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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; HIV
• Intervention / Treatment: Behavioral: PSFW+; Drug: Nicotine polacrilex; Behavioral: AHA

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.

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
  • New York
    • Bronx, New York, United States, 10804
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positively Smoke Free on the Web (PSFW+); 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+; 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 Names: AHA; Drug: Nicotine polacrilex; All participants, in both study arms, will be offered a 3-month supply of nicotine patches; Other Names: Nicotine patch
Placebo Comparator: American Heart Association Getting Healthy (AHA); 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	Drug: Nicotine polacrilex; All participants, in both study arms, will be offered a 3-month supply of nicotine patches; Other Names: Nicotine patch; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Johns Hopkins University; Westat
• Investigators: Principal Investigator: Jonathan Shuter, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• Shuter J, Morales DA, Considine-Dunn SE, An LC, Stanton CA. Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):59-66. doi: 10.1097/QAI.0000000000000226.
• Shuter J, Chander G, Graham AL, Kim RS, Stanton CA. Randomized Trial of a Web-Based Tobacco Treatment and Online Community Support for People With HIV Attempting to Quit Smoking Cigarettes. J Acquir Immune Defic Syndr. 2022 Jun 1;90(2):223-231. doi: 10.1097/QAI.0000000000002936.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2016
• Primary Completion (Actual): September 14, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimated): May 24, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Smoking; Tobacco; Cigarette; Internet; Cessation; Social Network
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2015-4723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD at this time.