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

Not Applicable

Completed

• Conditions: Overdose
• Interventions: Behavioral: Peer Education; Drug: Narcan Nasal Product

• Registration Number: NCT04212364
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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:

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 Timeline

• Study Start: 2019-03-15
• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-27
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Education	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.
Peer Education	Narcan Nasal Product	* 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.
Standard of care	Narcan Nasal Product	* 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

Primary Outcome Measures

Name	Time	Method
Network Enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Drug treatment entry	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.
Overdose Risk	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

Trial Locations

Locations (1)

Lighthouse Studies at Peer Point; 🇺🇸 Baltimore, Maryland, United States