Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

HIV Prevention Clinical Trial

Official title:

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05037513
• Other study ID #: 67933
• Secondary ID: R34DA053140
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Behavioral:
• SBCM-PrEP
Multi-session SBCM intervention adapted for PrEP initiation focus
• CDC-PrEP
1 session PrEP education following CDC guidelines

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Hilary L Surratt, PhD	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants initiating PrEP	Documented PrEP initiation, measured by dispensed PrEP prescription.	3 months post-baseline
Primary	Number of participants initiating PrEP	Documented PrEP initiation, measured by dispensed PrEP prescription.	6 months post-baseline
Secondary	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
Secondary	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