Clinical trial NCT04193787: EPIC-P Intervention
Official title: Expanding PrEP Implementation in Communities of People Who Inject Drugs and Their Risk Network Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2019-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention Rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Acceptability
timeFrame: Up to 6 months
measure: PrEP Adherence VAS
timeFrame: Up to 6 months
measure: PrEP Adherence Pharmacy
timeFrame: Up to 6 months
measure: PrEP Adherence DBS
timeFrame: Up to 6 months
measure: HIV Incidence
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Storefront
state: Connecticut
Study officials:
affiliation: Associate Research Scientist, Yale School of Medicine
name: Roman Shrestha, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: