A Setting Focus Overdose Prevention Intervention

NCT ID: NCT05320835

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2027-05-30

Brief Summary

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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

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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.

Conditions

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HIV Infections HCV Drug Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial (RCT)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Equal attention

Study Groups

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Experimental

behavioral training with 6 sessions

Group Type EXPERIMENTAL

HIV, HCV and overdose prevention

Intervention Type BEHAVIORAL

HIV, HCV and overdose prevention

comparison

Attention control

Group Type ACTIVE_COMPARATOR

HIV, HCV and overdose prevention

Intervention Type BEHAVIORAL

HIV, HCV and overdose prevention

Interventions

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HIV, HCV and overdose prevention

HIV, HCV and overdose prevention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Latkin, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Lighthouse Studies at Peer Point

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carl Latkin, PhD

Role: CONTACT

410-955-3972

Lauren Dayton, PhD

Role: CONTACT

4105025368

Facility Contacts

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Carl Latkin, PhD

Role: primary

410-502-5368

Melissa Davey-Rothwell, PhD

Role: backup

410-614-5854

Other Identifiers

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IRB00019139

Identifier Type: OTHER

Identifier Source: secondary_id

R01DA050470

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA050470

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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