Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Study Overview
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Brief Summary
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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.

Official Title
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Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: SBCM-PrEP
* Behavioral: CDC-PrEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CDC-PrEP<br>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 | Behavioral: CDC-PrEP<br>* 1 session PrEP education following CDC guidelines<br>|
| Experimental: SBCM-PrEP<br>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 | Behavioral: SBCM-PrEP<br>* Multi-session SBCM intervention adapted for PrEP initiation focus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants initiating PrEP | Documented PrEP initiation, measured by dispensed PrEP prescription. | 3 months post-baseline | 
| Number of participants initiating PrEP | Documented PrEP initiation, measured by dispensed PrEP prescription. | 6 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Intervention Engagement assessed by session checklist | 5 item Session Checklist completed by Nurse-Interventionist post-session; range is 0-15, higher scores are higher engagement | 8 weeks post-baseline | 
| Level of Intervention Satisfaction assessed by the IAQ | 8 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 0-32, higher scores are higher satisfaction | 8 weeks post-baseline |