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

Primary Purpose

Tobacco Use, Smoking, Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

POP:

TSP:

About this trial

This is an interventional treatment trial for Tobacco Use focused on measuring Tobacco, Gender Identity Minority, Sexual Identity Minority, Cessation, Intervention, Young Adults, Social Media, Internet, Cigarette

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of California San Francisco Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

The Put It Out Project (POP):

Tobacco Status Project (TSP):

Arm Description

a culturally tailored intervention developed for SGM young adults on Facebook

the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook

Outcomes

Primary Outcome Measures

7-day point prevalence abstinence at 3 months

Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.

7-day point prevalence abstinence at 6 months

Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.

Secondary Outcome Measures

Reduction in cigarettes smoked by at least 50%

Reduction will be assessed at 3 and 6 month follow-ups.

Tobacco use quit attempts

Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.

Readiness to quit tobacco

Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months

Thoughts About Tobacco Abstinence

Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal

Full Information

NCT ID

NCT03259360

First Posted

August 21, 2017

Last Updated

May 19, 2020

Sponsor

University of California, San Francisco

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT03259360

Brief Title

A Facebook Intervention for Young Sexual and Gender Minority Smokers

Acronym

POP

Official Title

A Facebook Intervention for Young Sexual and Gender Minority Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

April 23, 2018 (Actual)

Primary Completion Date

April 20, 2019 (Actual)

Study Completion Date

February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use, Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation, Tobacco Smoking, Smoking Cessation, Smoking, Cigarette, Smoking, Tobacco

Keywords

Tobacco, Gender Identity Minority, Sexual Identity Minority, Cessation, Intervention, Young Adults, Social Media, Internet, Cigarette

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The Put It Out Project (POP):

Arm Type

Experimental

Arm Description

a culturally tailored intervention developed for SGM young adults on Facebook

Arm Title

Tobacco Status Project (TSP):

Arm Type

Experimental

Arm Description

the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook

Intervention Type

Behavioral

Intervention Name(s)

POP:

Intervention Description

90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults

Intervention Type

Behavioral

Intervention Name(s)

TSP:

Intervention Description

90 days of Facebook messaging, weekly live sessions targeting tobacco use

Primary Outcome Measure Information:

Title

7-day point prevalence abstinence at 3 months

Description

Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.

Time Frame

3 months post baseline

Title

7-day point prevalence abstinence at 6 months

Description

Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.

Time Frame

6 months post baseline

Secondary Outcome Measure Information:

Title

Reduction in cigarettes smoked by at least 50%

Description

Reduction will be assessed at 3 and 6 month follow-ups.

Time Frame

3 and 6 months post baseline

Title

Tobacco use quit attempts

Description

Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.

Time Frame

3 and 6 months post baseline

Title

Readiness to quit tobacco

Description

Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months

Time Frame

3 and 6 months post baseline

Title

Thoughts About Tobacco Abstinence

Description

Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal

Time Frame

3 and 6 months post baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary L. Humfleet, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California San Francisco Department of Psychiatry

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26721211

Citation

Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.

Results Reference

background

PubMed Identifier

26561529

Citation

Thrul J, Klein AB, Ramo DE. Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? J Med Internet Res. 2015 Nov 11;17(11):e244. doi: 10.2196/jmir.4575.

Results Reference

background

PubMed Identifier

26374203

Citation

Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.

Results Reference

background

PubMed Identifier

25045624

Citation

Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.

Results Reference

background

PubMed Identifier

24575728

Citation

Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.

Results Reference

background

PubMed Identifier

31562765

Citation

Vogel EA, Ramo DE, Meacham MC, Prochaska JJ, Delucchi KL, Humfleet GL. The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot, Randomized, Controlled Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1614-1621. doi: 10.1093/ntr/ntz184.

Results Reference

derived

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A Facebook Intervention for Young Sexual and Gender Minority Smokers

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