Spouses, partners, and/or roommates of current study participants

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No