A Facebook Intervention for Young Sexual and Gender Minority Smokers (POP)

May 19, 2020 updated by: University of California, San Francisco
The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 mos.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.

Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • read English
  • between 18 and 25 years of age
  • indicate they use Facebook "most" (≥ 4) days per week
  • have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
  • identifies as SGM

Exclusion Criteria:

  • do not read English
  • are not between 18 and 25 years of age
  • indicate they do not use Facebook "most" (≥ 4) days per week
  • have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
  • does not identify as SGM

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Put It Out Project (POP):
a culturally tailored intervention developed for SGM young adults on Facebook
Behavioral: POP:
90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults
Experimental: Tobacco Status Project (TSP):
the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook
Behavioral: TSP:
90 days of Facebook messaging, weekly live sessions targeting tobacco use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day point prevalence abstinence at 3 months
Time Frame: 3 months post baseline
Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
3 months post baseline
7-day point prevalence abstinence at 6 months
Time Frame: 6 months post baseline
Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
6 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in cigarettes smoked by at least 50%
Time Frame: 3 and 6 months post baseline
Reduction will be assessed at 3 and 6 month follow-ups.
3 and 6 months post baseline
Tobacco use quit attempts
Time Frame: 3 and 6 months post baseline
Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.
3 and 6 months post baseline
Readiness to quit tobacco
Time Frame: 3 and 6 months post baseline
Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months
3 and 6 months post baseline
Thoughts About Tobacco Abstinence
Time Frame: 3 and 6 months post baseline
Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal
3 and 6 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Gary L. Humfleet, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2018

Primary Completion (Actual)

April 20, 2019

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA-15-263
  • R21MD011765 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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