Smoke-free Home Study in Subsidized Housing

NCT ID: NCT06170437

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2027-08-31

Brief Summary

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Comprehensive smoke-free policies have the potential to substantially reduce tobacco-related disparities among populations in subsidized housing. This study fills this gap by identifying approaches to increase the implementation of smoke-free policies in all types of subsidized housing by increasing the voluntary adoption of smoke-free homes and promoting access to smoking cessation services.

Detailed Description

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OBJECTIVES:

The investigators will build on previous studies, where a smoke-free home intervention to increase voluntary adoption of smoke-free homes in permanent supportive housing for formerly homeless adults was developed and evaluated.

Aim 1: To estimate the effect of our adapted smoke-free home intervention on the primary outcome of residents' voluntary adoption of smoke-free homes and the secondary outcome of biochemically-verified tobacco abstinence at 6-months follow-up.

Aim 2: To determine the cost of our adapted smoke-free home intervention and determine whether it is a cost-effective use of health care resources.

Aim 3: To evaluate variation in stakeholders' perspectives on the adapted smoke-free home intervention's adaptability, scalability and sustainability.The proposed intervention can expand access to smoke-free policies and smoking cessation services in subsidized housing, thereby reducing racial/ethnic disparities in tobacco use, tobacco exposure and chronic disease in these populations.

OUTLINE:

A wait-list cluster randomized controlled trial of the adapted smoke-free home intervention compared to usual care among residents from subsidized housing sites in Northern California. Participants from twenty-four subsidized housing sites will be randomized into intervention and waitlist control arms

Conditions

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Tobacco Dependence Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled groups
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

The study's investigators will train bilingual study staff to deliver the intervention to residents using a script that matches the content in the smoke-free home intervention pamphlet. The in-person delivery of the intervention and pamphlet will be the primary modes of intervention delivery to residents. The pamphlet will include: (1) the harms of tobacco, e-cigarette use, cannabis use and exposure (secondhand and thirdhand), (2) an exercise to calculate personal cost of tobacco use, (3) benefits of a smoke-free home, (4) skill-building on how to adopt a smoke-free home, and (5) motivational language on smoke-free home adoption. The study staff will qualitatively assess participants' knowledge by prompting questions on the topics covered and will refer participants to lay-health workers (LHWs) for one-on-one coaching. Participants will receive a pledge to designate their homes smoke-free.

Group Type EXPERIMENTAL

Smoke-free home resident intervention

Intervention Type BEHAVIORAL

Study staff delivered intervention on how to adopt a smoke free home using a pamphlet

Lay Health Worker coaching

Intervention Type BEHAVIORAL

Brief tobacco cessation coaching by lay health worker housing staff with residents within 2 weeks of the smoke-free home resident intervention, and on a monthly schedule as part of their routine encounters with residents (total 6 sessions).

Waitlist Control Group

The current standard of care does not include any interventions for smoke-free home adoption or referrals to tobacco treatment resources. At the end of the primary endpoint (6 months), control participants will be offered the intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smoke-free home resident intervention

Study staff delivered intervention on how to adopt a smoke free home using a pamphlet

Intervention Type BEHAVIORAL

Lay Health Worker coaching

Brief tobacco cessation coaching by lay health worker housing staff with residents within 2 weeks of the smoke-free home resident intervention, and on a monthly schedule as part of their routine encounters with residents (total 6 sessions).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Eligible resident participants

* Current smokers defined as:

* Smoked at least 100 cigarettes in lifetime
* Smoked daily in the past 7 days, and at least 5 cigarettes per day, verified by expired CO ≥ 5 parts per million \[ppm\] Smokerlyzer CO+ monitor),
* Smoke in their home
* Expect to live in the subsidized housing site for at least 12 months
* Age ≥ 18 years
* Speak Chinese (Cantonese or Mandarin), English, Spanish, or Vietnamese
* Able to provide informed consent.

Exclusion Criteria

* Contraindication to any study-related procedures or assessment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maya Vijayaraghavan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ana Martinez

Role: CONTACT

415-839-0572

Weijie Wang

Role: CONTACT

Facility Contacts

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Ana Martinez

Role: primary

Weijie Wang

Role: backup

References

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Hawes MR, Chakravarty D, Cheng J, Handley MA, Tsoh JY, Lin TK, Hiatt RA, Vijayaraghavan M. The Healthy Homes Study: Protocol for a cluster randomized trial of a place-based smoke-free home intervention in affordable housing. PLoS One. 2025 Jul 29;20(7):e0328786. doi: 10.1371/journal.pone.0328786. eCollection 2025.

Reference Type DERIVED
PMID: 40729126 (View on PubMed)

Other Identifiers

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R01MD016898

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24631

Identifier Type: -

Identifier Source: org_study_id

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