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OpenTrials
Completed

NCT Number: NCT03924505

Preventing Opioid Overdose Mortality in the United States

This study aims to conduct a randomized controlled trial of 105 syringe services programs (SSPs) throughout the United States to understand the effectiveness of a multifaceted, facilitation-based strategy at advancing naloxone implementation effectiveness within SSPs. Together, these efforts can improve access to naloxone for people at high risk of overdose, thereby improving our nation's response to the opioid overdose epidemic.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RTI International

Berkeley, California, 94704, United States

About this study

We conducted a randomized controlled trial of SSPs throughout the United States (US) and US Territories. Prior to the trial, 342 SSPs were known to be operating throughout the US and US Territories. Our team launched a national survey of syringe services programs (NSSSP) in February 2019 of all known SSPs operating throughout the United States and its Territories, receiving a response from 263 (77%) SSPs. Among the responding SSPs, 94% were implementing overdose education and naloxone distribution (OEND), and a total of 105 of SSPs implementing OEND were recruited into the trial. SSPs were randomized in a 1-to-1 fashion to either receive the OEND best practice recommendations (comparison SSPs) or the OEND best practice recommendations along with facilitation-based implementation strategies as detailed below (intervention SSPs).

We tested the effectiveness of a multifaceted, facilitation-based strategy at advancing OEND implementation effectiveness within SSPs. Implementation effectiveness is 'an organization-level construct that refers to the aggregated consistency, quality, and appropriateness of innovation use (OEND) within an organization (SSP).'

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

To be eligible, an organization must have: 1) met the definition of an SSP - an organization whose primary function is to distribute drug use supplies to participants to reduce harms associated with drug use, 2) implemented OEND for a minimum of 6 months, and 3) completed the national survey of syringe services programs fielded February-July 2019. We excluded organizations such as fire departments or emergency departments of hospitals that offered supply distribution since it would be an ancillary function of these organizations and OEND programs that were not part of a syringe services program.

Treatment and study plan

Organize and Mobilize for Implementation Effectiveness

Other

Our trial is trying to understand how a multi-faceted, facilitation-based implementation strategy advances effective implementation of naloxone within syringe services programs

Dissemination

Other

Our comparison group receives dissemination of best practice recommendations for naloxone implementation.

Primary outcomes

  1. Naloxone Coverage (Consistency)

    Time frame: 3 months

    Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants

  2. Naloxone Doses Distributed (Consistency)

    Time frame: 3 months

    The mean number of naloxone doses distributed per total number of SSP participants

  3. Best Practice Adoption (Implementation Quality)

    Time frame: 12 months

    The mean number of best practices adopted by the SSP

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2019
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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