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Completed

NCT Number: NCT04193787

EPIC-P Intervention

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Storefront

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EPIC-P

Other

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).

Primary outcomes

  1. Retention Rate

    Time frame: Up to 6 months

    To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.

Secondary outcomes

  1. Acceptability

    Time frame: Up to 6 months

    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.

  2. PrEP Adherence VAS

    Time frame: Up to 6 months

    Adherence to PrEP will be assessed using a visual analog scale (VAS).

  3. PrEP Adherence Pharmacy

    Time frame: Up to 6 months

    Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants.

  4. PrEP Adherence DBS

    Time frame: Up to 6 months

    PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels.

  5. HIV Incidence

    Time frame: Up to 6 months

    HIV incidence will be tracked in participants through testing up to 6 months.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 10, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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