An interventional study of EPIC-P in HIV, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by University of Connecticut · Not applicable, Interventional, and Prevention
This non-randomized, open-label study will address the following research aims in People who inject drugs (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.
University of Connecticut is the lead sponsor of 133 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will enroll in a bio-behavioral intervention aimed at preventing HIV transmission in people who inject drugs.
Other: EPIC-P
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).
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University of Connecticut