Nicotine DependenceHPINCT03506867
Healthy People Initiative (HPI)
A study testing Life skills, training, education and work/volunteer opportunities in people with Nicotine Dependence and Substance Use Disorders, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Substance Use Disorders
- What is being tested?
- Life skills, training, education and work/volunteer opportunities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2019to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
Title of Trial: 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
Short Title of Trial: HPI Trial
Principal Investigator: Smita Pakhalé
Trial Sites: Ottawa (The Bridge Engagement Centre) \& Toronto (Parkdale Activity Recreation Centre)
Primary outcome: The Healthy People Initiative (HPI) randomized controlled trial (RCT) builds on the pilot study to evaluate changes in participants' self-reported quality of life (QoL) as the primary outcome while implementing the Bridge Model™ approach to address tobacco management.
Secondary outcomes: The secondary objective is to quantify reductions in tobacco use and quitting tobacco use altogether, with quit rates validated biochemically, and changes in self-efficacy.
Tertiary outcomes: These include evaluating process-related metrics such as participant enrolment rates, consent rates, and adherence to protocol; estimating implementation costs to guide future cost-effectiveness analyses; and assessing additional patient-reported outcomes such as self-efficacy, participation in education or employment, and reductions in polysubstance use. Additionally, a cost-utility analysis from a health system perspective will assess the economic impact of the 52-week intervention by measuring total costs and healthcare utilization, linking trial data to administrative health records. We aim to provide robust evidence to support the utility of the Bridge ModelTM in addressing health and social inequities through community-driven, peer-led interventions that integrate social determinants with individual health outcomes.
Primary Objective: To assess the feasibility of a randomized controlled trial investigating access to improvements in 'social capital' in the low income population in Ottawa and Toronto.
Study Design \& Population: 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. Data sources include self-reports, biochemical validation, and administrative health records
Sample Size: 250
Trial Arms: The HPI RCT has two arms: usual care and intervention (Figure 1). The intervention arm employs the Bridge ModelTM, offering life-skills workshops, social integration, peer guidance, system navigation (e.g., housing), and APN (Advanced Practice Nurse) or NP (Nurse Practitioner) counselling, including primary care, preventive services, and referrals. Both arms receive monthly follow-ups from peers and APN/NP. Usual care includes resource information and counselling, with an option to switch to the intervention arm after six months. All participants receive nicotine replacement therapy (NRT) for 12 months as needed.
Trial Duration: 12 months Follow-up Duration: 12 months
- Conditions
- Nicotine Dependence, Substance Use Disorders
- Being tested
- Life skills, training, education and work/volunteer opportunities, Usual Care
- Keywords
- Health Equity, Community Based Participatory Action Research, Poverty Reduction
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life skills, training, education and work/volunteer opportunitiesBehavioural
Intervention arm will receive proactive and sustained access to enhanced education and socio-economic supports (e.g. volunteer and/or work opportunities).
Usual CareBehavioural
We will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (2)
Self-Reported Efficacy
To estimate change in self-reported self-efficacy.
Measured: 12 months
Tobacco use
To estimate self-reported reduced or quit tobacco use rate (corroborated with the measurement of exhaled Carbon Monoxide) and poly-substance use rate.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start3 Jan 2019
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smita Pakhalé, MD, MSc, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506867
- Sponsor's protocol ID
- 20180274-01H
- Acronym
- HPI
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2018
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request study de-identified data will be made available to interested and qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03506867
- Acronym / sponsor ID
- HPI / 20180274-01H
- Conditions
- Nicotine Dependence, Substance Use Disorders
- Keywords
- Health Equity, Community Based Participatory Action Research, Poverty Reduction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title of Trial: 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
Short Title of Trial: HPI Trial
Principal Investigator: Smita Pakhalé
Trial Sites: Ottawa (The Bridge Engagement Centre) \& Toronto (Parkdale Activity Recreation Centre)
Primary outcome: The Healthy People Initiative (HPI) randomized controlled trial (RCT) builds on the pilot study to evaluate changes in participants' self-reported quality of life (QoL) as the primary outcome while implementing the Bridge Model™ approach to address tobacco management.
Secondary outcomes: The secondary objective is to quantify reductions in tobacco use and quitting tobacco use altogether, with quit rates validated biochemically, and changes in self-efficacy.
Tertiary outcomes: These include evaluating process-related metrics such as participant enrolment rates, consent rates, and adherence to protocol; estimating implementation costs to guide future cost-effectiveness analyses; and assessing additional patient-reported outcomes such as self-efficacy, participation in education or employment, and reductions in polysubstance use. Additionally, a cost-utility analysis from a health system perspective will assess the economic impact of the 52-week intervention by measuring total costs and healthcare utilization, linking trial data to administrative health records. We aim to provide robust evidence to support the utility of the Bridge ModelTM in addressing health and social inequities through community-driven, peer-led interventions that integrate social determinants with individual health outcomes.
Primary Objective: To assess the feasibility of a randomized controlled trial investigating access to improvements in 'social capital' in the low income population in Ottawa and Toronto.
Study Design \& Population: 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. Data sources include self-reports, biochemical validation, and administrative health records
Sample Size: 250
Trial Arms: The HPI RCT has two arms: usual care and intervention (Figure 1). The intervention arm employs the Bridge ModelTM, offering life-skills workshops, social integration, peer guidance, system navigation (e.g., housing), and APN (Advanced Practice Nurse) or NP (Nurse Practitioner) counselling, including primary care, preventive services, and referrals. Both arms receive monthly follow-ups from peers and APN/NP. Usual care includes resource information and counselling, with an option to switch to the intervention arm after six months. All participants receive nicotine replacement therapy (NRT) for 12 months as needed.
Trial Duration: 12 months Follow-up Duration: 12 months
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care arm | Active comparator | Behavioral: Life skills, training, education and work/volunteer opportunitiesWe 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 | Active comparator | Behavioral: Usual CareThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life skills, training, education and work/volunteer opportunitiesIntervention arm will receive proactive and sustained access to enhanced education and socio-economic supports (e.g. volunteer and/or work opportunities). | Behavioural | Usual care arm |
| Usual CareWe will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies. | Behavioural | Life skills, training, education and work/volunteer opportunities, and peer support |
Primary outcome
Self-Reported Quality of Life
Time frame: 12 Months
To assess the trend in self-reported quality of life using the European Quality of Life 5 Dimensions 5 Level Version.
2 secondary outcomes
Self-Reported Efficacy
Time frame: 12 months
Tobacco use
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. Upon request study de-identified data will be made available to interested and qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Smita Pakhalé, MD, MSc principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life skills, training, education and work/volunteer opportunities in people with Nicotine Dependence and Substance Use Disorders, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Quality of Life (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.