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.
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
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).
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New Haven, Connecticut, United States
Retention Rate
To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
PrEP Adherence VAS
Adherence to PrEP will be assessed using a visual analog scale (VAS).
Time frame: Up to 6 months
PrEP Adherence Pharmacy
Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants.
Time frame: Up to 6 months
PrEP Adherence DBS
PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels.
Time frame: Up to 6 months
HIV Incidence
HIV incidence will be tracked in participants through testing up to 6 months.
Time frame: Up to 6 months
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