- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924505
Preventing Opioid Overdose Mortality in the United States
Study Overview
Status
Conditions
Detailed Description
The purpose of this study is to understand and improve naloxone implementation within Syringe Service Programs (SSPs) to reduce opioid overdose mortality in the United States. To achieve this goal, we will implement an external facilitation intervention that has been shown to improve implementation in HIV service settings. The intervention will leverage a naloxone implementation expert who will work with SSP organizational directors to identify barriers to and facilitators of achieving naloxone implementation quality and maximizing reach. We propose to assess the effectiveness of external facilitation, compared to dissemination of an implementation manual, in a national sample of SSPs in a randomized controlled trial (RCT). Our proposed specific aims are as follows:
Aim 1: To characterize United States syringe service programs along the exploration, preparation, implementation and sustainment (EPIS) continuum for delivering naloxone.
Aim 2: To test the effectiveness of external facilitation + dissemination of the naloxone implementation manual, compared with dissemination of the naloxone implementation manual alone, to improve the advancement of naloxone along the EPIS continuum among United States syringe service programs.
Hypothesis. The dissemination and external facilitation arm will be more effective in advancing naloxone implementation along the EPIS continuum between baseline and 12-month follow-up, than the dissemination-only arm.
To achieve these aims, 425 SSPs that are registered with the North American Syringe Exchange Network (NASEN) and /or receive information from harm reduction related web-based forums (e.g., online discussion groups, newsletters and listservs)will be asked to participate in an on-line cross-sectional survey and will be sent a hyperlink to the initial screening survey. We will use the on-line survey results to characterize the SSPs along the exploration, preparation, implementation and sustainment (EPIS) continuum for delivering the naloxone intervention (AIM 1).
The on-line survey includes a set of questions designed to collect information to evaluate where the SSP falls along the EPIS continuum for naloxone delivery. SSPs in the Implementation (I) phase of the EPIS continuum (estimated n = 100) will be contacted by research staff and offered the opportunity to participate in the RCT. SSPs that are interested in participating in the RCT will be enrolled in the study. For those SSPs who agree to participate, study staff will confirm eligibility by reviewing and documenting responses to the screening survey.
Following informed consent procedures, the study staff will administer the baseline survey to the SSP representative. The baseline survey will include questions about programmatic capacity, organizational culture, potential for internal champion or leader, perceived need for naloxone distribution within their community, and community acceptance of peer naloxone distribution programming. The study staff will then randomize SSPs into one of the one of the two study arms: (1) dissemination of the implementation manual and external facilitation for 12 months (experimental arm; n=50) and (2) dissemination of the implementation manual only (control arm; n=50).
All SSPs enrolled in the RCT will be sent a copy of the naloxone implementation manual either via email, hyperlink or the U.S. postal service depending on the preference of the participant. Those SSPs in the experimental arm will be enrolled in the EF intervention during which they will work directly with an OC to advance naloxone delivery as far along the EPIS continuum as possible during a 12-month period. The intervention will be delivered via phone calls, web-enabled audio and screen-sharing technology, and site visits. The key activities of the EF intervention include, initial SSP engagement, knowledge enhancement, capacity assessment, information gathering, identification of barriers and facilitators, development of action plans and provision of feedback, identification of funding and linkage to resources, and training of SSP staff.
At the end of the 12-month intervention period, SSPs in both study arms will participate in a follow-up survey, conducted by study staff, to evaluate advancement of naloxone implementation along the EPIS continuum.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barrot Lambdin, PhD, MPH
- Phone Number: 510-665-8254
- Email: blambdin@rti.org
Study Contact Backup
- Name: Lynn Wenger
- Phone Number: 510-665-8219
- Email: lynndee@rti.org
Study Locations
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-
California
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Berkeley, California, United States, 94704
- Recruiting
- RTI International
-
Contact:
- Barrot Lambdin, PhD, MPH
- Phone Number: 510-665-8254
- Email: blambdin@rti.org
-
Contact:
- Lynn D Wenger, MSW, MPH
- Phone Number: 510-665-8219
- Email: lynndee@rti.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- SSPs that participate in the on-line screening survey and fall into the implementation phase of the EPIS continuum will be recruited into the study.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implementation Manual and External Facilitation
This arm will receive the naloxone intervention implementation manual and the External Facilitation (EF) intervention.
The manual provides details for developing, implementing, and managing a naloxone intervention program within different types of organizations that serve people who use opioids, including SSPs.
The EF intervention is a collaborative, organization-centered form of guiding to navigate barriers and leverage facilitators to advance an evidence-based intervention along the EPIS continuum.
Guidance will be conducted by an External Facilitator.
|
Participating organizations will receive the implementation manual and the external facilitation (EF) intervention.
The manual provides instructions for organizations wanting to implement a high quality naloxone program.
The EF will assist syringe service programs to integrate naloxone delivery within their organization.
As part of these efforts, we will use a measurement framework to understand naloxone delivery within SSPs along the four phases of the implementation process-exploration, preparation, implementation and sustainment (EPIS).
|
Active Comparator: Implementation Manual - only
This arm will receive the naloxone intervention implementation manual.
The manual provides details for developing, implementing, and managing a naloxone intervention program within different types of organizations that serve people who use opioids, including SSPs.
|
Participating organizations will receive the implementation manual.The manual provides instructions for organizations wanting to implement a high quality naloxone program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adoption of Best Practices
Time Frame: Baseline
|
Number of Best Practices adopted by the SSP
|
Baseline
|
Adoption of Best Practices
Time Frame: 12 months
|
Number of Best Practices adopted by the SSP
|
12 months
|
Naloxone Coverage
Time Frame: Baseline
|
Number of SSP participants receiving a dose of naloxone
|
Baseline
|
Naloxone Coverage
Time Frame: 12 months
|
Number of SSP participants receiving a dose of naloxone
|
12 months
|
Number of Naloxone Doses Distributed to SSP participants
Time Frame: Baseline
|
Naloxone Dispensed
|
Baseline
|
Number of Naloxone Doses Distributed to SSP participants
Time Frame: 12 months
|
Naloxone Dispensed
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barrot Lambdin, PhD, MPH, RTI International
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- INOD
- 1R01DA046867-01 (U.S. NIH Grant/Contract)
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
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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