EPIC-P Intervention
Expanding PrEP Implementation in Communities of People Who Inject Drugs and Their Risk Network Members
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Sep 2020
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedFebruary 3, 2025
January 1, 2025
2.5 years
December 6, 2019
January 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Retention Rate
To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.
Up to 6 months
Secondary Outcomes (5)
Acceptability
Up to 6 months
PrEP Adherence VAS
Up to 6 months
PrEP Adherence Pharmacy
Up to 6 months
PrEP Adherence DBS
Up to 6 months
HIV Incidence
Up to 6 months
Study Arms (1)
EPIC-P
EXPERIMENTALParticipants will enroll in a bio-behavioral intervention aimed at preventing HIV transmission in people who inject drugs.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Connecticutlead
- Gilead Sciencescollaborator
Study Sites (1)
Storefront
New Haven, Connecticut, 06519, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Shrestha, PhD, MPH
Associate Research Scientist, Yale School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 10, 2019
Study Start
September 15, 2020
Primary Completion
April 1, 2023
Study Completion
September 1, 2024
Last Updated
February 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share