Access to Health CareNCT06854770
STRENGTH Pilot Project: A Study of a Women-led, Trauma-informed Model of Outreach to Foster Equity
A study testing STRENGTH Outreach Intervention in people with Access to Health Care and Gender-Based Violence, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this pilot study is to identify the core elements of outreach practice necessary to engage with women experiencing street-involvement who are underserved within health and social care settings. The primary research questions are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Access to Health Care, Gender-Based Violence, Safety
- What is being tested?
- STRENGTH Outreach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2018to 28 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as a woman, therefore the study is trans-inclusive.
- Have some degree of English proficiency in understanding and communication.
- Live or spend most of their time over a 24-hour period in the Downtown Eastside of Vancouver.
- Age 18 or over.
Who cannot join
- Women without any degree of English speaking or comprehension proficiency.
- People who self-identify as men.
- Youth under the age of 18.
- Women who do not spend time regularly in the Downtown Eastside of Vancouver.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 2B5
About this study
Official title: The Outreach Project: A Study of Women-led, Trauma Informed Outreach to Foster Equity
The goal of this pilot study is to identify the core elements of outreach practice necessary to engage with women experiencing street-involvement who are underserved within health and social care settings. The primary research questions are:
- How acceptable is the outreach intervention to women experiencing street-involvement?
- What factors act as barriers or facilitators to acceptability?
- How feasible is the outreach intervention to enhance women's access to health and social services?
Read more
Participants will:
- Meet regularly one-on-one with an outreach worker over an 18-month period
- Co-develop (with the outreach worker) a plan, based on the individuals self-identified needs, for connecting with health and social services
- Be invited to complete surveys at the start of their participation, and again every four months. These surveys ask questions about participants' resiliency, quality of life, independence, safety, and health status
- Be invited to participate in a one-on-one interview with a researcher about their experiences in the study.
Read the detailed description
The STRENGTH Pilot Project is a community-based, participatory action pilot study to design and test the acceptability of a women-led, trauma and violence informed model of outreach situated in the Downtown Eastside Neighbourhood of Vancouver, British Columbia.
Many women are underserved within health and social care due to numerous environmental factors affecting their access and receipt of services appropriate to their needs. These challenges are shaped by siloed service delivery, isolation, knowledge gaps about services, and negative encounters in support service settings. Outreach activities can build lasting relationships between support workers and women in ways that enhance quality of life and overall wellbeing, and are not harmful or re-traumatizing. The overall aim of the project is to develop and test the acceptability of a model of outreach that is women-led, strengths-based and trauma and violence informed.
In collaboration with community service experts and women with lived experience and drawing on existing empirical evidence concerning outreach interventions as a means to engage underserved women with health and social care, a preliminary model of outreach was developed to be tested within a pilot, single case study design focusing on acceptability of the intervention and feasibility of outreach to enhance women's access to health and social care. Within the intervention, outreach teams work with women in identifying their goals and needs and in partnership, support them to engage with services and supports to address their health and social care service needs.
In this pilot study, we will be evaluating (a) the acceptability of the outreach intervention; (b) environmental factors affecting acceptability; and (c) the feasibility of the intervention to increase women's engagement with appropriate health and social care services.
Because this project is a pilot study, the key research questions being addressed are:
- How acceptable is the outreach intervention to women experiencing street-involvement?
- What factors act as barriers or facilitators to acceptability?
- How feasible is the outreach intervention to enhance women's access to health and social services?
Research activities designed to answer the above research questions include
- Baseline data collection with women and at 4 month intervals to assess resiliency, quality of life, independence (mastery), safety, and health status;
- Qualitative interviews with women to study acceptability, satisfaction, burden and appropriateness of the intervention;
- Chart review of the plan of care documentation to study feasibility of increased engagement with services and women's retention in the intervention;
- Bi-weekly meetings with outreach workers to identify barriers and facilitators to effective engagement.
- Conditions
- Access to Health Care, Gender-Based Violence, Safety, Access to Social Services, Outreach Intervention
- Being tested
- STRENGTH Outreach Intervention
- Keywords
- pilot study, acceptability study, feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRENGTH Outreach InterventionBehavioural
The STRENGTH outreach intervention is a community-led, strengths-based, and trauma- and violence-informed program to support self-identifying women who experience interpersonal and structural gender-based violence. The outreach intervention aims to support individuals to achieve self-identified priorities.
| Study group | Role | What they receive |
|---|---|---|
| STRENGTH Outreach Intervention | Experimental | Participants enrolled in STRENGTH intervention elements Receives: Behavioral: STRENGTH Outreach Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outreach Team Engagement with Individual Participants
Number of times outreach team met with individual participants
Measured: From enrollment to end of intervention (up to 18 months)
Participants' Access to Consistent Health Care
Measured in a binary survey item assessing participants' access to a consistent health care provider
Measured: From enrollment to end of intervention (up to 18 months)
Participants' Confidence in Engaging with Services
Measured in a survey item (self-rated scale from 0-100%) assessing confidence in accessing services
Measured: From enrollment to end of intervention (up to 18 months)
Secondary outcomes (1)
Acceptability of Outreach Intervention
Measured using a qualitative interview question: "Are you satisfied with what you achieved in this project?"
Measured: At 12 to 15 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start15 Apr 2018
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Access to Health CareStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Inner-City Women's Initiatives Society, Vancouver Foundation
- Responsible party
- Principal investigator, Victoria Bungay, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854770
- Sponsor's protocol ID
- H18-00069
- Other IDs
- H18-00069
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bungay V, Dewar L, Schoening M, Guta A, Leiper W, Jiao S. Co-designing an Outreach Intervention for Women Experiencing Street-Involvement and Gender-Based Violence: Community-Academic Partnerships in Action. Violence Against Women. 2024 Jun;30(8):1760-1782. doi: 10.1177/10778012241233004. Epub 2024 Feb 19.
PubMed 38374653Gagnon M, Jiao S, Kassam S, Dewar L, Tait P, Bungay V. Relational trust in outreach with women experiencing street-involvement in British Columbia, Canada: a qualitative study. BMC Health Serv Res. 2025 Dec 11;26(1):71. doi: 10.1186/s12913-025-13875-3.
PubMed 41382150
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outreach Project: A Study of Women-led, Trauma Informed Outreach to Foster Equity
- ClinicalTrials.gov ID
- NCT06854770
- Acronym / sponsor ID
- H18-00069
- Conditions
- Access to Health Care, Gender-Based Violence, Safety, Access to Social Services, Outreach Intervention
- Keywords
- pilot study, acceptability study, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Inner-City Women's Initiatives Society, Vancouver Foundation
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 3 Mar 2025 (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.
The goal of this pilot study is to identify the core elements of outreach practice necessary to engage with women experiencing street-involvement who are underserved within health and social care settings. The primary research questions are:
- How acceptable is the outreach intervention to women experiencing street-involvement?
- What factors act as barriers or facilitators to acceptability?
- How feasible is the outreach intervention to enhance women's access to health and social services?
Participants will:
- Meet regularly one-on-one with an outreach worker over an 18-month period
- Co-develop (with the outreach worker) a plan, based on the individuals self-identified needs, for connecting with health and social services
- Be invited to complete surveys at the start of their participation, and again every four months. These surveys ask questions about participants' resiliency, quality of life, independence, safety, and health status
- Be invited to participate in a one-on-one interview with a researcher about their experiences in the study.
Detailed description
The STRENGTH Pilot Project is a community-based, participatory action pilot study to design and test the acceptability of a women-led, trauma and violence informed model of outreach situated in the Downtown Eastside Neighbourhood of Vancouver, British Columbia.
Many women are underserved within health and social care due to numerous environmental factors affecting their access and receipt of services appropriate to their needs. These challenges are shaped by siloed service delivery, isolation, knowledge gaps about services, and negative encounters in support service settings. Outreach activities can build lasting relationships between support workers and women in ways that enhance quality of life and overall wellbeing, and are not harmful or re-traumatizing. The overall aim of the project is to develop and test the acceptability of a model of outreach that is women-led, strengths-based and trauma and violence informed.
In collaboration with community service experts and women with lived experience and drawing on existing empirical evidence concerning outreach interventions as a means to engage underserved women with health and social care, a preliminary model of outreach was developed to be tested within a pilot, single case study design focusing on acceptability of the intervention and feasibility of outreach to enhance women's access to health and social care. Within the intervention, outreach teams work with women in identifying their goals and needs and in partnership, support them to engage with services and supports to address their health and social care service needs.
In this pilot study, we will be evaluating (a) the acceptability of the outreach intervention; (b) environmental factors affecting acceptability; and (c) the feasibility of the intervention to increase women's engagement with appropriate health and social care services.
Because this project is a pilot study, the key research questions being addressed are:
- How acceptable is the outreach intervention to women experiencing street-involvement?
- What factors act as barriers or facilitators to acceptability?
- How feasible is the outreach intervention to enhance women's access to health and social services?
Research activities designed to answer the above research questions include
- Baseline data collection with women and at 4 month intervals to assess resiliency, quality of life, independence (mastery), safety, and health status;
- Qualitative interviews with women to study acceptability, satisfaction, burden and appropriateness of the intervention;
- Chart review of the plan of care documentation to study feasibility of increased engagement with services and women's retention in the intervention;
- Bi-weekly meetings with outreach workers to identify barriers and facilitators to effective engagement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STRENGTH Outreach Intervention | Experimental | Behavioral: STRENGTH Outreach InterventionParticipants enrolled in STRENGTH intervention elements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as a woman, therefore the study is trans-inclusive.
- Have some degree of English proficiency in understanding and communication.
- Live or spend most of their time over a 24-hour period in the Downtown Eastside of Vancouver.
- Age 18 or over.
Key exclusion criteria (4 listed)
- Women without any degree of English speaking or comprehension proficiency.
- People who self-identify as men.
- Youth under the age of 18.
- Women who do not spend time regularly in the Downtown Eastside of Vancouver.
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 |
|---|---|---|
| STRENGTH Outreach InterventionThe STRENGTH outreach intervention is a community-led, strengths-based, and trauma- and violence-informed program to support self-identifying women who experience interpersonal and structural gender-based violence. The outreach intervention aims to support individuals to achieve self-identified priorities. | Behavioural | STRENGTH Outreach Intervention |
Primary outcome
Outreach Team Engagement with Individual Participants
Time frame: From enrollment to end of intervention (up to 18 months)
Number of times outreach team met with individual participants
Participants' Access to Consistent Health Care
Time frame: From enrollment to end of intervention (up to 18 months)
Measured in a binary survey item assessing participants' access to a consistent health care provider
Participants' Confidence in Engaging with Services
Time frame: From enrollment to end of intervention (up to 18 months)
Measured in a survey item (self-rated scale from 0-100%) assessing confidence in accessing services
1 secondary outcome
Acceptability of Outreach Intervention
Time frame: At 12 to 15 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Results publication: PubMed 38374653Bungay V, Dewar L, Schoening M, Guta A, Leiper W, Jiao S. Co-designing an Outreach Intervention for Women Experiencing Street-Involvement and Gender-Based Violence: Community-Academic Partnerships in Action. Violence Against Women. 2024 Jun;30(8):1760-1782. doi: 10.1177/10778012241233004. Epub 2024 Feb 19.
- Derived from this study: PubMed 41382150Gagnon M, Jiao S, Kassam S, Dewar L, Tait P, Bungay V. Relational trust in outreach with women experiencing street-involvement in British Columbia, Canada: a qualitative study. BMC Health Serv Res. 2025 Dec 11;26(1):71. doi: 10.1186/s12913-025-13875-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRENGTH Outreach Intervention in people with Access to Health Care and Gender-Based Violence, run by University of British Columbia 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Outreach Team Engagement with Individual Participants (time frame: From enrollment to end of intervention (up to 18 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854770, which also lists 2 linked publications.
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 3 Mar 2025.