- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05320835
- Original Trial
A Setting Focus Overdose Prevention Intervention (Oasis)
A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carl Latkin, PhD
- Phone Number: 410-955-3972
- Email: carl.latkin@jhu.edu
Study Contact Backup
- Name: Lauren Dayton, PhD
- Phone Number: 4105025368
- Email: ldayton2@jhu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Recruiting
- Lighthouse Studies at Peer Point
-
Contact:
- Carl Latkin, PhD
- Phone Number: 410-502-5368
- Email: carl.latkin@jhu.edu
-
Contact:
- Melissa Davey-Rothwell, PhD
- Phone Number: 410-614-5854
- Email: mdavey1@jhu.edu
-
Principal Investigator:
- Carl Latkin, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
behavioral training with 6 sessions
|
HIV, HCV and overdose prevention
|
|
Active Comparator: comparison
Attention control
|
HIV, HCV and overdose prevention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overdose prevention
Time Frame: 6 months
|
Frequency of carrying naloxone
|
6 months
|
|
HIV/HCV prevention
Time Frame: 6 months
|
Frequency of using used cookers
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overdose behaviors
Time Frame: 6 months
|
Frequency of testing drugs before using
|
6 months
|
|
Overdose behaviors 2
Time Frame: 6 months
|
Frequency of talking about overdose prevention
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carl Latkin, PhD, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Drug Misuse
- Mental Disorders
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Substance-Related Disorders
- Chemically-Induced Disorders
- Prescription Drug Misuse
- HIV Infections
- Drug Overdose
- Immune System Phenomena
- Seroconversion
Other Study ID Numbers
- R01DA050470 (U.S. NIH Grant/Contract)
- IRB00019139 (Other Identifier: JHSPH IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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