NCT04193787

EPIC-P Intervention

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Connecticut · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV

Interventions

Type	Name	Description
OTHER	EPIC-P	EPIC-P is a brief, bio-behavioral intervention based on the information-motivation-behavioral skills (IMB) model framework, which integrates i) a biomedical component (i.e., PrEP), ii) behavioral components (i.e., drug- and sex-related primary HIV prevention), and iii) mHealth technology (i.e., text messaging PrEP reminders).

Timeline

• Start date: 2020-09-15
• Primary completion: 2023-04-01
• Completion: 2024-09-01
• First posted: 2019-12-10
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States