Back to resultsAn Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
Primary Purpose
Overdose
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Education
Narcan Nasal Product
Sponsored by
About this trial
This is an interventional prevention trial for Overdose focused on measuring peer education, social networks
Eligibility Criteria
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.
Sites / Locations
- Lighthouse Studies at Peer PointRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peer Education
Standard of care
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Network Enrollment
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.
Secondary Outcome Measures
Drug treatment entry
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.
Overdose Risk
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
Full Information
NCT ID
NCT04212364
First Posted
August 27, 2019
Last Updated
September 28, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04212364
Brief Title
An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
Official Title
An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The specific aims of the study are:
Conduct a pilot of an HIV/HCV/overdose prevention and care intervention for people who use opiates.
Evaluate the feasibility of collecting donated drug preparation containers (i.e., cookers) to assess the presence of fentanyl, HCV, and HIV.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overdose
Keywords
peer education, social networks
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Index participants will be randomized into 1 of two study arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peer Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Peer Education
Other Intervention Name(s)
Experimental arm
Intervention Description
In this intervention, people who use opiates will be trained to be peer educators.
Intervention Type
Drug
Intervention Name(s)
Narcan Nasal Product
Intervention Description
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.
Primary Outcome Measure Information:
Title
Network Enrollment
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Drug treatment entry
Description
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.
Time Frame
12 months
Title
Overdose Risk
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl A. Latkin, PhD
Phone
4109553972
Email
carl.latkin@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa A Davey-Rothwell, PhD
Phone
410-502-5368
Email
mdavey1@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl A. Latkin, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lighthouse Studies at Peer Point
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Latkin, PhD
Phone
410-502-5368
Email
carl.latkin@jhu.edu
First Name & Middle Initial & Last Name & Degree
Melissa Davey-Rothwell, PhD
Phone
410-614-5854
Email
mdavey1@jhu.edu
First Name & Middle Initial & Last Name & Degree
Carl Latkin, PhD
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
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