An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses

The purpose of this study is to pilot and implement a peer mentor intervention focused on overdose prevention and care.

The intervention consists of 3 sessions. During the first and second session, each participant will meet individually with a trained staff member. In the 3rd session, the participant will invite a social network member to attend the session, and these 2 participants will meet with a trained staff member.

Study Overview

Status

Completed

Conditions

Detailed Description

The specific aims of the study are:

  1. Conduct a pilot of an HIV/HCV/overdose prevention and care intervention for people who use opiates.
  2. Evaluate the feasibility of collecting donated drug preparation containers (i.e., cookers) to assess the presence of fentanyl, HCV, and HIV.
  3. Conduct a randomized controlled trial to assess efficacy of the experimental Peer Mentor condition on (a) overdose prevention and care education to drug network members, (b) naloxone availability, and (c) drug treatment readiness and entry.

There are two types of participants: Index participants and network participants. Both type of participant will currently used opiates. Participants will take part in a baseline visit and up to 3 follow-up visits. Index participants will be randomized into the intervention or control arm of the study.

Study Type

Interventional

Enrollment (Actual)

614

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Melissa A Davey-Rothwell, PhD
  • Phone Number: 410-502-5368
  • Email: mdavey1@jhu.edu

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Lighthouse Studies at Peer Point

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Index participants:

  • self-reported use of opiates including heroin, fentanyl, or prescription opiates to get high at least 2 times in the last two weeks;
  • willing to invite a network member who uses drugs to the study;
  • ages 18-years or older;
  • living in the Baltimore metropolitan region, and
  • not previously enrolled in the study or currently enrolled in another Lighthouse study.

Inclusion Criteria for network participants:

  • self-reported use of illicit injecting or non-injecting opiates at least 2 times in the last two weeks;
  • sees the Index participant 2 or more times in the past week;
  • ages 18 years or older; and
  • living in the Baltimore metropolitan region.

Exclusion Criteria:

  • Index participants may not take part in the study as a Network participant.
  • Network participants may not take part in the study as an Index participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Peer Education
  • During Session 1, participants will be trained in Peer Education and how to use Nasal Narcan. They will be given two Nasal Narcan kit that includes 2 doses. One kit if for their use and one kit is to give someone in their social network after they have trained them in how to use it.
  • A week after Session 1, participants will be scheduled for Session 2.
  • During session 1 and 2 participants, Index participants will be taught information and skills pertaining to overdose prevention and response and how to train network members in overdose prevention and response.
  • At the 2nd session, index participants will be given 1 coupon to give to 1 member from their social network to attend Session 3.
  • Session 3 will be a dyad session where Index participants will use their peer mentors' skills to train their network member in overdose prevention and response.
  • Index participants will also be invited to up to 3 Booster Session (monthly) after they complete Sessions 1-3.
In this intervention, people who use opiates will be trained to be peer educators.
Other Names:
  • Experimental arm
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.
Active Comparator: Standard of care
  • Participants randomized to this condition will participate in one 1-hour session. This session will be an individual session where the participant will meet with a trained staff member in a private room at the Lighthouse.
  • This session will be standard overdose prevention and response information. Participants will also be trained in Narcan administration. Participants will be given 1 nasal Narcan kit.
  • At the end of this session, participants will be asked to refer a network member to the study for survey visits
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Network Enrollment
Time Frame: 6 months
The question will be: How many people in their social network did Index participants recruit to the study? Participants provide a number of 0 or higher.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug treatment entry
Time Frame: 12 months
The question will be: In the past 12 months, did you enroll in a drug treatment program including a medically assisted treatment program? The response options are yes and no.
12 months
Overdose Risk
Time Frame: 12 months
Change in risk will be measured by a score that includes frequency of naloxone availability when using opiates, testing drugs before injecting, and drug use alone. Higher scores will indicate increased overdose risk. Scores will be measured from 0-9
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carl A. Latkin, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

December 29, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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