Healthy People Initiative (HPI)

NCT03506867 | Enrolling By Invitation

• 1 other identifier: 20180274-01H
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use Disorders; Nicotine Dependence

Keywords

Health Equity; Community Based Participatory Action Research; Poverty Reduction

Outcome Measures

Primary Outcomes (1)

• Self-Reported Quality of Life

  To assess the trend in self-reported quality of life using the European Quality of Life 5 Dimensions 5 Level Version.

  12 Months

Secondary Outcomes (2)

• Self-Reported Efficacy

  12 months

• Tobacco use

  12 months

Other Outcomes (6)

• Consent and Protocol Violation Rate

  12 months

• Healthcare Utilization Rate

  12 months

• Access to Work, Training, and Volunteer Opportunities

  12 months

Study Arms (2)

Usual care arm

ACTIVE COMPARATOR

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

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

Life skills, training, education and work/volunteer opportunities, and peer support

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

Usual Care BEHAVIORAL

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

Life skills, training, education and work/volunteer opportunities, and peer support

Life skills, training, education and work/volunteer opportunities BEHAVIORAL

Intervention arm will receive proactive and sustained access to enhanced education and socio-economic supports (e.g. volunteer and/or work opportunities).

Usual care arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Declining consent
• 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
• Currently or recently (in the past 30 days) enrolled in any other smoking cessation program

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Bridge Engagement Centre

Ottawa, Ontario, K1K 4B7, Canada

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Substance-Related Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Smita Pakhalé, MD, MSc

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research staff analyzing the data will be blinded to the allotment and reported outcomes.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The HPI study is a crossover, community-based, multi-site pragmatic RCT (1:1 allocation ratio) in Ottawa and Toronto. It uses a 12-month follow-up to evaluate short- and long-term effects of the intervention on health, social, and economic outcomes.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 24, 2018
• Study Start: January 3, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon request study de-identified data will be made available to interested and qualified researchers. No time frame necessary.
• Access Criteria: No access criteria. De-identified raw data will be available upon request.

Locations

CA (1)