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

Georgetown University

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Behavioral: Web-Based Tailored Smoking Cessation Intervention; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01570595

R21CA163100 [NIH Grant #]

3358936

R21CA163100 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Web-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Web-Based Tailored Smoking Cessation Intervention

Standard Care

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard of Care

Behavioral: Web-Based Tailored Smoking Cessation Intervention