EPIC-P Intervention

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193787
• Other study ID #: E20-0594
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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).

Locations

Country	Name	City	State
United States	Storefront	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate	To determine feasibility, the rate of enrolled participants that are retained through the study will be assessed.	Up to 6 months
Secondary	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
Secondary	PrEP Adherence VAS	Adherence to PrEP will be assessed using a visual analog scale (VAS).	Up to 6 months
Secondary	PrEP Adherence Pharmacy	Adherence to PrEP will be assessed by monitoring the pharmacy refills of participants.	Up to 6 months
Secondary	PrEP Adherence DBS	PrEP Adherence will be objectively assessed using dried blood spot (DBS) testing for tenofovir levels.	Up to 6 months
Secondary	HIV Incidence	HIV incidence will be tracked in participants through testing up to 6 months.	Up to 6 months