EPIC-P Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: EPIC-P

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Storefront

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Residing in the Greater New Haven area;
• Confirmed HIV-negative;
• Reporting injection drug use (past 3 months) with substantial ongoing risk for HIV acquisition;
• Started on PrEP (within the last week).

Exclusion Criteria:

• Not on PrEP;
• Not available during the full duration of the study;
• Cannot speak English;
• Unable to provide consent;
• Anyone actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a consultant that is a licensed clinical psychologist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPIC-P; Participants will enroll in a bio-behavioral intervention aimed at preventing HIV transmission in people who inject drugs.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention Rate	To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	The acceptability will be assessed using a series of eight items acceptability rating profile. We will use a 5-point Likert scale (0= strongly disagree to 4= strongly agree) to rate the extend to which they agreed with each acceptability statement. A mean intervention acceptability score will be calculated with higher values indicating greater acceptability.	Up to 6 months
PrEP Adherence VAS	Adherence to PrEP will be assessed using a visual analog scale (VAS).	Up to 6 months
PrEP Adherence Pharmacy	Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants.	Up to 6 months
PrEP Adherence DBS	PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels.	Up to 6 months
HIV Incidence	HIV incidence will be tracked in participants through testing up to 6 months.	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Roman Shrestha, PhD, MPH, Associate Research Scientist, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: E20-0594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No