- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06854770
STRENGTH Pilot Project: a Study of a Women-led, Trauma-informed Model of Outreach to Foster Equity
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?
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 2B5
- University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STRENGTH Outreach Intervention
Participants enrolled in STRENGTH intervention elements
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment to end of intervention (up to 18 months)
|
|
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
|
From enrollment to end of intervention (up to 18 months)
|
|
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
|
From enrollment to end of intervention (up to 18 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Outreach Intervention
Time Frame: At 12 to 15 months post-enrollment
|
Measured using a qualitative interview question: "Are you satisfied with what you achieved in this project?"
|
At 12 to 15 months post-enrollment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H18-00069 (Other Identifier: UBC Behavioural Research Ethics Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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