A Setting Focus Overdose Prevention Intervention

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320835
• Other study ID #: R01DA050470
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: September 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Carl Latkin, PhD
• Phone: 410-955-3972
• Email: carl.latkin[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: January 31, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• HCV
• HIV Infections

Intervention

Behavioral:
• HIV, HCV and overdose prevention
HIV, HCV and overdose prevention

Locations

Country	Name	City	State
United States	Lighthouse Studies at Peer Point	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overdose prevention	Frequency of carrying naloxone	6 months
Primary	HIV/HCV prevention	Frequency of using used cookers	6 months
Secondary	Overdose behaviors	Frequency of testing drugs before using	6 months
Secondary	Overdose behaviors 2	Frequency of talking about overdose prevention	6 months