EPIC-P Intervention

HIV Clinical Trial

Official title: Expanding PrEP Implementation in Communities of People Who Inject Drugs and Their Risk Network Members

Status Completed

Clinical Trial Summary

This non-randomized, open-label study will address the following research aims in People who inject drugs (PWID):

• To assess the feasibility and acceptability of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk PWID.

• To determine the preliminary efficacy of the EPIC-P intervention in terms of increasing adherence to PrEP and primary HIV prevention among high-risk PWID.

Clinical Trial Description

A non-randomized, open-label design will be utilized to test the feasibility, acceptability, and preliminary efficacy of the Expanding PrEP Implementation in Communities of PWID (EPIC-P) intervention among high-risk people who inject drugs (PWID) with opioid dependence (N=100). Since the aim of this pilot study is to establish whether the EPIC-P intervention is feasible/acceptable among at-risk PWID in a community-based setting, proposed is a non-comparative design. With the hopes to target PWID who are not linked with existing harm reduction services, proposed is to recruit participants using respondent driven sampling (RDS), a chain referral method with demonstrated success in recruiting hard-to-reach populations. Initial RDS participants, called "seeds," will be carefully recruited from the community where the study team leadership have built a well-established relationship. Participants enrolled in the study will be assessed at baseline and will be followed for 9 months (with follow-up assessments at 3- and 6-months) by trained research assistants. Importantly, structured interviews will be conducted at follow-up visits to examine the barriers and facilitators and feedback about optimal implementation of the EPIC-P intervention. ;

Related Conditions & MeSH terms

• HIV

• NCT number: NCT04193787
• Study type: Interventional
• Source: University of Connecticut
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Completion date: April 1, 2023