NCT03962660.

Study name	Harm reduction for tobacco smoking with support of tobacco‐replacing electronic nicotine delivery systems (HaRTS‐TRENDS)
Methods	Parallel, randomized controlled trial Setting: USA Recruitment: from prominent Housing First programs serving chronically homeless people who are often multiply affected by psychiatric, medical and substance‐use disorders. The proposed sample will be recruited from a highly vulnerable and marginalized population in a tight‐knit urban community
Participants	Estimated enrolment: 94 Inclusion criteria: Having a history of chronic homelessness according to the widely‐accepted federal definition Being a current DESC client living in 1 of DESC's participating permanent supportive housing projects Being between 21 ‐ 65 years of age Being a daily smoker (> 4 cigarettes/day in the past year with a breath CO ≥ 6 ppm or salivary cotinine test at level 1 if CO < 6 ppm) Having adequate English language skills to understand verbal information and communicate in the study Exclusion Criteria: Use of other tobacco products besides cigarettes ≥ 9 days in the past month Refusal or inability to consent to participation in research Constituting a risk to the safety and security of other clients or staff.
Interventions	Intervention: HaRTS‐TRENDS: 4 individual sessions delivered in the context of the interventionist's pragmatic harm‐reduction mindset paired with a compassionate, advocacy‐oriented "heart‐set" or style. It comprises the delivery of 4 manualized components, including a) participant‐led tracking of preferred smoking outcomes, b) elicitation of participants' harm‐reduction goals and their progress toward achieving them, c) discussion of the relative risks of various nicotine delivery systems, d) instruction in using ENDS. Additionally, HaRTS‐TRENDS entails provision of commercially available ENDS. Standard care: The 4‐session, individual standard care control condition entails the well‐documented and evidence‐based 5 As intervention (i.e. Ask about nicotine use, Assess use, Advise to quit smoking, Assist with exploring current smoking/planning smoking cessation, Arrange follow‐up). Part of arranging follow‐up is the recommendation to call the smoking quit line, which can supply additional counseling and nicotine replacement therapy
Outcomes	Primary outcomes, measured across the 12‐month follow‐up: Biologically‐verified nonsmoking (i.e. self‐reported nonsmoking if corresponding CO measure is < 8) in the past 7 days Urinary concentration of a tobacco‐specific nitrosamine Secondary outcomes, measured across the 12‐month follow‐up: Self‐reported smoking intensity is the mean number of cigarettes participants report smoking per day in the 7 days prior to the assessment Self‐reported smoking frequency is the number of days participants report smoking in the 7 days prior to the assessment CO level Urinary cotinine FEV1% 10‐item Clinical COPD Questionnaire EQ‐5D‐5L Other outcomes: Smoking craving Side effects of ENDS
Starting date	9 May 2019
Contact information	Tatiana M Ubay, tatiubay@uw.edu
Notes