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

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04212364
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
300
1
2
42.5
7.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Education
  • Drug: Narcan Nasal Product
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Index participants will be randomized into 1 of two study arms.Index participants will be randomized into 1 of two study arms.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
Actual Study Start Date :
Mar 15, 2019
Anticipated Primary Completion Date :
Sep 29, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Peer Education
In this intervention, people who use opiates will be trained to be peer educators.
Other Names:
  • Experimental arm
  • Drug: Narcan Nasal Product
    All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.

    Active Comparator: 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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lighthouse Studies at Peer Point Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins Bloomberg School of Public Health
    • Centers for Disease Control and Prevention

    Investigators

    • Principal Investigator: Carl A. Latkin, PhD, Johns Hopkins Bloomberg School of Public Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins Bloomberg School of Public Health
    ClinicalTrials.gov Identifier:
    NCT04212364
    Other Study ID Numbers:
    • 1R01CE003021
    First Posted:
    Dec 27, 2019
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Johns Hopkins Bloomberg School of Public Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2022