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

NCT ID: NCT04212364

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 614 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2023-12-31

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.

Conditions

Overdose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Peer Education

Intervention Type: BEHAVIORAL

In this intervention, people who use opiates will be trained to be peer educators.

Narcan Nasal Product

Intervention Type: DRUG

All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.

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

Group Type: ACTIVE_COMPARATOR

Narcan Nasal Product

Intervention Type: DRUG

All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.

Interventions

Peer Education

In this intervention, people who use opiates will be trained to be peer educators.

Intervention Type: BEHAVIORAL

Narcan Nasal Product

All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.

Intervention Type: DRUG

Other Intervention Names

Experimental arm

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl A. Latkin, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Lighthouse Studies at Peer Point

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

1R01CE003021

Identifier Type: NIH

Identifier Source: org_study_id

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