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NCT02781090: PSFW+

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

Completed NA Results posted Last updated 4 August 2023
What this trial tests

NA trial testing PSFW+ in Tobacco Use Disorder in 512 participants. Completed in 14 September 2020.

Timeline
6 July 2016
Primary endpoint
14 September 2020
14 September 2020

Quick facts

Lead sponsorMontefiore Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment512
Start date6 July 2016
Primary completion14 September 2020
Estimated completion14 September 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Montefiore Medical Center

Who can join

18 and older, any sex, with Tobacco Use Disorder or HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use Primary · 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).

GroupValue95% CI
Positively Smoke Free on the Web (PSFW+)38
American Heart Association Getting Healthy (AHA)22
Positively Smoke Free on the Web (PSFW+)217
American Heart Association Getting Healthy (AHA)229
Website Satisfaction Secondary · Up to 6 months

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.

Not at all satisfied
GroupValue95% CI
Positively Smoke Free on the Web (PSFW+)16
American Heart Association Getting Healthy (AHA)16
A little satisfied
GroupValue95% CI
Positively Smoke Free on the Web (PSFW+)34
American Heart Association Getting Healthy (AHA)45
Moderately satisfied
GroupValue95% CI
Positively Smoke Free on the Web (PSFW+)62
American Heart Association Getting Healthy (AHA)50
Very satisfied
GroupValue95% CI
Positively Smoke Free on the Web (PSFW+)68
American Heart Association Getting Healthy (AHA)63
Extremely satisfied
GroupValue95% CI
Positively Smoke Free on the Web (PSFW+)25
American Heart Association Getting Healthy (AHA)24
Refused or missing
GroupValue95% CI
Positively Smoke Free on the Web (PSFW+)1
American Heart Association Getting Healthy (AHA)6

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Randomized Trial of a Web-Based Tobacco Treatment and Online Community Support for People With HIV Attempting to Quit Smoking Cigarettes.
    Shuter J, Chander G, Graham AL, Kim RS, et al · · 2022 · cited 14× · PMID 35175971 · DOI 10.1097/qai.0000000000002936
  2. Randomized comparison of two interventions to enhance understanding during the informed consent process for research.
    Taylor HA, Washington D, Wang NY, Patel HD, et al · · 2021 · cited 13× · PMID 33892597 · DOI 10.1177/17407745211009529
  3. Co-use of cigarettes and cannabis among people with HIV: Results from a randomized controlled smoking cessation trial.
    Ozga JE, Shuter J, Chander G, Graham AL, et al · · 2023 · cited 3× · PMID 37342512 · DOI 10.1016/j.dadr.2023.100172
  4. The Role of Seed Users in Nurturing an Online Health Community for Smoking Cessation Among People With HIV/AIDS.
    Wang X, Zhao K, Amato MS, Stanton CA, et al · · 2024 · cited 1× · PMID 37931160 · DOI 10.1093/abm/kaad063

Verify or expand the search:

Other recruiting trials for Tobacco Use Disorder

Currently open trials in the same condition.

Other Montefiore Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02781090.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing