Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Second Hand Tobacco Smoke
  • Smoking Cessation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: A cluster-randomized, wait-list controlled designed trial where PSH sites will be randomized into intervention and wait-list control groups. Those in the wait-list control group will receive usual care first and then cross over to the intervention arm.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PSH resident participants (200 each in the intervention and wait-list control arms) and within each site, all resident participants will be informed about the study and invited to participate. Participants will be recruited within blocks of four housing sites per month, with each block containing tw...

PSH resident participants (200 each in the intervention and wait-list control arms) and within each site, all resident participants will be informed about the study and invited to participate. Participants will be recruited within blocks of four housing sites per month, with each block containing two intervention and two wait-list control sites, and anticipating roll-out of one such block per month. Anticipated completion of recruitment and enrollment of all participants should occur within 6 months, allowing for a one-to-two-month extension to complete these activities. The intervention will be offered to the wait-list control participants once all participants in the intervention sites from the same block have completed their 6-month follow-up. 400 resident participants will be recruited, with 200 participants each in the intervention and wait-list control arms (~20 participants per site). Within each site, study staff will advertise the study to residents the week prior to enrollment by placing flyers at the study site and making announcements at community meetings. After the informational meeting, study staff will be present at the recruitment sites during designated times to screen interested participants for eligibility and enroll those eligible into the study. These study procedures were successfully employed the pilot study. Specific Objectives: Aim 1: Conduct a cluster randomized trial to estimate the effect of the smoke-free home intervention on residents' voluntary adoption of smoke-free homes. Aim 2: Evaluate the cost-effectiveness of the smoke-free home intervention. Aim 3: Determine characteristics of high and low adopters at the individual level, and social and environmental barriers and enablers of adoption, scalability and sustainability of the intervention. It will take 6 months for the intervention group participants to complete the study, and 1 year for the wait-list control participants to complete the study.

Tracking Information

NCT #
NCT04855357
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Maya Vijayaraghavan, MD, MAS University of California, San Francisco