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

Study Overview
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Brief Summary
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This trial will compare the efficacy of Positively Smoke Free on the Web+ (a smoking cessation program + social network for HIV-infected smokers) to the American Heart Association Getting Healthy website in promoting abstinence in a group of HIV-infected smokers. All participants will be offered a three-month supply of nicotine patches.

Detailed Description
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There are 1.1 million persons living with HIV (PLWH) in the US: 60% smoke cigarettes and 75% are interested in quitting. Two-thirds of PLWH use the Internet, making this a promising avenue to deliver smoking cessation treatment. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns. Cigarette smoking is responsible for 24%--61% of deaths among PLWH, and 30% of non-AIDS defining malignancies. It is driving the alarming rise in lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. Cessation websites offer smokers convenience, low (or no) cost, and anonymity; however, there are no publicly available web-based cessation programs specifically designed for PLWH smokers. Smokers living with HIV have high rates of nicotine dependence, anxiety, depression, loneliness, and substance use. The investigators developed Positively Smoke Free on the Web (PSFW), a theory-driven, culturally tailored web-based program designed to address the specific needs of PLWH smokers. The investigators' NCI-funded R21 pilot of PSFW demonstrated moderate-high levels of adherence and yielded higher 3-month abstinence rates compared to standard care (10% vs. 4%). The investigators' prior research on web-based cessation interventions has shown that smokers who participate in an online community - whether passively reading posts by others or actively engaging in online discussions - are more than twice as likely to achieve abstinence even after controlling for a broad range of covariates. In preparation for the proposed study, the investigators' partners at Truth Initiative (formerly known as the American Legacy Foundation) have enhanced and modernized PSFW by integrating an online community platform (now PSFW+), developing a training protocol for PLWH smoker seed users (to provide a critical mass of social network participants), and recruiting and training 11 PLWH smokers for this role. The prototype PSFW+ application has been successfully alpha- and beta-tested in anticipation of the randomized controlled trial. The investigators propose a study that will compare the efficacy of the PSFW+ smoking cessation website to an attention-matched website promoting cardiovascular health in a randomized controlled trial with repeated measures at baseline, 1, 3, and 6 months. Participants will be N=550 PLWH smokers interested in quitting in the next 30 days. All participants will be offered nicotine replacement therapy. It is hypothesized that PSFW+ will outperform the control condition on the primary outcome of 7-day point prevalence abstinence at 6 months post-randomization. Secondary aims and exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of treatment outcome (e.g., depression, anxiety, social support, loneliness, self-efficacy). Establishing the effectiveness of a web-based smoking cessation program for PLWH that has broad reach and could be scaled to reach PLWH smokers throughout the US would not only represent an enormous advance in the fight against tobacco use in PLWH, but would also provide a clearer understanding of the role of targeted, web-based health interventions in comprehensive HIV care.

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

Conditions
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HIV, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: PSFW+
* Behavioral: AHA
* Drug: Nicotine polacrilex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older current smoking as defined by a validated tobacco use measure laboratory confirmed HIV-infection; 3) residence in commuting distance to the Bronx, NY or Baltimore, MD English language fluency motivation to quit within the next 30 days at least weekly Internet and email access REALM literacy score of 19/66 or above, indicating reading level of at least 4-6 grade (PSFW content was written for this literacy level) willingness to provide informed consent and undergo randomization. Exclusion Criteria: previous participation in any trial of Positively Smoke Free interventions or use of PSFW+ pregnancy contraindication to nicotine replacement therapy current participation in an active smoking cessation treatment (e.g., group therapy, use of pharmacotherapy) PSFW+ seed users will be excluded To avoid study condition contamination and to maintain the statistical independence of subject outcomes, otherwise eligible individuals who are spouses, partners, and/or roommates of study participants will be excluded. All ineligible patients will receive a Positively Smoke Free smoking cessation brochure and will be encouraged to access nationally-available (free) quitline counseling.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positively Smoke Free on the Web (PSFW+)<br>Participants were assigned to the multimodal PSFW+ interactive web-based behavioral intervention hosted within an online social network. PSFW+: PSFW+ is an intensive eight session motivational/educational web-program, based on social cognitive theory, designed to promote cessation among HIV-infected smokers. It included a professionally administered social network/online support community. Nicotine polacrilex: All participants were offered a 3-month supply of nicotine patches | Behavioral: PSFW+<br>* PSFW+ is an eight session motivational/educational web-program promoting cessation for HIV-infected smokers. It includes a professionally administered social network/online support community.<br>* Other names: AHA;Drug: Nicotine polacrilex<br>* All participants, in both study arms, will be offered a 3-month supply of nicotine patches<br>* Other names: Nicotine patch;|
| Placebo Comparator: American Heart Association Getting Healthy (AHA)<br>Participants were assigned to the AHA Getting Healthy web-based control intervention program (the AHA later changed in name from Getting Healthy to My Life's Check, Life's Simple 7 AHA: The AHA Getting Healthy website is an attention-matched, health-promoting, seven-module website developed by the American Heart Association to encourage healthy behaviors in the general population Nicotine polacrilex: All participants were offered a 3-month supply of nicotine patches | Behavioral: AHA<br>* The AHA Getting Healthy website is a health-promoting, seven-module website developed by the American Heart Association to encourage healthy behaviors in the general population<br>Drug: Nicotine polacrilex<br>* All participants, in both study arms, will be offered a 3-month supply of nicotine patches<br>* Other names: Nicotine patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use | The number of participants achieving 7-day Point Prevalence Abstinence (PPA) from tobacco use at 6 months was determined for each study arm. 7-day PPA parameters for this study were based on the number of participants demonstrating biochemically confirmed exhaled carbon monoxide (< 10ppm). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Website Satisfaction | Questionnaires were administered to all study participants at 6 months to assess participant satisfaction with the PSFW+ and AHA 'Getting Healthy' website and online tools. Participants were asked to provide feedback regarding their level of satisfaction with the online platform using the following response options: Not at all Satisfied, A little Satisfied, Moderately Satisfied, Very Satisfied, or Extremely Satisfied. Participants responses were aggregated and tabulated. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Tobacco, Cigarette, Smoking, Social Network, Internet, Cessation