Tobacco Cessation, Tobacco Dependence, Tobacco Use Cessation, Tobacco Use Disorder, Tobacco-Use Disorder, Virus, Human Immunodeficiency
Conditions
Keywords
Tobacco Use Cessation, Tobacco Cessation, Tobacco Use Disorder, Tobacco Dependence, Tobacco-Use Disorder, Virus, Human Immunodeficiency
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.
Interventions
BEHAVIORALWeb-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).
BEHAVIORALStandard of Care
advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
Sponsors
Albert Einstein College of Medicine
University of Michigan
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Point-prevalence tobacco abstinence | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Participation in Intervention (Feasibility) | 3 Months (duration of intervention) | 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. |
| Knowledge and Behavior Change | Day 0, 42, 121 | 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). |
Countries
United States
Outcome results
None listed