Oasis: A Setting Focus Overdose Prevention

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05320835
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 58.8
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

A pilot injection-setting targeted peer-driven intervention to reduce HIV/HCV transmission and overdose risk behaviors among people who inject drugs (PWID).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; HCV; Drug Overdose	Behavioral: HIV, HCV and overdose prevention	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Clinical Trial (RCT)Randomized Clinical Trial (RCT)
• Masking: Single (Participant)
• Masking Description: Equal attention
• Primary Purpose: Health Services Research
• Official Title: A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland
• Actual Study Start Date: Mar 28, 2022
• Anticipated Primary Completion Date: Feb 20, 2026
• Anticipated Study Completion Date: Feb 20, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental behavioral training with 6 sessions	Behavioral: HIV, HCV and overdose prevention; HIV, HCV and overdose prevention
Active Comparator: comparison Attention control	Behavioral: HIV, HCV and overdose prevention; HIV, HCV and overdose prevention

Outcome Measures

Primary Outcome Measures

1. Overdose prevention [6 months]

   Frequency of carrying naloxone

2. HIV/HCV prevention [6 months]

   Frequency of using used cookers

Secondary Outcome Measures

1. Overdose behaviors [6 months]

   Frequency of testing drugs before using

2. Overdose behaviors 2 [6 months]

   Frequency of talking about overdose prevention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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

Investigators

• Principal Investigator: Carl 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: NCT05320835
• Other Study ID Numbers: R01DA050470
• First Posted: Apr 11, 2022
• Last Update Posted: Apr 11, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Drug Overdose

Study Results

No Results Posted as of Apr 11, 2022