NCT06170437

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
544

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jul 2024Aug 2027

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

December 6, 2023

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants adopting a smoke-free home for ≥90 days

    The percentage of participants who reported to adopt a smoke-free home in the past 90 days will be reported

    6 months

Secondary Outcomes (1)

  • Percentage of participants with point prevalent abstinence (PPA)

    6 months

Other Outcomes (1)

  • Percentage of participants adopting a cannabis-free home among cannabis users

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Smoke-free home resident interventionBehavioral: Lay Health Worker coaching

Waitlist Control Group

NO INTERVENTION

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.

Interventions

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

Intervention

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

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication to any study-related procedures or assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Smoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehaviorTobacco Use

Study Officials

  • Maya Vijayaraghavan, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijie Wang

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

July 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

De-identified datasets may be provided to other researchers upon request and approval by the investigator

Locations