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Recruiting NCT05320835

A Setting Focus Overdose Prevention Intervention

No phase Interventional HIV Infections HCV Drug Overdose

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HIV, HCV and overdose prevention.
Who it may be relevant to
Registry conditions: HIV Infections, HCV, Drug Overdose. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland

Overview

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.

Interventions

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

Primary outcome measures

  • Overdose prevention [Time frame: 6 months]
  • HIV/HCV prevention [Time frame: 6 months]
Secondary outcome measures (2)
  • Overdose behaviors [Time frame: 6 months]
  • Overdose behaviors 2 [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • Lighthouse Studies at Peer Point — Baltimore

Identifiers

NCT: NCT05320835 · R01DA050470 · IRB00019139 · R01DA050470

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗