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Enrolling by invitationNo phase

Healthy People Initiative (HPI)

Key facts

Who runs it
Ottawa Hospital Research Institute
Where
Canada1 site in 1 countryChoose a country to see its sites
Trial code
Status
Enrolling by invitation
People taking part
250 people, planned
Started
3 Jan 2019
Expected to end
31 Mar 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Life skills, training, education and work/volunteer opportunities
  • Usual Care
Record updated
24 December 2025

Who can take part

Age
16 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Participants must be 16 years or older, reside in Ottawa or Toronto,
  • Have smoked tobacco in the past 7 days
  • Identify as low socioeconomic status and/or at risk of homelessness, and be available for in-person follow-up for one year

Who cannot take part

  • Any person who is in or planning on accessing addictions treatment (in-patient drug rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow up
  • Declining consent
  • Currently or recently (in the past 30 days) enrolled in any other smoking cessation program

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Addictions do not occur in isolation. Tackling addictions requires addressing social determinants such as isolation, homelessness, marginalization, and unemployment. Research on individuals living with or at risk for HIV/AIDS highlights that unemployment correlates with higher levels of depression, anxiety, and social isolation compared to employment. In Ottawa, the PROMPT project engaged homeless or at-risk populations, including people who use drugs and those living with or at risk for HIV/AIDS or Hepatitis C using the Bridge ModelTM, a pragmatic community-based participatory action research approach operationalized through earlier projects at the Bridge Engagement Center in Ottawa, Canada. The PROMPT project demonstrated that implementing multi-component, complex interventions is both feasible and effective, achieving broader socio-economic outcomes beyond reduction and quitting tobacco and poly-substance use. However, PROMPT participants identified a lack of social and recovery capital -family and social connections, opportunities for volunteering and jobs- as a major barrier to recovery. To address this, we conducted a six-month feasibility pilot study with 20 PROMPT participants. By its conclusion, 15 participants were engaged in small paid or volunteer roles, including educational opportunities, fostering both social integration and recovery. Insights from this pilot study informed the design of a larger community-based multi-site pragmatic randomized trial (RCT) to further evaluate the effectiveness of the Bridge ModelTM, the Healthy People Initiative (HPI) project. The Healthy People Initiative (HPI) is a community-based, participatory, pragmatic parallel-arm multi-site with a cross-over design, recruiting 250 participants (16+) at risk of homelessness or low socioeconomic status in Ottawa and Toronto, Canada.

The 2 groups in the trial

  • Usual care armExisting treatment, for comparison

    We will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies.

    Treatment: Life skills, training, education and work/volunteer opportunities

  • Life skills, training, education and work/volunteer opportunities, and peer supportExisting treatment, for comparison

    The life skills, training, education, work/volunteer opportunities, and peer support arm will be offered to the usual care arm participants after the first six months of study enrollment.

    Treatment: Usual Care

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Healthy People Initiative (HPI) - Community-Based Participatory Action Pragmatic Parallel Arm Multi-Site Randomized Controlled Trial Using The Bridge ModelTM in Systemically Disadvantaged Populations: HPI Trial Protocol
Record updated
24 December 2025