A Setting Focus Overdose Prevention Intervention

Study Overview
=================
Brief 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).

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.

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

Conditions
-----------------
HCV, HIV Infections, Drug Overdose

Intervention / Treatment
-----------------
* Behavioral: HIV, HCV and overdose prevention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial (RCT)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>behavioral training with 6 sessions | Behavioral: HIV, HCV and overdose prevention<br>* HIV, HCV and overdose prevention<br>|
| Active Comparator: comparison<br>Attention control | Behavioral: HIV, HCV and overdose prevention<br>* HIV, HCV and overdose prevention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overdose prevention | Frequency of carrying naloxone | 6 months | 
| HIV/HCV prevention | Frequency of using used cookers | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overdose behaviors | Frequency of testing drugs before using | 6 months | 
| Overdose behaviors 2 | Frequency of talking about overdose prevention | 6 months |