Clinical trial NCT05037513: Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
Official title: Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Initiating PrEP
timeFrame: 3 months post-baseline
measure: Number of Participants Initiating PrEP
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: Level of Intervention Engagement Assessed by Session Checklist
timeFrame: 8 weeks post-baseline
measure: Level of Intervention Satisfaction Assessed by the IAQ
timeFrame: 8 weeks post-baseline
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Hilary L Surratt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Surratt 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.
citation: Surratt 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.