A Setting Focus Overdose Prevention Intervention (Oasis)
Primary Purpose
HIV Infections, HCV, Drug Overdose
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV, HCV and overdose prevention
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Current drug user (opioid use in the prior two weeks)
Exclusion Criteria:
- Any mental or physical health impairment that impedes ability to participate
Sites / Locations
- Lighthouse Studies at Peer PointRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
comparison
Arm Description
behavioral training with 6 sessions
Attention control
Outcomes
Primary Outcome Measures
Overdose prevention
Frequency of carrying naloxone
HIV/HCV prevention
Frequency of using used cookers
Secondary Outcome Measures
Overdose behaviors
Frequency of testing drugs before using
Overdose behaviors 2
Frequency of talking about overdose prevention
Full Information
NCT ID
NCT05320835
First Posted
March 30, 2022
Last Updated
September 28, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05320835
Brief Title
A Setting Focus Overdose Prevention Intervention
Acronym
Oasis
Official Title
A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).
Detailed Description
This is a pilot of an injection setting targeted peer-driven intervention to reduce HIV/HCV transmission and overdose risk behaviors. Participants will be randomized to conditions: 1) Peer education and stocking of semi-public injection settings (SPIS) with risk reduction materials, and the standard of care. Based on their SPIS use, 120 index PWID participants will be selected.
A conceptual model for the intervention: The conceptual model is based on social influence, social network, and social cognitive theory. The prior work delineated social influence mechanisms. It is expected that training and modeling of effective communication skills will increase the occurrence of conversations on HIV/HCV and overdose prevention. These conversations will then alter perceived descriptive and prescriptive social norms of risk behaviors. The prior work is being enhanced by increasing the availability of risk reduction materials as well as the cuing and modeling risk reduction behaviors in risk settings. It has been found that PWID are motivated to conduct peer education; it enhances their status and provides them a prosocial role in the community. It is hypothesized that peer outreach and supply of materials to SPIS will lead to reduced sharing of injection equipment and increased naloxone availability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HCV, Drug Overdose
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial (RCT)
Masking
Participant
Masking Description
Equal attention
Allocation
Randomized
Enrollment
285 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
behavioral training with 6 sessions
Arm Title
comparison
Arm Type
Active Comparator
Arm Description
Attention control
Intervention Type
Behavioral
Intervention Name(s)
HIV, HCV and overdose prevention
Intervention Description
HIV, HCV and overdose prevention
Primary Outcome Measure Information:
Title
Overdose prevention
Description
Frequency of carrying naloxone
Time Frame
6 months
Title
HIV/HCV prevention
Description
Frequency of using used cookers
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overdose behaviors
Description
Frequency of testing drugs before using
Time Frame
6 months
Title
Overdose behaviors 2
Description
Frequency of talking about overdose prevention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current drug user (opioid use in the prior two weeks)
Exclusion Criteria:
Any mental or physical health impairment that impedes ability to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Latkin, PhD
Phone
410-955-3972
Email
carl.latkin@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Dayton, PhD
Phone
4105025368
Email
ldayton2@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Latkin, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lighthouse Studies at Peer Point
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Latkin, PhD
Phone
410-502-5368
Email
carl.latkin@jhu.edu
First Name & Middle Initial & Last Name & Degree
Melissa Davey-Rothwell, PhD
Phone
410-614-5854
Email
mdavey1@jhu.edu
First Name & Middle Initial & Last Name & Degree
Carl Latkin, PhD
12. IPD Sharing Statement
Learn more about this trial
A Setting Focus Overdose Prevention Intervention
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