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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers

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

Intervention / Treatment
-----------------
* Behavioral: Web-Based Tailored Smoking Cessation Intervention
* Behavioral: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Based Intervention<br>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. | Behavioral: Web-Based Tailored Smoking Cessation Intervention<br>* 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).<br>* Other names: Web-Based Cessation;|
| Active Comparator: Standard Care<br>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). | Behavioral: Web-Based Tailored Smoking Cessation Intervention<br>* 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).<br>* Other names: Web-Based Cessation;Behavioral: Standard of Care<br>* advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Point-prevalence tobacco abstinence | The proportion of each group achieving 24-hour point prevalence abstinence at Visit 3 (i.e., abstinence on or around Day 121 - 3 months post-Quit Day in the Intervention condition) by exhaled carbon monoxide, an accepted method for biochemical validation of abstinence. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Participation in Intervention (Feasibility) | Intervention feasibility will be assessed using variables such as total # of logins, # of sessions viewed, # of web pages viewed, # of mouse clicks on interactive features, total time logged on to the site (automatic logoff occurs after 30 minutes of inactivity), proportion completing the final study visit, program satisfaction survey results, and total # of reminder phone calls/texts placed by clinic staff. | 3 Months (duration of intervention) | 
| Knowledge and Behavior Change | Validated measures will be used to collect data on continuous abstinence, number of quit attempts, and current daily cigarette consumption. Composite quit indices will be analyzed, especially the combination of 3 month continuous abstinence with expired carbon monoxide (ECO) confirmation. We will also analyze results of validated measures that have known associations with cessation outcomes (tobacco knowledge, depression, anxiety, motivation to quit, self-concept, perceived risks/benefits, self-efficacy, and decisional balance). | Day 0, 42, 121 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco Use Disorder, Tobacco-Use Disorder, Virus, Human Immunodeficiency, Tobacco Use Cessation, Tobacco Cessation, Tobacco Dependence