NCT02781090

Brief 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. All participants will be offered a three-month supply of nicotine patches.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 6, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2020

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 4, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

4.2 years

First QC Date

April 28, 2016

Results QC Date

July 13, 2023

Last Update Submit

August 3, 2023

Conditions

Tobacco Use DisorderHIV

Keywords

HIVTobaccoCigaretteSmokingSocial NetworkInternetCessation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Website Satisfaction

    Up to 6 months

Study Arms (2)

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

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

Behavioral: AHADrug: Nicotine polacrilex

Interventions

PSFW+BEHAVIORAL

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.

Also known as: AHA
Positively Smoke Free on the Web (PSFW+)
AHABEHAVIORAL

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

American Heart Association Getting Healthy (AHA)
Nicotine polacrilexDRUG

All participants, in both study arms, will be offered a 3-month supply of nicotine patches

Also known as: Nicotine patch
American Heart Association Getting Healthy (AHA)Positively Smoke Free on the Web (PSFW+)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Montefiore Medical Center

The Bronx, New York, 10804, United States

Location

Related Publications (3)

  • 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.

    PMID: 25118794BACKGROUND

  • Mdege 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.

    PMID: 39101506DERIVED

  • 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.

    PMID: 35175971DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Dr. Jonathan Shuter
Organization
Montefiore Medical Center
jshuter@montefiore.org
718-920-7845

Study Officials

  • Jonathan Shuter, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 24, 2016

Study Start

July 6, 2016

Primary Completion

September 14, 2020

Study Completion

September 14, 2020

Last Updated

August 4, 2023

Results First Posted

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

No plan to share IPD at this time.

Locations

US(2)