EPIC-P Intervention
- Conditions
- HIV
- Interventions
- Other: EPIC-P
- Registration Number
- NCT04193787
- Lead Sponsor
- University of Connecticut
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EPIC-P EPIC-P Participants will enroll in a bio-behavioral intervention aimed at preventing HIV transmission in people who inject drugs.
- Primary Outcome Measures
Name Time Method Retention Rate Up to 6 months To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.
- Secondary Outcome Measures
Name Time Method PrEP Adherence VAS Up to 6 months Adherence to PrEP will be assessed using a visual analog scale (VAS).
PrEP Adherence DBS Up to 6 months PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels.
PrEP Adherence Pharmacy Up to 6 months Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants.
Acceptability 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.
HIV Incidence Up to 6 months HIV incidence will be tracked in participants through testing up to 6 months.
Trial Locations
- Locations (1)
Storefront
🇺🇸New Haven, Connecticut, United States