Trial Outcomes & Findings for Smoke-free Home Intervention in Permanent Supportive Housing (NCT NCT04855357)

Last Updated: 2026-05-29

Results Overview

The proportion of resident-participants who self-reported a voluntary adoption of smoke-free homes for \>=90 days at 6 months follow-up will be reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

452 participants

Primary outcome timeframe

6 months

Results posted on

2026-05-29

Participant Flow

This study is designed as an intent-to-treat model so all resident-participants who completed the baseline assessment will be included in the outcome measures. Trained location staff-participants who were enrolled in the study were not included in any analysis but were consented to participate in the study and included in Participant Flow, Baseline, and Adverse Event tables.

Unit of analysis: Permanent supportive housing (PSH)

Participant milestones

Participant milestones
Measure	Smoke-free Home Permanent Supportive Housing (PSH) Resident Intervention + Staff Intervention Study staff will deliver a one hour, one-on-one counseling to permanent supportive housing (PSH) resident-participants that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.	Wait-List Control (Usual Care) The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up.
Baseline STARTED	226 20	226 20
Baseline Resident-Participants	191 20	209 20
Baseline Staff-Participants	35 13	17 7
Baseline COMPLETED	226 20	226 20
Baseline NOT COMPLETED	0 0	0 0
Month 6 STARTED	201 20	197 20
Month 6 Resident-Participants	171 20	184 20
Month 6 Staff-Participants	30 13	13 7
Month 6 COMPLETED	201 20	197 20
Month 6 NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline data is reported by participant type.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months

Population: This study is designed as an intent-to-treat model so all resident-participants who completed the baseline assessment will be included in the denominator of the outcome measures.

The proportion of resident-participants who self-reported a voluntary adoption of smoke-free homes for \>=90 days at 6 months follow-up will be reported.

Outcome measures

Outcome measures
Measure	Smoke-free Home Permanent Supportive Housing (PSH) Resident Intervention + Staff Intervention n=191 Participants Study staff will deliver a one hour, one-on-one counseling to PSH resident-participants that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.	Wait-List Control (Usual Care) n=209 Participants The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up.
Proportion of Resident-participants Who Adopt a Smoke-free Home Voluntarily	0.068 proportion of resident-participants	0.048 proportion of resident-participants

SECONDARY outcome

Timeframe: 6 months

Population: This study is designed as an intent-to-treat model so all resident-participants who completed the baseline assessment will be included in the denominator of the outcome measures.

The proportion of resident-participants with 7-day point prevalence abstinence at 6 months follow-up, measured as self-report of abstinence and an expired carbon monoxide of \<= 5 parts per million (ppm) as abstinence will be reported.

Outcome measures

Outcome measures
Measure	Smoke-free Home Permanent Supportive Housing (PSH) Resident Intervention + Staff Intervention n=191 Participants Study staff will deliver a one hour, one-on-one counseling to PSH resident-participants that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.	Wait-List Control (Usual Care) n=209 Participants The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up.
Proportion of Resident-participants Who Achieve Abstinence	0.063 proportion of resident-participants	0.0096 proportion of resident-participants

Adverse Events

Smoke-free Home PSH: Resident Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Smoke-free Home PSH: Staff Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-List Control (Usual Care) - Resident Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Wait-List Control (Usual Care)- Staff Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Maya Vijayaraghavan, MD, MAS

University of California, San Francisco

Phone: (415) 476-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Smoke-free Home Permanent Supportive Housing (PSH) Resident Intervention + Staff Intervention n=226 Participants Study staff will deliver a one hour, one-on-one counseling to PSH resident-participants that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.	Wait-List Control (Usual Care) n=226 Participants The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up.	Total n=452 Participants Total of all reporting groups
Age, Continuous Resident-Participants	54.97 Years STANDARD_DEVIATION 10.07 • n=191 Participants • Baseline data is reported by participant type.	54.13 Years STANDARD_DEVIATION 11.24 • n=209 Participants • Baseline data is reported by participant type.	54.53 Years STANDARD_DEVIATION 10.69 • n=400 Participants • Baseline data is reported by participant type.
Age, Continuous Staff-Participants	43.29 Years STANDARD_DEVIATION 12.41 • n=35 Participants • Baseline data is reported by participant type.	46.88 Years STANDARD_DEVIATION 10.59 • n=17 Participants • Baseline data is reported by participant type.	44.49 Years STANDARD_DEVIATION 11.85 • n=52 Participants • Baseline data is reported by participant type.
Sex/Gender, Customized Resident-Participants · Female	68 Participants n=191 Participants • Baseline data is reported by participant type	62 Participants n=209 Participants • Baseline data is reported by participant type	130 Participants n=400 Participants • Baseline data is reported by participant type
Sex/Gender, Customized Resident-Participants · Male	111 Participants n=191 Participants • Baseline data is reported by participant type	140 Participants n=209 Participants • Baseline data is reported by participant type	251 Participants n=400 Participants • Baseline data is reported by participant type
Sex/Gender, Customized Resident-Participants · Not Reported	12 Participants n=191 Participants • Baseline data is reported by participant type	7 Participants n=209 Participants • Baseline data is reported by participant type	19 Participants n=400 Participants • Baseline data is reported by participant type
Sex/Gender, Customized Staff-Participants · Female	20 Participants n=35 Participants • Baseline data is reported by participant type	14 Participants n=17 Participants • Baseline data is reported by participant type	34 Participants n=52 Participants • Baseline data is reported by participant type
Sex/Gender, Customized Staff-Participants · Male	13 Participants n=35 Participants • Baseline data is reported by participant type	3 Participants n=17 Participants • Baseline data is reported by participant type	16 Participants n=52 Participants • Baseline data is reported by participant type
Sex/Gender, Customized Staff-Participants · Not Reported	2 Participants n=35 Participants • Baseline data is reported by participant type	0 Participants n=17 Participants • Baseline data is reported by participant type	2 Participants n=52 Participants • Baseline data is reported by participant type
Ethnicity (NIH/OMB) Resident-Participants · Hispanic or Latino	33 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	29 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	62 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Ethnicity (NIH/OMB) Resident-Participants · Not Hispanic or Latino	154 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	179 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	333 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Ethnicity (NIH/OMB) Resident-Participants · Unknown or Not Reported	4 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	1 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	5 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Ethnicity (NIH/OMB) Staff-Participants · Hispanic or Latino	6 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	3 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	9 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Ethnicity (NIH/OMB) Staff-Participants · Not Hispanic or Latino	29 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	14 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	43 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Ethnicity (NIH/OMB) Staff-Participants · Unknown or Not Reported	0 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	0 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	0 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Resident-Participants · American Indian or Alaska Native	9 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	3 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	12 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Resident-Participants · Asian	2 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	3 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	5 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Resident-Participants · Native Hawaiian or Other Pacific Islander	3 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	1 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	4 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Resident-Participants · Black or African American	73 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	102 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	175 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Resident-Participants · White	55 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	62 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	117 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Resident-Participants · More than one race	43 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	36 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	79 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Resident-Participants · Unknown or Not Reported	6 Participants n=191 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	2 Participants n=209 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	8 Participants n=400 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Staff-Participants · American Indian or Alaska Native	1 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	1 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	2 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Staff-Participants · Asian	3 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	0 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	3 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Staff-Participants · Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	1 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	1 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Staff-Participants · Black or African American	20 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	9 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	29 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Staff-Participants · White	7 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	3 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	10 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Staff-Participants · More than one race	1 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	3 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	4 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Race (NIH/OMB) Staff-Participants · Unknown or Not Reported	3 Participants n=35 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	0 Participants n=17 Participants • There were two different participant populations: Resident-participants and Staff-Participants.	3 Participants n=52 Participants • There were two different participant populations: Resident-participants and Staff-Participants.
Region of Enrollment United States	226 participants n=226 Participants	226 participants n=226 Participants	452 participants n=452 Participants