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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04212364
Enrollment
614
Registered
2019-12-27
Start date
2019-03-15
Completion date
2023-12-31
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overdose

Keywords

peer education, social networks

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.

Interventions

BEHAVIORALPeer Education

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

DRUGNarcan Nasal Product

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

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Index participants will be randomized into 1 of two study arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Network Enrollment6 monthsThe 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

MeasureTime frameDescription
Drug treatment entry12 monthsThe 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 Risk12 monthsChange 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026