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

This study is not yet open for participant recruitment.
Verified May 2016 by Jonathan Shuter, Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781090
First Posted: May 24, 2016
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Westat
Johns Hopkins University
Information provided by (Responsible Party):
Jonathan Shuter, Montefiore Medical Center
  Purpose
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.

Condition Intervention
Tobacco Use Disorder HIV Behavioral: PSFW+ Behavioral: AHA Drug: Nicotine polacrilex

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers

Resource links provided by NLM:


Further study details as provided by Jonathan Shuter, Montefiore Medical Center:

Primary Outcome Measures:
  • 7 day point-prevalence abstinence from tobacco use [ Time Frame: 6 months ]
    Biochemically verified (exhaled carbon monoxide), self-reported, point prevalent abstinence from tobacco use


Secondary Outcome Measures:
  • Website satisfaction [ Time Frame: 6 months ]
    Satisfaction surveys will be administered to all study participants


Estimated Enrollment: 550
Study Start Date: June 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positively Smoke Free on the Web+
Subjects will be assigned to the PSFW+ website and social network. They will also be offered a three-month supply of nicotine patches.
Behavioral: PSFW+
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.
Other Name: AHA
Drug: Nicotine polacrilex
All participants, in both study arms, will be offered a 3-month supply of nicotine patches
Other Name: Nicotine patch
Placebo Comparator: American Heart Assoc Getting Healthy
Subjects will be assigned to the AHA Getting Healthy website. They will also be offered a three-month supply of nicotine patches.
Behavioral: AHA
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
Drug: Nicotine polacrilex
All participants, in both study arms, will be offered a 3-month supply of nicotine patches
Other Name: Nicotine patch

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18 or older
  2. current smoking as defined by a validated tobacco use measure
  3. laboratory confirmed HIV-infection; 3) residence in commuting distance to the Bronx, NY or Baltimore, MD
  4. English language fluency
  5. motivation to quit within the next 30 days
  6. at least weekly Internet and email access
  7. 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)
  8. willingness to provide informed consent and undergo randomization.

Exclusion Criteria:

  1. previous participation in any trial of Positively Smoke Free interventions or use of PSFW+
  2. pregnancy
  3. contraindication to nicotine replacement therapy
  4. current participation in an active smoking cessation treatment (e.g., group therapy, use of pharmacotherapy)
  5. PSFW+ seed users will be excluded
  6. 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781090


Contacts
Contact: Jonathan Shuter, MD 718-920-7845 jshuter@montefiore.org
Contact: Diana Okwali, MPH 718-920-5650 dokwali@montefiore.org

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10804
Sponsors and Collaborators
Montefiore Medical Center
Westat
Johns Hopkins University
Investigators
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
  More Information

Publications:
Responsible Party: Jonathan Shuter, Professor of Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02781090     History of Changes
Other Study ID Numbers: 1R01CA192954 ( U.S. NIH Grant/Contract )
First Submitted: April 28, 2016
First Posted: May 24, 2016
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD at this time.

Keywords provided by Jonathan Shuter, Montefiore Medical Center:
HIV
Tobacco
Cigarette
Smoking
Social Network
Internet
Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action