Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Hilary L Surratt, PhD

Status: Completed

Conditions: HIV Prevention

Treatments: Behavioral: SBCM-PrEP; Behavioral: CDC-PrEP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05037513

R34DA053140 (U.S. NIH Grant/Contract)

67933

Details and patient eligibility

About

The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the intervention comparators (SBCM-PrEP) and (Centers for Disease Control (CDC)-PrEP). Within this context, the Specific Aims are to: 1) Assess client, provider, organization, and structural-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine syringe service program (SSP) practice; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for people who inject drugs (PWID) in SSP sites; and, 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM-PrEP. 80 participants will be randomized into: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines) or SBCM-PrEP.

Enrollment: 80 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older;
• HIV-negative status;
• Past month drug injection;
• Client of SSP in targeted sites

Exclusion criteria

• HIV-positive status

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

CDC-PrEP

Active Comparator group

Description:

1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting

Treatment:

Behavioral: CDC-PrEP

SBCM-PrEP

Experimental group

Description:

Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting

Treatment:

Behavioral: SBCM-PrEP