Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
2 other identifiers
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
September 8, 2021
CompletedStudy Start
First participant enrolled
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2024
CompletedResults Posted
Study results publicly available
March 20, 2025
CompletedMarch 20, 2025
March 1, 2025
2.6 years
August 5, 2021
March 4, 2025
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Level of Intervention Engagement Assessed by Session Checklist
8 weeks post-baseline
Level of Intervention Satisfaction Assessed by the IAQ
8 weeks post-baseline
Study Arms (2)
CDC-PrEP
ACTIVE COMPARATOR1 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
SBCM-PrEP
EXPERIMENTALMulti-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
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years or older;
- HIV-negative status;
- Past month drug injection;
- Client of SSP in targeted sites
You may not qualify if:
- HIV-positive status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hilary L Surratt, PhDlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
Related Publications (3)
Surratt HL, Yeager HJ, Adu A, Gonzalez EA, Nelson EO, Walker T. Pre-Exposure Prophylaxis Barriers, Facilitators and Unmet Need Among Rural People Who Inject Drugs: A Qualitative Examination of Syringe Service Program Client Perspectives. Front Psychiatry. 2022 May 30;13:905314. doi: 10.3389/fpsyt.2022.905314. eCollection 2022.
PMID: 35706473RESULTSurratt HL, Brown S, Burton AL, Cranford W, Green C, Mersch SM, Rains R, Westgate PM. Examining HIV pre-exposure prophylaxis (PrEP) acceptability among rural people who inject drugs: predictors of PrEP interest among syringe service program clients. AIDS Care. 2024 Dec;36(12):1858-1868. doi: 10.1080/09540121.2024.2390067. Epub 2024 Aug 13.
PMID: 39137923RESULTSurratt HL, Brown S, Burton AL, Cranford W, Fanucchi LC, Green C, Mersch SM, Rains R, Westgate PM. Outcomes of a pilot randomized clinical trial testing brief interventions to increase HIV pre-exposure prophylaxis uptake among rural people who inject drugs attending syringe services programs. Ther Adv Infect Dis. 2025 Jan 29;12:20499361251314766. doi: 10.1177/20499361251314766. eCollection 2025 Jan-Dec.
PMID: 39886694RESULT
Limitations and Caveats
Small sample size on the pilot was not sufficiently powered to determine efficacy, however, percent difference and effect size estimates were determined as intended.
Results Point of Contact
- Title
- Dr. Hilary Surratt
- Organization
- University of Kentucky
Study Officials
- PRINCIPAL INVESTIGATOR
Hilary L Surratt, PhD
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 5, 2021
First Posted
September 8, 2021
Study Start
September 16, 2021
Primary Completion
April 9, 2024
Study Completion
April 9, 2024
Last Updated
March 20, 2025
Results First Posted
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share