Tobacco Use DisorderPSFW+NCT02781090
RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers
A study testing PSFW+, AHA and Nicotine polacrilex in people with Tobacco Use Disorder and HIV, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, HIV
- What is being tested?
- PSFW+, AHA and Nicotine polacrilex
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2016to 14 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins
Baltimore, Maryland, 21287
Montefiore Medical Center
The Bronx, New York, 10804
About this study
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.
Read the 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.
- Conditions
- Tobacco Use Disorder, HIV
- Being tested
- PSFW+, AHA, Nicotine polacrilex
- Keywords
- HIV, Tobacco, Cigarette, Smoking, Social Network, Internet, Cessation
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSFW+Behavioural
Also called AHA
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.
AHABehavioural
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
Nicotine polacrilexDrug
Also called Nicotine patch
All participants, in both study arms, will be offered a 3-month supply of nicotine patches
| Study group | Role | What they receive |
|---|---|---|
| Positively Smoke Free on the Web (PSFW+) | Experimental | 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 Receives: Behavioral: PSFW+; Drug: Nicotine polacrilex |
| American Heart Association Getting Healthy (AHA) | Placebo comparator | 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 Receives: Behavioral: AHA; Drug: Nicotine polacrilex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start6 Jul 2016
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Westat, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Jonathan Shuter, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781090
- Sponsor's protocol ID
- 2015-4723
- Acronym
- PSFW+
- Status last verified
- Aug 2023
- First submitted
- 28 Apr 2016
- Last updated
- 4 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share IPD at this time.
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.
PubMed 25118794Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
PubMed 39101506Shuter 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.
PubMed 35175971
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers
- ClinicalTrials.gov ID
- NCT02781090
- Acronym / sponsor ID
- PSFW+ / 2015-4723
- Conditions
- Tobacco Use Disorder, HIV
- Keywords
- HIV, Tobacco, Cigarette, Smoking, Social Network, Internet, Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Westat, Johns Hopkins University
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 4 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positively Smoke Free on the Web (PSFW+) | Experimental | Behavioral: PSFW+, Drug: Nicotine polacrilexParticipants 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 |
| American Heart Association Getting Healthy (AHA) | Placebo comparator | Behavioral: AHA, Drug: Nicotine polacrilexParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSFW+Also: AHAPSFW+ is an eight session motivational/educational web-program promoting cessation for HIV-infected smokers. It includes a professionally administered social network/online support community. | Behavioural | Positively Smoke Free on the Web (PSFW+) |
| AHAThe 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 | Behavioural | American Heart Association Getting Healthy (AHA) |
| Nicotine polacrilexAlso: Nicotine patchAll participants, in both study arms, will be offered a 3-month supply of nicotine patches | Drug | American Heart Association Getting Healthy (AHA), Positively Smoke Free on the Web (PSFW+) |
Primary outcome
Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use
Time frame: 6 months
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).
1 secondary outcome
Website Satisfaction
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25118794Shuter 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.
- Derived from this study: PubMed 39101506Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
- Derived from this study: PubMed 35175971Shuter 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.
- Individual participant dataSharing planned: No. No plan to share IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Shuter, MD principal investigator
Montefiore Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSFW+, AHA and Nicotine polacrilex in people with Tobacco Use Disorder and HIV, run by Montefiore Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781090, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.