Clinical trial NCT04212364: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overdose
Keywords: peer education
social networks
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2019-12-27
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Index participants will be randomized into 1 of two study arms.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Network Enrollment
timeFrame: 6 months
Secondary outcomes:
measure: Drug treatment entry
timeFrame: 12 months
measure: Overdose Risk
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Lighthouse Studies at Peer Point
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Carl A. Latkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: