EPIC-P Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Other: EPIC-P


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |